Hoe het begon in Amerika rond 1990…

In Amerika ontstond er veel onrust nadat problemen rond siliconen borstimplantaten steeds meer in de media kwamen. Met name de rechtszaken hierover verschenen in de media.  De  vrouwen hadden geen andere keus dan naar de rechter te stappen.  Artsen die de link met siliconen borstimplantaten legden werden uitgemaakt voor junk-wetenschappers.

De plastisch chirurgen geloofden heilig in de veiligheid van de implantaten. Jarenlang waren ze al op de markt, maar er was nog nooit lange termijn onderzoek gedaan en daar kwam door strengere regelgeving verandering in. De FDA had de fabrikanten gevraagd om lange termijn onderzoeken. Deze lange termijnonderzoeken ontbraken. Er volgde een vrijwillig moratorium.

Het onderstaande filmpje (A) uit 1991 werd gemaakt tijdens het (nog) vrijwillig van de markt halen van de siliconen borstimplantaten in Amerika. Het betreft een discussie tussen een plastisch chirurg en een advocaat vlak voordat bekend werd dat fabrikanten onderzoeken achtergehouden hadden. Dit werd nog eens bevestigd door de uitspraken van David Kessler in filmpje (B).

(A) Fragment  duurt 13:22 minuten. (Er zit een pauze in van 6:44 tot 7:24  deze kan vooruitgespoeld worden).

https://charlierose.com/video/player/9428

David Kessler voormalig FDA commissioner had vernomen  dat er fraude gepleegd was door de fabrikant van medische siliconen. Via een ‘court order’ moest hij de geheime documenten zien te krijgen die aantoonden dat de fabrikant fraude had gepleegd, tot die tijd mocht hij er niet over praten. 

Zie onderstaand stukje uit de SUNSHINE IN LITIGATION ACT OF 2011

(B) Fragment duur ongeveer 3 minuten.👇 

Deze geheime  interne documenten  zijn begin 1992 vrijgegeven.

In Nederland is er niets mee gedaan. Hier ging de verkoop en plaatsing van borstimplantaten gewoon door.

De interne documenten

Excerpts From: DOW DOCUMENTS

Document #1
00/00/00
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCEOUS DESREGARD

“Internal Audit and Corrective Action Plan” prepared by Dow Corning of its Toxicology Laboratory. The audit uncovered four studies in which a former Dow Corning employee (Mark Bejarano) created false data and violated Good Laboratory Practices (GLP). The studies which were falsified are a lifetime breast implant gel study in rats, a biodurability study of elastomer in orthopedic devices, a breast implant elastomer study.

The falsification involved the technician, Bejarano. who created multiple slides from a single animal and labeled them as though they had come from different animals. The report states, “It has been acknowledged by Mr. Bejarano that he: did create multiple slides, made a mistake, acted on his own, acted contrary to his Dow Corning training, and did not tell his supervisor or anyone else what he had done.” (p.4 or Temporary Dow Corning Bates Number 411) Dow Corning claims that none of the four studies were published or relied on for data on the safety of breast implants, that an outside audit will also be done, and that Dow Corning will examine its operating procedures for the toxicology laboratory to make sure it complies with applicable regulatory requirements.

Appendix A is a list of studies in Dow Corning’s PMAA master file and a list of studies in Dow Corning Corporation’s blue book. Appendix B is a list of studies containing duplicate slides created by Mark Bejarano. Appendix C is qualifications of the consultant.

CITE: DCC 411000406 – 411000525, Exhibit 25 to Zimmer Deposition; Exhibit 4 to Bejarano Deposition; Exhibit 5 to Bey Deposition; Exhibit 35 to McKennon Deposition.

Document #2
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled “Organosilicone Anticholesterol Agents” The intent of this experiment is to isolate organosilicon compounds capable of lowering total serum cholesterol in several species and of ameliorating atheromata in rabbits. Data collected coincidental to other experiments have indicated a number of organosilicon compounds that can lower serum cholesterol, triglycerides, and/or phospholipids in normally fed mice and rats. Dimethylpolysiloxanes can ameliorate atheromata in rabbits.

CITE: DCC 16001089 – 16001091, Exhibit to Bennett Deposition.

Document #3
00/00/00
ACKNOWLEDGEMTN OF NEED FOR TESTING
COHESIVENESS-LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Research Project Description entitled “Metabolism Of Organosilicone Compounds.” The intent is to study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the basis of silicon chemistry as exploited by Dow Corning. There have been no systematic explorations of the metabolism of these classes of organosilicon compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications, and in defining the environmental impact of all present and future products.

CITE: DCC 16001081 – 16001083, Exhibit to Bennett Deposition, and Exhibit to Isquith Deposition.

Document #4
00/00/00
est. 1970
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Draft of the “Proposed Agreement For Cooperative Research Program between Dow Corning and Lepetit Pharmaceutical Company to research the use of silicone compounds in biological systems. “These silicon chemicals

will likely be used systemically rather than locally, and their utility in biological systems. “These silicon chemicals will likely be used systemically rather than locally, and their utility in biological systems may dependent more upon their chemical, rather than their physical properties. (p.1)

The proposal notes that Dow Corning has acquired information that certain silicones are biologically active and has instituted a Biomedical Research Laboratory in July 1965 “to probe the potential utility of such silicon chemicals across the broad disciplines of biology, i.e., plant sciences, microbiology and animal science.” (p. 2) Dow Corning Does have the capability to conduct research on silicons in the pharmaceutical areas while Lepetit “has been engaged

in s specific endocrine cooperative research program with DC for a period of two years.” (p. 3) The proposal states that the parties would cooperate to develop new silicon chemicals as drugs including silicones with activity as androgen depression, central nervous system depression, antimicrobial activity, etc. (pp. 3-4). Additionally, Dow Corning and Lepetit personnel will exchange research and information and will travel to the other’s facilities.

CITE: DCC 2801011379 – 281010391, Exhibit to Bennett Deposition (also used as Exhibit 65 by Dow Corning), Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Isquith Deposition, Exhibit to LeBeau Deposition, Exhibit to Petraitis Deposition, Exhibit to Rowe Deposition, Exhibit 17 to Popoff Deposition, Exhibit to Julius Johnson Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 455-457). DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #5
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Script of an internal Dow Corning seminar presented by Dr. Isquith, and Tony Bennett and Pat Walters on the subject of microbiology. Isquith states that, “Our (Biomedical Research) primary function is to investigate the microbiology of organosilicon compounds through basic research. A secondary function is the development of utility from the information gathered, either academically or in an applied form. A third function is that of service. We are interested in the preservation, biodegradability, and microbiology of existing Dow Corning products.” (p. 2)

Abbott notes that the Microbiology Section has “the capability of conducting research in most areas of microbiology (i.e., Virology, tissue culture, immunology, mycology, bacteriology, etc.)” (p. 3) He notes that one function is to search for organisms capable of silicone degradation. (p.3) There is also a section on Page 3 which is crossed out on Silanols and then a handwritten outline on Silanols (Slide 2) beginning on page 4. Abbott states that silanols have provided “much

basic research information on the relationship of organosilicon compounds to microorganisms and has suggested new areas of research.” (p. 6)

CITE: Temporary Dow Corning Bats Number 671 – 685, Exhibit 4 to Isquith Deposition.

Document #6
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Research Project Description titled “Antiparkinsonism Activity of 2,6-cis- and 2,6-trans-(PHMESIO)2(ME2SIO)2).” The objective is to evaluate (PhMeSiO)2(Me2SiO)2) as an antiparkinsonism agent. It has been shown that these compounds increase whole brain dopamine within 5 days of daily oral administration.

CITE: DCC 16001084 – 16001085, Exhibit to Isquith Deposition, Exhibit to LeVier Deposition.

Document #7
00/00/00
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – COMPLICATIONS
TESTING

Report titled “Discussion of Toxicology of Various Dow Corning Products.” Topics include gel bleed, silicone transport across the skin, the need for further testing. Dr. Carson recommended that all possible evidence of adverse effects be collected with supporting data of literature on our part to show that Dow Corning has no part in these. The presence of Low Molecular Weight in 350 cs. is the same as in lower cs.

CITE: DCC 281041877 – 281041882.

Document #8
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
TESTING

Handwritten synopsis by Lake titled “Status of Biological Testing of Sila-admantoner Compounds, Dow Corning Report 4234” of research projects and patent activity. It includes notes regarding fibroblasts and immunopotentiation, antigen modification, and joint research on in vitro carcinogen bioassay.

CITE: LAK 133, Exhibit to Radonovich Deposition, Exhibit to Boley
Deposition, and Exhibit to Lake Deposition.

Document #9
00/00/00
TESTING
TISSUE REACTION

Dow Corning document: “I. Silicone Oils As Miticides (or mite-repellents)”; “II. Aphid Control With Silicone Emulsions”; “III. Effect Of Silicone Emulsions On Mealy Bugs”; and “IV. Effects Of Silicone Oils On Cockroaches.” The document was authored by “JWR” (unknown who this is). “Mites do not willingly invade silicone treated bean plants if untreated ones are available.” (DCC 16001144). Mites are not controlled by silicone-treated cucumber plants, possibly because the silicone oil is absorbed into the plant. A silicone spray was “completely effective in discouraging them. It is possible that a minor component, relatively volatile, may be acting as a contact insecticide.” (Id.)

Wild mustard plants sprayed with DC 200 fluid 10 cs. eliminated aphids. “The impression gained is that the insecticidal (or repellent) activity is due to some component of the fluid which has gone (presumably by evaporation or by becoming chemically bound within the plant) or a hydroxy-ended material. It seems worthwhile attempting to identify the active species and trying to modify it chemically to obtain a long-term effect.” (DCC 61001145).

Pachysandra plants, infested with mealy bugs, were sprayed with an antitranspirant emulsion with 5% silicone. After 5 days, all mealy bugs on the treated plants were eliminated. “The silicone appears to be slower acting here than upon other insects; possibly a repellent, rather than an insecticidal, effect is involved.” (DCC 61001146).

In the 1950s, Texaco and Shell did studies on hydrocarbon oils as insect attractants. In 1968, it was found by Gorzinski (of Dow Corning) that DC 360 fluid appeared to have an insect attractant and insecticidal activity. Cockroaches were attracted to the petri dish with silicone fluid. After coming out of the fluid, they “never got more than a few inches from the dish before dying.” These results indicate “some type of activity existed in the DC 360 fluid….” (DCC 61001147).

CITE: DCC 16001144 – 16001147, Exhibit to Bennett Deposition, Exhibit 11 to McKennon Deposition, Exhibit 8 to Harris County Gehring Deposition, Exhibit to Harris County and MDL LeVier Depositions, Exhibit to Ryan Deposition, and Exhibit to Isquith Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 880;15 – 882:8). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #10
00/00/00
KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

LeVier, Dow Corning, memo to C. Lentz and Nelson regarding “Activities Related to 2,6-cis.” There are twelve Dow Corning Products currently being sold by the Medical Business that could contain levels of 2,6-cis originating from SBM-18 in excess of the estimated allowable body burden. Medical Products has no active program to identify replacement stock other than conversion of developmental products based on SGM-18 wherever possible. The greatest concern rests with the replacement identified for SGM-18 (elastomer) in that it may be necessary to re-qualify the new stock for medical use including long-term implantation studies.

CITE: DCC 281031092, Exhibit to MDL and Harris County Tyler Deposition, Exhibit 8 to Harris County LeVier Deposition, Exhibit to MDL LeVier Deposition, and Exhibit to Ryan Deposition, NOTE: See document # 11 for attachment.

Document #11
00/00/00
MISCELLANEOUS

Table of 2,6-cis levels in selected products which was attached to LeVier’s memo (see document # 10 above). MDX-4-4514 (elastomer), shunts, penile implants, chin implants, and other products all contained 2,6-cis.

CITE: DCC 281031093, Exhibit to Tyler Deposition. NOTE: See document # 10.

Document #12
00/00/00
VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.

CITE: No Bates Number, Exhibit to Zimmer Deposition.

Document #13
10/08/92
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS
TESTING

“Catalog and Review of D4 Studies.” This is a list of all studies by Dow Corning on D4. There is a handwritten note at the top that says: “Meeting Oct. 16, 1992, Stark/BeyZimmer.”

CITE: DCC 260000855 – 260000878. WITNESS: Exhibit to Zimmer Deposition.

Document #14
00/00/00
MISCELLANEOUS – ORGANIZATIONAL SURVEY
MISCELLANEOUS – LOBBYING

List of “Desired Product Champion Features” includes that the relationship with the product champion should fit the Dow Corning Silicone Group Business Strategy. “PC (product champion) needs to understand and buy-in to the Silicones Group Business Strategy.” Listed features include that the PC serve as a substantive resource to Dow Corning, be loyal to the company, have positive peer influence, be politically astute, and demonstrate teamwork with Dow Corning. The document lists the names of product champions in the United States and Europe and includes a manual prepared by Lois Duel dated September 1, 1989 which addresses issues such as the desired product champion features, the role of the product champion, product champion management and specific product champion issues.

CITE: KKA 210877 – 210886

Document #15
00/00/00
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS – COMPLICATIONS
TESTING

Confidential report entitled “Chronology of Silicone Injection.” The report provides a historical account from Dow Corning’s perspective of the use of liquid silicone injections and the establishment of the Center for Aid to Medical Research. It notes that Dow Corning 200 fluid was used for industrial applications. When the Medical Products Division was established in the early 1960’s, the 200 fluid was designated Dow Corning 360 Medical Fluid. The report notes that, “The original label on the new product carried the inscription ‘formerly Dow Corning 200 Fluid.’” (DCC 267371450) The report also discussed the indictments against Dow Corning officials for distributing the drug, 360 fluid, and the pleas of no contest which were eventually entered.

CITE DCC 267371444 – 267371466. NOTE: The document also has Bates numbers QDC 124506 – 124528 on it as well as Bates numbers MM 369861 – 3698883.

Document #16
00/00/00
ACKNOWLEDGEMENT OF NEED FOR TESTING
SILICA
TESTING
TISSUE REACTION

W.D. Galloway reports on the “Analysis of Lifetime Carcinogenicity Study of Silicone Gels” conducted by Dow Corning under GLP regulations using Sprague-Dawley rats injected with Q7-2159A and MDF-0193 gels.

Galloway states:

“Both of the gel-implanted groups showed a large number of cancers compared to the control group. Particularly striking was the number of sarcomas (principally fibrosarcomas) which occurred in the treated groups.”

“The only obvious deficiency is that only one dose level was used. Ordinarily, three doses are used, and five are preferred. Based on the results obtained, I have little doubt that NTP would classify these substances as likely animal carcinogens.”

“According to Dow Corning, … the tumors were peculiar to rats, the so called foreign body tumors.”

“Absent epidemiologic data, and without waiting for results of additional lifetime studies, knowledge of the mechanism by which these tumors was induced is critical to estimating human risks. It is possible that the tumors were chemically induced, rather than being induced by a by a physical mechanism, as Dow suggests. If this is the case, then the argument that such tumors do not occur in man is untenable. If the tumors were chemically induced, the active agent is more likely to be one of the several chemicals which make up the gel, rather than a metabolically produced reactive intermediate, since the tumors which did occur did not occur selectively in metabolically active organs such as the liver.”

“Recent studies have shown that siloxanes may act as estrogen-like substances and can enhance the growth of tumor cells.”

CITE: M 780064 – 780065

Document #17
00/00/00
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS
SILICA

Dow Corning materials identification list for final devices. It lists all materials used in final devices with a Dow Corning code number. The two manufacturing sites, Michigan and Tennessee, use different identification codes. The list also gives material formulations, indicates the need for a low-bleed outer shell liner, identifies whether “responsive” gel or “firm” gel is used, and notes the percentage of silica used in the formulations.

CITE: KMM 447209 – 4477224

Document #18
00/00/00
Post 10/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
RUPTURE
SHELL STRENGTH – THICKNESS

Dr. O. Gordon Robinson Presents a paper entitled “Rate of Rupture of Silicone Prostheses: Excerpt From A Study Of Over #3000 Personal Cases and Twenty-Five Years Experience” at the Symposium on Reoperative Aesthetic Surgery of the Face and Breast in Naples. Florida. Robinson discusses results obtained after 115 patients were followed after the fall of 1990 after receiving breast implants. Of the 115 patients, 57% had rupture of one or both implants. An additional 20% had moderate to severe bleed on one or both sides. The patients had the implants from six months to 25 years. Dr. Robinson concludes that all gel and bi-lumen implants:

“should be replaced at about the eighth post-operative year because it can be fairly well predicted that at this stage the prostheses in most cases would still be intact and much easier to replace. If a period of time longer than twelve to fourteen years is allowed to elapse, then the prostheses have a good chance of being ruptured and the exchange would be much more difficult.

CITE: PSC Medical Articles CD, J 2698 – Exhibit 2 to Robinson Deposition, Exhibit 25 to McKennon Deposition. WITNESS: Robinson. DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare
Dow Corning Trial Exhibit List

Document #19
00/00/00
Post/10/92
KNOWLLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS

Dr. O. Gordon Robinson’s abstract of a paper entitled “Disruption Rate Of Silicone Gel Prostheses – A Report Of 200 Cases.” 200 patients from 02/91 – 10/92 had their silicone gel implants removed. The time from implantation ranged from six months to 25 years. Robinson found that 104 or 52% had one or both implants ruptured, 43 or 21.5% had severe bleed, and 147 or 73.5% had “distortion” – rupture plus severe bleed. Based on this data, Robinson projected future rupture rates using the Kaplan-Meier survival curve, and concluded that in 20 years, only 3.4% of the patients will have both prostheses still intact. He states, “Gel filled mammary prostheses wear out and in a certain predictable time frame. Based on this study, patients can be advised with a certain degree of accuracy as to the probable condition of their prostheses.”

CITE: No Bates Number, Exhibit 3 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #20
00/00/00
10/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
RUPTURE
SHELL STRENGTH – THICKNESS

Dr. O. Golden Robinson presents a paper entitled “Breast Implant Removal Or Exchange: which updated his prior study of 200 patients. He has seen an additional 100 patients and presents nine charts of statistics. Chart 2 lists “symptoms” of patients including burning and pain, numbness and tingling in extremities, joint and muscle pain, joint and muscle dysfunction, enlarged liver, flu symptoms, loss of appetite, swelling, arthritis symptoms, fibrocystic disease, deformity, kidney failure, vision problems, chronic fatigue, lupus, rash, insomnia, and hair loss. Of the 300 patients, 154 had a ruptured prosthesis, and 214 had a “disrupted” prostheses, i.e. loss of integrity of the silicone shell or severe silicone bleed where silicone “strings out at least 12 inches from intact capsule.” (p.1).

CITE: No Bates Number, Exhibit 4 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #21
00/00/00
Post 10/92
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
RUPTURE
RUPTURE – CLOSED CAPSULOMTOMY
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS

Dr. O. Gordon Robinson’s charts on the age of prostheses a significant number of implants ruptured 6-16 years post-implantation, ( observations at surgery 36.9% of his 73 patients were symptomatic), follow-up (most did not show any change in symptoms during follow-up), symptomatic (patient relates to prostheses-arthritic profile, refer, and “No Closed Capsulotomies”), asymptomatic (patient happy), and questions (“Do mammary prostheses last forever? What contributes to the silicone envelope wearing out? … How do you tell if an implant is ruptured? ….”

CITE: No Bates Number, Exhibit 9 to Robinson Deposition. WITNESS: Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #22
00/00/00
Post 10/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
RUPTURE
SHELL STRENGTH – THICKNESS

Draft of Dr. O. Gordon Robinson’s paper entitled, “Breast Implant Removal Or Exchange.” This is a draft of document number 22.

CITE: No Bates Number, Exhibit 10 to Robinson Deposition. WITNESS: Robinson. DEPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #23 through#31
00/00/00 #23
ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.

This includes an abstract by Dr. Robinson and Dr. Edwin Bradley entitled “Disruption Rate of Silicone Gel Prostheses – A Report of 200 Cases” published in the January 1995 issue of the American Medical Association Journal.

00/00/00 #24

PHOTOGRAPHS OF PLAINTIFF’S EXPLANT SURGERY

00/00/00 #25

EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.

00/00/00 #26

MEDICAL RECORDS OF PLAINTIFF.

00/00/00 #27

MEDICAL BILLS OF PLAINTIFF.

00/00/00 #28

PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.

00/00/00 #29

SPECIMEN BREAST IMPLANTS.

00/00/00 #30

SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.

00/00/00 #31

ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES.

Document #32
09/14/54
SILICA
KNOWLEDGE OF SYSTEMIC DESEASE

H.C. Spencer, Dow Chemical, note regarding “Dow Corning Hydrophobic Silica.” Testing shows a “high order of toxicity from dust inhalation.”

CITE: TDC 5488

Document #33
03/28/55
MISCELLANEOUS – COMPLICATIONS
SILICA
TISSUE REACTION

“Report Of Trip To Saranac Lake Laboratories” by V.K. Rowe of Dow Chemical prepared for Dow Corning. Rowe and other Dow Chemical scientists visited Saranac Laboratory to verify work they had done on D.C. Degusa silica for Dow Corning. Rowe, et al. reviewed the work and wrote this report on the conclusions of the tests.

Dow Corning silica consists of crystalline silica. Rowe states that, D.C. Degusa (silica) dust is “capable of causing diffuse cellular infiltration and fibrotic changes in the lungs and other organs of certain types of animals. It also produces bronchitis and sometimes emphysema.” However, he concludes that it is not likely to cause silicosis” in the ordinary sense of the word. If fibrotic changes of the lungs develop in man, they will probably be diffuse in character. If exposure is stopped, a measure of recovery is quite possible. Exposure to crystalline free silica reactivates and aggravates tuberculosis & causes progressive lesions.” (DCC 299000444).

CITE: DCC 266000443 – 266000453, Exhibit to Lynch Deposition, and Exhibit to California Braley Deposition.

Document #34
01/00/56
TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Dow Corning Report No. 1377 on “The Physiological Assimilation Of DC 200 Fluid” by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark. A copy was distributed to Collings, Bass, Kauppi, Hunter, Hutchison,

Hyde, Blackburn, Bennett, McHard, CRI, and others including Beamer of Dow Chemical. “An increasing use of siloxanes for medicinal applications has resulted in the need for information on their biological activity. Previous experiments of The Dow Chemical Company Biochemical Department has shown that many of these compounds were toxicologically inert. It was the purpose of this experiment to determine to what extent the polydimethylsiloxanes were assimilated, and if so were they were metabolized.” (I 169). C14 labeled PDMS in antifoam emulsion was administered to 2 albino rats and 2 lactating dogs. “The preoperative care, administering of the labeled fluid, sacrificing and dissecting of the animals was carried on by Dr. M.B. Chenoweth of The Dow Chemical Biochemistry Department. Samples of tissue were analyzed with the cooperation of Dow’s Radiochemistry Laboratory.” (I 171). With intramuscular injection, the C14 siloxane was found in the intestines, right adrenal, skin and hair, heart, skull bone, brain, kidney, urine, liver, muscle, lung, renal fat, blood and spleen. (I 172). Rats fed with the material had siloxane in the ileum, stomach and content, bladder and urine and kidney. (I 174). “The actual amount present may be greater by a factor of 3 corresponding to total polydimethylsiloxane from Dow Corning 200 Fluid and from gum. It is unlikely that the polydimethylsiloxane in the gum would be more readily assimilated than the lower molecular weight 200 Fluid.” (I 174). A lactating dog fed with the material has siloxane in the skin and hair, brain, bile,, liver, kidney, heart, milk, urine, skeletal muscle, lung, adrenal, and blood. (I 175). A second lactating dog also had siloxane in the bile, skin and hair, adrenal, urine, spleen, lung, heart, liver, thyroid, pancreas, blood from lung, skeletal muscle, and milk. (I 175).

“The studies conducted along these lines (C14 labeled fluid) to date have shown that these compounds are absorbed from the gastro-intestinal tracts to a slight extent, the amount absorbed being of the order of .0001%. Toxicological studies have shown these compounds to be inert.” (I 175). There is a cite to the lab notebooks for the studies. On 259803.

CITE: KMM 259794 – 259803, Exhibit to Harris County LeVier Deposition, Exhibit to Tyler Deposition, Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE: I 167 – 176.

Document #35
02/09/56
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS – COMPLICATIONS
TESTING

McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical Research, enclosing 9 samples of silicone fluids for determination of the effect of intravenous injection. McGregor wants to know if any of the silicone fluids can be tolerated when injected intravenously. The silicone samples include 200 fluid, 555 fluid, 710 fluid, antifoam AF emulsion (which contains 30% 200 fluid), and XEC-5027 (which contains 10% 200 fluid).

CITE: OOT 43674 – 43700, Exhibit to K. Olson Deposition, Exhibit to Rowe Deposition, Exhibit 24 to Harris County Rowe Deposition. and Exhibit to McHard Deposition.

Document #36
08/00/57
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by Stark titled ” The Physiological Activity Of Dow Corning 200 Fluid.” By a mechanism unknown at this time, a small amount of Dow Corning 200 Fluid is absorbed through the skin by the adrenal and kidneys of a rabbit.

CITE: KMM 259804 – 295808.

Document #37
10/05/57
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning’s version of a “Report Prepared for Dow Corning Corporation, Midland, Michigan on Five Silicone Materials.” The original report (see document #38 below) was prepared by Dr. W. Deichmann of the University of Miami on October 5, 1957 but was a report on six silicone materials. This version of Dr. Deichmanns report was altered to delete one compound and to delete all adverse effects identified in Dr. Deichmann’s original report.

In this version, five Dow Corning silicones were fed to albino male and female rats for a period of 90 days. The silicones were Dow Corning 200 Fluid (50, 350, 1000, 10000 and 60000 cs.). Based on the observations of body weight, food intake, hematology, organ weight at necropsy, and their gross and microscopic appearance, it was concluded that none of the Dow Corning 200 Fluids of the viscosity range fed caused any harmful or deleterious effects.

CITE: KKM 7896 – 7930. NOTE: Includes a summary of animal safety studies relating to dimethylpolysiloxane fluid. See document #38 for the original, unaltered version of Dr. Deichmann’s report produced by Dow Chemical. This altered version of the report was produced by Dow Corning.

Document #38
10/05/57
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Dr. W. Deichmann’s original “Report Prepared for the Dow Corning Corporation, Midland Michigan on Six Silicone Materials” Six Dow Corning silicones were fed to albino male and female rats for a period of 90 days. The silicones were Dow Corning 200 Fluid (50, 250, 1,000, 10,000, and 60,000 cs.) and Dow Corning Z-4141 Solvent Free (the latter compound is the compound deleted by Dow Corning is document #37 above).

ORIGINAL REPORT
DOW CORNING ALTERED REPORT

2 rats died during experiment
only 1 rat died

was a marked decrease in the number of leukocytes. This difference is considered statis tically significant.
there was an apparent decrease in the number of leukocytes. This is not statistically signi ficant.

It is apparent there is a depression in the output of granulocytes by the bone marrow.
The dietary feeding of DC 200 fluids had no significant effect upon the leukocyte counts of the treated animals.

The livers of the rat fed Z-4141 were significantly greater than the controls. This is consistent with the observation of liver damage in these animals
None of the organ weights differed from the controls.

The feeding of the six compounds depressed the granulocytic elements of the peripheral tail blood of female rats. The livers of the rats fed Z-4141 were significantly heavier than the livers of the controls and also demonstrated fatty infiltration or degeneration.
The feeding of the five compounds had no harmful or deleterious effects.

CITE: TDC 6079 – 6100

Document #39
10/09/57
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning, enclosing the results of the review of the six Dow Corning silicone compounds. He informs McGregor that all six compounds depressed the granulocytic elements of the peripheral (tail) blood of the female rats, and that the livers of rats fed Z-4141 were significantly heavier than the controls and demonstrated fatty infiltration or degeneration.

CITE: M 420103.

Document #40
12/09/57
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical Biochemical Research, to R.R. McGregor of Dow Corning with copies to H.H. Gay (Dow Chemical) and E.M. Adams (Dow Chemical ??) on “Results Of Range Finding Microbiological And Toxicological Tests on B-756-92 (a linear dimethylpolysiloxane of 6 units end-blocked with 2,4,5-trichlorophenxy radicals – being evaluated as potential fungicide for athlete’s foot).” The tests showed appreciable antifungal activity. “If large amounts of the material are allowed to remain in contact with large areas of skin, absorption may result in systemic injury and may even produce death.” Slight hyperemia followed the 3rd and 4th application and the rabbit died “possibly due from systemic injury due to absorption through the skin.” The other 2 rabbits also died.

Attached is a data sheet prepared by Olson and McCollister, a toxicology work sheet, “Request For Applications Testing,” and eye contact, skin contact – irritation, and skin contact absorption test records. NOTE: The document is stamped, “This Report Is The Property Of The Dow Chemical Company.”

CITE: TDC 6158 – 6175, Exhibit to K. Olson Deposition, and Exhibit to McHard Deposition.

Document #41
04/09/58
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

“Pharmacological Test Data For Various Organofunctional Silicon Compounds, Report No. 1641,” by Speier of Dow Corning. Pharmacological screening test data for 61 organofunctional silicon compounds are examined for use in drugs. In early 1952, a program was agreed upon with Eli Lilly for the pharmacological examination of assorted organofunctional silicon compounds. “The screening of these compounds has shown that a great many organofunctional silicon compounds and polymers have totally unexpected activities. Certain ones proved to be acutely toxic, even though closely similar structures were not especially toxic.” (DCC 281002214).

All the results are contained in Mellon Institute notebook 318 – all 61 tests in this study contain a reference to notebook 318. There is also a reference to Earl Warrick’s work at the Mellon Institute at 281002226.

CITE DCC 281002213 – 281002230, Exhibit to Tyler, MDK and Harris County Depositions, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, and Exhibit to Ryan Deposition.WITNESS: Bennett (ancient document exception to hearsay). DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare.

Document #42
07/31/58
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow Corning, with copies to Gay, Dow Chemical, and McHard regarding the results of skin irritation, skin absorption and acute oral feeding tests on Dow Corning 555 Fluid and Ethylan (a modified lanolin), file no. T2.42-54-1.

In McGregor’s 06/05/58 letter to Rowe he indicated that Helen Curtis Industries had observed untoward systemic effects in rabbits and rats due to absorption of the material through the skin. Autopsy revealed small yellowish bubbles and petochone (illegible) on the liver and lungs. Olson applied the material to the skin of rabbits and fed it toanother group for 5 days/ The results for the skin sensitization tests are illegible. There was a questionable to mild kidney disturbance in animals fed 555 fluid.

The conclusions on 6532 state that DC 555 fluid has a low acute oral toxicity, is essentially non-irritating to the skin upon prolonged repeated contact, and that there is no indication that the material is absorbed through the skin in sufficient amounts to produce systemic damage. Attached is a toxicology work sheet, “Requests For Screening Or Application Testing,” and skin contact absorption and acute oral toxicity test results.

CITE: TDC 6526 – 6555, Exhibit to McHard Deposition, and Exhibit to K. Olson Deposition.

Document #43
07/05/62
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Olson and Sadek, Dow Chemical Biochemical Research, letter to McHard, Dow Corning, on toxicity by subcutaneous injection of Dow Corning 200 Fluids and Dow Corning 555 And 550 Fluids. Dow Corning 200 fluid 10 cs. resulted in a moderate inflammatory response in the subcutis as indicated by the presence of polymorphonuclear cells and a very large mononuclear cells. “This type of inflammatory reactions is interpreted as due to infection.” With DC 555 and 550 Fluid, all injection sites showed evidence of inflammatory reaction indicated by the presence by mononuclear cells and polymorphonnuclear cells.

CITE: TDC 7493 – 7515, Exhibit 9 to Hancock Deposition, Exhibit to McHard Deposition, and Exhibit to K. Olson Deposition

Document #44
07/12/62
SHELL STRENGTH – THICKNESS
S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow regarding his findings from the use of the saline silastic prosthesis. A leak was discovered during implantation and Dr. Gerow “sealed it with cement on the operating table….” Also, he wanted Dow Corning to “make the Gel gooier.” Dr. Gerow reports that the saline he has been using in some of the silastic sacs has been in animals for nine months and that the body sets up a chemical balance. He has analyzed the fluid inside the sacs after this nine months and found protein, SO4 ions and also indications that the body had set up a balance of magnesium and other ions. Finally, Dr. Gerow stated that the “direct injection technique has worked out beautifully.”

CITE: M 320001 – 320002

Document #45
09/14/62
TESTING

Dow Chemical Texas Division, Agricultural Research, study by F.C. Turner, K.G. Seymour, and J.B. Jackson on “Tropical Application Of Various Solvents And Solutions To Evaluate Dermal Irritation.” Report No. 210. The report was circulated many persons including K.W. McCory of Dow International; persons at Bioproducts: Adm., J.E. Johnson; An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D, K.C. Barrons; Midland BRC Files, L.J. Lippie: Registration Section. G.E. Lynn; Synthesis Group, W. Reifschneider; and Formulation Res., J.W. VanValkenburg; to V.K. Rowe of Biochemical Research; and to the following persons at Pitman-Moore: C.W. Hinman, G.R. Burch, and D.C. Brinkman.

Dow Corning 200 fluid – silicone oil with 49% espesol 5 content was administered in 10 cc dosages to shaved strips on the hide to test for suitable solvents for Ruelene. Dow Chemical hoped to find a solvent that didn’t damage the hides of cattle when Ruelene was administered. The DC 200 fluid was rated ad bad, which indicated that the hide had extreme cracking or sloughing at 10 and 16 days after application. (TDC 7542).

CITE: TDC 7537 – 7543

Document #46
10/04/62
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
SHELL STRENGTH – THICKNESS
TISSUE REACTION

S.Braley, Dow Corning, memo regarding telephone call to Dr. Thomas D. Cronin. Braley told Cronin that the uncatalyzed breast material could not be sent out because there were too many problems with it. The problems with measuring and the variability of both the base material and the mixing techniques necessitates different amounts of cross-link resulting, along with the variability in mixing techniques, can cause difficulties.

Dr. Frank Gerow was also on the telephone and talked about the results he was getting regarding tissue reaction to the direct injection of the material.

Cronin said that he is not concerned about leakage if he were to use the thin material because a film forms around the implant retaining the material in place. Cronin said that he is getting chlorine, potassium and proteins both in and out through the wall of the bag. This is on apparently good bags.

It was decided that it would be wise to continue the work for long range testing for the acceptability of the material.

CITE: OOM 320665 – 320666

Document #47
10/31/63
KNOWLEDGE OF LIQUID SILICON DANGERS
GEL MIGRATION

Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on his injection of silicone fluid in mice. Two days after injection, silicone was found in most organs including the brain, liver, spleen, intestinal wall, adrenal and kidney. He also found “evidence of at least radio activity and most probably silicone in the brain and all of the various other organs….”

CITE: M 420051 – 420052

Document #48
11/27/63
TESTING
TISSUE REACTION

Dow Chemical’s Bioproducts Department report by Whitney, Pollock and Pauley on “Fluorosilanes As Fumigants.” Six flourosilanes:K-56,425 = n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane; K-57,317= trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane; K-59,697 =chlorometthyldifluoromethylsilane; K-58,739 = silicon tetrafluoride; andK-681 = methyl bromide were evaluated as fumigants for control of insects and microorganisms. All were very active against post-embryonic stages of tests insects. Tri and difluoro silanes were active against bacteria and molds. Most of the compounds killed all flour beetle eggs at one lb/1000 cu. ft. with a 16-hour exposure…. A patent disclosure has been submitted and further research is recommended for these and related compounds.

Results of toxicological work with mammals is reported in reports 55.11-56425-1, 55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and 55.11-2-1. the usefulness of these compounds has been reported in Patent Disclosure no. 16193. NOTE: None of these reports or patent disclosures were produced to the PSC.

“Further exploration of the biological and physical properties of these and related compounds is recommended.”

CITE: TDC 8901- 8904

Document #49
00/00/64
MISCELLANEOUS – COMPLICATIONS
SILICA STERILIZATION/CONTAMINATION
TISSUE REACTION

Braley, Dow Corning, states in the Trans American Society of Artificial Internal Organs, “The Medical Silicones,” that electrical charges exist on the surface of the silicone elastomer. Silicone elastomers are described as non-adherence products, nothing will stick to them “However, because of the dialectic (sic) properties of silicone rubber, it will develop a surface charge and can hold dust, lint, (etc.)…. This is not true adhesion.” Additionally, the reason

that the attempt to create a silicone vascular prostheses, to be inserted in a blood vessel, failed is because of the electrical charges on the surface which caused the blood to clot at the ingress end of the silicone prostheses tube.

Braley also describes the chemical composition, the characteristics and the various applications of silicone.

Document #50
01/13/64
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and Stebleton regarding “Notes on visit to Battelle Memorial Institute on December 19, 1963.” McHard and Hobbs met with representatives of Battelle and discussed the “Toxicology of silicones – past and future. … 1. Variation in toxicity with animal species. 2. Effect of polymer size on toxicity. 3. Extent of body metabolism. 4. Fate in kidney and liver. 5. Fate of catalysts. 6. Extent of carcinogenicity.” Also discussed was silastics for breast implants. Battelle’s study showed that the physical properties of silicone rubber when implanted were significantly affected/decreased. Also, “There was considerable discussion on how the various polymer sizes may be transported across the G.I. tract and how they may find their way into the kidney, liver, and subsequently, the urine.”

CITE: KMM 299059 – 299063

Document #51
05/16-17/64
COHESIVENESS-LIQUID COMPONENT OF GEL
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Silicone Injection committee Meeting on 05/16-17/64 attended by D.J. Badamo, S. Braley, C.E. Haberstoch, R.R. McGregor, E.G. Mullison, S.L. Bass, H.D. Dingman, E. Hodnett, M.J. Hunter, J.A. McHard, A.W. Rhodes and L.F. Stebleton of Dow Corning; by Drs. Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer, Murray and Rees, who are medical consultants; and by Steve Carson and Bernard Oster of Food & Drug Research Laboratories. Materials considered for the injectable trials: dimethyl siloxane 360 Medical Fluid “(formerly 299 fluid)”; phenylmethyl siloxanes including 555- “cyclic, very low molecular weight, 704 – linear, very low molecular weight, 550 – dimethyl and phenylmethyl copolymer; large amount of phenyl….” and others.

CITE: DCC 267371390 – 267371417, Exhibit to McHard Deposition, and Exhibit to K. Olson Deposition. DUPLICATE: m 30531 – 30558; KMM 183981 – 184009.

Document #52
05/28/64
FRAUD/MISREPRESENTATION
GEL MIGRATION
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Braley memo to Ashley, Blocksma, R. Dingman, Edgerton, Goulian, Lederer, Murray, Rees, Badamo, Bass, H. Dingman, Haberstroh, Hodnett, Honter, McHard, Mullison, Rhodes, and Stebleton regarding the attached article in the May 25, 1964 issue of “The Insider”s Newsletter.” Unknown factors with silicone injections include absorption, migration and hardening.. Braley writes, “We have no knowledge where the reporter obtained this information. If anyone knows anything about this, we’d appreciate hearing from him. We are trying to keep such articles as this out of the public eye as much as possible.”

CITE: M 350063 – 350064

Document #53
09/22/64
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Thomas Rees letter to Braley, Dow Corning, regarding the finding of altered fat cells in animals subcutaneously injected with silicone. Rees states that the spleens of the mice that have been injected with massive amounts of the material show definite collection of silicone within macrophages.

CITE: KMM 167416
Document #54
09/24/64
TISSUE REACTION
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS

Letter from Dr. Thomas Cronin to William Rhodes, General Manager of Dow Corning. Dr. Cronin reports that Dr. Brauer had to remove seven implants when, at intervals of 2-4 months, a blister would start in the scar and gradually break down. “(S)ome clear, straw colored fluid would be released”.

CITE: KMM 150269 – 150270. NOTE: Ivory flakes were being used to prepare the implants prior to surgery.

Document #55
11/12/64
EMBOLISM
KNOWLEDGE OF LIQUID SILICONE DANGERS

Harry Dingman, Dow Corning’s Legal Counsel, writes to Ban Smart of the FDA and informs him of a reported fatality following injection of a silicone. Dr. Crenshaw, California, injected a woman with silicone (source and type unknown) mixed with a vegetable oil. she “then went into a coma in a matter of a few hours, and died within a few days. Dr. Aronow had not received a formal coroner’s report, but the informal comment was to the effect that death was due to fat emboli in the lung and possibly in the liver. A suspicion of possible encephalitis was being checked by having a culture run on the brain.” (emphasis added).

CITE: KKM 1275 – 1276. DUPLICATE: KMM 48637 – 48638.

Document #56
12/00/64
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

“Tissue Reactions to Injected Silicone Liquids, A Report of Three Cases,” Archives of Dermatology, Vol. 90, 538-593 by Winer, Sternberg, Lehman and Ashley. Drs. Oppenheimer and Russell observed fibrosarcomas developing in 1.7% to 40% of the test animals. Drs. Hur and Neuman observed malignant epithelial tumors that were believed to be of sweat gland origin. The conclusion drawn from the test data is that “there seems to be sufficient evidence at this time that complications of this nature are to be expected.”

CITE: I 253 – 259, Exhibit 7 to McGhan Deposition, and Exhibit 16 to California Braley Deposition. DUPLICATE: PSC Medical Articles CD, J 3598 – 360

Document #57
12/08/64
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Dr. Franklin Ashley writes to Silas Braley, Dow Corning, regarding a “girl in Las Vegas who received the injections and had the eye trouble.” The 28 year old woman received 30 injections into the breast.

Ten to fifteen minutes following her final injection she noted onset of nausea followed by dizziness and almost complete loss of vision. At the same time she developed severe left anterior chest pains without dyspnea or tachypnea.

She was seen by an Internist who treated her with ACTH thinking that this possibly represented an anaphylactoid reaction. Visual disturbance cleared somewhat with ACTH. During this immediate post treatment period she experienced some loss of memory, as well as poor coordination which cleared gradually over a period of time. Also noted during this time was hematuria which lasted for one day only; no recurrence has been noted.

One week following the onset of symptoms she was evaluated by Dr. Albouth, at which time he noted a questionable positive Rhomberg and ophthalmologic findings consisting of some loss of visual acuity and hemorrhages within and anterior to the retina.

Follow-up to date has been over a six month period with the latest notation that her gait has returned to normal. Her dizziness has disappeared, but she still experiences some visual difficulties, specifically loss of visual acuity.

CITE KKH 63126 – 63127

Document #58
01/29/65
KNOWLEDGE OF LIQUID SILICONE DANGERS

Franklin Ashley, UCLA Center for the Health Sciences, to Braley, Dow Corning, reporting the death of a patient after various injections of silicone around the face.

CITE: M 340057

Document #59
04/01/65
CONCEALING FROM FDA
KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Franklin Ashley responds to Silas Braley’s, Dow Corning, letter concerning a girl in Argentina who was injected with large amounts of silicone fluid. “I believe this would fit in also with the observations of Goulian and others where a large quantity was injected any one time, and was taken up by the lymphatics. We have not observed this in any of our cases, however, probably due to the fact that we inject only a small quantity each time…. I do not think this should be reported to the FDA as it is an isolated case and from another country, and we do not know exactly what they injected really.” (emphasis added).

CITE: M 340044

Document #6005/27/65
EMBOLISM
KNOWLEDGE OF LIQUID SILICONE DANGERS

Frank Ashley, M.D., reports to Silas Braley of Dow Corning regarding a consultation with a patient in Las Vegas. Ashley states, “My diagnosis, of course, was multiple silicone emboli from the liquid silicone and possible additives, in the lungs, brain, liver, kidney and retina.” (emphasis added).

CITE: M 340037

Document #61
06/24/65
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Dr. T. Rees writes a letter to Dr. Silas Braley and Fred Dennett, Dow Corning Center for Aid to Medical Research. Dr. Rees states “The inevitable has happened. We found a case of carcinoma of the breast in a 37 year old woman who has had both breast heavily injected with pure silicone material.” He states’

“The carcinoma itself was a very small, isolated, intraductal type of carcinoma in the upper portion of the tail of the breast and there were some involved lymph nodes in the axilla. There are multiple ‘silicone cysts’ throughout the tissue and some of the silicone was injected in the immediate vicinity of the carcinoma. Also of considerable interest is that there is evidence of silicone deposits in the lymph nodes of the axilla and thus it appears that the silicone is drained to a certain extent by the lymphatic system….. We are thinking of writing this up as a case report, but would like the view of the entire committee before we commence doing so. We are hesitant to report it because undoubtedly it will create quite a stir but feel that the case must be reported for the sake of thoroughness and completeness. We are open to counsel as to just what manner this should be done. (emphasis added).

CITE: KMM 105815 – 105816, Exhibit to D. McGhan Deposition. DUPLICATE: KMM 3802 – 3803.

Document #62
10/05/65
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – COMPLICATIONS
SILICA
TESTING

Hobbs memo to Snedeker with copies to McHard regarding “Recommendations for the toxicological evaluation of J. Treated Dow Corning Silica Type A.” “At the present time very little is known on the toxicity of the various treated silicas at Dow Corning…. The exact toxic manifestations are unknown. They will cause death in laboratory animals by various routes of administration, including inhalation, for a period of four hours or less. Although these are high concentrations for a short period of time. we must assume until proven otherwise that low concentrations over long periods of time are detrimental to health. It is therefore our recommendation that acute range-finding studies be performed on J Treated Silica.” Testing programs (such as annual chest x-rays of workers) have been run with the cooperation of the Dow Medical and Biochemistry Departments on problems which have arisen with various chemicals. The programs at Dow and Dow Corning were dropped but, “Recently problems have arisen with chemicals and compounds which indicate that such a preventative medical testing program is not only desirable but also advisable…. While toxicity studies are being carried out on some of these materials at the Dow Biochemistry Department, they are made with animals, usually on short term acute exposures. This type of information does not indicate what might happen over long periods of time subjected to less than acute exposures.” The document also talks about a Medical-Biological-Safety Committee.”

CITE: KKA 230245 – 230249, Exhibit to McHard Deposition and Exhibit to K. Olson Deposition.

Document #63
10/27/65
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS
TESTING
TISSUE REACTION

Burdick, Dow Corning, memo to Don McGhan, Weiler, VerVoort, and Pellikka regarding “Mammary Implants.” He states:

“There are still a number of questions concerning our breast units that have not been answered. We know that a quantity of low molecular weigh material is exuding from the bag, but that is all.

He suggests a test to extract the material and analyze it. Burdick states:

“This test should tell us how the gel is affecting the rubber bag. Adhesion and tear strength should also be related to swell. The extractables may be of low enough molecular weigh to migrate throughout the body. If so, what quantity are we talking about?

CITE: OOM 321439 – 321449, Exhibit to Bennett Deposition and Exhibit to D. McGhan Deposition

Document #64
11/15/65
EMBOLISM
KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Ashley authors a paper, “Silicone Fluid And Soft Tissue Augmentation, as a result of the Boca Raton symposium. “Of significance is the fact that the clinical use of silicon liquids in man preceded any responsible and controlled experiments in animals.” As a result of the concern, ASPRS set up a committee consisting of Dr. Franklin Ashley, Dr. Ralph Blocksma, Dr. Reed Dingman, Dr. Milton Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr. Joseph Murray, Dr. Norman Orentreich, and Dr. Thomas Rees.

Dr. Ashley provides a historical overview of the chemical properties and development of silicone. He notes that with intravenous injection of silicone fluid in animals, large doses are usually fatal in rabbits and can produce emboli and death in dogs. He found no tissue reaction in animals when liquid silicone was injected subcutaneously.

Dr. Ashley also notes that silicone oil “will have a tendency to disappear” within the body and that:

“(S)ignificant questions … remain unsolved. First, what is the body distribution within its tissues of any absorbed material? Second, what is the ultimate fate of the absorbed material? … Third, if significant amounts are absorbed, does the body excrete the material, and if so, how, and how much? Fourth, if some is retained, in which organ or organs is a harmful effect produced – if any? Indeed, there is some evidence that silicone oils may be transported to far removed tissues and organs. In another study, one week after the intramuscular injection of a rat with dimethyl polysiloxane, 90 per cent of the C(14) labeled liquid oil was detected within the tissues of the intestinal tract. The fate and presence of silicone oil in human biology is unknown.” (emphasis added). He further notes that, “In large subcutaneous injections of silicone fluid, examination of the contents of the abdominal cavity showed that the mesenteric and omental fat was abnormally firm, with loss of normal color and adherence to adjacent viscera. This suggests that there may have been transport of silicone oil through the abdominal cavity.”

Animal studies of injection of RTVS 5392 silicone fluid showed tumor development in rats at eight, fifteen, and nineteen months after injection. MDX 44010 silicone fluid was also injected in mice, rats and monkeys. Nearly all animals developed hair loss over the implanted site, and several rats developed superficial cutaneous ulcers directly over the silicone mass. Both of these symptoms resolved themselves within six weeks. He also noted a significant “exothermic reaction,” “pronounced local reactions,” and tumor development in 3 of 6 rats at 14 and 16 months post-injection. He concludes:

“Although it is only speculation, the initial exothermic injection reaction and tissue injury may have provided a carcinogenic influence…. (T)he incidence of 3:6 (3:22) should not be attributed to random chance occurrence…. Tumor formation about buried synthetics has had important consideration by some, but discounted by others…. (A) tumor incidence of 3:6 or 3:22 indicates a need for further animal experimentation.” (emphasis added). He notes that human clinical experience in 35 patients noted breast abscess and apparent tumor formation. He reports on three cases of carcinoma of the breast in women following injection of silicone fluid. One woman developed a palpable axillary lymph node eight months following injection and required a radical mastectomy. Surrounding the cancerous lesion were “multiple small silicone cysts. The silicone was also found in the axillary lymph modes removed with the radical specimen.”

“At least two deaths are known to have followed the subcutaneous injection of 100.0ml. or more of Dow Corning 360 Medical liquid given in one single administration…. At least one patient is known to have developed blindness during the subcutaneous injection of Dow Corning 360 Medical liquid…. There is no reason to believe that the human will tolerate intra-arterial and/or intravenous injections any better than the experimental animals. (emphasis added).

CITE: M 360096 – 360141

Document #65
01/14/66
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

McHard memo to Bass with copies to Bennett, Dingman, Hunter, W.T. Rossiter and Rowe regarding “Toxicological testing of Dow Corning Pan Shield.” McHard is reporting on the results of a meeting today with Rowe and Bennett regarding DC Pan Shield. An initial formulation of this product indicated no apparent toxicological problems. However, the catalyst wasn’t potent enough to cure on the pan; therefore a new catalyst was used and the product reformulated. Based on the results of the testing with the first catalyst, no toxicological problems were anticipated and so marketing decisions were made about the product. As they got into the 90-day testing program, the toxicological information was insufficient to assure the degree of product safety necessary. Therefore, Rowe, Bennett and McHard met today (1/14/66) to review this product. “(I)t is our recommendation that marketing studies, even short-termed pilot tests, be postponed until product safety data can be accumulated.”

There are indications that adequate non-toxic oral levels may not be achieved. “It should also be borne in mind that if Dow Corning were obliged to defend the safety of this product today in a court of law, we would be at a serious disadvantage since we could be forced to disclose all data which has any bearing on the components of the product. You can well appreciate what our position would be in this event?”

CITE: DCC 281041086 – 281041087

Document #66
06/06/66
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Minutes of meeting with the FDA in Washington DC regarding Dow Corning 555 Fluid. Present were Steve Carson and Bernard Oser (FDRL), Otis Fancher (IBT), Bass, Bennett, Dingman and McHard (all of DC) and Drs. Lehman, Marzulli and Nelson with the FDA. McHard reported on the chemical composition of DC 555 and a summary of Dow Corning’s 555 fluid Safety Evaluation Program. DC 555 has been used in cosmetic preparation for 12 years. It was decided to have more detailed subacute tests performed on rabbits at IBT. The testicular size of the test rabbits was reduced and spermatogenesis was depressed on microscopic examination. The effect was traced to the DC 555 fluid in the hand cream. FDRL then evaluated the fluid and found no such activity in rats or guinea pigs, noted a marginal effect in dogs, and observed activity in the rabbit but not as severe as that noted at IBT.

“A consultation was held with Drs. Oster*, Carson*, Calandra (Industrial Bio-Test Labs.), and Rowe, toxicologist of the Dow Chemical Company. These consultants felt that the data were indicative of a species specific response and therefore it was suggested that a male monkey series be started in which the material would be applied dermally repeatedly.” The studies were done at IBT. A dose applied dermally repeatedly.” The studies were done at IBT. A dose of 5 mg.kg. produced a statistically significant effect. McHard mentioned that “the effect requires 20 days of daily application in the rabbit, but the effect is not grossly present until the 16th-17th day.

Oral studies in monkeys was begun in 1965. It was noted that in the orally dosed males, it was difficult to obtain ejaculate and a subsequent biopsy at 5 months of oral dosing in the males showed a marked depression of spermatogenesis at the 2000 mg.kg. level, and 2 of 3 monkeys showed spermatogenic depression at the 50 mg.kg. level.

McHard commented on the isolation of chemical species to determine the active agent. Dow Corning has not yet identified the specific structure which causes the observed systemic effect. McHard also commented on the quality-control of the product. McHard also noted that no ill effect had been observed or reported from people at Dow Corning exposed in the production area. Dingman hoped that the findings on DC 555 fluid would not cast any reflections on DC medical grade 360 fluid or industrial grade 200 fluids.

CITE: KMM 418744 – 418775, Exhibit to Bennett Deposition, Exhibit to Rowe Deposition, and Exhibit to McHard Deposition.

Document #67
07/00/66
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

T. Rees, et al., submits to Dow Corning a report titled “Visceral Response to Subcutaneous and Intraperitoneal Injections of Polymethylsiloxane in Mice” which evaluates histologically the systemic distribution of silicone fluid. Results indicate silicone deposition in the spleen, liver, adrenals, pancreas, ovaries, abdominal lymph nodes and kidneys of the test animals, suggesting distribution by the reticuloendothelial mechanism.

CITE: KKM 31076 – 31087

Document #68
08/02/66
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Braley memo to Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer, Murray, Orentreich, Steve Carson, Bennett, Bennett, Hunter and McHard regarding the attached letter and paper from Thomas Rees. Rees’ letter is dated 7/26/66 and notes that this is a privileged communication. “I hope this work doesn’t open a can of worms but I can’t see any alternative to publishing it.” The draft paper notes that subcutaneous administration of massive amounts of silicone produces considerable alteration of the tissue structure of the subcutis. The fat cells in the immediate vicinity of the encapsulated silicone show varying degrees of atrophy and the intracellular fat contains small regular vacuoles. Intraperitoneal injections or subcutaneous doses in excess of a total dose of 7 ml in mice resulted in widespread microscopic lesions by 3 months. The silicone also produced a generalized alteration of the abdominal and epicardial adipose tissue. The fat cells showed a finely granular, eosinophilic cytoplasm. “In many abdominal organs which included adrenals, lymph nodes, liver, kidney, spleen, pancreas, and ovary, focal infiltrates of macrophages with abundant clear cytoplasm were encountered. The nature of the cytoplasive material within the macrophages has not been ascertained, but it is presumed to be silicone as those lesions did not occur in control animals. The early adrenal lesions were found at the corticomedullary junction; as the lesions become more extensive they extended through the entire cortex. In the liver. lesions were observed in all parts of the hepatic lobule. The results of this study indicate that dimethylpolysiloxane fluid is deposited in the spleen, liver, adrenals, pancreas, ovaries, abdominal lymph nodes, and kidneys of mice when given by intraperitoneal injection of small amounts or by subcutaneous injection of large amounts, 7-8 ml. Smaller subcutaneous doses, 1 ml. of liquid silicone in the same animal species occasionally causes similar lesions which occur only in the sona reticularis of the adrenal glands.” “The mechanism of absorption and systemic distribution of silicone fluid in mice is still unknown. Venous embolism or phagocytosis with distribution in the reticuloendothelial system seems to be likely possibilities. Most visceral lesions did not occur prior to three months following injection except in isolated instances. This delay seems to implicate the reticuloendothelial system as being the most likely method of transfer.”

CITE: KMM 31074 – 31087

Document #69
09/06/66
MISCELLANEOUS – ORGANIZATIONAL SURVEY
Minutes of the Board of Directors’ Meeting for Dow Chemical Company with a reference to a secrecy agreement with Dow Corning Corporation regarding the biological properties of silicones.

CITE: TDC 11625 – 11627, Exhibit to Bennett Deposition and to Julius Johnson Deposition.
Document #70
10/10/66
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – PRODUCT LABELING
TESTING

Memo from Don McGhan (at Dow Corning) to McIntyre with copies to Pellikka, Hutchison, Bennett, Burdick, Weiler and Diamond regarding “Biological Testing of 360 Fluid, Our Project No. 5152.” Steve Carson of FDRL, Harry Dingman of Dow Corning’s legal staff, and McGhan “strongly suggest” that Dow Corning not proceed with biological testing of Dow Corning 360 fluid in containers smaller than 440 pounds. McGhan asks McIntyre to “review your marketing objective for 360 Medical Fluid and determine if biological labeling and certification is required in container sizes smaller than 440 lbs. in order to increase sales of the product.”

CITE: KKA 7168, Exhibit to D. McGhan Deposition

Document #71
10/12/66
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – SALES
STERILIZATION/CONTAMINATION
TESTING

“Chemical Research Progress Report (Restricted), Report No. 2964,” by R. McCarty and J. Speier – all of Dow Corning. Dr. Hunter established a committee of Bennett, Hobbs, McCarty, Stark, Weyenberg and Speier to isolate and identify a pharmacologically active substance believed to be present in DC 555 fluid.

Silanols are referenced on DCC 281002126 – 281002126 – they are “profoundly toxic” and have effect as a CNS depressant. Silanols have been under study since 10/65. There is a reference to the Mellon Institute on DCC 281002127. Also note that Dow Corning was using Dow Chemical’s animals and testing facilities.

CITE: DCC 281002121 – 281002162, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, Exhibit to Ryan Deposition, Exhibit to Isquith Deposition and Exhibit to LeVier Deposition. WITNESS: Bennett (ancient document exception to hearsay). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #72
01/10/67
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Rowe memo to McHard with copies to Bennett, Dingman, Heuerman, and Hunter. This memo is in reply to the 12/16 memo from McHard on Product Safety. Rowe has looked over the IBT testing outline and feels that “in general, (it) contains the type of information I believe is necessary. However, I do believe that some of the work which has been listed should be done at an earlier stage and a minimum of liability.” Rowe gives advice on the types of tests and the timing of the necessary tests in his critique of the IBR testing plan. Further, “I also have my doubts about the wisdom of selling the material, even though it is intra-state, before you at least have long-term studies going, and the data indicates no likely hazard. I realize that intra-state sales can be made without FDA approval, but nevertheless, if you were challenged, I fear that you would have difficulty in convincing any court that you had acted in a responsible way even though you might be within the limitations of the Federal Food, Drug, and Cosmetic Act.” He states that he will be happy to discuss any of these matters further with McHard.

CITE: DCC 281041120

Document #73
02/01/67
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Minutes of the meeting of the Executive Committee. Includes notes regarding a joint agreement with The Dow Chemical company pertaining to certain silicone products designated as DC-555, DC-555A, and compounds derived from and related thereto, and a joint development agreement relating to the physiological effects resulting from ingestion or injection into the systems of animals and men of particular physiologically active silicones.

CITE: DCC 1010001438 – 101001440, Exhibit to Bennett Deposition, Exhibit to LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to Caldwell Deposition, Exhibit to McHard Deposition, Exhibit to Julius Johnson Deposition, and Exhibit to LeVier Deposition.

Document #74
02/08/67
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE

“Report to Dow Corning Corporation Rabbit Teratogenic Study, TX-114,” by Industrial Bio-Test Laboratories. Nine test groups consisting of fifteen pregnant does were used in this study. It appears that TX-114 produces no adverse effect upon maternal growth or upon the ability to carry the reproduction process successfully form six to eighteen days inclusive. The number of resorption sites noted appears to be proportional to the total amount of material administered. It is felt that this reflects system damage to the maternal organism which obscures the secondary effect upon the developing fetal system. At a level of 200 mg/kg subcutaneously, slight alterations (clubbing of extremities and umbilical hernias) were observed in proportions which approach the upper limits of an expected non-treatment group. “(I)t is felt that the material is non-teratogenic. However, the incidence of abnormalities seen at lower levels, especially 200 mg/kg, would lead to a conclusion that the teratogenic potential of the material should be investigated in at least one other species and possibly in another rabbit strain.” Eldon Frisch, Dow Corning, in a 12/331/87 document, claims that this study was inconclusive. “(C)lubbing of extremities and umbilical hernias were near the upper limit….”

CITE: I 661 – 702. DUPLICATE: KMM 115833 – 115873; (Referenced in KMM 407480 – 407482). NOTE: See 12/31/87 entry in Master Timeline.

Document #75
02/16/67
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

“Discussion Of Toxicology Of Various Dow Corning Products.” A meeting was held on 02/16/67, present were Steve Carson (FDRL), Fancher (IBT), V.K. Rowe (Dow Chemical), Bennett, Boone, Braley, Bennett, Dingman, Hobbs, Hunter, Don McGhan, McHard and Radzius. They discussed the IND’s on file with the FDA including the IND for burned hand, the silicone injection IND, the bladder treatment IND, applications for Silastic rubber dental liner and dental impression material such as permanent tooth implants using Silastic rubber to anchor tissue contact material, implant testing on new or modified formulations, corneal implants, in-dwelling catheters, needle and syringe treatment, DC 360 medical fluid, elastomer for coating pacemakers, comparison of the reproductive studies carried out at FDRL including the findings of club footing and resorption as a result of the treatment, DC FS-1265 fluid and foot and hand protector products (“A recent report as a result of a one-year feeding in rats did seem to show a dose-related effect on testis and accessory sex organ weight but V.K. Rowe thought that because of the species difference and the time involved in the test and the fact that the test was oral and not dermal and since all of the dermal data looked good, there should not be any reason to suspect this product” (DCC 281041880), and tests on Dow Corning 555 fluid and 360 medical fluid.

A discussion was also held on the different viscosity grades of “Dow Corning 200 fluid or Dow Corning 360 fluid” compare with regard to polymer size distribution. Although higher viscosities show broader distributions, “there appears to be almost as much of the lower polymer ends in the 350-centistoke” as in the lower viscosities. (DCC281041877). The agenda is located at 281041882.

CITE: DCC 281041877 – 281041882, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, Exhibit to Rowe Deposition, and Exhibit to LeVier Deposition.

Document #76
03/10/67
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

“Summary of Toxicological Testing of Dow Corning FS-1265 Fluid and Ointment, Foot Protective” by “jar” (Joseph Radzius). It was reported to the FDA in June 1966 that Phenylmethyl polysiloxane – DC 555 fluid – exhibited biological activity, i.e., a depressant effect on spermatogenesis and a reduction in testicular size. Dow Corning elected to withdraw the product from the market. Very recently Dow Corning received a report from FDRL on a 12-month oral administration of FS-1265 fluid in rats which also showed a dose-related spermatogenic arrest, depressed testicular and seminal vesicle size similar to that observed for 555 fluid. Thus, this fluid also exhibits biological activity.
CITE: DCC 281041861 – 281041863

Document #77
03/14/67
TESTING

Dow Corning study titled “Biologically Active Organosilicon compounds, Report No. 3035,” by McCarty, Lee and Burk. Test data on 83 organosilicon compounds which have proved active in biological screens. The activity listed includes anti-cancer, anti-malarial, anti-echistosomasis, anthelmintics, soil bonding agents, premergent herbicides, post-emergent herbicides, anti-coccidiosis, fungicides and bactericides, contact insecticides, fumigants, anti-crusting agents, and general pharmacological screen in which the compounds were examined for use in drugs. Dow Chemical does the screen on agricultural, animal science, solvent stabilizers, etc. on these compounds.

CITE: DCC 281002231 – 281002247, Exhibit to Tyler MDL and Harris County Depositions, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition, Exhibit to Julius Johnson Deposition, Exhibit to Himnam Deposition, and Exhibit to LeVier Deposition.

Document #78
03/21/67
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

S. Carson, Food and Drug Research Laboratories, issues report entitled “Summary of Histopathological findings in Primates.” Findings include cystic spaces with vacuolated cell and a few foreign body type cells in soft tissues and around minor salivary gland tissue and skeletal muscles, cystic spaces with vacuolated cells and foreign body type giant cells in both breasts, acute necrotizing pneumonitis in the lungs, similar changes in the submaxillary gland, degenerative changes in the kidneys, pleural fibrosis and edema in the lungs, small and large cystic spaces in the dermis and subcutaneous tissues, focal calcification in the adrenal glands, chronic stomach inflammation, and chronic phclonephritis in the kidneys. Include letter sent from F. Ashley to S. Carson dated 12/02/66 enclosing pathological slides showing area and amount injected and the autopsy date of the animal. Includes letter from S. Carson to S. Sternberg dated 01/04/67 enclosing slides prepared from tissues of sumi apes sent by Dr. Ashley; a member of the Silicone Injection Committee of the Dow Corning Corporation (Carson and Food and Drug Research Laboratories are consultants for Dow Corning Corporation). Carson writes:

“The tissues which Dr. Ashley submitted together with information regarding total volumes injected and the date of the last injection (copy enclosed) represent some of the most critical tissues available in the United States since they involve between two and three years of chronic study….This material represents the closest parallelism to human experience that we have been able to obtain in any animal studies to date.

… We have mentioned that this material is precluded from use in mammary tissue augmentation. However there is a considerable black market in a Japanese product which contains a similar silicone fluid with some type of oil.”

CITE: T 822 – 832, Exhibit 107 to Harris county Rathjen Deposition. DUPLICATE: F 316 – 326.

Document (On PLAINTIFF’S LITERATURE LIST)
(this is between #78 & #79)
04/00/67
(ON PLAINTIFF’S LITERATURE LIST)

F. Ashley, S. Braley, T. Rees, D. Goulian and D. Ballantyne author “The Present Status of Silicone Fluid in soft Tissue Augmentation” published in Plastic and Reconstructive Surgery, Vol. 39, No. 4, 411-420. The clinical use of silicone liquids in man preceded any responsible and controlled experiment in animals. The unresolved problem related to silicone is migration to distant organs, cautioning against its use for mammary augmentation. The authors report one case of unnecessary force during the injection of silicone that may have caused blindness in one patient by possibly disrupting the arterial or venous system. They also caution against using silicone fluid with any additives such as olive oil.
CITE: PSC Medical Articles CD, J 157 – 166

Document #79
04/28/67
GEL MIGRATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

“Reproduction Study, Albino Rats, TX-114, Dow Corning Tox. File No. 1059-5” conducted by Industrial BIO-TEST Laboratories, Inc. and sponsored by Dow Corning Corporation. PDMS, 350 cs., was tested for its effects on fertility, reproductive performance, embryongenesis and perinatal and postnatal performance in rats and rabbits. Albino rats given up to 1000 mg of TX-114 per kilogram of body weight daily by subcutaneous injection show normal growth patterns, have the desire to mate and the ability to conceive, carry the reproduction process to parturition and are able to successfully nourish the resulting progeny. The offspring are free of external and internal malformations and are judged to be normal as indicated by both normal survival indices and progeny body weights. Treatment with TX-114 from implantation through the completion of organogenesis did not produce teratogenic effects in the rat. Lactation, measured in rats by dosing parental animals from the end of fetal organogenesis through the lactation period, was unaffected by daily subcutaneous administration of TX-114.
CITE: P 13605 – 13611

Document #80
04/28/67
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
TISSUE REACTION

“Studies of the Effects of Dow Corning 360 Medical Grade fluid (MDX-4-4011) on Reproduction in Rats and Rabbits” conducted at Food and Drug Research Laboratories and sponsored by Dow Corning. This polysiloxane compound was subcutaneously administered to rats and rabbits. One significant effect is a dose-related incidence of in-utero mortality at 200mg. and 1000 mg. during the third trimester of rat pregnancy. (FDA 26359 – 26377: T001064 – 001103). Eldon Frisch, Dow Corning, in a 12/31/87 document claims that this study was inconclusive. The fetuses of some rats had “slight increase in frequencies of incomplete developed sternebra and incomplete closure of cranial bone. Some rabbits in the FDRL study had slightly higher in utero mortality.”
CITE: T 1064 – 1103 (Referenced in KMM 407480 – 407482).
NOTE: See 12/31/87 entry. DUPLICATE T 996 – 1029.

Document #81
07/19/67
MISCELLANEOUS
SILICA STERILIZATION/CONTAMINATION
“Dip Coated Mammary”, project no. MD-50 by P. Lange, L. Crusen. This report constitutes the final phase in the transfer of Medical Development Project No. 50, dip Coated Mammary, to the Medical Products Plant. This report contains the raw material specifications, formulations, manufacturing procedures, formulation specifications and the dip coating procedure and specifications.
CITE KMM 320434 – 320454.

Document #82
08/17/67
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – PRODUCT LABELING
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Women’s Wear Daily article titled “Dow Corning Indicted on Breast Expanding Fluid.” charges include illegal distribution and improper labeling of Medical Fluid 360. It is charged that the labeling failed to include adequate directions for use and adequate safety warnings. The indictment also charges that the drug had not been approved by the FDA and had not been exempted from the normal requirements of the Food, Drug and Cosmetics Act.
CITE: GEG 8984 – 8986.

Document #83
10/18/67
TESTING

J. McHard, Dow Corning, memo to I. Hutchinson, Bennett, Dingman, Hunter and Don McGhan describing the policy in the toxicological evaluation of Silastic silicone rubber for implant use. It involved a two year implantation in dogs with one interim sacrifice in six months. Providing there was no toxicity and tissues looked normal, marketing could begin after six months. Based on recent information from the Medical Products Division, he believes that Dow corning is not strictly adhering to its toxicological evaluation policy. CITE: KMM 337147

Document (NOT ON PLAINTIFF’S EXHIBIT LIST)
(this is listed between #83 & #84)
10/30/67
(NOT ON PLAINTIFF’S EXHIBIT LIST)

Hobbs, Dow Corning, memo to H. Dingman, Hutchison, Don McGhan, McHard, and Pellikka regarding “Minutes of Meeting Held October 27, 1967.” The meeting was held at the request of Hutchison: “to discuss toxicity testing of SILASTIC implants and more specifically the penile implant.

Ira expressed his feelings relative to the necessity of 2-year toxicity studies on new materials in dogs. In general he feels the 2-year study is not necessarily due to the absence of carcinomas being produced when foreign bodies have, through the years, been implanted into the human body. Ira did feel the 2-year data would be advantageous to have on record in case of product liability and also if and when the FDA assumes the regulation of devices.

J.A. McHard expressed the recommendations of the Product Safety Committee based on advice from various Dow Corning consultants, i.e., Steve Carson, V.K. Rowe, Joe Calandra and (illegible). This recommendation is that new SILASTIC (illegible). This recommendation is that new SILASTIC (illegible) to be used for long-term implants shall have a 2-year carcinogenicity study in dogs. Preliminary marketing could begin after the testing had progressed six months if tissues are normal.”
CITE DCC 204001107 – 204001108.

Document #84
11/10/67
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION
SILICA

Hobbs and Himmelsback memo to Barry, Bennett, Clark, Fenn, Greenhalgh, Hansen, Hargreaves, Hedlund, Hunter, Hyde, Donkle, C. Lentz, Maneri, McHard, Nelson, Quinn, Ragborg, Ringey, Stinton, Tyler, Weyenberg and Zeman regarding “Status of the Toxicity and Industrial Safe Handling of J-DCA.” J-DCA is Dow Corning Silica A; results from a recent study indicate that under certain conditions, exposure to this “will cause significant change in the links.”
CITE: DCC 281041072 – 281041074.

Document #85
12/15/67
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
TISSUE REACTION

Food and Drug Research Laboratories issues its report to Dow Corning Corporation, “Studies of the Effects of Injected Dow Corning 360 Fluid In Dogs.” Fifteen beagles were subcutaneously injected with Dow Corning 360 fluid in the scapular region for ten successive days. There was a shifting of the injected mass, signs of mange, fluctuations in weight, elevations of the hemoglobin concentrations, differentials in the leukocytic counts, congestion and changes in all organs. One of the beagles died with congestion of the liver, kidneys and heart accompanied with hemorrphagic changes in the lungs and the adrenals.
CITE: T 1202 – 1209, Exhibit to Petratis Deposition. DUPLICATE: T 1251 – 1302; KKH 8185 – 8290; FDA 33172 – 33227; F28 -79.

Document #86
01/04/68
MISCELLANEOUS – ORGANIZATIONAL SURVEY

Minutes of the Board of Director’s Meeting of Dow Chemical Company with a reference to loans and advances made to Dow Corning Corporation.
CITE: TDC 11702 – 11703, Exhibit to Bennett Deposition, and Exhibit to Julius Johnson Deposition.

Document #87
02/20/68
KNOWLEDGE OF LIQUID SILICONE DANGERS

Bureau of Regulatory compliance reports on the prosecution of Dow Corning, Bass, Rhodes, and McIntyre for selling a new drug – Dow Corning 360 Fluid – without an approved New Drug Application.
CITE I 470.

Document #88
02/28/68
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Steve Carson, Food and drug Research Laboratories, issues a Supplement to the Report on “Studies of the Effects Of Injected Dow Corning 360 Fluid 350 cs In Dogs. ” Following a single subcutaneous injection, silicone was transported to all organs via the lymphatic or vascular network.

“(D)espite parenteral route of administration, C(14) (DC 360 Fluid) was present in the gastrointestinal tract, in the aorta and apparently in the lymphatic pathways as evidenced by the lymph nodes, and salivary glands, thus suggesting that transport and distribution in these animals was via the vascular system, the lymphatic, and recirculation via the bilary tract.”

Distribution occurs throughout the entire body with no apparent concentration in any specific organ. In Dow Corning’s Toxicology Report Reference 99, Dow Corning’s abstract states, “The distribution of radioactivity was ubiquitous with evidence of greater activity in liver, spleen, kidneys, heart, lungs and brain.

CITE: T 38842 – 38866, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE: KKP 16422; FDA 26696 – 26701; I 1333 – 1341; KKP 16422 – 16431; M 100145 – 100154.

Document #89
03/07/68
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Minutes of the Board of Directors’ Meeting of the Dow Corning Corporation with reference to the officers of Dow Corning being approved to sell to Dow Corning employees common stock in the Dow Chemical Company. The minutes also refer to an agreement between Dow Corning and Dow Chemical for joint research, development, evaluation and commercialization programs on the physiological effects of organosilicon compounds.
CITE: DCC 101001529 – 101001543, Exhibit to Bennett Deposition, Exhibit to Julius Johnson Deposition.

Document #90
04/22/68
TESTING
TISSUE REACTION

“Histopathological Findings In Animals of Various Species from Experiments conducted by Thomas D. Rees” is prepared S. Carson and Food and Drug Research Laboratories for Dow Corning Corporation. Findings using mice include various tissue reactions in the liver, spleen, kidney, fat, adrenal glands, pancreas, ovaries, uterus, endometrium, lymph nodes, small intestine, and stomach. Findings using rats include various tissue reactions in the fat, spleen, kidney, pancreas and adrenal glands. Findings in guinea pigs include various reaction in the fat, kidney, pancreas, adrenal glands, spleen and liver. Findings using hamsters include various tissue reactions in the fat, spleen and kidneys.
CITE: T 1467 – 1528

Document #91
04/26/68
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA
MISCELLANEOUS – LOBBYING
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Rowe, Dow Chemical, letter to Goggin, the new President of Dow Corning (who was recently transferred from Dow Chemical), regarding Dow Corning’s need to establish its own toxicology laboratory. Rowe states that Dow corning has a “poor image” with the FDA which is “partly deserved, partly undeserved.” He suggests that Dow corning needs a “change in philosophy” to turn its image around. He writes:

“Respect in Washington or elsewhere cannot be acquired except by earning it through demonstrated competency, integrity, and an open willingness to cooperate. I have had the feeling at times in the past that these desirable characteristics have not always been apparent, in fact, it has seemed to me that there has been a reluctance to deal openly with the FDA. An antagonistic approach toward the FDA usually, in my experience, results in a reaction on their part which, sooner or later, becomes apparent in one form or another and will be regretted.”

(p. 1) Rowe recommends that Dow Corning create a position entitled “Director of Government Regulatory Relations” to interact with the FDA and help Dow Corning’s image. He also recommends that Dow Corning Establish a toxicological laboratory in-house so that they are able to “know and understand the physiological properties of all such materials.” (p. 6) The Dow Corning laboratory should be patterned after the Dow Chemical laboratory. Rowe recommends Dow Corning hire Ken Olson of Dow Chemical for this position. He also explains that:

“It appears to me that one of the most important areas for toxicological study of DC materials, particularly those designed for use in or on human beings, is that which may be called biochemical. By this I mean studies which will completely describe the fate of materials applied to, or administered to, the intact living organism including animals and plants.” (p. 9)

CITE: DCC 410000031 – 4100000040, Exhibit 2 to Bennett Deposition, Exhibit 1 to LeBeau Deposition, Exhibit 6 to K. Olson Deposition, and Exhibit to Rowe Deposition.

Document #92 & #93
05/23-24/68 (this is listed as #92 & #93)
ACKNOWLEDGEMTN OF NEED FOR TESTING
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Minutes of Meeting at Midland on May 23-24, 1968 with representatives form Dow Corning, Industrial Bio-Test, Food and Drug Research Laboratories, and the Dow Chemical Company.” Attending were Bennett, Calandra (IBT), Carson (FDRL), Bennett, Frisch, Hobbs, Hunter, Hutchison, McHard, Radzius and Rowe, Dow Chemical. The subject of the meeting was a “Toxicology Review of Dow Corning Products.”
CITE: DCC 281041054 – 281041059.

Document #94
05/31/68
TESTING
TISSUE REACTION

FDA: “Informational Materials Supplied To clinical Investigators” provided to the FDA sponsored by Dow Corning corporation for Dow Corning 360 Medical Fluid 100 Centistokes (as used for the immersion of burn victims). The purpose of this study is to evaluate continual immersion therapy as a treatment modality in the management of the burned patient. The fluid in which the patient is to be studied is Dow Corning 360 Medical fluid of a viscosity of 100 centistokes. Dow Corning 360 Medical Fluid (MDX-4-4066 Fluid) is a dimethylpolysiloxane fluid and is identical to the product known to FDA scientists as Dow Corning 200 Fluid except that more rigid quality control procedures have been established for the medical grade product.

This fluid had been tested on pigs, monkeys, rabbits and dogs at Food and Drug Research Laboratories. Observations were made of the effects of administration to rabbits and rats of diets containing 1% Dow Corning 360 Medical fluid, 50 or 350 centistokes, for eight to twelve months, respectively. These were compared to effects resulting from administration of the basal ration alone. No significant differences were found between the groups receiving the polysiloxanes and the basal control in growth or any of the parameters of physiological function, organ weight, or tissue morphology.

Clinical experience with silicone immersion has included the immersion treatment of thirteen healthy unburned control vs. eighteen burned victims and the immersion treatment of one patient suffering from toxic epidermal necrolysis. Results indicates that silicone immersion is contraindicated in burn cases with open-chest injuries and/or venous cutdown on the leg. Continued immersion is contraindicated if sever skin rash develops which does not resolve with adequate skin hygiene and/or rigorous quality maintenance of the silicone fluid.

Immersion may precipitate or increase hallucination. Immersion results in external fluid pressure on the chest which may produce sufficient splinting effect to reduce chest motion and prevent adequate aeration of the lungs in those patients who are debilitated or who have chest injuries. Intermittent positive pressure breathing may be required in these cases to enhance aeration of the lungs.

Skin rash has been observed in immersed patients. Severe and persistent skin rash which does not resolve with adequate skin hygiene and quality maintenance of the fluid is adequate reason to terminate immersion.
CITE: KMM 104968 – 105041.

Document #95
06/03/68
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
TESTING

Dow Corning completes a study of the biological distribution of dimethylpolysiloxane in adult male mice. Significant amounts of radioactivity were found in the tissues and body fluids analyzed. The level of absorption and the biological distribution of the radioactivity were not dependent upon the molecular weight distribution of the fluid or the method by which the fluids were administered.
CITE: DCC 281001381 – 281001399, Exhibit to Harris Country LeVier deposition, Exhibit 3 to Harris Country Rathjen Deposition, Exhibit 19 to Harris County Zahalsky Deposition, Exhibit to Harris County Tyler Deposition, and Exhibit to Weyenberg Deposition. DUPLICATE: M 100155 – 100174; DCC 242031103 – 242031121; FDA 43184 – 43202.

Document #96
07/16/68
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE

FDA: Dr. Wilson writes a letter to Dr. Inscoe of the FDA regarding his analysis of the reproduction studies done on Dow Corning Medical Fluid 360 by Food and Drug Research Laboratories. He states that the reports “were not presented in such a way as to inspire complete confidence….” He also concludes the compound causes an “appreciable increase in fetal death and resorption in rabbits” which is dose related and also causes an increase in malformations in rabbits at certain doses. Thus, “the compound under consideration cannot be declared to have no teratogenic potential.”
CITE: KMM 128723 – 128724.

Document #97
08/08/68
GEL MIGRATION
TESTING
TISSUE REACTION

FDA: The FDA recommends that Dow Corning’s IND 2702 remain ineligible for reinstatement because of the lack of toxicity information, deficient protocols and the lack of declaration that the IND has no teratogenic potential. The FDA directs Dow Corning to provide data on the metabolic fate and migratory sites of silicone, including studies on the kidney and liver.
CITE: FDA 28545 – 28547. NOTE: See 09/24/68 entry.

Document #98
10/09/68
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Hobbs, Toxicologist at Dow Corning, letter to Dr. Charles Riffkin, The Squibb Institute for Medical Research, responding to his inquiry about the distribution and fate of injected silicones. He encloses the study, “Studies of the Effects of Injected DOW CORNING 360 Fluid, 350 cs., in Dogs,” stating:

“The results of this study indicate that distribution occurs throughout the entire body with no pronounced concentration in any specific organ. It is evident by the preliminary nature of this study that the fate and chemical nature of the material after it vacates the injection site is unknown

CITE: FDA 27154 – 27155, Exhibit to K. Olson Deposition.

Document #99
10/17/68
FRAUD/MISREPRESENTATION
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – PRODUCT LABELING
TESTING

Olson memo to Pail with copies to Bennett, Currie, Gergle, Hobbs, Hunter, McHard, Radzius and Vaughn regarding “Suitability for Industrial Use of Protective Hand Cream Formulated with Dow Corning FS-1265 Fluid Unstripped of Cyclic Trimer.” The Dow Corning Toxicology Department recommends the use of Protective Hand Cream, industrially, does not pose a significant hazard, and “represents an appropriate risk for Dow Corning.” Olson reviews the studies to date on FS-1265 Fluid including studies by IBT – 20 day subacute dermal study in rabbits (spermatogenic depression was found to be mild to moderate in the controls and not significantly different in the test groups); one-year dietary feeding study in rats (“There was evidence of decreased spermatogenesis in the male test animals”); IBT – 14 week dermal toxicity in rhesus monkeys (biopsies at 30-days showed testicular hypoplasia); Dow Chemical (cyclic trimer possesses a relatively high acute oral toxicity); and IBT – acute percutaneous absorption study. He recommends industrial use of Protective Hand Cream containing less than 15 p.p.m. of cyclic trimer and that this is an appropriate risk. “We wish to emphasize that the front label flagrantly (sic) misrepresents the product from an efficacy viewpoint. All data generated to date shows, unequivocally, that the cream does not protect against the irritating properties of the chemicals studied. Ethically, such advertising leaves much to be desired and is frowned upon by government agencies and all who are charged with matters pertaining to consumer protection and proper representation”
CITE: DCC 218041771 – 281041776, Exhibit to K. Olson Deposition, and Exhibit to LeVier, Deposition.

Document #100
11/29/68
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Steven Carson, Food and Drug Research Laboratories, issues a report on “Chronic Implantation Studies of Polysiloxanes In Dogs” contracted by Dow Corning. The report states:

“Chronic implantation studies were conducted in dogs over a three year period utilizing a variety of polysiloxane materials. When possible comparisons were made between solid and perforated wafers of individual materials implanted into intramuscular, subcutaneous and intraperitoneal sites. The number of implants utilized, provided for microscopic examination of replicate tissues at each time period, i.e. 3, 9, 24, and 36 months.

Inasmuch as each type of polysiloxane was evaluated independently no direct comparison between materials is provided, however the physical forms of each were compared. It may be concluded that in every instance the degree of reaction about the perforated implants was less intense than that associated with the solid implant, particularly with respect to the degree of fibrous reaction or extent of hyalinization or inflammatory cell reaction.

Samples of polysiloxane materials 370, 372 (including Cronin breast), fine and coarse sponge, silphenylene and LS each involved samples in which the physical form of the implant was the major variable. In the instance of the sponge implants (coarse and fine), a somewhat more intense connective and fibrous tissue reaction was observed with fine sponge in the initial 9 month period but lessened markedly at 24 and 36 months. The prosthetic breast samples with 372 revealed no untoward tissue reactions. Comparison of cured and uncured samples 386, 382, 5392, X-3-0855 and Medical Adhesive Type A generally revealed a more severe inflammatory cell reaction at 3 months in the uncured samples of 386, 5392 as compared to the cured samples. This reaction was absent at 24 and 36 months. The Medical Adhesive Type A differed, in that the initial tissue reactions were minimal in each.

Generally, no untoward chronic tissue reactions were noted with any of the implant materials. Systemic tissue responses were not observed at 24 or 36 months. There was no evidence of tumorigenesis, with any of the samples or at any of the sites of implantation over a 3 year period of testing in dogs.”

The first page of this report states that “this report is not to distributed outside Dow Corning Corporation.”
CITE: T 2033 – 2096, Exhibit 35 to Bennett Deposition (used by Dow Corning), Exhibit 29 to MDL
Rathjen Deposition (used by Dow Corning), and Exhibits 19 and 20 to Zahalsky Deposition. DUPLICATE: FDA 27384 – 27409.

Document #101
01/29/69
SHELL STRENGTH – THICKNESS
RUPTURE

G. Robertson, Dow Corning, memo to Koning regarding a mammary implant ruptured 1 1/2 years after implantation which was returned by Dr. Crosby. Robertson states, “(T)he envelope edges adjacent to the rupture, appeared to be of a very low tear strength. The physical properties of this envelope may never have been adequate.” (emphasis added).
CITE: KKH 1654

Document #102
03/24/69
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Franklin Ashley, a clinical investigator for IND 2702, writes to Dr. Frank McDowell regarding an article by Bishoff and Bryson on the carcinogenicity of silicone in fluid in rats and mice. Braley, Dow Corning, has reviewed the article and has stated to Dr. Ashley that:

“According to what he says, and he would not want to say this to you, he feels that this article is well written and should not be published. I agree.”

CITE: OOM 320814.

Document #103
06/10/69
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Memo from Olson to Frisch with copies to Bennett, Hobbs, Hunter and Radzius regarding “Telephone Communication with Dr. John Wilson of Johnson & Johnson.” Dr. Wilson, toxicologist at Johnson & Johnson, was contacted by telephone regarding their subacute dermal rabbit study on Dow Corning 556 and 360 fluids and Dow Corning MDDX-4-4122 wash resistant base. Dr. Wilson stated that the materials had been applied to rabbit skin daily. All animals showed a trend toward testicular atrophy. “There was a suggestion of dose-response relationship with Dow Corning materials although the effects were not statistically significant. A subacute oral rat study is in progress.” Olson indicated to Wilson that Dow Corning would be concerned about positive findings with the second study and would be agreeable to meeting with them to compare their respective data.
CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K. Olson Deposition, and Exhibit to LeVier Deposition.

Document #104
07/15/69
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Food and Drug Research laboratories report on the findings in the chronic parenteral (intraperitoneal) study initiated by Dr. Ballantyne, Rees and Hawthorne at the NYU School of Medicine. After silicone fluid in the peripheral erythrocytes in early hematologic examinations was observed, Dow Corning transferred the study and its financial sponsorship from NYU to Food and Drug Research Laboratories. “When the animals received 51 cc and 62 cc of fluid, inflammatory cells were observed in the spinal meninges (which was not stated in earlier reports). Injections of large volumes of silicone produces wide spread deposition throughout the reticuloendothelial system, silicone vacuole accumulation in cells and a systemic distribution of silicone droplets.

CITE: T 2866 – 2945 (The study is referenced in FDA 26875 – 26889). NOTE: See 06/30/75 entry.

Document #105
08/06/69
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Isquith, Dow Corning Biomedical Research Laboratory, memo on the “Current Status of Microbiological research.” Isquith states that:

“The main purpose of the survey is to help in establishing the basic relationship between organosilicon structure and biological activity, the further pursuit of which rests with our own secondary stage research activity into the physiology (metabolism, mechanism of action, site of action, etc.) of the compounds and a good screening procedure for identification of developmental potential. (DCC 16000004)

Another area for research is the development of a biological assay for determination of organosilicone interferon induction. (DCC 16000004). Dow Corning has developed sufficient expertise in viral methodology to conduct the assay, but “there would be considerable advantage in using such a system (more stable virus, greater lethality) as is currently being employed in a survey for interferon inducers at Dow (Chemical) Human Health by Dr. N. Miner….” (DCC 16000005) He recommends using Dr. Miner’s lab for seeking a long lasting interferon inducer among organosilicone compounds. (DCC 16000006)

Finally, another area is the “Investigation of Physiological Effects of Some Organosilicon Compounds.” (DCC 16000011). Isquith concludes that the area of microbiology in relation to organosilicon chemistry “is mushrooming at a pace that even now we are unable to adequately provide this cover. A wise investment at this time would be the hiring of a virologist (M.S. preferably) with training in tissue culture, virology, and immunochemistry. I have not had time to investigate thoroughly, but feel there is a good chance for development of possible potential in the areas of hypersensitivity, graft rejection, and autoimmune disease (arthritis, glomerulonephritis, etc.) which should be within the scope of a person with the training I suggested.” (DCC 16000014)

CITE: DCC 16000002 – 160000014, Exhibit 2 to Isquith Deposition, Exhibit 3 to D.McGhan Deposition, Exhibit to Blocksma Deposition (used by plaintiffs and Dow Corning), Exhibit to LeBeau Deposition, Exhibit to Bennett Deposition, Exhibit to Boley Deposition, and Exhibit to Julius Johnson Deposition WITNESS: “Bennett (Authenticated in Isquith, Vol. I, 119-120).

Document #106
08/14/69
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Letter of agreement between Dow Chemical Company, Dow Corning Corporation and Lepetit SpA for a joint development program regarding the biological activity of organosilicon compounds. The agreement requires the full disclosure of all proprietary and confidential information of each party to the agreement to each other party.
CITE: TDCH 1275 – 1276.

Document #107
11/15/69
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Doremire memo to Bennett regarding chemical warfare and riot control agents, XZ8-3063. This is a silicone glycol. It goes through the skin as if there was no skin there. “Do you have any suggestions for a chemical that could be added to XZ8-3063 which would cause a variety of effects? These effects could vary from a drug that would act as a simple tranquilizer to a drug which would cause a loss of consciousness.” In the case of riot control, the drug might be effective for 1/2 hour whereas a chemical warfare use might need 2-4 hours effectiveness. He plans on checking with the “Analytical Laboratory on toxicity information.

CITE: DCC 281014081, Exhibit 3 to Harris County LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to Bennett Deposition, Exhibit to McHard Deposition, and Exhibit to Ryan Deposition.

Document #108
00/00/70
00/00/71
00/00/72
FRAUD/MISREPRESENTATION

Dow Corning advertisement; “New sterile package provides Silastic Mammary Prosthesis ready to implant. This convenient, sterile blister pack assures greater product reliability, eliminates excessive handling and can be easily opened with scissors.” It also includes references to sizing rings and that the mammary implant no longer is fitted with fixation patches.
CITE: M 700003; M 700008 – 700009. DUPLICATE; M 370049 – 370052; M370108 – 370109; M 370113 – 370114; KKH 62679 – 62682; M 700019 – 700020.

Document #109
09/20/76

Hobbs, Dow Corning, memo to Hinsch with a copy to Lentz regarding information concerning migration of silicone gels. Hobbs states that experimentation had not demonstrated migration of Dow Corning mammary gel but this factor does not appear to be true for all silicone gels. Hobbs further states that gels having a low consistency due to low levels of cross-linker appear to migrate along tissue planes in much the same manner as large injected doses of silicone fluid.
CITE: M 170104, Exhibit 130 to Burda Deposition; Exhibit 91 to Braley Deposition. DUPLICATE: M 570060. NOTE: The document was listed as 00/00/70 on Plaintiff’s Trial Exhibit List.

Document #110
01/12/70
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

Silas Braley, Dow Corning, memo to various Dow Corning employees distributing interim research report on the investigation of Dimethylpolysiloxane Fluid Injections at the Institute of Reconstructive Plastic Surgery, New York University. The interim report states that “our most interesting recent findings indicate that in both mice and rats, injection of large volumes of liquid silicone, either interperitoneally or subcutaneously, in multiple injections, apparently produces a wide spread deposition of this material throughout the reticuloendothelial system. A more recent finding of some interest is that there is an apparent accumulation of silicone vacuoles both within the red cells and the leukocytes of the peripheral blood in mice and rats, which appears about one to three months after injection and persists for several months.” The NIH grant will run out in about one year and these studies will have to be terminated. “It is our feeling that the evidence of systemic distribution of silicone droplets or vacuoles can not necessarily be considered an adverse effect, but is more likely related to total dosage. The dosages employed in animals rarely can be achieved in man with the possible exception of breast injections….”
CITE: T 2881 – 2885. NOTE: The report itself was an Exhibit to the K. Olson Deposition (KKH 9841 – 9845). This document also has the Bates number OOM 321368 – 321672 on it.

Document #111
02/02/70
STERILIZATION/CONTAMINATION

J.H. Wetters, Dow Corning Medical Products Plant, Report No. 229 to Burdick with copies to Reilly, Mantle, Piper, Don McGhan, Houle and Robertson regarding “White Particle Contamination of the Mammary Gel.” The major contaminant was found to be crystalline by microscopy and potassium chloride and potassium bicarbonate by x-ray. Wetters cannot explain the presence of potassium bicarbonate. The white poly lined can in which it is contained could possibly be the source of this material.

J.P. Fitzgibbon feels that the crystalline potassium salts are the major portion of the contamination. “Gordon Robertson and Ken Olson should be contacted for an opinion as to whether these potassium salts are harmful.” (MM 234057)
CITE: KMM 234056 – 234057.

Document #112
02/18/70
KNOWLEDGE OF LIQUID SILICONE DANGERS
ACKNOWLEDGEMENT OF NEED FOR TESTING
TISSUE REACTION

Report prepared Food and Drug Research Laboratories for the Dow Corning Toxicology department. There are relatively little specific experimental data available on the reactivity of biological systems to silastics and polymethylsiloxane (PMSs) fluids. Prior studies by other laboratories showed “significant testicular atrophy resulted” from topical application of a polymethylsiloxane fluid. In the present study, 15 applications of PMS fluid was applied topically on rats, guinea pigs, rabbits and dogs for a 20-day period, and was administered in the diets of rats and rabbits for eight months. In the rabbits that were topically applied with PMS fluid, “the reduction in the testicular weights of the PMS-treated rabbits is considered biologically significant.”

In the rats that had PMS administered orally for one year, growth was retarded as early as the first week in feeding. The differences in weight gain between the test and control groups was “statistically significant” during the third week, with the weight gain in the test group lower than the control. In the female rats, there were “notable endocrine effects,” smaller ovaries, enlarged pituitary, and increased weight in the adrenals and thyroids.

In the rabbits that had PMS administered orally for eight months, there was a “trend toward decreased testicular size in the test group…,” a tendency toward lower hemoglobin and hematocrit in all rabbits in the test group, “some effect of PMS fluid on sperm maturation…,” and testicular atrophy in the test rabbits.
CITE: T 2302 – 2341, Exhibit to K. Olson Deposition, and Exhibit to LeVier Deposition.

Document #113
02/19/70
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
SILICA

Dow Corning study titled “Acute Inhalation of 14C-Labeled J-DCA” (silica) by Hobbs and Lacefield finds that the acute inhalation of a relatively large amount of J-DCA appears to confine its residence and effect to the lung. The low levels of J-DCA found systemically is a strong indication that the acute adverse response is confined to the lung. This would also indicate the lung to be the target organ from a chronic exposure.
CITE: DCCF 5008903 – 5008907, Exhibit to K. Olson Deposition.

Document #114
03/02/70
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING

D. Ballantyne letter to E. Hobbs, Dow Corning, answers questions about the investigation regarding dimethylpolysiloxane fluid raised by Hobbs’ letter of 02/19/70. Current findings show an apparent accumulation of silicone vacuoles that were observed on the erythrocytes of rats only. He currently has studies underway on mice and baboons but the results are not substantial at this time. A research paper should appear in the April issue of the Reticuloendothelial Society.
CITE: T 2888 – 2889.

Document #115
04/13/70
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
RUPTURE
TISSUE REACTION

Olson memo to Boone with copies to Hunter, Hobbs, Koning, Radzius and Stark regarding “Inflatable Mammary Toxicology.” He responds to Boone’s memo stating, “The stability of dextran solutions in an implant situation over the long haul, particularly if there is diffusion of body fluids across the membrane would be difficult to accurately assess without biological data generated under use conditions. It is important to know these things prior to marketing. With my cursory knowledge of the problem I would tend to feel that such a device might cause some patients and Dow Corning some degree of grief. I would think that a rather extensive clinical investigation is indicated in order to assess benefit versus risk for Dow Corning.”
CITE: KMM 146382-146384.

Document #116
04/14/70
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

“Two-Year Implant Studies with Silastic Materials in dogs” by S. Carson and Food and Drug Research Laboratories for Dow Corning Corporation. Carson states:

“A two-year study was undertaken to evaluate the effects associated with implantation of silastic materials into three sites of beagle dogs. Its purpose was to determine the tissue reaction and systemic effects associated with the implantation of silastic materials into subcutaneous, intramuscular, or intraperitoneal areas in dogs and to evaluate these responses to the implants with relation to time. No adverse findings were seen which could be associated with the implantation of the test materials. Fibrous capsule formation is the only histomorphologic change found in these animals. Capsule formation was of a 1 to 2+ thickness during the first six months of study and ranged from 2+ to 3+ thickness during the final examination after two years of test. In several cases, inflammatory cell reactions were also found. These were however anticipated, and were observed at the six-month and two-year sacrifice periods. The findings, therefore, are primarily associated with a minimal degree of foreign body reaction and no adverse systemic pathological manifestations are associated with the implantation of the silastic materials.

CITE: T 1529 – 1572.

Document #117
04/20/70
TESTING
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE

A study contracted to Food and Drug Research Laboratories by Dow Corning entitles “Two Year Studies with Miniature Silastic Mammary Implants TX-202A and TX-202″B in Dogs, Dow Corning Tox. File No. 1306-3” is sent to Dow Corning. In this study, one of the four dogs died and the three others had a chronic inflammatory response to the implants. While FDRL reports that the only adverse effects two years after implantation are fibrous tissue encapsulation and chronic inflammation, the attached chart (Table 3) shows reactions at 6 months of “large granulomatous mass adjacent to capsule” and “liver and kidney-congested.” Dow Corning submitted this study, with the incorrect chart (Table 3) as part of its PMA Double Lumen Silastic II and Silastic MSI Gel Saline HP application.
CITE: F 462 – 483, Exhibit 9 to California Braley Deposition. DUPLICATE: p A75460 – 17482; T 2363 – 2383. NOTE: See 00/00/73 – F 12 – 16; P 17491 – 17496; and Depo. of Bobby Purkait, MDL 926, p. 50-51, Exhibit 22 (07/09/93).

Document #118
05/06/70
RUPTURE
SHELL STRENGTH – THICKNESS

J.K. Boone, Dow Corning , handwritten note to F. Stark regarding inflatable mammary development assurance. Boone writes:

“The bags for the inflatable mammary prostheses are taken directly from the production of the standard seamless mammary. It is expected that gel filled bags are softened by the gel somewhat, giving an ultimately softer bag with somewhat higher elongation. Thickness of the bags varies with the size and width, but it is ordinarily between 0/010″ and 0.020” with the average being about 0/017.

Several individual prostheses were subjected to severe testing (after filling and tube removal). They were slammed repeatedly against a smooth wall. Valves functioned well, bags can be broken under stress without the valves leaking.

To date, 153 of these devices have been submitted to quality assurance, and 18 of these have been rejected for a variety of reason. Leakage through the valve has not been a problem.

It is very difficult to project the eventual clinical failure rate for this device at this time. I would estimate failures less than 1% on devices successfully implanted, another failure rate should be expected for devices damaged during surgery. These will be immediately detectable as these devices are filled. This will cause professional irritation but little liability. Patients are being cautioned that these devices may break or leak at some later date…. The device now marketed (gel filled) has certainly not been complication free but to date it has not caused us severe liability problems. Over the long haul, I would guess that we might be sued about as often for hard, painful breasts as for ‘shrinking’ ones.”

Document #119
06/01/70
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
SILICA
TISSUE REACTION

Minutes of the Inflatable Mammary Meeting sent to Bennett, Boone, Bennett, Hobbs, McIntyre, Olson, Rathjen and Stark.

CITE: KMM 77733 – 77750, Exhibit to Bennett Deposition and Exhibit to
Isquith Deposition.

Document #120. (ALSO LISTED AS 121.)
06/16/70
TESTING
SHELL STRENGTH – THICKNESS

Boone, Dow Corning, memo to Hobbs and others regarding the “Physical Property Testing on Two Year Implant Specimens.” The study was by Food and Drug Research Laboratories on silicone elastomers implanted intraperitoneally, intramuscularly and subcutaneously. Fifteen dogs were tested with silicone elastomer and seamless mammary constructions. The results showed “in almost all cases (that there has been some rise in durometer with attendant loss in elongation and increase in modulus of the materials.”
CITE: T 1573 – 1577. (Document # 121 on the Trial Exhibit List states that this document does not have a Bates Number).

Document #122
07/08/70
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Olson letter to Michael Robbins, Pharmaceutical Division of The Dow Chemical Company in Indianapolis, regarding Robbin’s recent request for information on the toxicity of dimethylpolysiloxane when injected intravenously into laboratory animals. A search of the toxicology files at Dow Chemical reveals that preliminary acute and subacute studies were conducted in 1956 on Dow Corning 200 Fluid, 350cs.” He then summarizes the data where 2 of 4 rabbits died immediately after being injected with DC 200 fluid at .50 g/kg, 2 of 4 died at 1 g/kg dose and all 4 died at 2 g/kg dose.
CITE: FDA 27229 – 27230, Exhibit to K. Olson Deposition, and Exhibit to Hinman Deposition.

Document #123
09/23/70
MISCELLANEOUS
SHELL STRENGTH – THICKNESS
STERILIZATION/CONTAMINATION

Dow Corning Corporation Report entitled “Manufacture of Silastic Mammary Prosthesis.” The purpose of this report is to provide a detailed description of the manufacturing processes involved in the production of Silastic Mammary Prostheses. The report gives a detailed description of the manufacturing facilities, product composition, processing materials, component specifications, manufacturing process and quality assurances. This report also includes product run sheets for the seamless mammary prosthesis and packaging component information and specifications.
CITE: KMM 223739 – 223806.

Document # 124
01/21/71
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Handwritten memo to Hunter from Bennett regarding “Trip Report -Europe, Jan. 6-20, 1971.” Section 2, beginning on p.10, discusses a visit with Lepetit Pharmaceutical co. in Milano on January 14-15, 1971. Present at this meeting were Wm. Caldwell, Zeller – Director of Central R&D, Carati – Lepetit legal counsel, Levier and Bennett. Levier and Bennett also met with Lerner.
CITE: DCC 281011474 – 281011491 (Temporary Dow Corning Bates Numbers 5455 – 5472), Exhibit to Bennett Deposition, Exhibit to Hinman Deposition, Exhibit to Isquith Deposition, Exhibit to Julius Johnson Deposition, Exhibit to LeBeau Deposition, and Exhibit to LeVier Deposition.

Document #125
01/26/71

Wayne Koning, Dow Corning, memo to Forrest Stark regarding a returned implant by Dr. Bankof. Jan Varner reported that this was an “old” style implant and that he “was able to break through the envelope with minimal effort and perhaps there is some degradation of the envelope over a period of time.”

Koning reports to Stark that “Jan appears to be loosing confidence in the stability of the envelopes physical properties over an extended period of time because of frequent comments that are being given recently by large volumes (sic) users that he calls on.” Koning also states that, “The terms, friable, disintegration and degradation are being used frequently in some areas to describe the condition of the envelope of removed SILASTIC (R) mammary prostheses.”
CITE: M 570119. DUPLICATE: KMM 335110

Document #126
03/09/71
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE
TISSUE REACTION

Morgan, Dow Corning, memo to Koning, regarding a complaint made by Dr. Condie concerning the composition of the silicone gel in a ruptured implant. The patient developed a reoccurring infection and staph infection four months post-op with fluid “oozing from the wound.” The memo states “the prosthesis was practically empty of gel and what gel was there was extremely fluid and oozed out of the prosthesis and the surrounding tissue…. It appears to me that we have had a gel breakdown but I did not discuss this in any way with Dr. Condie.”
CITE: KMM 423343 – 423344. DUPLICATE: KKA 152366 – 152367; CO 82 – 83. NOTE: Dow Corning was using V. Mueller as its sales agent.

Document #127
05/11/71
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Dr. Glenn Burt, Department of the Army, letter to Silas Braley, Dow Corning, reporting on an augmentation patient who “encountered a most traumatic experience. On the second postoperative day the patient developed a fever which during the next few days spiked tremendously – as high as 105 degrees – and the patient went progressively down hill so that we had to remove the prostheses on the twelfth post-operative day…. During this time she developed an erythematous rash, joint swellings, considerable weakness, and an enlarged liver, all of which made us feel this was a rejection type phenomenon.”
CITE: M 240089, Exhibit 46 to Hinsch Deposition (used by Dow Corning), Exhibit to D. McGhan Deposition, Exhibit 21 to California Braley Deposition, and Exhibit 5 to Harris County Burchiel Deposition.

Document #128
06/14/71
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Dr. Condie writes to Wayne Koning, Dow Corning, regarding a patient with breast implants who developed and “allergic reaction in the skin over the right breast, or an infection in the skin of the right breast. There was slight itching associated with the condition. This was also associated with some swelling of the upper lip and it was felt that she might have angioneurotic edema, however, with antibiotic therapy the cellulitis cleared up. This was approximately 16 days after she was first seen for the condition.” Six months later, the right breast again became red and swollen. Upon aspiration, silicone escaped from the needle’s puncture wound, resulting in wide spread necrosis. The implant was removed and Dr. Condie noted that “it was extremely difficult to remove all of the silicone which was flowing and not gel like in consistency.” Dr. Condie also states that the silicone in this case was “extremely watery and flowed very easily. I cannot help but feel in my own mind that there was something which caused chemical change in the silicone, making it liquid instead of a gel. The culture which was taken showed staph coagulasa positive.”
CITE: M 570103 – 570104. DUPLICATE: KMM 98372 – 98373; M 240090 -240091.

Document #129
07/07/71
SHELL STRENGTH – THICKNESS

Manikian, Dow Corning, memo to Boone stating that he has accumulated data on the “long term” stability of the envelope. He refers to three lost of mammaries – 1 from June 1966, 1 from August 1967, and 1 from April 1971. “There are changes in the physical properties of the bag after filling. Contact with the gel seems to soften the bag and lessen its tensile strength…. (W)e neither have data on the properties of a bag immediately after filling nor have in storage a large enough number of units to perform a controlled study.”
CITE: KMM 220303. DUPLICATE: KMM 223111 – 223114.

Document #130
12/13/71
STERILIZATION/CONTAMINATION

W. Koning memo to Bill Mantle, Dow Corning, which states “Bill, here is another hairy implant from Jan! Please comment. Too bad they didn’t reject before unsealing the package.”
CITE: KMM 423367.

Document #131
12/00/71
EMBOLISM
GEL MIGRATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS

Publication by Blocksma entitled “Experience With Demethylpolysiloxane Fluid In Soft Tissue Augmentation.” Plastic & Reconstructive Surgery, Vol. 48, No. 6, 564-567. The release of silicone fluid for general distribution could make every general surgeon think he has become a plastic surgeon overnight. Used improperly, silicone fluid has a serious potential for harm. Therefore the author is opposed to the release of this material to any but bona-fide plastic surgeons at this time.
CITE: DCC 204005370 – 204005374; Exhibit 71 to Braley Deposition, Exhibit to D. McGhan Deposition, Exhibit 45 to Hinsch Deposition (used by Dow Corning), and Exhibit 99 to Harris County Rathjen Deposition.

Document #132
00/00/72
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Article by Bennett, Gorzinski and LeBeau entitled “Structure-Activity Relationships of Oral Organosiloxanes on the Male Reproductive System,” Toxicology And Applied Pharmacology, Vol. 21, 55-67 (1972). The abstract at the beginning of the article states that:

“A series of low molecular weight organosiloxanes depressed male reproductive function in the mouse, rat, and rabbit. The rabbit was the most sensitive, and the mouse was the least. Active compounds were found among phenylmethyl-substituted silanes, linear disiloxanes, and trisiloxanes; cyclic trisiloxanes and tetrasiloxanes. Cyclic siloxanes were the most active cyclic. Monophenylheptamethylcyclotetrasiloxane was quite active; however, the presence of an additional phenyl group enhanced activity providing the 2 phenyl groups had the correct sterile configuration, i.e., 2,6-cis-diphenylhexamethylcyclotetrasiloxane….

A spectrum of activity was noted in the male animal when active compounds were administered po for 3-21 days. Small doses sequentially decreased seminal fluid, seminal vesicle, prostate and testes weight, associated with decreased blood levels of testosterone. Large doses caused adrenal hyperplasia, hepatomegaly, decreased body weight, and decreased serum levels of cholesterol, phospholipids, and alkaline phosphatase.”

CITE: DCC 281000743 – 281000755. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 547-548). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #133
04/00/72
FRAUD/MISREPRESENTATION

Dow Corning advertisement: “The Silastic Mammary Prosthesis makes a world of difference.” Over the past ten years “we have initiated 207 rigid quality control tests to assure the reliability of every prosthesis manufactured. We have continued to make significant design improvements. It is simply the most reliable answer to breast augmentation and restoration following subcutaneous mastectomy.”

CITE: M 700010. DUPLICATE3: KKH 62691; KKH 62692; M 370064; M 370065; M370106; M 370123: M 700011

Document #134
04/07/72
GEL MIGRATION

“Dimethylpolysiloxane Fluid 14C (Dow Corning 260 Medical Fluid 14C) Distribution and Disposition In Rats Following Subcutaneous Injection,” by LeBeau and Gorzinski of the Research Department of DC. A copy was sent to Ryan, Bennett, Braley, Hunter, Isquith, Frye, LeVier, Speier, Stark, Boley and others. DC 360 fluid was administered subcutaneously to rats to measure the distribution of the fluid in expired air, urine and feces at 8, 30, 60 and 90 days. The highest percentage (.94%) was detected at the original injection site <10% was detected in urine and feces. “There was a ubiquitous distribution of low concentrations of radioactivity in the tissues and organs (<.02%). However, lymphatic tissue near the injection site had a higher (ten-fold) concentration of radioactivity of all tissues and organs examined suggesting migration via lymphatic routes.”

Rodents receiving massive subcutaneous doses of silicone fluid were examined histopathologically. Droplets of vacuoles were found throughout the reticuloendothelia systems including the regional lymph nodes and extending to the liver, spleen, kidneys and adrenals. Definitive proof of silicone fluid in the droplets was not demonstrated but the authors assumed it was silicone fluid.

CITE: KMM 260056 and KMM 270609 – 270623, Exhibit to Bennett Deposition (used by plaintiffs and Dow Corning), Exhibit to Isquith Deposition, Exhibit to K. Olson Deposition, and Exhibit 3 to Harris County Rathjen Deposition. NOTE: The exhibit list also lists Bates Numbers T 2765 -2780 but there are no documents in the binder with these numbers. DUPLICATE: DCC 205001829 – 205001841; KMM 173800 – 173816; DCC 204004553 – 204004580;

Document #135
04/24/-26/72
TESTING
FRAUD/MISREPRESENTATION

Article entitled, “Toxicological Studies, quality control, and efficacy of the Silastic mammary prosthesis” is published in the journal Medical Instrumentation. Authors are Gordon Robertson and Silas Braley of Dow Corning. The article cites and discusses the FDRL Report on “Two-Year Studies With Miniature Silastic Mammary Implants” (P 017460 – 017496). Robertson and Braley reprint the 6 month test results in Medical Instrumentation and claim that these are the results after 2 years of implantation.

CITE: F 12 – 26, Exhibit to Palensky Deposition, Exhibit 19 and 20 to California Braley Deposition, and Exhibit to LeVier Deposition. DUPLICATE: KMM 249816 – 249822, J 5223 – 5226.

Document #136
05/04/72
TISSUE REACTION
SHELL STRENGTH – THICKNESS
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS

Silas Braley, Dow Corning, letter to Dr. Douglas Lake expressing his reservations about the use of silicone to fill inflatable implants. He states:

(T)here is a very good reasons for this: the silicone fluid being of the same basic nature as the silicone polymer used to make the rubber will dissolve into the rubber and very seriously weaken and soften it… Another factor which must be taken into consideration if a silicone fluid is used to fill a silicone rubber bag, is that the outer surface of such a bag will become oily with the silicone fluid. This means that the fluid is now capable of being absorbed by the body and very extensive toxicological work would have to be done to prove that this is not deleterious to the tissues…. We rejected the silicone fluids for the above reasons and went immediately to silicone gel. (emphasis added).

CITE: KMM 141906 – 141907, Exhibit 32 to California Braley Deposition.

Document #137
07/14/72
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning Research Report No. 4006 (formerly classified) entitled “A Toxicological Evaluation Of Trimethylsilanol (Me3Si(OH2) In The Rat.” The authors postulated that two potential end products of the biological degradation of trimethyl en-blocked linear dimethylpolysiloxane polymers or cyclic dimethylpolysiloxane polymers might to Me3SiOH and Me2Si(OH)2. Other studies are currently underway at Dow Corning’s Biomedical Research Department to determine the potential for degradation of dimethylpolysiloxan polymeric species. (p. 4)

The authors conclude that there were no significantly different dose-related values for body weight, food consumption, hematology or organ weight ratios for liver, kidneys, adrenals, heart or gonads. There did appear to be a modest dose-related significant elevation of blood glucose in the Me2Si(OH)2 treated rats. There may also be a slight depression of the triglyceride blood level at the low dose of Me3SiOH and total lipid is at the low level of normality for this group as well. (p. 13)

CITE: DCC 281001689 – 281001726 (Temporary Dow Corning Bates Number 3424 – 3461), Exhibit 49 to Bennett Deposition (used by Dow Corning), Exhibit to Frye Deposition, and Exhibit to Isquith Deposition.

Document #138
08/18/72
MISCELLANEOUS – COMPLICATIONS
SILICA
TESTING
TISSUE REACTION

Robert LeVier and Michael Jankowiak, Dow Corning, report on “The Effects of 20 CS DC-360 Fluid And Related Linear/Cyclic Dimethylpolysiloxanes Administered Orally And Dermally For Four Weeks To Male And Female Rats On Whole Body Oxygen Consumption, Serum Total Cholesterol, Organ Weights, And Silicon Distribution.” There was increase in tissue thyroid weight; potential of accumulation increasing cholesterol; and slight increases in silicone levels for heart, serum, urine, liver and thyroid. In addition, the female rat appeared to accumulate more silicone than did the male rat.
CITE: DCD 154000169 – 154000188, Exhibit to Bennett Deposition. NOTE: The exhibit list identified this document as T20844 – 20863.

Document #139
10/17/72
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE
SHELL STRENGTH – THICKNESS

Dr. Gregory letter to Rathjen regarding an implant he ruptured unknowingly during surgery. Three months after implantation, the patient experienced redness on her breast and perforation of the skin with the implant protruding outside and “Gel dripping out of the hole.” He says that this “may be a blessing in disguise, because perhaps we have all been trying to make too soft and too fragile an envelope. I do not believe that the old envelope would have perforated as easily as this one did with the mosquito hemostat. Perhaps the viscosity of the Gel may have to be reconsidered in view of this particular type complication.”

CITE: KMM 54876 – 54877, Exhibit 9 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: B 949 – 950.

Document #140
11/16/72
ACKNOWDEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS COMPLICATIONS
TESTING
TISSUE REACTION

Dr. Bennett, Dow Corning, “Bioscience 1972 Status Repost.” Bennett states that “The interaction of the Chemicals in the biological organism can be detrimental to the consumer. A chemical which has no overt direct action in its own right but potentiates the action of a second chemical taken into the organism simultaneously, forces us to consider each

produce in its use situation to make sure that this phenomenon is not a hazardous one if it exists.” (p., 1) Also, biological research in all areas is being constrained because of economic considerations. “There is considerable interest in chemicals which affect viruses, cancer, population control, immuno-therapy, animal and plant hormones, aging, and genetic engineering.” (p.2)

Bennett recounts the major projects of each of the segments of the Bioscience Research Department: Animal Sciences – there is a continuing Evaluation of 2,6-cis, working with KABI and others; Microbiology – a program has been developed based on the creation of antimicrobial activity on surfaces of many diverse types; Plant Sciences – they are exploring antitranspirant activity of polydimethylsiloxane fluid; and Metabolism of Organosilicon Compounds – Bennett believes this unit is the “keystone in the development of silicon chemicals in profitable biological applications as well as continuing to assure the Corporation of the safety of present products.” (p. 4)

CITE: DCC 16001173 – 16001178, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. III, p. 630-631). DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Document 141
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Antimicrobial Research” prepared by Dr. Isquith. The objective is to “investigate the effect of ‘substrate-bonding’ of organosilicon antimicrobial agents on their potency; spectrum of activity; reaction to their agents (i.e., protein, lipids, detergents; mode of action; biodegradability; and toxicity in comparison to similar non-silicon containing agents.”

(DCC 16001104) Isquith notes that Weetall and co-workers published a series of articles on the use of alkoxysilanes to immobilize enzymes on inert surfaces, and that this technology is currently being developed as a processing aid in various industries. He states, “The bonded biologically active agent concept is further expected to greatly alter the immunological field….” (DCC 16001105) He notes a potential business opportunity for Dow Corning.

CITE: DCC 16001104 – 16001109.

Document #142
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE
SILICA

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Exploratory Virus and “Cell Biology” Prepared by Dr. Robert Lake. The objective is to “Examine the role of enjogenous Si, organosilicon modified viral antigens, and endogenously applied organosilicon compounds in modifying humoral and cellular-mediated immune response to animal viruses.” (LAK 50) There are three approaches to viral diseases – immunological, host-resistance, and chemotherapy. Defining a role for silicon containing chemicals in the immunological or host-resistance approaches will require examination of the basic interaction of these chemicals with the lymphoid elements of the cellular immune system, i.e., lymphocytes, monocytes, and granulocytes.

When organopolysiloxanes are installed in the blood, lungs, peritoneum or GI tract of the body, they illicit a selective interactive with macrophages. Macrophages are the first to encounter and process viral antigens in the immune response and “virtually control the outcome of and recovery from virus infection.” (LAK 50) The material is phagocytized by neutrophils and macrophages, redistributed to lymphoid tissue and a fibrous wall builds around the material. It is this interaction of macrophages that Dr. Lake would like to study because “the potential for organosilicones as modifiers of immunological phenomena has not been exploited.” (LAD 52) He states, “Critical variables such as polymer type, size, and organofunctional groups on the time course of these cellular responses have never been reported.” (LAK 50)

CITE: LAK 50 – 52, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit 1 to Randonovich Deposition, Exhibit to Boley Deposition, Exhibit 4 to Lake Deposition, and Exhibit to LeVier Deposition, DUPLICATE: LAK 47 -49. WITNESS: Bennett (Authenticated in Isquith, Vol. II p. 423:15 -424:11). DEPOSITION; admitted in Toole (II) v. Baxter Healthcare.

Document #143
00/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DESEASE

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Organosilicone Polymer Particle Technology.” The objective is to “Synthesize uniform particles of a number of organosilicon resin polymers” to create reactive drug sites on these particles. The particles could be given locally or systemically as direct drug deliver systems, i.e., the instillation of a local anesthetic bonded to an organosilicon resin in joint spaces, GI tract, etc. to relieve pain. They could also be diagnostic or therapeutic uses such as binding antigen and/or antibody or used in diagnostic immunological tests. (DCC 16001050)
CITE: DCC 16001050 – 16001055.

Document #144
00/00/73
TESTING
FRAUD, MISREPRESENTATION

Robertson and Braley, Dow Corning, author “Toxicological Studies, Quality Control, And Efficacy Of The Silastic Mammary Prosthesis,” relying on the 1970 dog study. They use a chart to illustrate complications and claim that the findings are the results at the end of the two-year study, when the chart is actually the findings at six months.
CITE: T 3003 – 3006

Document #145
00/00/73
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION

A Dow Corning study examines the suitability of injectable silicone fluid for soft tissue augmentation. Four observed positive tumorigenic findings of fibroadenoma and fibrosarcoma are dismissed as tumore characteristically and typically seen spontaneously in rodents and not related to treatment with silicone fluid. Data reveals phagocytosis evidenced by the presence of macrophage histiocytes and basal giant cells, with absorption of silicone and deposition throughout the reticuloendothelial system.
CITE: KMM 48449 – 48498.

Document #146
03/12/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
SHELL DEGRADATION

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Biodegradation” prepared by Dr. Isquith of Dow Corning. The objective is “To determine the ability of microorganisms to biodegrade a polydimethylsiloxane (PDMS) structure and the subsequent microbial fate of its degradation products.”
CITE: DCC 16000273 – 16000279

Document #147
03/19/73
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study from Bennett, Statt, LeBeau, Golzinski, E. Wiessbruger, J. Weissburger and Ulland regarding item 17, “Primate Absorption and Elimination Balance Studies Including Pulmonary, Urinary, Biliary and Fecal Excretion of T-butanol, Trimethylsilanol, Dimethylilanediol and Hexamethyldisiloxane,” item 18, “Primate Absorption and Elimination Balance Studies Including Pulmonary, Urinary, Biliary and Fecal Excretion of Octamethyl-cyclotetrasiloxane and 2,6-cis-Diphenylhexamethylcyclotetrasiloxane,” item 19 “Chronic Toxicity and Carcinogenicty of Industrial Chemicals and Pesticides.”
CITE: DCC 281061215 – 281061216, Exhibit 56 to Bennett Deposition (used by Dow Corning).

Document #148
04/05/73
EMBOLISM
KNOWLEDGE OF LIQUID SILICONE DANGERS
STERILIZATION/CONTAMINATION

Report by S. Braley, Dow Corning, of telephone conversation with Mrs. Herman D. Jones of the Georgia Crime Lab regarding a death caused by a breast injection of silicones. Pathologist reports large amounts of silicone emboli in the brain and lungs. In the case of the breast tissue, the silicone was dripping out. Current testing equipment and procedures will accurately test for the carbon silicon bond but will not detect where the silicone came from, whether there were additives in the silicone or whether it was pure silicone. They will detect whether they were phenyl methyl silicones or all methyl.
CITE: KMM 305064 – 305065.

Document #149
05/02/73
SHELL STRENGTH – THICKNESS
RUPTURE

Gary Corbeill, Reliability Engineer for Dow Corning, analyzes a Silastic Round implant returned by Drs. Terino and Sengleman to Bill Mantle, who in turn sent them to Art Rathjen. Corbeill states that, “Due to their thin ‘skin’ these mammaries are delicate and will rupture when subjected to undue pressure.” (emphasis added).
CITE: CR 160 – 161. NOTE: Bill Mantle is the sales representative for the Los Angeles area.

Document #150
05/22/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Exploratory Antigen Modification,” prepared by Dr. Isquith of Dow Corning. It was later re-titled “Silicon-containing Antigens.” The objective is “To determine the capability of organosiclicon-midified antigens to stimulate or reduce immunogenic response.” Isquith suggests a direct modification of antigens by chemical attachment of low molecular weight organosilicon moieties” as an alternative to other antigens (such as peanut oil) which cause adverse health effects. (KMM 546449) He states that, “This project is aimed at examining the effect, if any, of silicon-modification on known antigens. The value will be in the immuno-therapeutic valve of the modified effects. An increase or decrease in antibody synthesis, caused by antigen modification, may be desirable.” (KKM 546453)
CITE: KMM 546448 – 546453, Exhibit to Bennett Deposition, Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Radonovich Deposition, Exhibit to Isquith Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has the Bates Number KMM 491075A – 491080A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 355: 1-6 and 357: 13- 16). DEPOSITION: Not introduced in Toole (II) v Baxter Healthcare.

Document #151
06/00/73
COHESIVENESS – LIQUID COMPONENT OF GEL
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory “Research Project Description: entitled “Bioscience Research Support Project – Systemic Migration Of Prosthetic Gel In The Rhesus Monkey.” This cooperative project between Dow Corning’s Medical Products Business and Dr. Gerow will “to examine the efficacy of using the gel as an injection or implantation for mammary augmentation. This project is designed to examine the potential of gel components to migrate systemically from the site of instillation.” (DCC 16001066) “The gel is a complex mixture of which the low molecular weight fraction (up to 1% w/w of the gel; 330 Fluid) is assumed to offer the greatest potential for migration. Present data acquired in rats indicate that such low molecular weight components tend to appear in depot fat and lymph nodes and that maximum tissue concentrations are attained shortly after instillation…. The relative contribution of the various routes of elimination may include the lung, kidneys and liver based on the elimination of orally administered permethylated cyclic tetramer….” (DCC 16001066)

None of the data to be gathered will allow definition of the structural types that may migrate. The 330 Fluid fraction components of the gel “are the most likely candidates … (so) it may be advisable to repeat the study with a gel formulation containing a minimum of low molecular weight linear and cyclic siloxanes.”
CITE: DCC 16001066 – 16001068, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol. II, p. 546: 12-23). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #152
06/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Metabolism of Organosilicon Compounds.” The objective is to “study systematically the absorption, distribution, storage, metabolism and elimination of those organosilicon structures forming the bases of silicon chemistry as exploited by Dow Corning.” (DCC 016001081) “There have been no systematic explorations of the metabolism of classes of organoxilicone compounds. Such explorations are necessary for their predictive value in selecting and developing efficacious biological applications…. A few of the current projects now requiring an understanding of metabolic potential include:

1. In vivio disposition of low molecular wt. linear/cyclic permethylated and hydroxylated siloxanes in the breast prosthetic gel. (DCC Compounds to be evaluated in the rhesus monkey include cyclic and linear D3 through D5.

CITE: DCC 16001081 – 16001083, Exhibit to Bennett Deposition. WITNESS: Bennett (Authenticated in Bennett Depo., Vol. I p. 254-257). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #153
06/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning Bioscience Research Laboratory “Research Project Description” entitled “Silicon Adjuvants.” The objective is to “investigate the action of silicon compounds on the humoral and cellular immune response.” (DCC 16001092) “Substances which are non-immunogenic or only slightly immunogenic can often be made strongly immunogenic by simultaneous administration with adjuvants.” (Id.) Because of the drawbacks with presently known adjuvants, research will determine if the cellular or humoral response can be selectively enhanced through the use of organosilicon compounds.

CITE: DCC 16001092 – 16001093, Exhibit to Bennett Deposition (used by plaintiffs and as Exhibit 83 by Dow Corning), Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett (Authenticated in Boley, Vol. I p. 141-143 and 153: 19 – 154:12). DEPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #154
06/09/73
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
MISCELLANEOUS – SALES

Telephone call report by Braley with Dr. F. McDowell with copies to Rathjen, Stark and Bennett regarding Bromley Freeman’s paper on the use of free gel implantation. “I explained Dow Corning’s great concern with this situation and that we had finally gone to outside counsel in Washington for advice. The situation is serious enough that we are going to considerable length to notify all persons that the breast implant is not to be cut open. The outside counsel has felt that the FDA could interpret this used as a drug being furnished in a very elaborate package, and could thus eliminate all beast implants of any kind.”

Dr. McDowell suggested getting an injunction against the FDA concerning the injection program. Braley explained the “impossibility” of this and said that DC does not have sufficient information to give to the FDA yet.
CITE: KMM 112207 – 112208, Exhibit to MDL Rathjen Deposition.

Document #155
06/16/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning bioscience Research Laboratory “Research Project Description” entitled “Exploratory Hapten Modification.” The objective is to “determine the antigenic (haptenic as well as conjugate) capability of organosilicones of various molecular weights and to explore their potential use as biological tracers.” (KMM 546454) Among the organosilicon compounds to be examined for determination if they function as conjugates or complete immunogens are dimethylpolysiloxanes. Research in this area will most certainly advance our knowledge of the chemical reactions of organosilicone compounds to biological chemicals…. The development of specific antibody in response to organosilicon determinant groups would provide us with an exquisitely sensitive biological tracer for detecting distribution and storage of organosilicones in the body.” (KMM 546455)

CITE: KMM 546454 – 546465, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Boley Deposition, Exhibit to LeVier Deposition, and Exhibit to Lake Deposition. This document also has Bates Numbers KMM 491081A – 491083A on it. WITNESS: Bennett (Authenticated in Isquith, Vol. II, p. 378:21 – 379;16). DEPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Document #156
6/19/73
KNOWLEDGE OF LIQUID SILICONE DANGERS

Joe Radqius, Dow Corning Food and Drug Counsel, memo to numerous Dow Corning employees regarding “misuse of the Silastic Mammary Prosthesis.” Radzius states that, “we are now aware of isolated instances where physicians are purchasing the Mammary Prosthesis and removing the gel from it for subsequent implantation.” (Kmm24296 – 242499). He recommends a warning be put on the data sheets and information brochures. “If the matter is not given our immediate attention, and if the practice continues, Dow Corning may have no alternative but to remove the product from the market because of potential liability.”

CITE: KMM 242496 – 242499, Exhibit to Mantle Deposition, Exhibit 92 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit to Venn Deposition. DUPLICATE: OOM 880025 – 880027.

Document #157
08/00/73
SHELL STRENGTH – THICKNESS
Dow Corning mammary envelopes are in short supply. There are high losses at the dipping machines for tears and poor release from the mandrels. The reject rate at the dipper is in the range of 50%.
CITE: KMM 220138 – 220147.

Document #158
08/01/73
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH – THICKNESS

Study by Alcott titled “Physical Comparison Between Camp External Mammary Prosthesis and Dow Corning Silastic External Mammary Prosthesis.” The Camp “Symmetry”, external mammary prosthesis was found to be a tough, somewhat unyielding prosthesis. A good fabrication system is used with good results. No migration of silicone oils through the envelope is likely since the envelope is not a silicone rubber. The envelope may resist body fluid and odors better than silicone rubber. Camp’s advertisement is quite misleading since it implies that the same materials are used in implants.
CITE: KMM 354646 – 354651, Exhibit to Tyler Deposition.

Document #159
09/18/73
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding “Precise Choice of Words/Accurate Written Reports When Returning Unusable Or/Remove Mammary Implants To Quality Assurance.” Rathjen discusses recent trip reports which used the word “reject” when referring to a physician’s use of the Silastic. Other words or phrases sales person use which Rathjen does not like include “faulty product,” “faulty,” and “defective.” Words like this “are imprecise and could be damaging to Dow Corning if they are used incorrectly when repeating a condition or a set of circumstances…. If a patient elects to file a lawsuit against the surgeon or Dow Corning, the patient’s lawyers have a right to review our written files. Our files must be disclosed and the attorneys are entitled to use our records as evidence to try and prove their case against us.” (emphasis in original).
CITE: KMM 243010 – 243015, Exhibit to MDL Rathjen Deposition, Exhibit 4 to Hinsch Deposition, Exhibit to Mantle Deposition, and Exhibit 62 to Harris Country Rathjen Deposition. DUPLICATE: M 880016 – 880018; DCC24000537 – 24000542; OOM 880016 – 880018.

Document #160
10/00/73
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING
TISSUE REACTION

Publication by Rowlett, Nichols, Bailey and Dion titled “Silicones -Can They Further Improve The Quality of Life?,” Dow Corning News, Vol. 15, No. 4, Sept. – Oct. 1973. Includes a description of the Bioscience Facility, the History of Bioscience activity at Dow Corning. States that 2,6-cis can alter their behavior of the pituitary, the master gland that chemically controls the function of all the other glands in the body. Describes Bioscience research as opportunity-oriented or for developing profit making products.
CITE: DCC 282001118-282001149, Exhibit to Bennett Deposition, Exhibit to Petraitis Deposition, Exhibit to Tyler Deposition, Exhibit to Boley Deposition, and Exhibit 1 to Randonovich Deposition. DUPLICATE: LAK 1 – 11.

Document
10/08/73
(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)

Memo from Lake and Ng, Dow Corning, to Isquith and Bennett regarding “Experimental Activities in the Virus and Cell Biology Section of Microbiology 1973-1974.” The laboratory is now functional to analyze metabolism of cell cultures, cytogenetics, serology, ultracentrifugation, chromatography, electrophoresis, and fluorescent, phase and light microscopy. “The broad focus of our mission is to circumscribe those areas in the total realm of virus and cell biology where organosilicon entities manifest exploitable biological activity. Antimetabolite, virucidal, antiviral, interference inducing, or cytostatic activities are being sought.” (LAK 12) Anticipated areas of research include:

A. Endogenous Si and exogenously applied silicates: The notion that endogenous Si and trace quantities of Si play a role in atherosclerosis, connective tissue structure and function, mammalian cell aging, and lymphocyte transformation has prompted interest in this area. (LAK 14)

Research will also be conducted on new agonists and chemotherapeutic agents with selected groups of organosilicon compounds. Activities that will be monitored include viral interference induction (interferon), antiviral activity against 4 RNA and 4 DNA viruses, modification of cell growth kinetics and modification of cultural characteristics. Also, the authors seek to establish a method to measure the response and processing of fluids resins and silastic materials in macrophages. (LAK 14)
CITE: LAK 12 – 15, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, and Exhibit 1 to Radonovich Deposition. WITNESS: Bennett (Authenticated in Lake, Vol. 11, p. 306:19-23). DISPOSITION Not introduced in Toole (II) v. Baxter Healthcare.

Document #161
12/04/73
MISCELLANEOUS – SALES

Art Rathjen memo to numerous Dow Corning Employees informing them of an “Album For Clinical Photographs, Silastic Mammary Prostheses.” This album is later used by sales persons.

CITE: DCC 24000523 – 24000524, Exhibit 23 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/13/73. DUPLICATE: DCC 266000237.

Document #162
12/13/73
MISCELLANEOUS – SALES

Maurice Popple memo to Art Rathjen, both of Dow Corning, stating, “Art, I am in receipt of your pornographic picture album and think it’s a great idea. As you are aware, salesmen spend long weeks away from home and such an album is a comfort to take along. I am awaiting with adrenalized anticipation the next batch of photos… Anyhow, I have always considered myself a leg man so I don’t claim any special expertise (sic) in the subject area.” CITE: KMM 46084, Exhibit 24 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: See 12/04/73. DUPLICATE: DCC 24000967.

Document #163
01/22/74
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – COMPLICATIONS
STERILIZATION/CONTAMINATION
TESTING
TISSUE REACTION

Abbott memo to Stark with copies to Bennett, Larson, Rathjen and Robertson regarding “Summary of Gel Review Meeting, January 16, 1974.” All of the gel samples except X-30885 showed a reaction when implanted in rabbits at Huntingdon, suggesting that some gel samples may not be properly cured and “will, therefore, show a reaction.” Also, he recovered the volatiles from the gel which consisted of cyclic pentamer and constituents larger than pentamer. Many gel samples tested are “highly contaminated with bacteria. Also the samples that gave a reaction at IBT were found to be contaminated. The number of organisms is so high that the antibiotics in the tissue culture medium will not control them There is a possibility that the organisms involved are resistant to the antibiotics which are in the medium. In a recent study in our laboratory, it was found that S. auras (gram positive) can survive in mammary gel for approx. 120 days. Because of this data, we would like to isolate and identify the bacterial that are present in the gel.”
CITE: T 21169 – 221172, Exhibit to Harris Country LeVier Deposition and Exhibit to MDL Rathgen Deposition.

Document #164
01/23/74
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Boley and LeVeir memo regarding organosilicon immunopotentiators. Forty-eight silicon-containing compounds were examined in guinea pigs for their ability to enhance serum antibody levels. Nine of the compounds showing high enhancing activity were further evaluated in a rat model. Of the nine, four prolonged and enhanced serum antibody levels.
CITE” DCC 281061454 – 281061486 (Temporary Dow Corning Bates Numbers 16362 – 16377), Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit to Isquith Deposition.

Document #165
02/18/74
SHELL STRENGTH – THICKNESS

Tom Talcott, Dow Corning, memo to Boone, Stark, Ringey, Hoyt, Houle, Polmanteer, and Brodhagen regarding “Control of the Aesthetic Character of our Soft Contour Mammary Prosthesis.” Talcott states:

Some of us have felt for some time that we need to do much better on envelope thickness control for the round prosthesis. Gel control maybe also, but this is another separate subject. Envelope thickness control appears even more important in the soft contour product line. This is because of the general shape of the product. The envelope if too thin can be extended and/or sag, allowing the peak of the projection to be grossly underfilled. There are also some severe irregularities in the tooling for this product line that contribute to the problem in certain sizes.

CITE: KKM 21110

Document
03/00/74
(NOT ON PLAINTIFF’S EXHIBIT LIST)

Handwritten document produced by Dow Corning synopsizing three classified Dow Corning reports: 1) Lake, Isquith and Bennett report “Status of Biological Testing of Sila-adamantoner compounds, Dow Corning Internal Report 4234”; 2) Lake, Schultz, Radonovich, Dittenber and Kociba report “Joint Research Contract Report, February 197_, Evaluation of the Syrian hamster fibroblast system for direct and host-mediated carcinogen bioassays”; and 3) Lake, Radonovich and Boley’s 1975 report “Immunopotentiating activity of dimethylpolysiloxanes and phenylmethylpolysiloxanes. In preparation for submission to Infection & Immunity.” The note states that patent memos have been submitted on antigen modification, immunopotentiators, and silicone substitutes for tissue culture.
CITE: LAK 133.

Document #166
04/10/74
SHELL STRENGTH – THICKNESS

J.L. Boone, Dow Corning, memo to Hoyt, Talcott, Emmons, Polmanteer and Ringey regarding production analysis for 1973-74. He chronicles problems during 1973 consisting of gel shipments, gel yellowing and platinum level adjustments, extraordinary high tear losses, reject rates as high as 50% in some months, contamination with “lemon-scented I.P.A.,” and irregular thickness in envelopes which cause a loss of 10,000 bags and a 10% breakage rate. During 1974, Dow Corning experienced “extraordinarily high reject rates” with yields of approximately 20-35% of the actual output. Reject losses were heavy at every step and particularly at dipping and placing.

Boone states that the fixation patch on the envelope “covered up air bubbles and other flaws that will reject the NFP style.” Manufacture of the NFP mammary requires considerably more skill and diligence. This is a “permanent problem inherent in the design….”
CITE: KMM 220138 – 220147

Document #167
06/11/74
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING

Memo from Hobbs, Dow Corning, to Needleman about a study of DC 200 fluid injected intravenously in rabbits. Seventeen of the twenty eight rabbits tested died during the study probably due to lung, liver and kidney congestion.

CITE: FDA 27196

Document #168
06/28/74
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING

United States Patent No. 3,821,373 for “Organosilicon Compositions In Methods Of Treatment Involving Increasing The Dopamine Content Of The Brain” granted to Donald R. Bennett and Robert R. Levier of Dow Corning. The patent is for the method by which the dopamine content of the brain is increased by administering 2,6-cis. The purpose of this is to alleviate some of the symptoms caused by Parkinsonism, manganese poisoning, and similar diseases.
CITE: DCC 281001098 – 281001100, Exhibit 3 to Isquith Deposition, Exhibit 70 to Bennett Deposition (used by Dow Corning). and Exhibit to LeVier Deposition.

Document #169
08/20/74
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Patent No. 3,830,912 for a method for decreasing the reproductive function of mammals by Bennett and McHard, A method for altering the reproductivity function of mammals by administering a pharmacologically effective amount to certain organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.0 gn. To 5000 mg. per kilogram of body weight or an organosilicon compound thereby rendering the subject infertile.
CITE: DCC 281061389 – 281061395, Exhibit 71 to Bennett Deposition (used by Dow Corning).

Document #170
08/21/74
MISCELLANEOUS – ORGANIZATIONAL SURVEY

Bennett memo to Tyler regarding technology generation and patents. Crises primarily initiate needed technological change in biological affairs rather than long range planning. Bioscience Research has a better credibility and interface with outside biological businesses that it often has within Dow Corning. Consensus between Dow Corning Legal and Federal Regulatory Agencies regarding all biomedically-related activities and products should exist rather than the current practices such as guarded “win-no lose” or compromise mechanisms.
CITE: LAK 62 – 64, Exhibit to Bennett Deposition and Exhibit to Tyler Deposition.

Document #171
09/23/74
KNOWLEDGE OF LIQUID SILICONE DANGERS

Frisch, Dow Corning, letter to James McDonough, Department of the Army, regarding his letter of 09/12/74. Frisch states, “I want to emphasize that we do not recommend implantation of the gel except when fabricated in devices with intact silicone elastomer capsule.”
CITE: DCC 240000861 – 240000862.

Document #172
09/30/74
MISCELLANEOUS
TESTING

Bennett memo to Bennett, Hobbs, Larson, Radzius and Stark regarding the product safety committee meeting. Handwritten note to complete gel chg. (Mam) and the Lake transformation screen.
CITE: DCC 281061484.

Document #173
09/30/74
MISCELLANEOUS – COMPLICATIONS

Bioscience Research Quarterly Status Report – July 1 – September 30, 1974. There are reports on 2,6-cis and KABI; Microbiology’s work on biodegradation, the environmental effect on soil microflora, antimicrobial surface treatment, nonabsorbable antimicrobials, development of carcinogen bioassay – “Dow Chemical has yet to indicate the extent to which they will support this project,” antigen modification, and modulation of interferon response – “Four compounds … (Me2Si0)4 (and others) have been shown by W. Boley to have immune adjuvant activity and are also being examined for their ability to potentiate IF induction.” (LAK 56). Under Plant Sciences, there are reports on antitranspirants, large tree transplanting, cherry cracking, hormonal – siloxqane diols could retard opening of flower and leaf buds, insecticide – “previous information on spider-mite, mealy-bugs and aphids has been confirmed and extended. Additional work has been done on mosquito larvae, tomato hornworm and potato beetle, for all of which DC 200 fluid is effective, and on white fly and ladybird larvae, which are not harmed by the fluid.” (LAK 58). Under Environmental, there is a report on the Idaho project – silicon analysis of foliage, soil and water samples: and the Salzburg Road project – spills of silicone fluids on soil to look at plant damage, effects on flowering and effect on percent coverage of the plant species.

CITE : LAK 53 – 59, Exhibit to Blocksma Deposition (used by Dow Corning), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Weyenberg Deposition, Exhibit 9 to Harris County Gehring Deposition, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition, Exhibit 5 to Lake Deposition (used by Dow Corning), and Exhibit to LeVier Deposition. WITNESS: Bennett (Authenticated in Bennett, Vol III, p. 749-750). DISPOSITION: Not introduced in Toole (II) v. Baxter Healthcare.

Document #174
10/02/74
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Bioscience Research Report No. 4319 by Boley and LeVier, Dow Corning, entitled “Immunological Enhancing Activity Of Organosilicon Compounds And Non-Functional Fluids.” Forty-nine (49) silicon-containing compounds were examined in guinea pigs to screen for “potential adjuvant activity.” Nine compounds showing “good antibody producing activity” were evaluated for their ability to enhance serum antibody levels. Four compounds including (Me2Si0)4 showed good adjuvant activity. Dow Corning plans future work to evaluate these four compounds for their ability to enhance the antibody response to viral, bacterial and soluble proteins antigens.

Organosilicon compounds can stimulate the immune response. No information is currently available about the mechanism of action of these compounds.
CITE: T 21287 – 21304, Exhibit to Dillon Deposition, Exhibit to Frye Deposition, Exhibit to Bennett Deposition, Exhibit 14 to Edwards Deposition, Exhibit to Isquith Deposition, Exhibit to Harris County Klykken Deposition, Exhibit to LeVier Deposition, Exhibit to Lynch Deposition, Exhibit to Lake Deposition, Exhibit to D. McGhan Deposition, Exhibit to Palensky Deposition, Exhibit to Weyenberg Deposition, Exhibit to Compton Deposition, Exhibit 3 to Harris County LeVier Deposition, Exhibit 18 to Zimmer Deposition, Exhibit to Boley Deposition, Exhibit 1 to Harris County Boley Deposition; Exhibit to Hudson Deposition, Exhibit 23 to Harris County Rich Deposition, Exhibit to Harris County Burda Deposition, Exhibit to Frisch Deposition (used by Dow Corning), Exhibit to Oppelt Deposition Exhibit to Peters Deposition, Exhibit 10 to California Braley Deposition; Exhibit 1 to Dallas Espinoza Deposition, Exhibit to Radonovich Deposition, and Exhibit to Harris County Tyler Deposition. DUPLICATE: This was originally listed as P 14028 – 14046 on the exhibit list; DCC 80061481 – 80061530: F 86 – 103; DCC 281001575 – 281001589. WITNESS; Bennett (Authenticated in Boley, Vol. I, p. 155:4-24). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document (Not Listed)
(Note: this is not numbered but is between 174 & 175)
10/21/74
(NOT ON PLAINTIFF’S EXHIBIT LIST)

Memo from G. Robertson, Dow Corning, to Bennett, Bennett, Hobbs, Radzius and Stark with copies to Brodhagen and Larson regarding “Minutes of Product Safety Committee Meeting, October 11, 1974.” They discussed proposed changes for mammary gel including using 360 fluid rather than 330 fluid (DCC 267380231).
CITE: DCC 267380231 – 267380234 (page 2 is missing). NOTE: This document also has Bates Numbers QDC 118693 – 118696 and MM 220066 – 220069 on it. WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 954-968). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #175
11/22/74
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS

Stark memo to Frisch, Rathjen & Talcott with copies to Hoyt and Nelson regarding “Capsular Contracture Studies.” Stark writes, “THE WELL IS DRY! we cannot give financial support for more studies of capsular contracture in ’74 and ’75 … I think our future role in these studies should be to provide input on the technology of silicones and to provide samples of materials.”
CITE: M 190131, Exhibit to MDL Rathjen Deposition.

Document #176
11/26/74
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Silas Braley, Dow Corning, telephone call report of his conversation with Dr. Charles Vinnik. Braley states:

” Dr. Vinnik then launched into a very extended discussion of how terrible he thinks the silicone fluid injections are and the fact that it is going to mean the financial ruin of Dow Corning if we ever get it approved by the FDA. He said that he had just treated the wife of a doctor from Saginaw who had obtained pure #360 medical fluid directly from a friend at Dow Corning in the days before it was restricted. She had exactly the same typical inflammatory and foreign body reaction that the patients he had seen from Kleifgen and Dr. Haines in Las Vegas. He said he has seen some good results in the face and thinks this is put in in (sic) tiny amounts and in a highly vascular area, but to put it into other areas of the body, he feels is catastrophic. He said he is going to do everything he can to prevent this from ever becoming cleared until further work has been done. He has gone to Senator Cannon and to the FDA commissioner to protest the clearance of the IND. He states that he will offer himself as an expert witness against anybody who chooses to use it in the future.

CITE: DCC 240000051, Exhibit 35 to California Braley Deposition.

Document #177
00/00/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Abstract of Lake, Radonovich and Boley report entitled “Potentiation of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane.” D4 increases serum interferon levels in mice induced with bacterial endotoxin, apparently potentiating production of “early” interferon induced by endotoxin but not viral-induced “late” or “virus-type” interferon. Forty-eight hours after intraperitoneal inoculation, mice exhibit weight loss, decreased spleen/liver weight ratio, decreased in vivo carbon clearance and peritonial monocytosis.

CITE: LAK 65 – 66A, Exhibit to Bennett Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition, and Exhibit 1 to Radonovich Deposition. NOTE: See entry dated 10/30/75.DUPLICATE: DCC 281061469 – 281061470. WITNESS: Radonovich. DISPOSITION; Admitted in Toole (II) v. Baxter Healthcare.

Document #178
01/13/75
SHELL STRENGTH – THICKNESS
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE

Brashier, Dow Corning, memo to Salisbury and VerVoort regarding a patient of Dr. Goldwyn’s who reported a “stringy gooey substance” that was coming out of a woman’s breast who had just been implanted. The patient snipped the substance with a scissors. The implants were removed and replaced and the same thing happened.
CITE: M 570188 – 570189

Document #179
01/22/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Study by Lake, Radonovich and Boley with abstract titled “Potentiation of Endotoxin Induced Interferon in Mice Treated With Octamethylcyclotetrasiloxane.” D4 has been found to increase serum interferon levels in mice induced with E. coli endotoxin. Because spleen cells but not peritoneal exudate cells from D4 treated mice continue to produce augmented amounts of endotoxin-induced IF upon removal and incubation in vitro, a direct interaction between IF producing lymphoreticular organs and D4 is being considered.
CITE: LAK 67, Exhibit to Radonovich Deposition, and Exhibit to Boley Deposition.

Document #180
(Note: this is all that is listed for #180)

01/22/75
DUPLICATE OF DOCUMENT # 177 (see above).

Document #181 & 182
(Note: #181 (ALSO LISTED AS #182)
01/22/75
TESTING
MISCELLANEOUS – SALES

Hoyt, Dow Corning, memo to Rathjen with copies to Salisbury, Talbot, Thompson, Houle, Meads, Leach, Polmanteer, Boone and Nelson regarding “Mammary Prosthesis Task Force.” He announces that a Dow Corning Task Force has been organized to further development of the Silastic Mammary prosthesis, Low Profile Round and Contour, with “flo gel” and which will be packaged in a new sterile container. Permanent members of this committee include: A. Rathjen (Chair), D. Houle, T. Salisbury, J. Thompson, and T. Talcott. Active consultants include: T. Abbott, G. Robertson, W. Larson, and Z. Bennett. The deadline for product introduction is 06/01/75. There is a 90-day gel implantation test scheduled with Biometric. Although there was no planned gel testing at Dow Corning’s Biomedical facility, this was requested by Robertson.

Hoyt writes that:

“I can’t emphasize enough the urgency and importance of this project for the business in 1975.The basic assignment is to insure rapid commercialization of a new mammary prosthesis product line, incorporating new shapes, sterile pack, and responsive gel. The low profile round – targeted for June 1 introduction/ low profile contour – by September. The many variables connected with this particular program make it a challenging management assignment but we can and must make it happen. How this assignment is handled in detail is up to the Task Group. We are primarily interested in the final result…. Because of our market position and tight corporate business situation as we progress into 1975 we really cannot accept any delays in getting the product onto the market. The big mammary prosthesis sales months will be May, June, and July in which approximately 36% of our total business sales will be made. Missing one of those months would have a dramatic impact. We could, and might be able to accept trade-offs, but certainly not delays…. I would like to emphasize that this task and the assignment of all members has received total Business and PMG support.”

CITE: F535 -540, Exhibits 35, 37 and 94 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. NOTE: In a rush to get the product to market, Dow Corning cut the 90-day study short by 10 days. See 04/25/75 entry, which is the result of the 80-day study. DUPLICATE: M 630061 – 630061; M 540001 – 540006.

Document #183
01/28/75
KNOWLEDGE OF GEL BLEED

Art Rathjen memo to numerous Dow Corning employees regarding “Gel Bleed – New Gel In Mammary Prostheses Scheduled For June 1 Introduction.” Rathjen writes that, “there is only a two week period before the new ‘flo-gel’ is scheduled to be formulated and filling begins. A question has not yet been answered is whether or not there is an excessive bleed of the gel through the envelope…. We must address ourselves to this question immediately…. The stakes are too high if a wrong decision is made.”
CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition.DUPLICATE: KMM 260794; KMM 19824; FDA 19671 – 19672; M 150001.

Document #184
01/31/75
KNOWLEDGE OF SYSTEMIC DISEASE TESTING

Patent Memorandum Number 4320 by Boley, Lake and LeVier entitled “Organosilicon Immunopotentiators” is received by Dow Corning’s Patent Department on this date. The memorandum essentially outlines findings that various organosilicon fluids potentiate the formation of humoral antibody, modulate cell mediated immunity and promote the induction of interferon by stimulation of the immune system.” The document also includes a memo dated 08/03/76 from J.I. Pulley to LeVier noting that this patent memorandum has been inactivated and “that Dow Corning would probably not reactivate work in this area in the near future.” Another memo dated 07/15/76 from Pulley to LeVier notes that “Dow Corning is no longer actively involved in this (the use of silicone fluids as immunopotentiators)….”

Another document is a “Patent Memorandum” by Boley and LeVier with the suggested title of “Immunological Enhancing Activities of Organosilicon compounds and Non-Functional Fluids” which was renamed to “Organosilicon Immunopotentiators.” Nine of 48 silicon-containing compounds showed a “strong immunological enhancing” effect. Boley and LeVier wanted to explore possible applications of these compounds including for potentiation of veterinarian vaccines and in the “production of high quality and expensive experimental antibodies.”

Some of these compounds were tested for their ability to augment or potentiate endotoxin induction of IF. Dow Corning 200 fluid and D4 “show a significant potentiation of endotoxin induced IF.” (DCC 281061466).

There is also a one page abstract of the Lake, Radonovich and Boley report on “Potentiation Of Endotoxin Induced Interferon In Mice Treated With Octamethylcyclotetrasiloxane.” Interferon appears to be involved in the Immune response to bacterial, viral and protozoal infections. Substances able to modulate the interferon response may be useful in the control of many infectious diseases and cancer. This report describes the immunopotentiating activity of some structurally defined linear and cyclic polydimethylsiloxane fluids which have been found to mimic the potentiating effects of mineral oil adjuvants (Boley and Levier Dow Corning Report 4319, 1974).
CITE: DCC 281061451 – 281061468 (Temporary Dow Corning Bates Number 16359 – 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Document #185
02/03/75
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Patent department memo to Boley, LeVier and Lake regarding organosilicon immunopotentiators patent memo assigned #4320.
CITE: DCC 281061471 (Temporary Dow Corning Bates Number 16379), Exhibit to Lake Deposition, and Exhibit to LeVier Deposition.

Document #186
02/13/75
SHELL STRENGTH – THICKNESS

J. Thompson, Cow Corning, memo to A. Rathjen that the new low profile round envelopes are being dipped on the automatic dippers at a rate of 1,000 bags per day, but, “PROBLEM: NO SPECIFICATION EXISTS TO Q.C. THESE BAGS!!! WHERE IS IT?
CITE: F 552 – 553, Exhibit to MDL Rathjen Deposition.

Document 187
02/14/75
SHELL STRENGTH – THICKNESS

Dow Corning’s Mammary Task Force meets. The minutes of the meeting report that Dow Corning is “15 weeks, 170 days, 2,568 hours (and) 154,080 minutes” from the 06/01/75 deadline. Will Larson reported gel migration in monkeys with the new gel. A “major point of contention” is that, “No specification exists on the acceptable thickness for the low profile round envelope.” TS&D and Production have differing opinions on what is acceptable. There has also been a breakdown in the special fabrication program, evidencing that acceptable envelope fabrication was a problem. “RIGHT NOW I (Rathjen) CONSIDER THIS THE MAJOR PROBLEM CONFRONTING THE TASK FORCE. I RECOMMEND THAT FILLING WILL NOT COMMENCE UNTIL THERE IS AN AGREEMENT BETWEEN MARKETING, TS&D AND PRODUCTION AS TO WHAT IS AN ACCEPTABLE ENVELOPE! (emphasis in original).

CITE: F 549 -551, Exhibit 40 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 446914 – 446916: M540023 – 540025. NOTE: Why does Marketing decide what is an acceptable envelope?

Document #188
02/19/75
MISCELLANEOUS

Hommel memo to Rathjen with copies to Hagerman, Salisbury and Leach regarding “Revision of the “Facts About Your New Look” Pamphlet.” Rathjen volunteered to compile information to revise the Facts About Your New Look brochure. Hommel encloses “a series of questions which were submitted during a survey (by Karen Lott) among a number of the ladies working in the advertising agency in Grand Rapids. I think there is merit to giving due thought to these questions while working toward the revision of the booklet.”
CITE: M 400001, Exhibit 84 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #189
02/25/75
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
TISSUE REACTION

Nawash memo to Salisbury, both of Dow Corning, regarding low molecular weight gel diffusion. He writes:

“The reactivity between free low molecular weight silicones and the subcutaneous tissue seems to be of increasing concern among plastic surgeons. It is thought that the soft gel used by Heyer-Schulte in the mammary implant is obtained by mixing low viscosity silicone fluid in the regular gel. It is also thought that the low molecular weight components of the fluid eventually diffuse through the rubber envelope of the breast implant and elicit the untoward reaction which is occasionally observed and results in an undesirable, relatively thick fibrous capsule. I do not know the actual method used by Heyer-Schulte to obtain their soft gel: nor do I know the process we developed for making our own soft gel.

However, If I may, I strongly recommend that we take measures to insure against the presence of unwarranted free low molecular weight fluids in our now soft breast implant.”

CITE: M 190133, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition.

Document #190
04/25/75
TESTING

Biometric Final Report to Dow Corning on “Implantation Study in Rabbits with Four (4) Mannary Gels.” This is a report of an 80 day test using the new flo gel or responsive gel – X7-2159A in rabbits. Results showed the “presence of mild, subacute granulomatous inflammatory lesions….”
CITE: t 3740 – 3755, Exhibit to Peters Deposition, Exhibit 87 to Harris County Talcott Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: P 16689 – 16694. NOTE: The 01/22/75 minutes of the first Mammary Task Force states that this was supposed to be a 90-day test. See also 03/08/75 entry, with interim report of the 90-day test.

Document #191
04/25/75
MISCELLANEOUS

Boone memo to Talcott, Hoyt, Leach & Salisbury with copies to Rathjen and others regarding the scale up of the new low profile contours and setting of specifications. “I am not prepared to repeat the acrimonious exercises that were encountered during the scale-up and specification setting of the low profile round envelopes. That scale-up was accomplished with the Production Department assuming fundamental responsibility for arriving at optimums after considerable trial and error with eventual prototyping and specification recommendations being done by this department. I am willing to repeat this work with the low profile contour product line because we are certainly the best qualified to do the work. If, however, there are any doubts as to the quality or intensity of our desire to produce the thinnest product manufacturable, I will be happy to relinquish this scale-up responsibility to any other group prepared to man and supervise the equipment on a three-shift basis for the first several weeks of production. This scale-up should lead to procedures, spec recommendations, supporting data, and prototypes illustrating limits of acceptability for all sizes.”
CITE: KMM 220579, Exhibit to MDL Rathjen Deposition

Document #192
05/01/75
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – SALES

Boone memo to Hoyt, Leach & Salisbury with copies to Larson, Talcott, Peters, Brodhagen, Rathjen and Ringey regarding “Oily Effect on New Mammaries.” They have observed that the new mammaries tend “to bleed noticeably after the product is massaged and handled. We are relatively confident that the doctor will not see any appreciable bleed on the product as it is removed from the package. The salesman, however, will experience bleed on his detail samples, particularly the day after they have been squeezed. It would be advisable for the salesman to understand this and clean his detail samples prior to demonstrating to the customer.”
CITE: KMM 220570, Exhibit to MDL Rathjen Deposition

Document #193
05/13/75
KNOWLEDGE OF GEL BLEED

Tom Talcott, Dow Corning, memo to Larson, Dow Corning Mammary Task Force and other Dow Corning colleagues, regarding silicone gel bleed from implants. He states, “We are hearing complaints from the field about the demonstration samples they are receiving. The general claim is that the units bleed profusely after they have been flexed vigorously. This may tie into the soaking to wash off excess gel which was occurring in the early stages of production or the time interval between fill and cure…. Please run appropriate testing when you receive these samples to determine if a bleed rate problem exists.”
CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to MDL Rathjen Deposition (used by Dow Corning). DULICATE: M 16003; M570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 17.

Document #194
05/16/75
KNOWLEDGE OF GEL BLEED

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction is “2 weeks, 16 days, 384 hours, 23,040 minutes.” Rathjen began by reading a memo which officially turned the round and low profile rounds “back to its jurisdiction.” The minutes do not say what this jurisdiction is. On the issue of gel bleed, “A range of solutions is possible – from reformulating the gel to eliminating salesmen’s abuse of the product during demonstrations. It seems to be a function of the porosity of the envelope; the lower molecular weight gel passes through the pores more easily, especially after stretching and pulling.”
CITE: F 590 – 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris County Rathjen Deposition. DUPLICATE: KMM 446988 – 446991: M540064 – 540070.

Document #195
05/16/75
KNOWLEDGE OF GEL BLEED

Tom Salisbury memo to Dow Corning sales force regarding the “Oily Phenomenon With New Mammary Prostheses.” Salisbury writes that, “It has been observed that the new mammaries (sic) with responsive gel have a tendency to appear oily after being manipulated. … You should make plans to change demonstration samples often. Also, be sure samples are clean and dry before customer detailing. Two easy ways to clean demonstration samples while traveling, 1) wash with soap & water in nearest washroom, dry with hand towels, 2) carry a small bottle of IPA and rag.”
CITE: F 635, Exhibit 2 to Hinsch Deposition, Exhibit 63 to Harris County Rathjen Deposition, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540071; KKA 152381; KKH 868: KMM446993: KMM 148337: KMM 518441: DCC 80061333 – 80061334.

Document #196
05/23/75
COHESIVENESS – LIQUID COMPONENT OF GEL

Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction, “1 week, 8 days, 192 hours, 11,520 minutes.” The Task Force discussed the economic reasons for getting the contours on the market by 10/01/75. Also, “Marketing wanted to use a sealed bottle of gel as a sales aid to show the flowability and cohesiveness of the responsive gel. However, Talcott and Larson discouraged (this) because the gel may not retain constant properties with continued manipulation such as this. The aesthetics of doing this would probably not show our product in a good light.” The Task Force decides on “aggressive marketing tactics” including rebates, consignment, back-up units-singles for immediate rupture – replacement, and price breaks for big users.
CITE: F 599 – 601, Exhibit 45 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540087 – 540089.

Document #197
06/01/75
COHESIVENESS – LIQUID COMPONENT OF GEL
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS
TESTING

Study titled “New responsive Gel – ‘”Effect on Mammary Envelope Physical Properties” by James Vallender, cc to Rathjen. Conclusion, “the new gel seems to cause slightly weaker envelope in ultimate properties but appears to cause slightly less weakening on aging. The difference in effect on physicals by new and old gel is considered insignificant.”

The study was approved by Matherly and Stark.
CITE: OOT 41627 – 41629, Exhibit to Peters Deposition, Exhibit 112 to Harris County Rathjen Deposition, Exhibit 129 to Burda Deposition (used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: F 630

Document #198
06/30/75
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study sent to Dowell by Lince, Pruitt, Neagele, Kenaga, Moss, Hymas Goring, Bjork, Coulter, Johnson, Osborne, Getzendaner, Meulder, Seymour, Sheldon, Barrons, Hinman, Laskowski, Gray, Hunter, Hanson, Little, Kurihara, Hamaker, Meikle, Regoli, Magana, Dalman, Edumura, Geronimo, Turner, Ferguson, Simon, Scott, MacDougal, Shaver, Fears and Regan regarding the rapidity of German roach knock-down with fospirate formulated on dri-die.

Dow Chemical U.S.A. Ag-Organics Research in Walnut Creek, California report by F.H. Dowell on “Rapidity of German Roach Knock-Down With Fospirate Formulated On Dri-Die.” The report was distributed to numerous departments within Dow Chemical including Ag-Org. Information Center (M. Lince), Ag-Org. R&D Planning (name illegible), U.S. Area R&D Dir. M.E. Pruitt, Ag-Organics Dept. Manager RD Naegele, Ag-Organics R&D Director R.E, Hefner, Ag-Org. Regist. D. McCollister and E. Kenaga, Ag-Org. Chemistry Dir. R.D. Moss, Ag-Org. An. Health Devel. T.A. Hymas, Plant Sci. R&D Dir. C.A.I. Goring, Ag-Org Areas Pestic. Coord. L.L. Coulter, Corp. Prod. Dept. R.B. Johnson, Ag-Org. Synthesis Res. Mgr. D.W. Osborne, Ag-Org. Residue/Metab. M.E. Getzendaner, Ag-Org. Formulations K.G. Seymour, Ag-Org. Prod. Bus. Mgr. H.W. Sheldon, Ag-Org. R&D Tech. Advisor K.C. Barrons, Chem. Biol. Res. C.W. Hinman, Ag-Org. Environ. Studies D.A. Laskowski, Prod. Plan. Team R&D Spec. H.E. Gray, Res. Mgr. Field R&D R.C. Hunter: persons in the Ag-Org. department at the Walnut Creek lab; and to people in international locations.

The 2% fospirate + Dri-Die Formulation appears to combine flushing action, residual rapid knock-down and indefinite slow residual action, all highly desirable properties in a roach control formulation. Dri-Die (micronized silica gel) is widely used for cockroach control.
CITE: TDCH 345 – 356, Exhibit to Bennett Deposition, Exhibit to Ryan Deposition, and Exhibit to Hinman Deposition

Document #199
07/15/75
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Letter to Dr. Fleming from M. Popple, bcc to Rathjen, regarding patient with excessive capsule contraction after mammaplasty.
CITE: m 470064 – 470065, Exhibit to MDL Rathjen Deposition

Document #200
08/12/75
ACKNOWLEDGEMENT OF NEED FOR TSTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
TESTING

Dow Corning submits New Drug Application (NDA) for DYMASYL(R) Brand Injectable Silicone for Soft Tissue Augmentation. The NDA 2702. Ancillary to the filing of the New Drug Application, Dow Corning will pursue activities to elicit data relative to safety and efficacy on a long-term basis.
CITE: M 410001 – 410003, Exhibit 25 to Harris County Rathjen Deposition.

Document #201
08/12/75
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Dr. Upton (Cronin”s associate) letter to Rathjen regarding capsular contracture. Dr. Wilflingseder and Dr. Laub have been able to demonstrate small particles of free silicone inciting inflammatory reactions in adjacent soft tissue. They have noted the same phenomenon. “Although the etiology of the problem is multifaceted, I am sure, we still wonder if the surface of the silicone polymer plays a significant role.”
CITE: DCD 173003034, Exhibit 27 to MDL Rathjen Deposition (used by plaintiffs and Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M 190146.

Document #202
08/28/75
TESTING

Tony Abbott, Dow Corning, memo to Bey and numerous other employees regarding “Mammary Gel biocompatability.” Abbott states that he now has a test procedure (Tissue Cell Culture) for evaluating biocompatability of products on a lot to lot basis. Each lot of mammary gel consists of several drums of materials. “Test results show that there is a difference in the biocompatability of the gel on a drum to drum basis.” Abbott also recommends a permanent solution to the problem with the butyl carbitol acetate solvent as a catalyst. Wil Larson is working on this.”
CITE M 170101 – 170103.

09/03/75
(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)
(this document is between #202 & #203)

Memo from Art Rathjen, Dow Corning, to Drs. Anderson, Ashley, Barrett, Blocksma, Dingman, Dufourmoutel, Edgerton, Epstein, Giannestine, Goulian, Murray, Orentreich, Rees, Smith, Stark and Vinnik regarding “News Release – Silicone Fluid Injection.” “Because of legal complications, any inquiries from the media should be referred to Silas Braley or Joseph Radzius at Dow Corning.” Rathjen encloses a Dow Corning news release stating that it has filed a New Drug Application with the FDA requesting approval to market silicone fluid for injections.
CITE: M 350161 – 350163, Exhibit 29 to Harris County Rathjen Deposition.

Document #203
09/10/75
KNOWLEDGE OF LIQUID SILICONE DANGERS

Silas Braley, Dow Corning, Summarizes a phone call with Dr. Charles Vinnik in response to the press release. Braley states that Dr. Vinnik:

“wanted to know what we were doing about preventing this use so that all of the incapable people don’t get a hold of it for this kind of use…. He said that the Moss subcommittee in Congress is all poised waiting for Vinnick’s (sic) statement to jump on an investigation of the silicone fluid injection story. He has been keeping a lid on this all along…. He said he felt that the information we have had given to us by the investigators is faulty. That his information is much greater and much better and shows that volumes of silicones under high pressure can cause all kinds of things that we do not have in our study. He said that the longest we had was four years in monkeys and even that showed fat necrosis. He explained fat necrosis as being identical with the situations he has seen in the patients that he has treated in Lass Vegas.

CITE: DCC 240000054. DUPLICATE: KKM 3364.

Document #204
09/29/75
MISCELLANEOUS – COMPLICATIONS
SILICA
TISSUE REACTION

Letter to Rathjen from Dr. Laud regarding Dr. Wilflingseder’s discovery, and publication, of silicon dioxide (silica) in breast capsule specimens and “I was able to tell him what I had learned at Dow Corning.”

CITE KMM 29957

Document #205
10/06/75
TESTING

Abbott, Dow Corning, reports on “biocompatibility Evaluation Of Mammary Gel.” “The problem with biocompatibility is the butyl carbitol acetate solvent in the catalyst…. There are localized high concentrations of BDA in the gel. Evaluation of the compatibility of the solvent with the gel has shown that BCA does not mix in the formulation at a very desirable rate.” Also, “Visual observations of uncured gel shows the presence of globules or highly contracted pockets of the solvent…. The permanent solution to the problem involves the replacement of the present solvent with a different solvent or a different catalyst system.”
CITE: KMM 39105 – 39121.

Document #206
10/30/75
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Dow Corning Bioscience Research Report No. 4509 by Lake and Radonovich entitled “Action of Polydimethylsiloxanes on the Reticuloendothelial System of Mice: Basic Cellular Interactions and Structure Activity.” The abstract for this report states that:

“Because of their hydrophobic character, dimethylpolysiloxanes of various viscosities are known to distribute to the reticuloendothelial system (RES) in association with phagocytes. The site, magnitude, specificity and time course of murine RES response to high doses of various dimethylpolysiloxane fluids has been studied to characterize the basic cellular interaction and immunological consequences of dimethylsiloxane administration. Type I interferon production and clearance of colloidal carbon were used to assess RES function. Linear 3,4 and cyclic 4,5 dimethylpolysiloxanes when given parenterally to mice caused a transient response in lymphoreticular tissues with a maximum at 48 hours. This response was found to involve phagocytic cells (macrophages) such that augmented amounts of Type I endotoxin-induced interferon are made. Carbon clearance by the RES is also depressed with the same time course as this hyper-reactivity to interferon induction. Hexamethyldisiloxane and dimethysiloxanes greater than 5 siloxy units do not cause these changes, but do cause a characteristic eosinophilia at an intraperitoneal inoculation site.

A consistent hypothesis for this observed increase in early interferon production is that dimethylsiloxanes in the 305 size range are sub-lethally surface active in macrophages of the RES. Like lead acetate and mineral oil-surfactant mixtures, which are known to augment early interferon production, low molecular weight dimethylsiloxanes decrease the phagocytic capacity of macrophages. Because endotoxin is not cleared (phagocytosed) or detoxified, the viable but phagocytically impaired macrophages undergo a prolonged and more complete interaction with endotoxin. (OOT 42327)”

CITE: OOT 42325 – 42352, Exhibit 1 to Radonovich Deposition (abstract only), Exhibit 23 to Harris County Hayes Deposition, Exhibit to Harris County Tyler Deposition, Exhibit 11 to Zimmer Deposition, Exhibit to Lake Deposition, Exhibit to Isquith Deposition, and Exhibit 23 to Harris County Rich Deposition. DUPLICATE: DCC 281001636 – 281001662; DCC 281061445 – 281061450. WITNESS: Radonovich. DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #207
11/03/75
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Letter to Rathjen from Dr. Laub regarding the Toronto meeting. “Dr. Bob Briggs from New Jersey has seen several patients from the original study (mostly Orentreich patients) who have had intractable swelling. … This case is similar to the ones reported at a meeting in Mexico City several years ago by physicians from Buenos Aires. … I have followed patients myself in this are ‘suffering’ from the same condition. …”
CITE: KKM 31788, Exhibit to MDL Rathjen Deposition.

Document (no number) dated 11/7/75
(this document is between #207 & #208)
11/07/75
(NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)

Memo from Larson, Dow Corning, to Talcott with copies to Bey, Rathjen, and Kelley regarding “Capsule Formation & Mammary Implants.” Larson states that Stark commented in a staff meeting that “implanted silica causes the formation of a very heavy tough capsule…. Possibly we could minimize capsule formation around the mammary prosthesis if they were over coated with a pure silicone polymer…. These are the basis for the concept that maybe some exposed silica on the very surface of the envelope rubber can cause excessive capsule formation and that this might be minimized if the capsule were formed and interfaced against pure silicone polymer.” On M 190174 there is a handwritten note from Talcott to Ron Kelley: “I’d like more proof of silica at interface causing problems.”
CITE: m 190174 – 190175. NOTE: M 190175 is a duplicate of M 190174 but it has different marginalia on it.

Document #208
11/18/75
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

Memo to Boone, Leach, Meads, Polmanteer & Talcott from Bey regarding capsule contracture studies. “Our TS&D budget situation for 1976 is simply this, we have considerably less discretionary spending money for 1976 than we had in 1975. I can’t see any way we can support these proposals in 1976. I suggest we discourage the proposals as much as possible….”
CITE: M 190186, Exhibit to MDL Rathjen Deposition.

Document #209
12/10/75
KNOWLEDGE OF LIQUID SILICONE DANGERS

Telephone call report by Silas Braley regarding a call with Richard Samuels about a grand jury investigation being done on Hal Ellison for doing injections of silicone fluid. Ellison had been receiving Dow Corning fluid through a company called Silaco. Braley states that, “I told Mr. Samuels that we had been fighting, the breast injections since we had heard about them and were trying to get the information across to people. We find now that people are very confused about breast injections vs. breast implants and I explained that the latter are both ethical and legal and that the problems of injections do not apply. I asked for his help in differentiating between these two procedures so that those women who have had surgical augmentation will not worry when they read about the horrors of injections.” (emphasis added). The call report notes that additional phone calls from Mr. Samuels occurred throughout the morning. Joe Radzius, Dow Corning legal counsel, advised Braley that Dow Corning’s position “from here on in” was “no comment.”
CITE: KKM 3537 – 3538

Document #210
12/12/75
KNOWLEDGE OF GEL BLEED

T. Talcott, Dow Corning, memo about a telephone call from Dr. Frank Gerow. Gerow attended a meeting in Phoenix recently and reported that “the general tone to him was something is coming through the envelope to the tissue.” Gerow concluded that Dow Corning needed a “100% tied up gel now.” Talcott writes that he’s inclined to agree that something’s coming through the envelope. “Could it be miscellaneous contamination during our manufacturing process? Do we need an audit of the process?”
CITE: F 636, Exhibit to Frisch Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit 64 to Harris County Rathjen Deposition. DUPLICATE: M 170143; M190203; FDA 32914; DCC 242031351 – 242031352.

Document #211
12/12/75
TESTING

Franklin and Annelin, Dow Corning, report on “Subcutaneous Implants Of Developmental Prosthetic Gels In Monkeys And Rats: Examination Of Tissue Deposition And Urinary, Fecal, And Respiratory Elimination Routes.” “In the rats, dosed with the new production gel, only the axillary lymph showed an increase in total silicon; a similar increase in hexane extractable silicon was not observed.: In the monkeys, “the low cross-linker formulation moved along tissue planes and formed only a very thin capsule.”
CITE: KMM 140087 – 140104, Exhibit to Frisch Deposition, Exhibit 42 to Hinsch Deposition (used by Dow Corning), Exhibit to LeVier Deposition, Exhibit 45 to Harris County Peters Deposition, Exhibit 115 to Harris County Rathjen Deposition, Exhibit 88 to Harris County Talcott Deposition, Exhibit 92 to Bennett Deposition (used by Dow Corning), Exhibit 15 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit to Isquith Deposition. DUPLICATE: P 17497 – 17515.

Document #212
12/12/75
SHELL STRENGTH – THICKNESS
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Rathjen, Dow Corning, memo to various Dow employees regarding Breast Symposium in Phoenix, Arizona on November 23-26, 1975. Reports that Dow has lost the number one position as “the innovator.” He states:

“Surgery was performed by members of the faculty, put on tape, edited and viewed during the three day course. Each manufacturer donated implants for this use. Dr. Eugene Courtiss and Dr. Robert Winslow used our prostheses. In both instances the doctors broke an implant during their surgery. Fortunately these were edited from the tape; but ours were the only ones to break, and they really let us know about it. The Medical Products Business should consider a full scale research program to fully evaluate the current status of our gel (chemistry, toxicology) and to begin a concentrated program to develop a dry gel (dry to touch, cohesive, non-adhesive with absolutely no bleed). I would also like to see the development of a radio-opaque envelope which would allow the examination of an implant “in situ” if and when capsular contracture is suspected. How contracture develops by observing an implant “in situ” could contribute to a better design of an implant. (emphasis added).

CITE; M 190200 – 190202, Exhibit to Mantle Deposition, Exhibit 80 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #213
00/00/76
FRAUD/MISREPRESENTATION

Dow Corning brochure, “Facts You Should Know About Your New Look,” Which contains the following question and answer: “How long will the implants last? Based on laboratory findings and human experiences to date, a gel-filled breast implant should last for a lifetime.”
CITE: M 650012 – 650019, Exhibit to Harris Country Jakubczak Deposition, 27 to Harris County Peters Deposition (used by Dow Corning), Exhibit to MDL Rathjen Deposition, and Exhibit 77 to Harris County Rathjen Deposition. NOTE: From 1963-73, Dow Corning only “warned” of fluid accumulation and foreign body reactions in its product inserts. From 10/74 – 09/76, Dow Corning added to its product inserts the following for the Silastic implant: capsular contracture/firmness, pain or discomfort from surgery, ptotic breasts, additional surgeries/implantations, and the risks associated with surgery. See PSC World of Warnings for Dow Corning and Dow Corning Wright.

Document #214
01/07/76
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
STERILIZATION/CONTAMINATION
TISSUE REACTION

Testimony of Joseph Radzius to the California legislature regarding silicone injections. He states that DC’s study “absolutely contraindicates injection of the fluid in the mammary area.”

CITE: M 350149 -350155, Exhibit 33 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition, NOTE: The document also has the Bates Numbers DCD 173002728 -173002734 on it.

Document #215
01/15/76
SHELL STRENGTH – THICKNESS

Tom Talcott memo to Kelley and Rathjen, Dow Corning, discusses the recent Phoenix Breast Symposium in which Dow Corning introduced its new mammary. During the taped implantation surgery, two of Dow Corning’s implants ruptured/broke. Talcott expresses dismay that at Dow Corning the consensus was that the envelope was “good enough” despite finding:

“gross thin spots and flaws in the form of significant bubbles…. The allowable flaws are written into our current specifications…. When will we learn at Dow Corning that making a product “just good enough’ almost always leads to products that are ‘not quite good enough’? It is unfortunate that the thinner dispersion, four dip method proved by Bartolo and Vallender in early 1974 appeared too expensive to plant personnel to even try, although a much higher acceptance rate would be obtained. I sincerely hope this experience will convince us to support programs for ‘high quality’ rather than ‘just enough quality’ in the future.
CITE: F 534, Exhibit 65 to Harris County Rathjen Deposition. Exhibit to MDL Rathjen Deposition. DUPLICATE: DCC 8003157; M 600007; KMM 140185; KMM 380078.

Document #216
01/22/76
TESTING

Dow Corning stated a Two-Year Implant Study with Q7-2159A and MDF-0193 at Industrial Bio-Test Laboratories (IBT).
CITE: Referenced in KMM 390371. NOTE: See 02/03/78 entry.

Document #217
01/23/76
ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees (Mammary Task Force) regarding “Research/Testing – Mammary Gel/Envelope.” Rathjen states, “I have suggested verbally and in writing that we better get going on a basic long range project relative to gel, its formulation, toxicology, etc. over and above what is now underway. The same goes for the envelope. The complaint report from Dr. Horowitz Manchester, Conn., is just one more flag.”
CITE: F 809, Exhibit to MDL Rathjen Deposition, and Exhibit 76 to Harris County Rathjen Deposition. DUPLICATE: M 170171: M 580066: KKA 152383: DCC 17016569: KKA88865: KMM 447050.

Document #218
02/16/76

Rathjen, Dow Corning, memo to the IND 2702 clinical investigators – Ashley, Blocksma, Dingman, Edgerton, Goulian, Murray, Orentreich and Rees – regarding “Proposed California Legislation To Control Injection Of Silicone Fluid.” Dr. Ashley disagrees with regulating injections and states that breast injection should be a xontraindication to the use of liquid silicone.
CITE: M 350147 – 350148, Exhibit 33 to Harris County Rathjen Deposition.

Document #219
03/03/76
TISSUE REACTION
RUPTURE

Dr. Terino presents a paper on “Technique and Results of 50 Breast Capsule releases” at the California Society of Plastic Surgeons. He reports a 36.5% rate of contracture. Also, a Dow Corning implant was removed 10 years post-op. “Upon opening the capsule bilaterally there was a thick sticky layer of silicone outside the envelope. On taking the implants out bilaterally there was no perforation from the envelope whatsoever, but there was clearly silicone on the outside. And pathology showed extensive foreign body giant cell granulomas.”
CITE: M 290302 – 290306.

Document 220
03/17/76
TISSUE REACTION
KNOWLEDGE OF GEL BLEED

Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding a paper presented by Dr. Edward Terino at the California Society of Plastic Surgeons on 03/03/76. The paper discussed a Dow Corning Silastic implant removed 10 years post-op. Silicone was found on the outside of the implant and “pathology showed extensive foreign body giant cell granulomas…. This event, as described by Dr. Terino, cannot be ignored. An attempt must be made to get an answer or explain this phenomenon before the manuscript is submitted to the Journal for publication. If we don’t, everyone of the 350 member audience, the Journal readers, and the lawyers may interpret this as proof that our gel causes problems.”
CITE; F 833 – 834, Exhibit 36 to California Braley Deposition, Exhibit 66 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190247 – 190248; M 250038 – 250041; KMM242493 – 242494; DCC 240000437 – 240000438. See 03/03/76, 03/19/76 and 03/26/76 entries. The implants were from lot number H0209.

Document #221
03/19/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA

Dow Corning’s New Drug Application submitted pursuant to Section 505(b) of the FDA Act, for the preparation Dymasyl (dimethylpolysiloxane) Fluid is not approved. The FDA reviewed the application and found that the information presented is inadequate. The application fails to report adequate animal studies in support of the safety of the drug.

Presently reported carcinogenic studies in animals are inadequate to determine the carcinogenic potential of dimethicone. It is recommended that new studies be initiated in accordance with our current guidelines for testing of products for carcinogenic potential.

The FDA also found that Dow Corning’s application failed to report the clinical studies in full detail, that there was no long-term data or patient follow-up, that manufacturing instructions are ambiguous, that sterility tests were not submitted, and that information on laboratory tests was not submitted. As a result of this, the FDA has closed Dow Corning’s NDA file. The Director, J. Richard Crout, states, “(T)he only potentially acceptable indications for use of dimethicone, on a benefit/risk basis, are for the major facial defects and severe acne scars. We regard the benefit/risk ratio of dimethicone for minor cosmetic uses as unacceptable.” (emphasis added).
CITE: DCC 106006714 – 106006719, Exhibit 29 to California Braley Deposition, and Exhibit to MDL Rathjen Deposition.

Document #222
03/19/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED

Art Rathjen, Dow Corning, reports on the “backlash” from Dr. Terino’s paper to the California Society of Plastic Surgeons. Dr. Barker approached Rathjen after Dr. Terino’s presentation and stated he was also studying capsular contracture. “He (Dr. Baker) also subscribes to the possibility that the migration of fluid or low moleculars through the envelope which causes the greasy feel to the envelope may be contributing to the contracture…. Nevertheless, the question remains in his mind, as it does in a number of other plastic surgeons around the country “Dr. Baker wants to take Dow Corning’s Silastic implants in a centrifuge to collect what is forced through the envelope. The quantity of what comes through should then be implanted in animals in a very small quantity to see what kind of tissue reaction develops. Rathjen thinks that it would be in the best interest of Dow Corning if they were to “take the initiative” and attempt to do something of a similar basis first. He states in this internal memo:

I think it would be embarrassing for Dow Corning and for any of our research expertise if we find that this type of testing has to be left to a doctor in this field. If he were to come up with something detrimental, I think we ought to be prepared for it. (emphasis added).

CITE: M 160001 – 160002, Exhibit to MDL Rathjen Deposition, Exhibit 67 to Harris County Rathjen Deposition. DUPLICATE: M 190249 – 190250; DCC 17031054.

Document #223
03/19/76
SILICA
Hinsch, Dow Corning , memo to Criger, Hoyt and Leach with copies to Bey, Petraitis, Larson and Rathjen) regarding a conversation with Dr. William Jervis. Dr. Jervis claims that “silica (a component of the bag and gel of a mammary prosthesis) is an irritant. Tom also said (according to the doctor) that the silica in the silicone can be released from its entrapped state by over-curing and that the bag of a gel implant was more over-cured than that of inflatables. Tom admitted that some inflatables also probably had some of this silica on them. Tom speculated to me later that a final polymer coating might help retain the silica if that is in fact what is happening.”
CITE: KMM 74769, Exhibit to Frisch Deposition, Exhibit 49 to Hinsch Deposition (used by Dow Corning), and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190251; KMM 120458.

Document #224
03/22/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION

Handwritten note to Milt Hinsch from Greg Bicket, both of Dow Corning, discussing the bleed question and Dr. Terino’s presentation. Bicket notes that many persons are asking questions about, “What is that stuff on the outside of DC’s implant…. Do you want that bleeding into your patient’s body … will it cause capsule contracture. We say they all do it; McGhan must be cleaning their implant very carefully.” He lists 8 questions including whether the gel migrates and, if so, to what parts of the body and with what effects. Bicket feels “uncomfortable” since he can’t answer all of the questions. He notes that McGhan is raising these questions with doctors.
CITE: M 160026 – 160027, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4026 – 4027; M 190255 – 190256, KMM 3831 – 3832. NOTE: This date is approximate and is based on the date on the top of the page from the ASPRS meeting on 03/22/76.

Document #225
03/26/76
KNOWLEDGE OF GEL BLEED
FRAUD/MISREPRESENTATION

Art Rathjen, Dow Corning, letter to Dr. Terino with blind carbon copies to numerous Dow Corning employees. Despite Rathjen’s knowledge that gel bleeds through the envelope, Rathjen tells Dr. Terino that this is “physically impossible” from a polymer chemistry standpoint. He attempts to cast doubt on Dr. Terino’s claims that the substance on the outside of the Dow Corning implant Dr. Terino examined was silicone gel, particularly since the implant was not torn or ruptured. Rathjen suggests that Terino shouldn’t publish his paper stating, “I truly think it would be to the best interest of all concerned if we try to get some answers before there is any further dissemination of information which might be erroneous….(Rathjen) would like to … help solve the mystery, if that is possible, before your presentation is submitted for publication.”

He requests that Dr. Terino send him any explanted Dow Corning prostheses with “a strange color or a questionable envelope surface or seem to have a change in the normal physical qualities.”
CITE; M 250018 – 250019, Exhibit to MDL Rathjen Deposition, and Exhibit 68 to Harris Country Rathjen Deposition. DUPLICATE; DCC 240000435 -240000436; M 570126 – 570127.

Document #226
03/31/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL DEGRADATION

Art Rathjen, Dow Corning, memo to Overton, Bey, Bennett, Harlow, Hinsch, Lewis, Stark, and VerVoort regarding “Your Request For Information, i.e., Radiation Treatments Of The Breast Following Implantation – Dr. John Lindsay.” He states:

“I want to re-affirm again that Dow Corning personnel cannot become involved in medical judgments relative to patient care…. The following information is conjecture. Depending on the amount of x-ray or gamma radiation, one could expect the gel to stiffen with no major change to the physical properties of the envelope. It can be suggested that some chemical reaction might take place with the prosthesis, but we absolutely do not know what affect such a reaction would have on tissue or systemically. It is also an assumption that the implant would act as a screen for the tissue against the posterior side of the implant. Obviously, the screening effect would be in relationship to the thickness and/or density of the implant…. (In) no way do I agree that this be used to endorse or suggest the safety and efficacy of radiation therapy following augmentation using our SILASTIC Mammary Prosthesis. (emphasis added)

CITE: KMM 29699, Exhibit to MDL Rathjen Deposition.

Document #227
04/00/76
ACKNOWLEDGEMENT OF NEED FOR TESTING

A study entitled “Mammary Capsular Contraction (A Situation Analysis 1976)” by P.A. Walters of Health & Human Services. Eldon Frisch, Dow Corning, receives the report. Walters recommends the following:

“Concentrate the initial research effort in the one area Dow Corning knows best, i.e. materials. Do not terminate any existing clinical programs with respect to data generation on mammary capsule contracture. However, I would recommend postponing Dow Corning’s involvement in any new clinical program(s) until some very basic research questions are answered. I realize that rejecting some clinical proposals is very difficult because of the political and economic implications, but participating also carries some very high risks. There is a 50/50 chance that the data may be bad data, i.e., damaging by implicating a product…. Remember, a product which is implicated with bad data requires additional expenditures of time, personnel and money to generate defensive research. There are several data gaps which should be investigated before any long-term clinical involvements are undertaken.”

Walters recommends further studies on gel bleed and elastomer formulation. (emphasis added).
CITE: KMM 4113 -4129, Exhibit 77 to Harris County Rathjen Deposition. DUPLICATE: M 290021 – 290037.

Document #228
04/05/76
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – PRODUCT LABELING
RUPTURE – CLOSED CAPSULOTOMY
TISSUE REACTION

FDA: The FDA, after receiving information that some persons had experienced serious problems with silicone mammary and testicular implants, met with Dow Corning to inspect their files. Mr. Radzius, Dow Corning’s Food and Drug counsel, and Milt Hinsch, Product Supervisor, Dow Corning, claim to John Nicholson, FDA, that current data shows approximately 18% of mammaries implanted will cause a contracture problem. Of this 18%, somewhat less than 10% will require corrective surgery or other techniques. Hinsch also states that a new technique of manually breaking the capsule has recently been developed and shows promise as a solution to contracture. Hinsch also stated that it has always been a policy of Dow Corning to include “adverse reactions” as part of its labeling but, recently, competitors have been using this statement in the literature as a tool to convince surgeons not to use Dow Corning’s products.
CITE: FDA 17180 – 17182. NOTE: HINSCH was aware that the contracture data was much higher than 18%, i.e., see Dr. Terino’s paper presented 03/76.

Document #229
04/13/76
KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, discussed how the market place is telling Dow Corning that improvements can be made to the current production line including to the envelope, gel, and design of the prosthesis. One suggested improvement would be that the gel should be a no bleed gel with very low viscosity, “Doctors are now being sensitized to the oiliness of our current prosthesis….” Hinsch wants Dow Corning to place its name and product size on the mammary in case it needs to be removed and replaced for any reason. “This is a consideration which will become more important as time goes on.”
CITE: M 160007 – 160008. DUPLICATE: GEG 4343; M 160079 – 160080; KKH 2632.

Document #230
04/14/76
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING

Eldon Frisch, Dow Corning, responds to Milt Hinsch’s memo on Greg Bicket’s questions on gel bleed. “The material which bleed from a mammary implant is a polydimethylsiloxane, or more appropriately a silicone fluid. It comes from within the gel…. Since the gel starts as a fluid, these materials are also fluids, and they tend to migrate about in the gel, eventually dissolving in the envelope and passing through it…. We have no scientific data to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture.” He questions whether Dow Corning’s field inventories are getting too old, allowing “the bleed (to become) more evident.” Frisch also talks about injected silicone fluid studies which showed absorption of the silicone fluid into the body. “We have no scientific evidence to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture.”
CITE: M 190259 – 190261, Exhibit 13 to California Braley Deposition (used by Dow Corning), Exhibit to Petraitis Deposition, Exhibit to MDL Rathjen Deposition. DUPLICATE: KKH 1561 – 1565; GEG 4023 -4025; M5700445 – 570047, KMM 3828 – 3830; GEG 4246 – 4250.

Document #231
04/19/76
COHESIVENESS – LIQUID COMPONENT OF GEL
MISCELLANEOUS – SALES
RUPTURE
TESTING

Robertson memo to Blackmore, Coyne, Fredricksen, Pryor, Trischler, Doolittle, Flora, Hauser, McLellan and Murray regarding a discussion with Donald McGhan on 04/14/76. McGhan is now receiving Dow Corning silicone. For the gel uses McGhan prefers the GE product which has a lower level of low molecular weight components. McGhan mammary implants are also more consistent than Heyer-Schulte’s because of the mandrel molding technique used – the madrels are polyester and cast individually.
CITE: MMM 1445 – 1450, Exhibit 6 to D. McGhan Deposition, Exhibit to Horgan Deposition, Exhibit 43 to Harris County D. McGhan Deposition, and Exhibit 68 to Harris County Coyne Deposition. DUPLICATE: MMM 666 -671.

Document #232
04/20/76
SHELL STRENGTH – THICKNESS
RUPTURE

Milt Hinsch, Dow Corning, memo to Brodhagen, et al., regarding demonstration implants used at the “Aesthetic Show in Atlanta on April 11-15, 1976. He writes, “Of these 23 (demonstration implants), 5 had large bubbles in the gel, 1 broke when picked up, and 3 others developed bubbles in the gel around the patch area during the show. We were unable to show the entire line as planned.”
CITE: KMM 219977.

Document #233
04/22/76

Kelley, Dow Corning, memo to Hinsch with copies to C. Lentz, Criger, Leach, Meads, Becker, Petraitis, Bey and Rathjen regarding “Milt Hinsch Memo of April 13 – Attached “Gel Filled Mammaries Of The Future.’” Kelley notes that the attached memo from Hinsch documents specific marketplace requirements for the mammary prosthesis line. CITE: KKH 2633

Document #234
05/04/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
TISSUE REACTION

Greg Bicket, Dow Corning, reports that he met with Dr. Richard Phares regarding the Silastic Mammary Prosthesis. He is “interested in reports of freshly healed augmentations failing to adhere with subsequent loss of implant. (Phares) experienced this, and was upset to hear others reports of this at the Southeastern meeting. Apparently, the theory is that the opposing faces of the wound are closed, and in ten to fifteen days no appreciable healing has taken place. The suture lines then break down, and the implants are not retained. ‘Greasy implants” sliding into the pocket, providing a release agent against healing, were postulated to be the cause.”

Further, “The second area of concern was the reported actions of migrating gel/fluid of other manufacturers’ gel. Giant cells, granulomae, and siliconomae were reported in and around the locations where the migrating gel/fluid was said to have come to rest.” Phares proposes a dog study.
CITE: M 600009 – 600010, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: F 713 – 714; KMM 380053; DCC 80010141 – 80010142. NOTE: Dow Corning never followed through with a dog study. See 06/08/76 entry.

Document #235
05/11/76
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION

Neal Langley and Jon Swanson, Dow Corning, report on the “Effects Of Subcutaneous Implantation, Through Two Years, On The Physical Properties Of Medical Grade Tough Rubber (MDF-0198).” MDF-0198 is a “new high performance medical grade elastomer for orthopedic (sic) devices…. Questions to be answered were: do physical properties change during implantation; are body fluid absorbed into the elastomer; and is PDMS leached into the body during the two year subcutaneous implantation period?” Langley and Swanson state that there was little change in tensile strength, tear resistance and ultimate elongation. “Maximum loss of PDMS into the body ranged from 0 to 0.7% of the sample weight after 32 weeks and from 0 to 1.3% after two years…. This degradation may become important over longer periods.” There were significant changes in the flaw propagation life after implantation, a 10% decrease in tensile strength and flaw propagation life, a 20% decrease in elongation and a 5% increase in modulus. “Differences to be noted between this study and service conditions include the absence of flexing during implantation, and any differences between the subcutaneous environment in dogs Vs the various locations in the human body where the devices are in service.”
CITE: T 21431 – 21444. DUPLICATE: KKH 68344 – 68357; DCC 204001179 -204001192.

Document #236
05/17/76
ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen, Dow Corning, memo to Bey and C. Lentz regarding a capsular contracture study proposed by Dr. James Penoff. “We are engulfed in qualified speculation – nothing to date is truly quantitative or qualitative; therefore, Dr. Penoff’s suggestions for a course of action merit some serious consideration.” (emphasis added). Phase I of the proposed study includes:

A. Is there something in the implant that migrates out or off the mammary prosthesis? yes or no!
B. Does it continue for the life of the implant or is it limited or controlled for a period of time?
C. Does it come from the gel or envelope or both?
D. What is it?
E. Considering the evolution of the mammary prosthesis, have changes in both the gel and envelope altered the degree or changed what might migrate through or off the prosthesis?

Phase II would be pre-clinical implant testing to determine whether components of the envelope and gel migrate. Phase III is human implantation.
CITE: F 715 – 716, Exhibit to MDL Rathjen Deposition, and Exhibit 78 to Harris County Rathjen Deposition DUPLICATE: FDA 31438 – 31439; M 210001 – 210002.

Document #237
06/00/76
GEL MIGRATION
TESTING
TISSUE REACTION

G. Frugard’s Dow Corning trip report from Heyer-Schulte’s library. Includes 08/06/76 memo from J. Erhardt to T. Talcott regarding confidentiality agreement with Dow Corning requiring all information being confidential for a period of ten years from the date of disclosure of delivery. Frugard’s trip report was sent to S. Koorajian and is dated 07/14/76. Frugard reports that there are both positive and negative aspects of his trip to Dow Corning. On the positive side, he feels that he was successful in bringing back a comprehensive summary of all of Dow Corning’s animal data; or at least “all that I was given access to”. The negative aspect is that the data does not answer the key questions concerning migration and its consequences. Many of the experiments were not well controlled. The animal studies indicate no significant pathological findings and, in cases were there were, they were attributed to experimental procedures.

Frugard concludes that:

“due to the fact that there was no apparent difference in reaction to any of the gels, the inflammatory response must be considered to depend solely on tissue injury and not upon gel migration. This conclusion is tenuous at best considering there were no controls. Perhaps all gels were reactive…. Gel migrates into the capsule…. Unfortunately, the data collected in this study does not answer questions concerning migration, even though that was the main objective.

I regret the fact that Dow Corning’s data was lacking in quality and left many questions unanswered.”

CITE MD 114416 – 114428.

Document #238
06/02/76
SHELL STRENGTH – THICKNESS
RUPTURE

Mazelin, a Dow Corning sales representative, files Complaint Report F76023 for a rupture of a Silastic Round mammary implant. Dr. Kellett, the implanting physician, noted that this was the second rupture in the past few weeks. He “feels ’thinner’ envelope weakens it (the implant) significantly.”
CITE: CR 3172 – 3173.

Document #239
06/07/76
GEL MIGRATION
MISCELLANEOUS – COMPLICATIONS
RUPTURE
TISSUE REACTION

Braley, Dow Corning, telephone report concerning a conversation with Dr. Nicholas Georgiade. Dr. Georgiade’s patient developed a mediastinal node enlargement and lung lesions and suspects gel migration from a ruptured implant. He notes that the patient’s husband is a “smart ass” trial lawyer and wants to know how to handle this. He wants a letter from Dow Corning so that he has “enough information to counteract any feelers that this lawyer may put out.”
CITE: M 250053, Exhibit 35 to Hinsch Deposition (used by Dow Corning), Exhibit 87 to Harris county Rathjen Deposition, Exhibit 39 to California Braley Deposition, Exhibit to MDL Rathjen Deposition. NOTE: for Rathjen’s response, see M 250050 – 250052 dated 07/12/76

Document #240
06/08/76
ACKNOWLEDGEMENT OF NEED FOR TESTING

Art Rathjen memo to Al Bey, C. Lentz and others, all of Dow Corning, regarding “G. Bicket Trip Report No. 504, May 4, 1976, i.e., Dr. Phares, St. Petersburg, Florida.” Rathjen states:

“I have proposed again and again that we must begin an in-depth study of our gel, envelope, and bleed phenomenon. Capsule contracture isn’t the only problem. Time is going to run out on us if we do not get underway. Believe me when I tell you that the A.S.P.R.S. is also going to begin their own investigation. A committee will be organized, and they will come to the manufacturers asking questions. It would certainly be to our advantage to be ready for them.
CITE: F 712, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE: M 600011; GEG 003999; KMM 242518; DCC 80061401; M 600008.

Document #241
06/10/76
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF GEL BLEED

Study by Brill titled “Development Of A Low Oiling Gel For The External Breast Prosthesis.” The resulting gel caused substantially less swell of the silicone rubber envelope and gave a low rate of migration of silicone material through the envelope compared to existing silicon gels formed from low viscosity fluids and plasticizers. It was also shown that gels and fluids based on methyltrifluoropropyl polymer as well as silicone organic copolymers could produce a very low order of elastomeric swell and bleed with polydimethylsiloxane envelope rubber.
CITE: KKH 63280 – 63299, Exhibit to Petraitis Deposition, and Exhibit to
MDL Rathjen Deposition.

Document #242
06/11/76
MISCELLANEOUS

W. Larson and Y. Peters, both of Dow Corning Corporation, issue an internal Dow Corning report entitled “Medical Products, Technical Service and Development”. The authors report that:

“The mammary gel, MDDF0193, often develops a yellow color which detracts from the appearance of the prosthesis. The cause of this problem has been traced back to the catalyst, XY173. Four catalysts were evaluated on the basis of color, XY173. Four catalysts were evaluated on the basis of color, XY173, XF95504, PtII and MDDFoo69. The color intensity of the gels was found to decrease in the following order: XY173, XF95504,PtII, MDF0069.

The results indicated that the easiest solution to the problem was to switch to MDF0069.”
CITE: KMM 8596 – 8605. NOTE: The first page states that this document is Dow Corning Proprietary and that neither this document nor the information contained in it may be reproduced except in TIS, nor distributed outside the company without permission from the Director of Technical Service and Development.

Document #243
06/25/76
SHELL STRENGTH – THICKNESS
RUPTURE

John Gallagher, Dow Corning, memo to Bob Becker regarding the “large increase in rupture returns in the past month….” Gallagher states that:

“All the doctors claim that the ruptures are happening from 90% of the prosthesis with the creases and large air bubbles. I had a discussion with Milt Hinsch today and he told me he has had three telephone calls, one from Tom Mazelin, one from Greg Whittaker, and one from Jim Reisma (sic – Reitsma), all having the same problem – an excessive amount of ruptures. I wanted to bring this to your attention because I have one customer that has had a return of thirty ruptures in the last three months…. We have enough problems with competition without worrying about ruptures constantly.

CITE: CR 3272

Document #244
07/07/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Nicholas Georgiade responding to expressed concerns regarding gel migration. Rathjen states:

“The first silicone gel-filled mammary prosthesis was implanted in a patient of Dr. Tom Cronin’s in 1962, and as of July 1976, she still has them, and her course during the past 14 years has been uneventful. Since that time, mammary implants numbering in the hundreds of thousands have been used for augmentation and reconstruction of the breast.

The percentage of complications has been minimal, and very frankly, gel migration due to breakage of the silicone envelope has not been a problem nor can I recall when a surgeon has questioned us about this, relative to a Dow Corning Product.

We also have test data on the implantation of our materials; and there is, to my knowledge, no indication or proof that phagocytes pick up the material and carry it off. I agree with Si on that Point – the size and consistency of the gel, and even more specifically, our gel used in 1970 does not make it feasible.”

CITE: KMM 354956 – 354957.l

Document #245
07/12/76
FRAUD/MISREPRESENTATION
GEL MIGRATION

Rathjen, Dow Corning, letter to Dr. Nicholas Georgiade stating that he has never heard of a problem of gel migration “relative to a Dow Corning product.” (emphasis added). He notes that the gel is “very cohesive.” Rathjen also claims that Dow Corning does not have any test data or knowledge showing that phagocytes pick up the silicone and carry it through the body, claiming that this is not “feasible.”
CITE” M 250050 – 250052, Exhibits 36 and 37 to Hinsch Deposition (used by Dow Corning), Exhibit 40 to California Braley Deposition, Exhibit 63 to MDL Rathjen Deposition (used by plaintiffs and Dow Corning), Exhibit 88 to Harris County Rathjen Deposition, and Exhibit 40 to California Braley Deposition. NOTE: There are numerous instances of gel migration noted in Dow Corning’s internal and external tests as well as in letters from physicians. See, e.g., 04/00/67 – GEG 4301 – 4304; 04/01/67 – PSC Medical Articles CDE, J 157 – 166; 04/11/67 – T 38842 – 38866; and 08/02/71 – KMM419744). NOTE: Also see 06/07/76 telephone report, M 250053.

Document #246
07/14/76
DOCUMENT DESTRUCTION
TESTING

Milt Hinsch, Dow Corning, memo to Rathjen, Kelley, Leach, Lentz, Bey, Bennett, Hoyt, Mantle, and Nelson regarding “The Milt Hinsch Grant.” Hinsch turned down a request for funding by Dr. Tanski which Rathjen supported and then agreed to fund a similar study by Drs. Horton and Rasato. Rathjen has suggested that Drs. Horton and Rasato had gone “shopping” for funding and were turned down by Heyer-Schulte already. Hinsch responds that it was a marketing sponsored decision to support Horton and Rasato because they are product champions. In response to Rathjen’s question about what to do with the data Horton and Rasato generate, Hinsch states, “Question number 9 about what will we do with the data depends upon the data which is generated, Art. It may turn out that we will take the paper on which this data is printed, roll it up and light pipes and cigars with it.” (emphasis added).
CITE: M 190344 – 190345, Exhibit to MDL Rathjen Deposition, and Exhibit 82 to Harris county Rathjen Deposition.

Document #247
07/15/76
KNOWLEDGE OF SYSTEMIC DISEASE

Pulley memo to LeVier regarding “Patent Memo 4240 – Insecticidal Activity of Silicone Oils and Emulsions.” The subject patent is being placed in our inactive files in the Patent Department. Note: The referenced patent memo is not attached.
CITE: DCC 281041374 (Temporary Dow Corning Bates Number 16359 – 16379), Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, Exhibit to LeVier Deposition.

Document #248
07/23/76
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION

FDA: A hearing is held by the FDA Panel on Review of General and Plastic Surgery Devices. On the issue of breast implants, J. Radqius, Dow Corning, states that he has evidence that doctors may be altering the breast implants by injecting an antibiotic into the prosthesis which is gradually released through the membrane of the implant.
CITE: This document also has the Bates numbers KMM 489852A – 4900119A (This document also has Bates numbers KMM 545507 – 545555, 547162, 545556 – 545557, 547163 – 547164, and 545558 – 545671 on it.) DULICATE: FDA 160 -161 (Pages 150 and 151 only).

Document #249
08/02/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Hobbs, Dow Corning, memo to Atwell, Bey, LeVier, Radzius, Ryan, Smith, Stark, Gamon, Lentz, Maneri, Tyler, Wehrly, and Weyenberg regarding “2,6-cis Toxicity.” Hobbs states:

“A six month chronic toxicity study conducted on 2,6-cis has demonstrated possible relationship between the appearance of mammary tumors in the (word is cut off) and the feeding of the chemical. This possibility may have implications which involve products other than 2,6-cis. There are three major questions we must answer concerning this possible effect:

1. Is the occurrence of mammary tumors an absolute response in the rat when fed 2,6-cis?
2. Do any of our products contain 2,6-cis?
3. Is the production of these tumors a result of the estrogenic activity of 2,6-cis or is it related to certain low molecular weight silicone compounds?
CITE: KMM 482556 – 482557, Exhibit to Tyler Deposition, Exhibit to Ryan Deposition. NOTE: The right hand side of the page is cut off.

Document #250
08/03/76
KNOWLEDGE OF SYSTEMIC DISEASE

Pulley, Dow Corning, memo to LeVier concerning the inactivation of Patent Memorandum 4320. Because LeVier represents “that the project which supported the subject disclosure in on the shelf and that Dow Corning would probably not reactivate work in this area in the near future,” the patent memo is inactivated, to be reactivated “whenever you consider it appropriate.”
CITE; DCC 281061472, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to Lake Deposition, and Exhibit to LeVier Deposition. NOTE; Refer to entry dated 01/31/75. This was listed on Plaintiffs’ Exhibit List in Carter as “No Bates Number.”

Document #251
08/12/76
MISCELLANEOUS – COMPLICATIONS

Dr. John Wolfe, Detroit Medical Center, writes to Milt Hinsch of Dow Corning expressing concerns regarding silicone mammary prostheses. Wolfe writes, “I would like to stress to you that the present prostheses composed of silicone are more than an inconvenience but a very serious problem. Very often women who have an augmentation have severe mammary dysplasia. Severe mammary dysplasia is related to a high incidence of developing breast cancer. Prostheses effectively block from view a great amount of the breast tissue on radiographic examination…. We have the situation where implants are being put into breast which are at high risk for developing breast carcinoma and we are seriously impairing our ability to recognize the carcinoma in its early and curable stage.”
CITE: COM 361 – 362. DUPLICATE; GEG 4090.

Document #252
08/23/76
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE

Jim Rudy, President of Heyer-Schulte sends a “Dear Doctor” letter regarding “the possible and known problems and complications” of breast implants. It is noted that subtle processes of degradation should be expected to occur, and that the knowledge associated with long-term implantation is imperfect. If the implant is torn the gel will migrate and that is why Heyer-Schulte placed warnings in data sheets in May 1975. Doctors and patients should expect some patients to exhibit adverse response to silicone implants.
CITE: M 190413 – 190417, Exhibit 159 to Harris County Powell Deposition, Exhibit to Harris County LeVier Deposition, Exhibit to Nawash Deposition, and Exhibit 140 to Harris County Rathjen Deposition.

DUPLICATE: GEG 004050 – 004054; KMM 262028 – 262032; BAX 36899 – 36903. WITNESS: Rudy Exhibit 34; Hyans Exhibit 24. DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Document #253
08/24/76
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
TESTING
TISSUE REACTION

Hobbs memo to Atwell, Bey, LeVier, Radzius, Ryan, A. Smith, F. Stark, A. Gamon, “C. Lentz, R. Maneri, L. Tyler, J. Wehrly and D. Weyenberg regarding “2,6-cis Toxicity Action Meeting – 8/23/76.” The parties met on 8/2/76 and discussed and agreed to the following activities: all products having potential for 2,6-cis formation will be identified along with their known uses: existing data will be reviewed to determine estrogenic potency of various low molecular weight organosilicon compounds when compared to 2,6-cis and/or DES: all areas will be identified where 2,6-cis is a known process by-product.
CITE: DCC 281031680 – 281031681, Exhibit to Harris County Tyler Deposition, and Exhibit to LeVier Deposition.

Document #254
09/20/76
GEL MIGRATION

E. Hobbs, Dow Corning, Memo to Milt Hinsch and Charles Lentz providing information on the migration of silicone gels. Experimentation utilizing various animals has not demonstrated migration of Dow Corning mammary gel. However, “Gels having a low consistency due to low levels of cross-linker appear to migrate along tissue planes in much the same manner as large injected doses of silicone fluid.” One gel, in a test situation having a low cross-linker material, moved from its original implant site apparently along tissue planes aided by gravity.
CITE: D 972, Exhibit 141 to Harris Country Rathjen Deposition, and Exhibit 2D to Harris County Talcott Deposition. DUPLICATE: M 170104; M 570060; DCC 8200611.

Document #255
09/20/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION

Dr. C. Vinnik writes a letter to Art Rathjen of Dow Corning, copying Dr. Brody of ASPRS. Dr. Vinnik reports on a patient with a breast implant who developed a lump in her left breast. During surgery Vinnik noted that the Heyer-Schulte implant was intact and the lump or mass was eternal to the capsule. Vinnik notes that the pathologist’s report showed:

“extensive fibrosis and granuloma formation that I have seen previously with silicone injections…. I do not know what the implications of this problem are, however, one consideration must be that there was extensive reaction within the tissue to the silicone gel with which it was in contact. I believe this is a serious matter and is something that the Standards Committee of the American Society of Plastic and Reconstructive Surgeons should ultimately consider. I might add that the type of reaction described in this case is similar to that of injected silicone gel as reported several years ago by Dr. Boo-Chai of Singapore. You will recall that Dr. Boo-Chai ran a series of breast injections with silicone gel through a dissection subcutaneous pocket with disastrous results…. It certainly goes along with reactions I have seen with silicone gel extrusion by another manufacturer utilizing the General Electric gel.” (emphasis added).

CITE: DCC 24000504 – 24000506, Exhibit to MDL Rathjen Deposition. DUPLICATE: M 190364 – 190366; CO 21 – 23; KHH 54148 – 54150.

Document #256
09/22/76
GEL MIGRATION
TISSUE REACTION

Milt Hinsch memo to the Dow Corning sales force concerning Dow Corning’s response to Heyer-Schulte’s “Dear Doctor” letter discussing problems and complications of gel-filled mammary prosthesis. Hinsch claims that Dow Corning’s implants are considered “non-active in the body” and he “would not expect shape or softness to change appreciably.” Also, Dow Continues “to test 100% for cohesive gel during production” and “their gel offers the softest possible feel while retaining cohesiveness.” Hinsch states that, “there are no cases of Dow Corning gel migration. Conversely, in documented cases where the envelope was ruptured, the gel did not migrate.” He claims that all materials are subjected to “extremely sensitive” tests for tissue reaction and must show no tissue reaction to be accepted. Hinsch states that Dow Corning does not plan a written response to the ” “Dear Doctor” letter.
CITE: M 240432 – 240433, Exhibit 8 to Hinsch Deposition (plaintiffs), Exhibit 44 to Hinsch Deposition (Dow Corning), Exhibit to Peters Deposition, Exhibit to Harris County Rudy Deposition, Exhibit 97 to Harris County Rathjen Deposition, Exhibit 2D to Harris County Talcott Deposition, Exhibit 113 to Burda Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4048 – 4049; M 880029 – 880030; OOM 880029 -880030.

Document #257
10/01/76
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
RUPTURE
STERILIZATION/CONTAMINATION
TISSUE REACTION

Donald Barker, M.D., presents a paper, “Reactions to Silicone Implants in the Guinea Pig,” to the Scientific Session of the American Society of Plastic and Reconstructive Nurses.
CITE: GEG 4000 – 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill Lee Schultz, R.N.

Document #258
10/09/76
SHELL STRENGTH – THICKNESS

Bill Overton, a Dow Corning sales representative, files Complaint Report L76001 regarding service problems and thick envelopes on Silastic Round mammary implants. In an accompanying memo dated 10/19/76 from Overton to Hinsch, Leach, Darling, Brodhagen, Woodard, Hoyt, Schultz, and VerVoort, Overton states that, “Frankly, I was a little surprised to see such a difference in the comparison (between the new Silastics and the Silastics in Dr. Forrest’s inventory)…. Dr. Forrest stated he felt the new SILASTIC stock had an envelope about three times as thick, and also stated he would be able to feel the thick envelope in a patient…. I know he was upset more at this point when he sort of threw the implants from his locker onto the floor. If the implants I picked up from Dr. Forrest are typical of mammary product we are making today, I can’t help but feel I will loose half of my business in the next six months. I prefer giving a few extra out for breakage than lose $100M in sales…. We cannot afford to make noticeable changes if we expect to retain present market.” Dow Corning’s Quality Assurance Reliability Engineer noted that the returned implants did exceed envelope thickness specifications and that there was inconsistency in envelope thickness specifications and that there was inconsistency in envelope thickness on the same implant as well as in comparing implants.
CITE: CRM 200 – 203.

Document #259
10/13/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Report of 10/12/76 phone call from Dr. Colocho to Rathjen regarding 6 of Dr. Colocho’s patients with palpable nodes in the axillary area, and Dr. Colocho’s “very real concern” regarding possible gel bleed.
CITE: KKM 42792, Exhibit of Rathjen Deposition.

Document #260
10/15/76
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Letter to Dr. Colocho from Rathjen submitting questions regarding Dr. Colocho’s 6 implant patients with palpable nodes.
CITE: M 190376 – 190378, Exhibit 32 to MDL “Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition. DUPLICATE: M 240009 – 240011.

Document #261
10/23/76
GEL MIGRATION

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration, “Obviously, whether it is a Dow Corning implant or a competitors’ the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility: therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin.” Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implants until the first quarter of 1976. General Electric supplied the materials.
CITE: KKH1719. DUPLICATE: GEG 4009

Document #262 (Possible)
10/31/76 (NOT LISTED ON PLAINTIFF’S EXHIBIT LIST)

Art Rathjen, Senior Clinical Research Specialist for Dow Corning, writes to Kurt Wagner, M.D. about a problem with gel migration. “Obviously, whether it is a “Dow Corning implant or a competitors’, the fact that this phenomenon would exist is disturbing enough. We have always been conscious of this possibility; therefore, you certainly caught me off guard when you first reported that the gel from one of our implants had indeed migrated to the groin. ” Rathjen claims that Dow Corning did not supply any materials to competitors for the manufacture of mammary implant until the first quarter of 1976. General Electric supplied the materials.
CITE: GEG 4009.

Document #263
11/02/76 KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE

Dr. Charles Vinnik writes to Art Rathjen, Dow Corning, about a histologic response to a patient whose breast implant ruptured. Dr. Vinnik states that “microscopically it appeared to resemble the reaction (sic) seen around silicone injected breasts.” He also notes that the response to silicone materials in humans is “a very variable thing….” (emphasis added) CITE: KKH 6944 – 6945, Exhibit 47 to MDL Rathjen Deposition (used by Dow Corning).

Document #264
12/07/76
TISSUE REACTION

Guillermo Colocho. M.D., of New Mexico, letter to Art Rathjen, Dow Corning, enclosing tissue specimens of patients who experienced problems with implants. Patient number 1 had a small nodule in the right breast three years post-op. Following biopsy, pathological diagnosis revealed lymphoid hyperplasia. Patient number 2 developed multiple tender nodules and lumps in her breast five months post-op. Following bilateral biopsies, pathological diagnosis revealed bilateral lymphoid hyperplasia.
CITE: M 240013 – 240014, Exhibit 32 to MDL Rathjen Deposition (used by Dow Corning), and Exhibit 69 to Harris County Rathjen Deposition.

Document #265
01/04/77
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Patent No. 4,001,403 for a method for reducing the reproductive function of mammals by Bennett and McHard. A method for altering the reproductive function of mammals by administering a pharmacologically effective amount of certain fluoroalkyl-substituted organosilicon compounds. As a means of illustration, one can orally or parenterally administer from 1.00 mg. to 100 mg. per kilogram of body weight of an organosilicon compound thereby rendering the subject (either a male or female mammal) infertile.
CITE; DCC 281061 – 281061408, Exhibit 73 to Bennett Deposition (used by Dow Corning).

Document #266
01/10/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF GEL BLEED

Becker, Dow Corning, memo to C. Lentz regarding silicone found in tissue. He writes, “The question of bleed and contracture is indeed of concern by our competitors and the physician. There is no question in my mind that Dow Corning’s leadership position is expected to provide answers to the questions. I am very surprised to find that we do not have any data on Si levels in tissue or the distribution and fate of trace levels of polymer in the body.”
CITE: F 810, Exhibit to California C. Lentz Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 70 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260614; M 170124; KMM 380071

Document #267
10/18/77
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – SALES

Rathjen, Dow Corning, memo to Bey, Hoyt, Hutchison, Lentz, and Nelson regarding “observations Relative To Dow Corning’s Future In The Mammary Implant And External Breast Markets.” Rathjen states; “In my opinion, we, Dow Corning, are no longer the recognized leaders or innovators in either segment; and our present position will continue to decline unless specific measure are taken now to turn things around…. I am powerless to change anything, and my sphere of influence in this business continues to diminish: hopefully, I still have the privilege to express opinions even if they are not shared by all.”
CITE: KMM 12998 – 13000 and 13004, Exhibit to MDL Rathjen Deposition, and Exhibit 83 to Harris County Rathjen Deposition. DUPLICATE: m 190101.

Document #268
02/10/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Will Larson, Dow Corning, memo to Art Rathjen, Becker, Bennett, Bey, Kelley and Lewis concerning an allergic reaction in a patient of Dr. Vanduyn. The patient was implanted with a Silastic Mammary Prosthesis, No Fixation Patch. One month following implantation, the patient contracted the flu. Shortly thereafter, the implant “broke through” the healed incision and the implants were removed. The augmentation was redone and, within days after the surgery, the implants again “broke through.” Dr. Vanduyn suggested a possible allergic reaction and asked if there were any similar reports. Larson told him, “I was unaware of any allergic reaction to silicones”.
CITE: M 240368

Document #269
02/17/77
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING

Larson, Dow Corning, memo to Bennett, Hoyt and Rathjen regarding mammary bleed. “The permeability of silicone elastomers is a well known phenomena…. Permeation in this case is … toxicologically unknown…. It is of great concern because of what can be made of the unknown….” Also, “We would also anticipate bleed may be a function of heretofore unmeasured factors, e.g. manipulation and stress…. Dow Corning’s product development direction has been an attempt to strike a balance between: 1)What we factually know about bleed. 2)What gel and envelope polymer intermediates can be produced. 3)What toxicological data we have on materials. (and) 4What is a marketable product…. In conclusion, any physiological effect or consequence of this permeation remains speculative. What can be done and what should be done is an open topic of discussion.”
CITE: OOM 320448 – 320449, Exhibit to MDL Rathjen Deposition, and Exhibit 71 to Harris County Rathjen Deposition. DUPLICATE: KMM 176928; KKH 2263: M 150002 – 150003: M 190423 – 190424.

Document #270
02/25/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
SHELL STRENGTH – THICKNESS

Rathjen, Dow Corning, memo to Hoyt, C.Lentz, and Nelson stating, for the record, his objection to the Product Marketing Group’s (“PMG”) decision to market the Silastic Inflatable Mammary Prosthesis. Rathjen believes a six month review of clinical experience with the implant is necessary before a meaningful assessment could be made regarding the efficacy of the implant. At the time, Dow Corning was only six weeks into a clinical trial on the inflatable. He cites Bob Becker who reported to the PMG that, based on his investigation of the envelope production, he believed the quality of the inflatable envelope now was no better than when Dow Corning made it in 1971-72, when the inflatable line failed.
CITE: KMM 3333245 – 333426, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.

Document #271
03/11/77
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
RUPTURE

“Thoughts relative to Meeting – March 10 – Inflatable – Telephone Conversation with Mel Nelson – March 11.” Dow Corning held a meeting on March 10 with Hoyt, Meads, Bennett, LeVier, Leach, Petraitis, Radzius, Hinsch, Criger, Steele, Rathjen, and Lewis. The author is unidentified but believe it is Rathjen. The author states:

“I sat there and listened to the various opinions that were offered and it became evident to me that actually it was a matter of having everybody stroke one another hoping that a consensus of opinion would be developed that would allow a positive decision on the distribution and sales question with nobody taking firm responsibility for a final decision. In the meeting, when it got around to the legal aspects of product liability, Joe Radzius read the memo that had been delivered by Norm Lewis which stated that our liability was wide open and if we did have any problem that Dow Corning would have a very difficult time defending its position and the recommended course of action by Steve Giadard, Harry Dingman, and Norm Lewis was that we not accelerate the calendar (sic) or time relative to our distribution and sales of the product. The ultimate decision of this meeting was of course that they would continue on there (sic) course for a projected May 1 distribution and sales limited area and therefore, they were willing to take a chance over and above the recommendations of the legal department.

I continued to hold my position that I did not feel that it was prudent for Dow Corning to consider an early distribution and that we should wait until at least a six month period when the (sic) clinical evaluation data would be in and evaluated and therefore, I was certainly in the minority when Hoyt put it all to a vote at the end of the meeting.

Between Thursday, the 10th of the March and Friday, the 11th of March, I had occasion to think about this and I felt that I still couldn’t live with this decision and therefore, at approximately 8:15 on Friday, March 11th, I called Hemlock and spoke with Mel Nelson. In doing so I told him I was concerned because the meeting yesterday was the fourth meeting on this same subject and it (sic) indicated to me that people were still uneasy and not entirely committed and to have such indecision requiring these repeated meetings to go over the same subject indicated a shakiness (sic) on the part of the parties concerned. I told Mel that I actually really felt that the people in that conference room on Thursday afternoon really wanted to be stroked. There was safety in numbers. I asked him who the person would be that one individually would be held accountable if this project were to get underway and things were to go to hell in a bushel basket, I did not get an answer to that and of course I think that Mel felt that ultimately he would be the one that had to make an accounting for this. But I find it hard to believe that he would allow himself to succumb to the pressures of several of the members of the Marketing Department and possibly Ron Kelley of TS&D, simply for the sake for getting 500 inflatable mammary prostheses out in 1977, which would only amount (to) $70,000. I think that the disregard for a plan and our disregard for the ethics of clinical testing and product reliability for (sic) to sale isn’t worth jeopardizing for the sake of this small amount of money.

My second point to Mel on the phone was that I truly believe that this decision , as fostered by John Hoyt and Chuck Leach, is a violation of Ray Maneri’s Codes of Business Conduct. I think the Marketing Department Planned very poorly and I think the PMG has not been very realistic in pushing forward in this and therefore, a decision to go ahead with an early marketing date violates Maneris Codes of Business conduct in the U.S. area that was circulated by all Dow Corning employees. Ray has very emphatically stated in his little pamphlet (sic) that Dow Corning “Dow Corning will strive to assure product efficacy, assure that its products are of the highest practical quality and that product characteristics and potential hazards are made clearly known to the user.” If they go with an early market introduction date, they have violated that statement in the code. Further on in the same pamphlet, it states “the product sold by Dow Corning will be thoroughly tested to determine their effect on the environment.” Here again I feel that an early distribution would violate that part of the code. I made both of these points to Mel Nelson and pointing out that we were succumbing to Marketing pressure. I also brought up the subject of a problem we had years ago when the Marketing Department and Gordon McIntyre elected to distribute all the (sic) silicone foley catheter in the southern California area prior to any conclusive testing relative to safety and efficacy. That decision turned out to be a real fiasco (sic) in several months we had telephone calls and letters and telegrams from hospitals and Urologist and nurses from southern California relating incidents of balloon failure, balloons coming off the end of the catheter, etc. and immediately we had to cease and while we retrieve (sic) all of these catheters, our legal council (sic), Joe Radzius was down in Washington trying to keep the lid (sic on this thing so it would not become an official recall. This meeting on Thursday, bothered me because Joe was back in that meeting offering Legal Council (sic) which was opposite what had been voiced by Steve Gaidard and Harry Dingman and Norm Lewis in the memo that was left for Joe to discuss. All three of these people including the chief legal council (sic) for the corporation, Steve Giadard stated that there (sic) recommendation that we not go with an early market distribution, Joe on the other hand (stated) that he felt that the risk was worth it. I felt his contribution at the best (sic) biased because he had already made it known to the Corporation that he is resigning and so whatever he said would have little effect anything that would transpire past March 31, when he officially leaves the employment of Dow Corning.

I mentioned to Mel that I felt that the strength of the position by the Marketing Department, namely Hoyt, Leqach, Hinsch also pivoted on their having to save face within the last week they had a general sales meeting down in Houston and I come to find that they did announce to the sales force that the inflatable was coming and it would be offered for limited distribution. Now here some of these problems are being posed to them and would require their having to go back to the sales force and tell them that there (sic) initial decision was incorrect and retract all that they have said and therefore their credibility as being challenged I think that it wasn’t in the best interest of this corporation to go down and tell the salesmen in the first place we are going to have a product, while it was still under test.

I think that we are indeed putting Dow Corning’s name and reputation on the line for a measly (sic) $70,000 and there is not (sic) guarantee that there would be sale of pairs between May 1 and the end of the year. Finally I said to Mel Nelson that for the last several years we have (been) under strict criticism (sic) by the American society of Plastic and Reconstructive Surgeons because of our position with the silicone injection program. When we first got involved with the A.S.P.R.S. with the silicone symposium, we were accused as a Corporation of disregarding safety and efficacy data to jam our product through so that we could recoup (sic) some of our investment dollars and we were looked at as a large corporation who disregarded safety and efficacy standards to make money. I had to defend Dow Corning’s position in this regard at the California Plastic and Reconstructive Society meeting last year because the same accusation was made that we were more interested in profit and dollars then (sic) we were in ethics and good testing. I told Mel that one of our current clinical evaluators for the inflatable was Dr. Verner Lindgren who is Vice-President elect of the A.S.P.R.S. and also Fred Grazer who, both of these men being very active in Society matters. I would find it hard (to) believe and in fact I would find it a very difficult thing to do, to go and have to tell these men that now that they are testing the product, that Dow Corning has taken upon themselves to market this product. Therefore I wanted a written statement from the Business stating the rational and the decision behind this move and that I would use that statement when these investigators were to be informed of Dow Corning’s decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn’t even gotten that far to consider what the ramifications would be and what the impact would be on these investigators were to be informed of Dow Corning’s decision. Mel Nelson pointed out that the Business as a whole and the Business Board hadn’t even gotten that far to consider what the ramifications would be and what the impact would be on these investigators and that this would be something that would have to be looked at in great detail. While I find this whole matter very disconcerting (sic), I personally am very uneasy about the whole thing. I find it hard to believe that after so many difficult experiences in the past that management for the Medical Products Business would be so narrow — in their vision that they are going to go out and promote a product that has not been tested. It is my sincere hope that there will be a reversal to this decision.”
CITE: KMM 333230 – 333234, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Document #272
03/16/77
GEL MIGRATION

Dr. Swanson calls Eldon Frisch, Dow Corning, noting that he had written to Zeke Bennett urging that Dow Corning undertake appropriate studies to determine the potential migration of silicone elastomer particles throughout the body. Dr. Niebauer, San Francisco, is presenting a paper and speech about silicone particle migration in monkeys, particularly in the liver. also, Dr. Rose from the Massachusetts Institute of Technology will propose his theory on silicone elastomer degradation by interaction with lipids at the upcoming Biomaterials Meeting. Frisch suggests that Dow Corning attend these meetings and publish their own position that “biodegradation does not occur.” He also suggests an animal study at the University of Michigan because they are “open to suggestions.”
CITE: M 190441 – 190443, Exhibit to Harris County Tyler Deposition.

Document #273
03/22/77
MISCELLANEIOUS – COMPLICATIONS
TISSUE REACTIONS

Complaint report from Dr. Tony Emmett filed by Green. Report states that Dr. Emmett has removed implants after a cancer was found in the breasts. This is one of several such cases sighted by Emmett. The cancer cells have seemed to follow the capsule.
CITE: COM 4331 – 433

Document #274
03/28/77
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

Dow Corning employee, D. Petraitis, memo regarding bleed studies for Dr. Barker. There is serious concern whether any gel bleed data should be released to the public because “any general release of this data could be misinterpreted or misconstrued, and could result in severe repercussions in the public sector.” (emphasis added). Also, “The bleed measurement may not be representative of actual in vivo results…. I still believe that Dow Corning should convey the impression that we are indeed working in this area.”
CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel.

Document 275
03/31/77
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

Leach, Dow Corning, memo to Bob Levier regarding “Contracture Phenomenon.” Leach refers to recommendations made by Pat Walters on contracture and states that Dow Corning has taken no significant action on any of Walter’s recommendations, except for a “half-hearted” low priority program at Northwestern University. He reports that he is losing customers because doctors believe Dow Corning implants bleed more than others. Leach writes:

Several of our customers looking to us as leaders in the industry, asked me what we were doing. I assured them, with crossed fingers, that Dow Corning too had an active ‘contracture/gel migration’ study underway. This apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies….l I am not sure where this unrest is leading but suspect that our PMG, as the steward of Dow Corning’s implantable products, should not be to (sic) comfortable with our current lack of focus and coordinated leadership relating to this entire issue. I suggest that this question be addressed at our next PMG Meeting and clear definition given as to what answers we can reasonably be expected to have, and what steps need to be taken to fill whatever gaps that may exist in our needed storeroom of knowledge. In my opinion, the black clouds are ominous and should be given more attention.

CITE: F 717 – 718 (Handwritten note, “R-grand push. Where does Ron Kelley stand w/summarizing available data? John.”)’ M 190439 – 190440 (Handwritten note, “Chuck, excellent memo. We must not be complacent as in past. Unlikely other co.s research will favor us. Are we going to do something? Dick.”) Exhibit to MDL Rathjen Deposition. DUPLICATE: F 683 – 684; GEG 4028 – 4029; KMM 140266 – 140267.

Document #276
04/13/77
SHELL STRENGTH – THICKNESS

Petraitis, Dow Corning, memo to LeVeir, Rathjen, et al. about returned inflatable implants. One of the implants had a pinhole leak which Petraitis believed was not caused by procedures. Concerned about the problem Petraitis recommends a halt to the current program plan as he is convinced the current envelope is “questionable.” Cycle testing had raised doubts regarding the envelope, confirmed subsequently by the pinhole leak problem. He recommends Dow Corning officially halt all additional clinical implantation, continue close monitoring of those patients with inflatable implants to develop a data base, emphasize improved envelope production and take a conservative, responsible attitude before gearing up again. Finally, he strongly recommends Dow Corning not take any assumptions regarding their envelope quality improvements until they have some definite history.
CITE: KMM 333250, Exhibit 9 to Hinsch Deposition, and Exhibit to Petraitis Deposition.

Document #277
05/03/77
FRAUD/MISREPRESENTATION
SHELL STRENGTH – THICKNESS
STERILIZATION/CONTAMINATION

Hinsch, Dow Corning, memo to Kelley, Metevia and Petraitis regarding a conversation he had with Jim Cox. The topic of conversation was Cox-Uphoff’s method of manufacturing mammary prostheses. Hinsch first states that at Cox-Uphoff, when raw materials are received, they undergo additional filtering because they are not as clean as they would like to have them. Secondly, Hinsch comments on Cox’s vulcanization times. Jim Cox suspects that he and the people on the West Coast vulcanize their gel implants longer than Dow Corning. Cox’s comments lead Hinsch to believe that there is some correlation between his longer vulcanization time and the lack of oily feel on the prosthesis. The third and final comment concerned manufacturing double lumen implants. “Jim conceives that he can ‘dump’ gel implants which are not ideally manufactured by using them in these Double Lumen Prostheses…. This is something we should keep in mind should we eventually move into the area of double lumen type of implants.”
CITE: OOM 320455.

Document #278
05/16/77
MISCELLANEOUS – LOBBYING
MISCELLANEOUS – ORGANIZATIONAL SURVEY

Helmer memo to Sanders regarding Breast Implant Manufacturers Association, California meeting.

515(B): First meeting of manufacturers called by Dick Compton of McGhan because he “desired that an association be formed of the manufacturers of breast implants.” Al Cohen requested a study be jointly funded by manufacturers on the issue of constrictive capsules. Tom Talcott of Heyer-Schulte tells Jerry Helmer of Surgitek that Heyer-Schulte is not in favor of a trade association research program. Other manufacturers are not in favor of trade association for joint research either and inform Dr. Jack Fisher, ASPRS, they would instead support a workshop to discuss issues with plastic surgeons.

CITE: MEM 415 – 417, Exhibit to Lynch Deposition, Exhibit to D. McGhan Deposition, Exhibit to Sanders Deposition, and Exhibit to Compton Deposition.

Document #279
05/26/77
RUPTURE
SHELL STRENGTH – THICKNESS

Complaint analysis prepared by Woodard and forwarded to Rathjen.
CITE: M 460026 – 460028 and M 570200 – 570203, Exhibit to MKL Rathjen Deposition.

Document #280
06/16/77
SHELL STRENGTH – THICKNESS
RUPTURE – CLOSED CAPSULOTOMY

A.H. Rathjen, Dow Corning, reports a telephone call from Dr. Ben T. Gregory regarding two incidents of ruptured mammaries immediately upon attempting to “pop a capsule,” i.e., performing a closed capsulotomy. Upon explantation, Dr. Gregory found a quantity of loose gel. The doctor called to let the company know that, “He does not subscribe to those in his profession who claim that–under no circumstances when you ‘pop a capsule’ will you break and implant.”
CITE: M 570125, Exhibit 13 to Harris County Rathjen Deposition. DUPLICATE: M 240322; KKH 001616.

Document #281
08/12/77
TISSUE REACTION
SHELL STRENGTH – THICKNESS
RUPTURE

Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen’s article on capsular contracture. Frisch states, “during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity…. Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process.” Frisch also states that ruptures most likely occur because “during certain activities such as love making, vigorous hugging, strenuous physical exercise,” and that “physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant.”
CITE: OOM 320474 – 320476. NOTE: Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies.

Document #282
08/24/77
KNOWLEDGE OF GEL BLEED
COHESIVENESS – LIQUID COMPONENT OF GEL

John R. Hilliard, Dow Corning, writes to Bob Gruber of Surgical Appliances Industries Inc., regarding a new gel to consider as an alternative to the current gel. The new gel, X7-2339, bleeds only 60% more than the current gel, Z7-2339, while the pre-1976 gel bleeds almost 600% more than the current gel.
CITE: M 250044.

Document #283
08/31/77
TISSUE REACTION

Dow Corning Telephone call report noting a person who developed severe bilateral infections seven days post-op. She entered the hospital with a temperature of 105 degrees in a “life threatening situation. Upon opening up the chest cavity, the doctor found large quantities of puss. … In an effort to forestall a potential lawsuit, I told the doctor that I would recommend free replacement of these prostheses — even though no rupture upon removal.
CITE: KHH 35213.

Document #284
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DESEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection site on the thigh. The pathology report notes there was a “chronic inflammation reaction.”
CITE: KMM 418633 – 418656, Exhibit to MDL Rathjen Deposition.
DUPLICATE: I 6182 – 6190.

Document #285
09/07/77
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Ashley sends Art Rathjen, Dow Corning, a letter and medical records of a silicone injection patient who developed a mass the size of an orange and experienced reddening, hardness and itching at the injection sit on the thigh. The pathology report notes there was a “chronic inflammation reaction.”

CITE: KMM 418633 – 418656, Exhibit to MDL Rathjen Deposition. DUPLICATE: I 6182 – 6190.

Document
09/29/77
SHELL STRENGTH – THICKNESS
RUPTURE

Petraitis, Dow Corning, memo to Roush and Becker setting forth “The Reasons For Proceeding With An Inflatable Introduction.” Petraitis notes that the clinical evaluations “indicated a high incidence of deflations: but claims that most were caused by small pinholes in the envelope. He assumes he can improve the envelope to prevent these pinholes by making it thicker. Petraitis concludes, “I feel that any risk associated with marketing the inflatable made from the improved envelope without additional clinicals is certainly worth taking…. The decision to delay introduction is equivalent to eliminating the product forever.”
CITE: KMM 149569 – 146570, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition.

Document #286
09/30/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Roush, Dow Corning, memo to the Medical Business Board announcing that the Implants PMG has decided to introduce the inflatable mammary prosthesis at the Plastic Surgery Show on October 30, l977. There is a risk being assumed in doing this since the product has not been clinically tested. The PMG believes, however, that the risk of the Product not performing is much smaller than the risk of losing market share. Dow Corning was concerned with a permanent loss in market share unless it moved quickly.
CITE: KMM 333267. DUPLICATE: KMM 149564 – 149566.

Document #287
10/03/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
FRAUD/MISREPRSENTATION

Rathjen, Dow Corning, memo to PMG and MPPBB (Medical Products Business Board) reiterating his objection to marketing the inflatable prosthesis when there are doubts about its efficacy. He notes, “This suggestion was turned down because some members of this business thought the product would indeed stand up. Well, it hasn’t!” Rathjen believes the product’s efficacy should be determined after clinical trials and not merely “on the bench….” He believes it is a “moral issue… whether Dow Corning was really, truly being honest and straightforward with our customers?” He recommends the product be tested further on 50 patients over the next four to five months and hard facts be developed before introduction as surgeons believe a ten percent deflation rate is absolutely unthinkable. (emphasis added).
CITE: KMM 333259 – 333261, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: OOM 321512 – 321514. NOTE: The deflation rate with the inflatables over a nine month period was 12%.

Document #288
10/06/77
KNOWLEDGE OF SYSTEMIC DISEASE
STERILIZATION/CONTAMINATION
TISSUE REACTION

Hobbs memo to Atwell, Bey, Lentz, LeVier, Owen, Pearce, Ryan, A. Smith, F. Stark, J. Campbell, S. Guittard, L. Tyler and D. Weyenberg regarding “Minutes from 2,6-cis meeting of 9/20/77.” Certain unvulcanized food grade elastomers contain 250-450 ppm 2,6-cis, 996 resin contains approximately 50 ppm, and DC 550 fluid using the new process contains 1-5 ppm. The verbal results of the genetic tests on 2,6-cis show positive results and “indicate aggressive action is necessary to evaluate the potential hazard of this impurity.” Hobbs states that he has obtained technical and legal opinions from Joe Raddzius and Dr. Steve Carson.
CITE: DCC 281031108, Exhibit to Tyler Deposition, and Exhibit to LeVier Deposition.

Document #289
10/20/77
COHESIVENESS – LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
STERILIZATION/CONTAMINATION

Peters, Dow Corning, memo to Chandler with copies to Lentz Wendel and Rathjen regarding mammary gel review, part II. The molecular weight given for the gels are much lower than actual since the gels have a significant amount of branching and are polydispersed. X7-2151 would be the better gel for implantation since for a given penetration it has a high molecular weight distribution. The report also lists trace metal amounts for various gels.
CITE KMM 453922 – 453928.

Document #290
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation in which Rathjen, Dow Corning, tells Dr. G. Perrin he is unhappy with the marketing department’s decision to introduce an inflatable mammary that had a 14 percent deflation rate when tested. He says he was concerned about the decision and feels “there is an ethical matter involved here.” Dr. Perrin replies “if you are too hasty (sic), things backfire on you. Both of us know that….”
CITE: KMM 255487 – 255488

Document #291
10/26/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Log of a telephone conversation between Dr. Glazer and A. Rathjen, Dow Corning. Dr. Glazer says he is surprised they were putting the inflatable mammary implant on the market without all of the data being collected and feel such a move is premature. Rathjen agreed and stated, “There is no two ways about that, but it hasn’t been tested….” Rathjen feels that he has “been muscled and I am mad because here we said we were going to stop and retrench and they insisted the thing keep going.” Rathjen states that he is prepared to resign because his “reputation is on the line as it relates to the silicone injection fluid….”
CITE: KMM 194463 – 194466, Exhibit to Oppelt Deposition, and Exhibit to MDL Rathjen Deposition.

Document #292
11/10/77
GEL MIGRATION

Dr. Jerrold Abraham responds to Eldon Frisch’s letter of 10/21/77. He states, “I am quite disappointed by your letter of October 21, 1977. It seems you remain unwilling to accept the fact that I am able to identify the silicone material in the tissues and to separate it from contamination from dust, glass, etc…. The FDA has expressed interest in supporting some limited studies, but they will not of course, support studies designed to improve your implantable devices. They must limit their support to studies testing available devices already on the market.”

“I must have examined human tissue from patients with implants and find no difficulty in identifying the silicone material migrating from prostheses in joints.” (emphasis added). Dr. Abraham goes on to request an opportunity to review animal specimens from earlier studies and informs Frisch of improved detection techniques. “This latter technique has provided additional confirmation that the material we are looking at is indeed the polydimethylsiloxane rubber. I urge you to reconsider and to aid in this study of your long term animal implantation experiments.”
CITE: OOM 320482 – 320483.

Document #293
12/07/77
FRAUD/MISREPRESENTATION

Jim Bolland, Dow Corning, responds to Woodard analysis of Arm No. 0964 and “Complaint Forms And Their Resolution.” He indicates that the complaint procedure does not seem like it designed to give doctors qualitative information regarding their complaint. “If the idea of returning defect material to you is to cover ourselves from the liability point of view then perhaps we should know this and we will be careful not to tell the doctor that he can expect a full report when his complaint is being investigated.”
CITE: COM 494.

Document #294
12/15/77
SHELL STRENGTH – THICKNESS
RUPTURE

Frank Lewis, Dow Corning, Memo to Milt Hinsch regarding the “inordinate rate” of ruptures occurring with mammary implants. Lewis lists four doctors who are experiencing “abnormal percentage(s) of ruptures.” Dr. Don Davis of Lansing, Michigan with 14%, Dr. Fusilero of Lorain, Ohio with 32%, Dr. James Scarcella of Lakewood, Ohio with 12% and Dr. Richard Straith of Detroit, Michigan with 11%. Lewis states, “I am sure some of these were the fault of the doctor, but that alone could not account for such a high percentage of ruptures. These doctors have on the average ten years of experience in this procedure.”
CITE: M 240328 – 240329. NOTE: A handwritten comment is at the bottom of the memorandum and reads, “A detailed study of mammary rupture frequency is being made and should be completed by 1/31/78 for the year 1977. Data to be made available from Midland Marketing.” DUPLICATE: F 731 – 732; M 570147 – 570148; M 460300 – 460301; KMM 351899; KKH 1631 – 1632; KHH 67459 – 67460; KKA 88982. NOTE: No such studies have been located.

Document #295
00/00/78
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Publication by LeVier, Chandler and Wendell titled “The Pharmacology of Silanes and Siloxanes, Biochemistry of Silicon and Related Problems.” pages 473-514. The salient features of silicon chemistry that may be considered of interest to life scientists have been reviewed while the biochemistry of silicon compounds has received only brief comment because this subject remains largely unexplored. Indeed, so little is known that we continue to categorize structures only on the basis of intended use with some consideration for bioavailability and a few emerging trends relating activity to structure and reactivity. This approach at least allows a clear division of though between popular silicones known for their lack of bioactivity and the less well known reactive silicon compounds.
CITE: DCC 281061312 – 281061353; Exhibit 64 to Bennett Deposition (used by Dow Corning).

Document #296
01/20/78
SHELL STRENGTH – THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to various members of the Marketing Department – Nelson, Hoyt, Bey and Hinsch – and to members from Dow Corning’s in-house Legal Department – Steinberg and Lewis. Rathjen reports that the current deflation rate for the inflatable clinicals from January to August 1977 is 22%. Several patients had bilateral deflations.
CITE: KMM 333270. DUPLICATE: KMM 261276 – 261277.

Document #297
02/28/78
FRAUD/MISREPRESENTATION
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Tyler memo to Campbell, C. Lentz, John Ryan, Weyenberg, Gergle, Hartlein and Maneri regarding “Adventitious 2,6-cis.” “I am concerned lest Dow Corning employees generate an unwarranted number of documents containing adventitious 2,6-cis.. I see no reason for any documents not authorized or reviewed by C. Lentz or L. Tyler. Even the verbal communications can be very simple. We know of no health problems associated with the extremely low levels of adventitious 2,6-cis in hundreds of Dow Corning products. However, there could be a ‘business’ risk associated with adventitious 2,6-cis. Because of (the business risk) we are proceeding to eliminate adventitious 2,6-cis from almost all Dow Corning products.” There is a handwritten note to copy to Stark and LeVier.
CITE: DCC 281031106, Exhibit to “Weyenberg Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 9 to Harris County Tyler Deposition, Exhibit to MDL Tyler Deposition, Exhibit to Ryan Deposition, and Exhibit to LeVier Deposition.

Document #298
03/02/78
SHELL STRENGTH – THICKNESS
RUPTURE

Dow Corning salesman, Frank Lewis, informs Milt Hinsch that he has experienced an “excessive number of ruptures” in the Detroit area. Numerous doctors report an increase in ruptures and are commenting, “Noticing a difference in the envelope.”
CITE: F 729 – 730. DUPLICATE: M 570150 – 570151; KMM 3919 – 3920.

Document #299
03/10/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING
TISSUE REACTION

Study titled “Biological Evaluation of an Implantable Silicone Gel: Summary of Acute and Chronic Studies” by Lentz, Chandler and LeVier. The authors report:

“The current data do not support the use of X7-2151 gel by direct instillation. While no deleterious effects were noted, the long term localization of the gel is uncertain as is the end point of the tissue reaction. To permit use of this gel by instillation, future studies should address the questions of whether the reaction stops short of complete dispersal of the gel, whether gel fragments are carried to remote sites and if so the fate of this material, whether this reaction is dependent upon the ways of gel injected, and whether a similar fragmentation occurs in humans.”
CITE: DCD 154000246 – 154000266, Exhibit to Weyenberg Deposition. DUPLICATE: KMM 174130 – 174159l

Document #300
03/16/78
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Bob LeVier, Dow Corning, memo to Bey and Nelson (both are in the Marketing Department) proposing development of the implantable gel implant. He writes, “The 180-day rabbit gel implantation study led to two conclusions based on the data:

l. The evidence for progressive subdivisions of gel is sufficient to warrant the conclusion that a hypothesis favoring efficacy in mammary augmentation and/or mammary reconstruction cannot be supported without further experimentation.

2. The evidence for the presence of small isolates of gel surrounded by potentially phagocytic cells is sufficient to raise a theoretical question concerning dissemination of gel or its components.

LeVier states that animal studies are needed on these issues and on questions relating to gel subdivision “by connective tissue and gel-associated systemic toxicity,” He has designed a study which will provide the “minimally required information … (in) the shortest practical time course for completion and at as low a cost as possible.” CITE: F 744 – 746. DUPLICATE: M 3320004 – 320005.

Document #301
04/10/78
STERILIZATION/CONTAMINATION

Dow Corning Complaint Report 20602 notes a “hair inside package.”
CITE: CRM 296 – 300. DUPLICATE: KKH 33333.

Document #302
04/17/78
SHELL STRENGTH – THICKNESS
RUPTURE

Rathjen, Dow Corning, memo to Gant regarding the deflation problems of the Varifil Mammary Prosthesis. Some clinicians report deflation rates as high as 8 out of 13 patients. Rathjen states “the most important factor for all of us to keep in proper perspective is that a mammary implant, with very few exceptions, is expected to function and remain in the human body for the lifetime of the patient…. Therefore, in no way can we even remotely think that a mammary prosthesis that has functioned for six months and failed is any worse than one that has functioned for a year or 18 months, and then deflated. When a product stays inflated for four months and then deflates overnight, we can’t blame the doctor.”
CITE KMM 333262 – 333264, Exhibit to MDL Rathjen Deposition.

Document #303
05/17/78
GEL MIGRATION
TESTING
TISSUE REACTION

Lentz, Chandler and LeVier, Dow Corning, report on the “Biological Evaluation Of An Implantable Silicone Gel: Summary Of Acute And Chronic Studies.” They write:

“The majority of subcutaneous implant sites at three and six months showed subdivision of the gel mass by bands of fibrous connective tissue. The current data does not support use of this gel by direct instillation. While no deleterious effects were noted, the long term localization of the gel is uncertain as is the endpoint of the tissue reaction. To permit use of this gel by instillation, future studies should address the questions of whether the reaction stops short of complete dispersal of the gel, whether gel fragments are carried to remote sites and if so the fate of this material, whether this reaction is dependent upon the mass of gel implanted, and whether a similar fragmentation occurs in humans.”

CITE: KMM 174130 – 174159, Exhibit 33 to Harris County Peters Deposition, Exhibit 30 Rathjen Deposition (used by Dow Corning), Exhibit to Harris County Tyler Deposition, Exhibit to Weyenberg Deposition, and Exhibit to Ryan Deposition. DUPLICATE: KMM 453860 – 453893; DCC 80061699 – 80061732; DCC 281002010 – 281002045.

Document #304
06/00/78
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Donald E. Barker, M.D., Marvin I Retsky, M.D. and Sherill Schultz, R.N., report in the Plastic and Reconstructive Surgery Journal that, “Modern silicone bag-gel breast implants leak silicone gel through the bag, the amount leaked varies from one implant to another and is not constant for any type or brand, and the silicone will be found in fibrous thickening and various degrees of inflammation will be found in capsules surrounding the implants….”
CITE: M 260116 – 2601121, Exhibit 44 to Harris County Duel Deposition (used by Dow Corning), Exhibit 37 to Frisch Deposition (used by Dow Corning), Exhibit to D. McGhan Deposition, Exhibit to Oppelt Deposition, Exhibit 2B to Harris County Talcott Deposition (used by Dow Corning), Exhibit 2 (and 125) to Harris county Rathjen Deposition, and Exhibit to Steward Deposition. DUPLICATE: D 3583 – 3585, M 260269 – 260275.

Document #305
09/06/78
SILICA

The Department of Health, Education and Welfare issues a pathology report on monkeys exposed by inhalation to Amorphous Silica-F (99.5% of its particles are less than one micron in size). Noting that “the abundance of vacuoles containing fine bands of connective tissue is significant in view of previous reports that amorphous silica is innocuous,” the report concludes that the “effects of particulates containing silica … should be a cause for concern.”

CITE: KMM 313106 – 313110

Document #306
10/18/78
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
MISCELLANEIOUS – RECKLESS/CONSCIOUS DISREGARD
TISSUE REACTION

Swanson memo to Ludington, Hargreaves, Maneri, Layne, Tyler, “Reed, Griffin, Klauser, Bott, Dion, Seeberger and Schumack regarding Zemker & Associates communications clinic. A prepared question of Mr. Layne states that Dow Corning’s marketing strategy apparently dictates that the responsibility stops with the doctor. But according to MS. Magazine there is a 60% complication rate. The question asks that many people have trouble understanding that since Dow spends a few million dollars promoting the safe sealants and defoamers to the end user why doesnt it spend a red cent to give thousands of young women the true facts about implants and at the same time warn them about silicone breast injections. The question goes on to ask if Dow doesn’t feel some ethical and moral responsibility to do more than you are doing.
CITE: DCC 80021587 – 80021589, Exhibit to Tyler Deposition.

Document #307
00/00/79
RUPTURE – CLOSED CAPSULOTOMY
SHELL STRENGTH – THICKNESS

A brochure entitled “Suggested Surgical Procedures for Silastic Mammary Prostheses” states that “an alternative to surgical release of a tight capsule is the closed compression technique for rupturing a contracted capsule around a breast implant.”
CITE: M 660189 – 660204, Exhibit to MDL Rathjen Deposition.

Document #308
00/19/79
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION

Handwritten letter advising that the gel represents a potential rupture or immunogenic problem and a mild inflammatory problem which is probably beneficial since this will stimulate encapsulation of the gel and help minimize gel migration. Gel will probably eventually be found in the regional lymph nodes.
CITE: M 460274.

Document #309
02/13/79
SHELL STRENGTH – THICKNESS
RUPTURE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Dow Corning minutes of a PMG (Product Marketing Group) meeting with R. Rylee, G. Jakubcvzak, A. Rathjen, M. Nelson, A. Bey and others. Three areas of importance concerning the inflatable mammary prosthesis were discussed – ethical/morality, legal, and business. The 1972 study was presented which showed there was a deficiency in the envelope.

Jakubczak reported failures in the clinicals were the result of pinholes of undetermined origin. (NOTE: This is inconsistent with Rathjen’s prior memos.) Rathjen outlined his ethical concerns that “no matter when the product fails, it is the fact that it did fail….” There was discussion whether Dow Corning should stay in the market with the inflatable, do clinicals on the HP envelope, or market the HP. Marketing claimed that the field results showed there was no problem. Rathjen, however, stated that his clinical experience showed there was a “definite serious problem.” (NOTE: See Rathjen’s memos throughout 1977 and 1978). Bey, in Dow’s Marketing Department, proposes that they put the HP on the market but increase envelope thickness to 7 mils. The HP will replace what’s on the market but there will be “no recall.”

Rylee questions two different sets of data from marketing and clinical and whether “Dow Corning is selling quality. The notes reflect: “1. Do we stay on the market with the existing product? (lack of clear existing data); 2. Do we introduce it without clinical trials?… A subjective decision.” Dow then reviews the damages to patients: “Damages – minimal with deflation (saline) much more with gel migration.” They again reaffirm there will be no recall, that the HP will be phased in, and Dow Corning will do limited clinical evaluations.
CITE: KMM 261081 – 261085, Exhibit to MDL Rathjen Deposition.

Document #310
02/27/79
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH – THICKNESS

Del Petraitis memo to Bill Oppelt, both of whom are former Dow Corning employees who are now at McGhan Medical. Petraitis is critical of Dow Corning’s inflatable shells because of their method of dipping which results in significant differences in thickness, making the shells “very susceptible to aneurysm formation.”

With gel-filled implants, the shell thicknesses are less. Also, he states that Dow Corning’s gel “achieves its responsiveness by utilizing a large quantity of non-functional polymer in the gel formation…. This free polymer is not chemically cross-linked and is only mechanically trapped in the gel matrix. As a result, it is free to migrate through the shell and makes the entire implant much more prone to the ‘bleed’ phenomenon.”
CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh Deposition, Exhibit to Oppelt Deposition, Exhibit to Schreiber Deposition, and Exhibit to Petraitis Deposition.

Document #311
04/04/79
KNOWLEDGE OF GEL BLEED
GEL MIGRATION

Gene Jakubczak, Dow Corning, memo responding to Bill Overton’s, sales representative in Texas, memo to Milt Hinsch discussing gel bleed and the effect of therapeutic radiation. Jakubczak begins by stating, “I remain intrigued that what appears to be obvious TS&D activities continue to be sent to the marketing function. Is this by design? Is it due to lack of response from TS&D? Do sales personnel understand TS&D functions? Do sales personnel understand who to contact? Enough!!”

In response to question of mammary bleed, Jacubczak states that Dow Corning’s “fluid injection program … does give some guidance on what happens when polydimethylsiloxane is injected in-vivo. Dow Corning does have data from its industrial sales effort on polydimethylsiloxane fluids. The buildup in organs is reviewed however, I do not know what it says…. If you detect reluctance on DC’s part to provide data bear in mind that most surgeons (obviously not all) do not deal well with scientific accuracy as it impacts on data interpretation.”

With regard to Overton’s question on what material is bleeding, Jacubczak states that, “The material referred to as bleed represents the soluble fraction of the prosthesis gel component. Bleed is silicone (polydimethylsiloxane polymer)….” In addition, “Silicone bleed has been shown to move out and away from the gel prosthesis. Insufficient information exists to say how much and where it travels and accumulates, if it does, much less what are its affects. Dow Corning again from the industrial sales side, does have data on polydimethylsiloxane fluid and its bio path and the effects in the body.”

Finally, in response to whether there is any difficulty with x-ray and mammography exams of women with breast implants, “experience will usually overcome difficulties.’ Also, Jakubvczak will review the effect of therapeutic radiation on implants.
CITE: M 250045 – 250047.

Document #312
06/29/77
RUPTURE
SHELL STRENGTH – THICKNESS

Vaz da Silva, Dow Corning, memo to Venn and Beyruth regarding ruptures. She states, “Our sales could be bigger if these ruptures didn’t happen. As I have already said, our Plastic Surgeons are afraid of using our Mammary Prosthesis and with complete reason. At first I was thinking that was (the) fault of the surgeons but now, I really don’t think this.” A handwritten note at the top of the document from Venn to Bob Becker states, “I think her comments are self explanatory. Hope we begin seeing more uniform envelopes and non-reinforced patches soon.”
CITE: CR 4006 – 4007
Document #313
07/03/79
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by Spielvogel, Robinson and Hanneman titled “Metabolism of Cis and Trans 2,6 Diphenylhexamethylcyclotetrasiloxane In The Rhesus Monkey, Rat and Man,” by Speilvogel, R.J. Robinson and Hanneman. A copy was sent to John Ryan, Bey, Frye, Hobbs, C. Lentz, Boley, Nelson, Rylee, Stark, Tyler, Weyenberg and others.
CITE: DCC 281002046 – 281002085 (Temporary Dow Corning Bates Number 3781-3820), Exhibit 6 to Isquith Deposition.

Document #314
09/28/79
SHELL STRENGTH – THICKNESS
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Dr. Gordon Robinson Jr. letter to A. Rathjen, Dow Corning, stating he had to replace 13 out of 16 inflatable mammaries that were part of the clinical trial since they deflated. He states, “I feel like the handwriting is on the wall. This was a bad adventure.”
CITE: KMM 256659 – 256660, Exhibit to MDL Rathjen Deposition.

Document #315
11/07/79
SHELL STRENGTH – THICKNESS
RUPTURE
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
TISSUE REACTION

Operative report from Dr. Vinnik’s patient. Patient reported being involved in a “very trivial accident, when she struck her right breast against the ‘monkey bars’ while playing with her child in a playground.” During explantation for the ruptured prostheses, Dr. Vinnik noted that the gel ran “down the patient’s chest, onto the operating table and onto the floor…. This procedure is performed because of medical necessity as a ruptured breast implant can produce serious medical problems…. Free silicone gel, particularly when it is non-cohesive as (sic – has) been known to migrate through the local area, and produces severe granulomatous response.”
CITE: KMM 423161. NOTE: See KMM 423155 – 423156

Document #316
11/08/79
SHELL STRENGTH – THICKNESS
RUPTURE

Dr. Vinnik’s cover letter to G. Jakubczak, Dow Corning, sending him the 11/07/79 operative report about a broken implant. He states, “The implant … was definitely defective and decidedly not up to the proper standards…. I am very distressed about this apparent breakdown in quality control, as I have removed many broken Dow Corning products….(Dow Corning) should have a recall … of some sort to the physician.”
CITE: KMM 423153 – 423154.

Document #317
11/13/79
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTIONS

Letter to Dr. Goldwyn from Dr. Murray, with a copy to Rathjen, regarding patient who received 4 silicone injections, 4 years earlier, who was having pain and lesions in her face near and adjacent to sites of injection; microscopic report revealed epidermal inclusion cyst without any evidence of silicone fluid. Murray will follow “with great interest because one wonders if some of the long term results with liquid silicone may be undesirable.”
CITE: DCC 106003480 – 106003481, Exhibit to MDL Rathjen Deposition

Document #318
00/00/80
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Hunter handwritten notes regarding 2, 6-cis project new ventures milestones for 1980. He notes that Dow Corning used Dow Chemical’s laboratory and its subsidiary, Lepetit, to conduct testing on 2,-cis.
CITE: DCC 281031798.

Document #319
01/22/80
KNOWLEDGE OF SYSTEMIC DISEASE

Joseph Connelly, M.D., writes to Dow Corning Wright about a patient whose Silastic implant ruptured when she was involved in car accident. The implants were removed shortly thereafter because the patient experienced draining fluid from the implant through the skin. The patient’s family doctor performed tests “which he says are suggestive of chronic lupus erythematosus.” He wants to know if Dow Corning has any information whether the silicone implants can cause lupus.
CITE: CM 1133 -1134. He writes a second letter on 04/01/80 because Dow Corning did not respond to the first letter. For Dow Corning’s response, see 04/23/l80 entry.

Document #320
03/14/80
KNOWLEDGE OF GEL BLEED

Milt Hinsch, Dow Corning, memo to Bartolo, Gant, Peters, Jakubczak, Haas, and Smith stating that, “We are now saying (seeing) extremely greasy lots of Gel Saline Mammary implants. The H.P. envelope accentuates gel bleed.” (emphasis in original).
CITE: KMM 518831.

Document #321
04/14/80
RUPTURE
SHELL STRENGTH – THICKNESS

Memo from W. Lynch and W. Stich to the Medical Engineering Corporation Field Force. They discuss Dow Corning’s new shell material for their inflatable implant and claim that this new shell has twice the tear resistance of their former material. “Regrettably one of the characteristics of silicone rubber is that it has a very low tear strength. Even if Dow Corning has made a shell with twice the tear strength of what they presently have, the new value will still be low compared to other materials, such as Saran Wrap.”
CITE: MEA 22 – 25. DUPLICATE: MEC 7835 – 7838: MEC 9278 – 9180

Document #322
04/23/80
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning responds to Joseph Connelly, M.D., concerning his inquiry about a patient who developed lupus erythematosus following a rupture of a Silastic mammary implant. William Boley, senior Group Leader for the Health Care Group Research, responds:

“Dow Corning has performed extensive safety testing, in animals, on the silicone materials from which SILASTIC breast implants are made. I have also reviewed our product complaint files. Your inquiry appears to be the first Dow Corning has received asking whether a silicone breast implant could be a causative agent for chronic lupus erythematosus. The data Dow Corning has suggest that it would be highly improbable that your patient’s symptom of chronic lupus erythematosus could be attributed to the silicone breast implants.”
CITE: CM 1135. NOTE: See 01/22/80 entry

Document #323
04/29/80
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

B. Schnabel, a Dow Corning salesman, writes Milt Hensch regarding a complaint from a customer, F. Grazier, M.D. The doctor is complaining about excessive gel bleed and a “greasy” feel to the envelopes. “The lot number involved is H129700. It has been brought to my attention that this particular lot was put on the market with prior knowledge of the bleed problem.” Schnabel continues, “As you know he (Dr. Grazer) had a bad experience with our varifils and with our gel salines he has yet another bad experience and we wind up with egg on our face. To put a questionable lot of mammaries on the market is inexcusable. I don’t know who is responsible for this decision, but it has to rank right up there with the Pinto gas tank.”
CITE: F 629 – 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M 250022 – 250023; M 570059.

Document # 324
05/07/80
KNOWLEDGE OF GEL BLEED

Yolanda Sue Peters and R. Gant, Dow Corning, author an internal Lab Report For Silastic II Mammary Implant Bleed Study. Gel bleed is “a property common to all gel-filled prostheses” which is attributable to the semi-permeable nature of silicones and the similarity in the composition of the gel and the envelope. Test results show that the fluorosilicone coating of the mammary envelope reduces the bleed by approximately 90%.”
CITE: KMM 136950 – 136958. DUPLICATE: D 2926 – 2935; KMM 151111 -151120; T 8417 – 8425.

Document #325
05/29/80
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING
TISSUE REACTION

Report by Dow Corning Toxicology Department, authored by Ronald Annelin, entitled, “Trace Analysis of Organosilicon In Human Urine And Milk By The ASFT Technique.” The report concerns the use of the Aqueous Silanol Functionality Test to determine the organosilicon level in human urine following the incidental inhalation of Dow Corning 344 Fluid Vapors. Also included is a single analysis of human breast milk. All of these samples contained detectable amounts of monomethyl and dimethyl silicon species. Nearly twenty percent of the estimated intake of Dow Corning 344 fluid was excreted in the urine in the eight hours following exposure. The presence of monomethyl silicon in the urine suggests that cyclic dimethyl species undergo demethylation during human metabolism.
CITE: DCC 284020681 – 284020686, Exhibit l to Frye Deposition, Exhibit 1 to Petraitis Deposition, Exhibit to Isquith Deposition, and Exhibit 3 to MDL Rathjen Deposition.

Document #326
07/01/80
DOCUMENT DESTRUCTION

M. Gill memo to J.C. Smith, Dow Corning, regarding returned materials – complaints file. Gill reports that complaints had been taken to the Bio Lab for investigation. “It was noticed that all boxes had been removed from the Bio Lab and destroyed. It was discovered that the janitors had removed all these boxes and destroyed them…. These complaints … will not be investigated.”
CITE: CR 5489 – 5490. DUPLICATE: KKM 25426 – 25427.

Document #327
07/16/80
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DESEASE

“R. LeVier, Dow Corning, memo to W. Boley and L. Veresh, regarding immediate adverse reactions to mammary gel implants from two patients of Dr. Charles Stone. Both patients experienced rapid evolution of wound edema with inflammation and tissue breakdown 3-6 weeks after implantation. LeVier recalls 8 patients who experienced allergic reaction to silicone fluid. “It may be that there is a small population capable of a vigorous immune rejection response to silicone fluid/elastomer; could be a complement mediated response.”
CITE: M 240072. DUPLICATE: KMM 197618.

Document #328
07/22/80
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE
ACKNOWLEDGEMENT OF NEED FOR TESTING

Dr. Vinnik writes to Jakubczak, Dow Corning, regarding a “defective Dow Corning prosthesis.” The patient reported a sudden onset of pain, changing consistency of the implant, and changing configuration of the left breast. Vinnik states:

“At surgery, you will note the Operative Report findings of an apparently defective gel in terms of both consistency, cohesiveness, and possibly color…. What we need to have accomplished is a thorough evaluation as to why this implant had a late failure. Was the problem inherent in the bag? Were there variabilities of thickness of shell, less than those of design tolerances? Why is this gel not cohesive as it should be? This is the second implant that we have removed which has been non-cohesive, and has shown spontaneous rupture for no apparent reason…. We need to consider whether or not a recall of all patients bearing this Lot number should be made. I think it may be wise to at least alert physicians that there may be a problem with this particular lot number.
CITE: KKH 53276 – 53277.

Document #329
07/31/80
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Letter to Dr. Goldwyn from Dr. Woolf, cc to Rathjen, regarding patient in the silicone study who “was doing very well until March of this year, when suddenly the face flared up again on both sides. … The temperature in the area she was visiting in Mexico was about 110 degrees, and her face completely flared up again. … When she returned again, she had a definite abscess in the left cheek, just beneath the anterior border of the zygomatic arch … The abscessed area has resolved, but she still has diffuse swelling in both cheeks, with some overlying discoloration.”
CITE: DCC 106006691 – 106006692, Exhibit to MDL Rathjen Deposition

Document #330
11/19/80
KNOWLEDGE OF GEL BLEED

Handwritten note from J. Reitsma to M. Hinsch, both of Dow Corning Wright, regarding problems with the gel-saline implants. He states, “Milt, I feel we have a potential problem with the quality of our gel-saline mammary prosthesis, that is gel bleed in excessive amounts going through the outer membrane in such volume as to cause a greasy look and feel to the using surgeon.” Several physicians have refused to use the product stating that they have no confidence in it – “it’s to (sic) damn greasy.” Reitsma informs Hinsch that the gel-saline product “has me feeling uneasy about its quality and even safety. I can not in good faith introduce this product to a competitive or new account.”
CITE: KMM 232094 – 232095.

Document #331
12/10/80
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

“Metabolism of Octamethylcyclotetrasioxane in the Monkey, Report No. 5265,” by Spielvogel and Robinson. A copy was sent to Boley, Hobbs, C. Lentz, LeVier, Stark, Frye, Ryan, Speier, Bey and others. D4 was administered orally to two monkeys and the excretions (urine and feces) were collected and examined. Gas chromatography-mass spectrometry revealed the presence of three metabolites: dimethylsilanediol, tetramethy1-1,3-disiloxane diol and hexamethyl-1c5-trisiloxane diol. The authors reasoned that D4 might undergo metabolic transformation to either an alkyl hydroxylated and/or conjugated species or silanol functional species that would likely be soluble in moderately polar solvents.” (KP 30523).

D4 appears to be well absorbed from the gastro-intestinal tract and broadly distributed throughout the body. The primary route of excretion is urine. “The bio-transformation of D4 is similar to that 2,6-cis and 2,6-trans-diphenylhexamethyltetrasiloxane and diphenysilanediol. All of the compounds appear to be readily hydroxylated and as a result are converted from highly lipophilic compounds to highly polar, easily excretable metabolites.” (KP 30626). Also, “The metabolic fate of D4 closely parallels the metabolic fate of 2, 6-cis and 2, 6 – transdiphenylhexamethylcyclotetrasiloxane. All of the cyclic siloxane compounds examined to date are metabolized to a series of low molecular weight polar compounds that are predominantly excreted via the kidneys.”
CITE: T 8796 – 8813, Exhibit to Harris County Ruhr Deposition, Exhibit to Bennett Deposition, Exhibit to Isquith Deposition, Exhibit to LeVier Deposition, Exhibit 4 to Stark Deposition, Exhibit to Compton Deposition, Exhibit to Ryan Deposition, Exhibit to Isquith Deposition, and Exhibit 31 to Zimmer

Document #332
02/09/81
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION

Boley, Dow Corning, memo to Frisch, LeVier, Spielvogel, Cooper, Rylee, and Wessel regarding “Baboon Study To Evaluate the Fate of Silicone Wear Particles.” Boley notes that:

“Silicone particles have been found in the axillary lymph nodes of patients with Silastic finger joints. These particles have been detected as a consequence of biopsy of nodes that have become painful and enlarged…. Of concern to the surgeon is whether these particles will continue to migrate beyond the regional nodes into the thoracic or abdominal cavities. Since concerns about malignancies requires that any chronic swelling of lymph nodes be biopsied or excised, wear particles could create the need for a surgeon to breach the body cavities.
CITE: KMM 328166 – 328167. DUPLICATE: KMM319434 – 319435.

Document #333
03/05/81
KNOWLEDGE OF LIQUID SILICONE DANGERS
TESTING

Yolanda Sue Peters, Dow Corning, letter to Dr. Frank Gerow requesting his information and data that supports the use of gel for implantation. All the data Peters has contraindicates its use in this manner. She understands that Dr. Gerow has both animal studies and clinical information on the implantation of gel for augmentation of soft tissues areas such as the face and breast.
CITE: M 320037.

Document #334
04/16/81
KNOWLEDGE OF SYSTEMIC DESEASE
TESTING

Gerry Schoenig, Toxicology Consultant for Dow Corning, reviews the data from the Two-Year Implant Study of Q7-2159A and MDF-0193 Gels at Industrial Bio-Test Laboratories (IBT). He finds “fibrosarcoma around implant and malignant lymphoma in rat colony said we had a problem with cancer.”
CITE: KMM 390371

Document #335
04/29/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED

Peters, Dow Corning, memo to Jacubczak, Marlar, Rylee and Wessel reporting that Dr. Gerow has requested an injectable gel for soft tissue augmentation (face and breast). There is very little published data on the fate of implanted gel. Some authors feel that the gel which bleeds from the envelope contributes to capsular contracture. Dow Corning data indicates that the gel is subdivided by vascularized connective tissue, which could result in the site of the implantation becoming very firm (breast) and/or transport of gel away from the site. No data was received from Dr. Gerow. Seventeen of twenty doctors who were asked for their opinions said they were not in favor of the concept. The commercialization of such a gel would require long term animal studies, careful definition of the material, an IND and a campaign to overcome the bad press and emotions associated with the disastrous results reported from silicone fluid injection.
CITE: KMM 140223 – 140228, Exhibit to Blocksma Deposition, Exhibit to Peters Deposition, and Exhibit to MDL Rathjen Deposition.

Document #336
05/19/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
DOCUMENT DESTRUCTION

Bill Boley memo to Sue Peters and other Dow Corning employees regarding “Biological Safety Testing of LS Q4-2840.” Boley has “serious reservations” about using LS Q4-2840 to replace LS 422 as an internal coating for low bleed mammary prostheses. Boley states, “My conservative nature requires me to say that any material intended for long-term implantation in the human body should have long-term animal implant testing.” At present, “Q4-2840 as a formation (has) no long-term implant data.” However, Dow Corning decides to go with a 6 month study. “if in the future safety problems should arise due to the use of Q4-2840 for this application I am sure the decision to not do 2-year animal testing would be questioned. Therefore, I think it is important that this be a business decision and not a personal decision.

In my judgment the proposed testing is adequate and ethically appropriate.”
CITE: DCC 8200651 – 8200616. NOTE: On the copy M 170172, there is a handwritten note dated 06/30/81 stating, “LS 422 may be discont. 2840 is potential repl. is “HP” LS is (illegible) modulus closer than LS 422.”

NOTE: Attached to the version of DCC8200615 is a one page handwritten note which states, “No litigation reason to keep the records in this file. It should be brought into Rec. Retention Policy Compliance.” This Same handwritten notes is located at KKA 119791. DUPLICATE: D 885; M 170172; KKA 228295.

Document # 337
07/22/81
MISCELLANEOUS – RECKLESS/CONSCIOUS DESREGARD
RUPTURE

Hinsch, Dow Corning, memo to Jakubczak, Kelly, Burda, Jack Smith, Marlar, and Wessel regarding a marked decline in sales of the Varifil inflatable. “For 1980, we had approximately $10,000 in prelitigation expenses for Varifil mammary deflations. Y-T-D through July, 1981, we have approximately $16,000 in prelitigation expenses. With a decline in sales and an increase in prelitigation expenses, we should review our position with this product again.” CITE: KMM 78011 – 78039

Document #338
08/00/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
FRAUD/MISREPRESENTATION
MISCELLANEOUS-ORGANIZATIONAL SURVEY
MISCELLANEOUS-PRODUCT LABELING
MISCELLANEOUS-SALES
TESTING

Dow Corning News for July/August 1981 containing an article on product liability. The article discusses the three theories of product liability, describes how Dow Corning fulfills its duty, and describes the anatomy of a lawsuit. The article also states that Dow Corning should follow the recommendations of Jenkins by continuing to refine its product, implement stronger training, refine and clarify warnings, make sure these warnings are explicit, review the marketability and pricing of products, continue strong research efforts and continue to study each product as it is being used to make sure any potential hazards are made known. The article also recommends that Sales, Marketing and TS&D avoid denying the importance of written disclaimers as found in the product literature, avoid making erroneous verbal representations about a product’s performance and avoid promising to take care of any problems in the use of the products.
CITE: DCC 282001978 – 282001997.

Document #339
09/16/81
TISSUE REACTION
RUPTURE
SHELL STRENGTH – THICKNESS
MISCELLANEOUS – RECKLESS/CONSCIOUS DESREGARD

C. Burda, Dow Corning, handwritten notes regarding the Varifil prosthesis, “Probably most vulnerable in product line w/regards to efficacy and litigation. Potential for class action suit. Product did not have clinical testing. Rathjen recommended that product not be put into market. Charged w/writing protocol but technical people did not follow….Poor field performance led to 78 decision to go to Failure to Varify causes: 1. contracture, 2. infection, 3. rupture (good or imperfect products both may fail). Varifil may have small pinhole & fluid will leak out. Also may actually split….”
CITE: KMM 78006 – 78007

Document #340
09/16/81
SHELL STRENGTH – THICKNESS
RUPTURE
SHELL DEGRADATION

Dr. Vinnik letter to Bob Rylee, President of Dow Corning Wright. He states, “I am considerably worried about the failure rate of gel implants, and this correlates with the research that has been done by Mr. Garth W. Hastings of England on the matter of shell fatigue.” Dr. Vinnik reports a second patient experienced shell fatigue also.
CITE: KMM 427907.

Document #341
09/16/81
TISSUE REACTION
RUPTURE
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Vinnik’s operative report to Dow Corning notes a patient who experienced a rupture and found an “irregular nodular mass” in her right breast which “became increasingly fibrotic and dense, raising some concern about malignancy. At surgery, the right breast was found to be totally disrupted with the implant shell incorporated within the gel mass.

Contiguous with the gel mass and separately isolated by capsule, was a roughly 4×6 cm irregular nodular mass which upon excision was an obvious siliconoma.” The attached pathology report notes that, “The process ranges from a fibrous rather acellular one through concentrations of lymphocytes and plasma cells to small foreign body type giant cells tending to form granulomas. One section demonstrates an acute necrotizing inflammatory cell reaction.”
CITE: F 687 – 689

Document #342
09/23/81
KNOWLEDGE OF LIQUID SILICONE DANGERS
SHELL STRENGTH – THICKNESS
TISSUE REACTION
RUPTURE

Dr. Vinnik writes a second letter to Bob Rylee, President of Dow Corning Wright, regarding a failed silicone gel implant. He writes,

“(T)here is suspicion in my mind that we are dealing once again, with a shell failure. You will see from the enclosed Pathology Report that this patient had considerable silicone reaction to the extruded material. Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that ‘pure silicone’ can cause severe foreign body reactions in susceptible individuals.”
CITE: F 685 – 686. DUPLICATE: M 780645 – 780646.

Document #343
11/16/81
SILICA

Gene Jakubczak, Dow Corning, informs Sue Peters of a telephone conversation with Dr. Charles Vinnik on 10/10/81. Dr. Vinnik believes that the work performed by Garth Hastings and Paul Wulfusander (sic: Wilflingseder) (his European partners), concerning phagocytoses or silicone shedding from the breast prosthesis, is a factor in the failure of an implant. Also, Dr. Vinnik thought the LS bleed resistant mammary implant was “worse than what was brought out previously.” Jakubczak informs Dr. Vinnik, “that we would review the data … plus Dow Corning’s own internal data to determine… the fate of silica shedding from the breast prosthesis.” Jakubczak says Dow Corning is also looking at data on the permeation of drugs out of silicone.
CITE: F 728. DUPLICATE; KMM 447167; DCC 242031444.

Document #344
11/30/81
SHELL STRENGTH – THICKNESS

Sue Peters, Dow Corning, memo to Milt Hinsch discussing the shelf life of the Silastic and Silastic II implants after (1) year. “After one year shelf life, the Silastic standard mammary has a 78.6% decrease in tear resistance, a 31.6% decrease in tensile strength, and a 23.3% decrease in elongation.” “The Silastic I and Silastic II No Barrier also have significant decreases in tear resistance, tensile strength and elongation after a one year shelf life.”
CITE: M 160031 – 160036. DUPLICATE: M 180106 – 180107; M 570068 – 570073; D 247 – 248; F690 – 691; KKA 227400 – 227401; M 180136 – 180137). NOTE: Breast implants lose 50% of their strength when left on the shelf for 1 year but plastic surgeons were never informed.

Document #345
12/10/81
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTIONS

Monthly activity summary for a 14-day subchronic oral gavage study with octamethylcyclotetrasiloxane (D4) in rats absolute and relative liver weight data. Lists organ weight data for females foe each animal number and to dosage levels. CITE: P 15115.

Document #346
12/22/81
TESTING
TISSUE REACTION

Hughes Research and Development sends a letter to W. Boley, Dow Corning, regarding the proportion of rats with malignant lymphoma in groups treated with TX-1210 and TX-1211 fluid. It states “We feel that there is a treatment related increase in the incidence of malignant lymphoma in male and female rats treated with TX-1210 and TX-1211….”
CITE: KMM 33826 – 33827. DUPLICATE: KMM 330368 – 339374. NOTE: KMM 339368 includes KMM 339369 – 339374 which is a revision of the histopathology report to evaluate the carcinogenic potential of TX-1208, TX-1209, TX-1210 and TX-1211 (Dow Corning B-7811 implant study in albino rats).

Document #347
01/12/82
SHELL STRENGTH – THICKNESS
RUPTURE – CLOSED CAPSULOTOMY

Sue Peters, Dow Corning, memo to Milt Hinsch regarding closed capsulotomies and the Silastic II mammary prosthesis. “Please make it very plain to your sales people that it is incorrect to promote or to imply any benefit of this mammary because of increased strength allowing a closed capsulotomy to be performed. We have no data to support that type of claim or implication.”
CITE: D 4897. NOTE: Dow Corning did not warn of the risks of closed capsulotomy with the Silastic II until 1986.

Document #348
02/04/82
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION

Handwritten notes concerning the history of the Dow Corning Varifil implant. (Handwriting appears to be Chick Burda’s). He notes that in 1977, Petraitis warned Bey and Jakubczak that the “boob tester was indicating failure and Petraitis wanted to spill the story but was not listened too (sic). Petraitis quit.” The author also noted that Rathjen was told that it was a business decision and to “fall back.”
CITE: KMM 261745 – 261746.

Document #349
03/30/82
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION

Dr. Bernard Morgan writes to Dow Corning Wright regarding implants which “showed heavy leaching and were almost disintegrated…. I would like to know if there is a change in the envelope which produces spontaneous disintegration and/or whether this leaching is a phenomenon which has been reported to you previously.”
CITE: KMM 23084

Document #350
04/08/82
CONCEALING FROM FDA

515(B): Betty Lock Wiles, Manager of Regulatory Affairs, Medical Engineering, sends their outline on proposed reclassification to HIMA. (MCG 004946 – 004951). Harvey Steinberg, Senior FDA Legal Counsel to Dow Corning, also sends their outline and comments to HIMA.
CITE: MCG 4953 – 4956

Document #351
04/22/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
GEL MIGRATION
MISCELLANEOUS – PRODUCT LABELLING

Dr. Vinnik sends a letter regarding his meeting with G. Jakubczak, Bob Rylee and Tom Brown, Dow Corning, in which he details many breast implant problems and his proposed solutions. He recommends changing the patient and physician pamphlets to include warnings on shell fatigue, rupture, and gel migration. He provided Jakubczak with the pathology reports of a patient who showed such “…extensive and violent silicone reactions comparable to the worst of those seen with the old silicone injections.”
CITE: KMM 140193 – 140197. duplicate: KMM 243027 – 243031; KMM354986- 354990.

Document #352
05/10/82
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

J. Cooper, Dow Corning, memo stating that the Two-Year Implant Study of Q7-2167 and Q7-2168 was flawed and useless. Cooper states that, “Prior to completion of the study and interpretation of the results IBT (Industrial Bio-Test Laboratories) was cited by the FDA for poor clinical/laboratory practices including loss of records and falsification of data. The corporation was subsequently dissolved.” In addition, “the data were considered highly suspect because of abnormally high disease rates among all of the test animal groups — including the saline injected and untouched groups…. We have since had opinions from several external pathologists and veterinarians that the colony was disease ridden and the entire exercise was badly flawed and useless. We have concluded this study has resulted in no usable information and that no conclusions can be drawn from it. We are now back at the same point we were at in 1975 except that we have expended $200M in the study and its subsequent evaluation/condemnation.”
CITE: F 814 – 815. DUPLICATE: m 170070 – 170071: M 430209 – 430210; KMM 361951 – 361952; KMM 339375 – 339378. NOTE: Dow Corning has no long-term studies and, even though they admit that “we still need the two year study…,” Dow Corning does not begin another such study until 1988.

Document #353
05/14/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Dr. Robert Parsons, Professor of Surgery at the University of Chicago, writes a letter to Gene Jakubczak at Dow Corning informing them of their research on implanted silicone prostheses. “our data suggest strongly that the fibrosis and capsular contracture seen clinically maybe (sic) an immunologically mediated phenomenon.” (emphasis added). Dr. Parsons states that macrophages aggregate and adhere to the surface and actively erode the silicone envelope after implantation: macrophages ingest and process silicone; macrophag-lymphocyte communication occurs by intracellular bridging in the lymph nodes and have identified silicone containing microvacuoles in both the macrophages and lymphocyte ends of the bridges; and significant inhibition of macrophage migration by silicone sensitized lymphocytes in vitro has been shown. Dr. Parsons, Dr. Heggers and their research assistant, Nir Kossovsky, suggest that their work may enable them to develop a method of screening patients for “hypersensitivity to silicone” before they are implanted.

The research team found that the body’s reaction to silicone created giant cells called macrophages that erode the silicone envelope and can migrate to the lymph nodes. Dr. Parsons believes that the body’s immune reaction could be causing such problems as capsular contracture. Requests for finding from Dow Corning for further research to better understand this immune response were denied by the company.
CITE: F 748 – 749. DUPLICATE: FDA 19612 – 19613: KMM 447084 – 447085; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of the Committee on Government Operations, December, 1992, p. 15.

Document #354
05/17/82
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Dow Corning submits its portion of the industry-coordinated response to the proposed reclassification to HIMA. Dow Corning’s portion consists of a discussion of the long-term effect of silicone breast implants.
CITE: MCG 5454 -5462.

Document #355
10/19/82
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an allergy-type reaction to Silastic brand implants made from medical grade silicone. Frisch states:

“Clinically, the implants have been used in several million patients with very few reports of suspected inflammatory or allergic reactions. In the past, with one recent exception, when the reactions were evaluated by patch testing, by subdermal implantation of a small specimen, or by cell culture studies of the implant the reactions have universally been negative.”

Frisch notes another report of a potential allergic reaction to silicone reported by George Francis, M.D. (emphasis added).
CITE: M 480031 – 480032.

Document #356
05/20/82
CONCEALING FROM FDA

515(B): Two meetings take place in Washington D.C.: one in the morning for manufacturers and HIMA, and afternoon meeting for manufacturers, ASPRS and HIMA, and afternoon meeting for manufacturers, ASPRSS and HIMA. 3M, Dow Corning, Medical Engineering Corporation, ASPRS, HIMA, and the AMA attend the meetings. Harvey Steinberg, Dow Corning’s FDA Counsel, Tells group that reclassification is important to Dow because from the industry standpoint “$$ have to be diverted, generated for PMA. (This) effects how co.’s practice – sites, plant improvements …, effects how management allocates resources. Very significant cost factors enter in.” (MCG 5427 – 5431). He also states that “Risks 40 yrs. down the road cannot be determined.” Betty Lock Wiles, Surgitek, writes a memo to Surgitek personnel about the May 20 meeting and states that the manufacturers “reviewed the cost, time, and liability affect of Class III.”
CITE: MCG 5427 – 5431. DUPLICATE: MED 11222.

Document #357
06/03/82
MISCELLANEOUS – LOBBYING
TESTING

Letter to Goldwyn from Rathjen regarding the unacceptable situation with the clinical investigators, “I am missing annual follow-up reports (see protocol), photographs, injection reports, etc. With a very few investigators, the lack of attention to the protocol is absolutely unacceptable. … The FDA doesn’t want to hear excuses why investigators’ records are incomplete or why there is an apparent lack of control or attention to detail. … This impression concerning the conduct and results could conceivably carry over into other device areas, i.e., the breast prosthesis reclassification.” Strongly worded letter.
CITE: DCC 106006096 – 106006099, Exhibit to MDL Rathjen Deposition.

Document #358
06/11/82
GEL MIGRATION

Burda, Dow Corning, reports on Complaint Report WM2570 in which the left implant ruptured and “silicone gel migrated down the patient’s arm.”
CITE: CO 1417 – 1429.

Document #359
06/30/82
CONCEALING FROM FDA

FDA: Dow corning submits its response to the FDA concerning the proposed reclassification of silicone breast implants.
CITE: KMM 275488 – 275512.

Document #360
07/13/82
KNOWLEDGE OF GEL BLEED

Duel, Dow Corning, memo to Jakubczak regarding comments, questions and recommendations on the letter from Dr. Schmidt. Among Duel’s comments are shells are very oily, we lubricate the valves with silicone, H.P. shells have visually more bleed, all gel-saline units bleed, and our distributors are well educated but poorly informed.
CITE: M 250033 – 250034.

Document #361
08/11/82
ACKNOWLEDGEMENT OF NEED FOR TESTING

Gene Jakubczak, Dow Corning, memo to Jim Wessel and Jerry Marlar on the two year rat implant studies using mammary prosthesis silicone gels. He supports the acquisition of implant data on Q7-2167 and Q7-2168 gels. Further, he “recommend(s) that systemic fate of the material or extract should be stud(ied) as well as the metabolic fate…. The study should be expanded to make sure that we know what happens to gel bleed or gel and what is its metabolic fate.”
CITE: M 250033 – 250034.

Document #362
09/01/82
SHELL STRENGTH – THICKNESS

Tom Brown, Dow Corning, memo to Milt Hinsch about the staggering reject rate with the larger size Silastic II mammaries. Dow Corning changes from a 3.2 cm patch to a 4.5 cm patch to “compensate for the inherently less responsive and elastic character of the Flourosilicone-coated envelope.CITE: d 2226

Document #363
09/13/82
COHESIVENESS – LIQUID COMPONENT OF GEL

McMahon and Sweet, Dow Corning, memo to Cooper and Metevia regarding “Progress Report On The Mammary Gel Cohesion Project.” Sample implants were taken from the plant and a gel cohesion test was performed. “The data generated showed that 23% failed the gel cohesion test.” They observe that “inconsistency within a lot could mean mechanical breakdown of gel or a shift of the cross-link network.” Also, they state, “First of all, we found that the catalyzed gel was approximately 75% non-reactive fluid….” Using gel with the additional factors enter in “although the extent of importance is not understood. The mammary envelope is an addition cured elastomer and … any unsaturated vinyl groups at the envelope/gel interface can react with active hydrogen from the gel cross-linker. If this occurs then part of the cross-linking network is disturbed.”
CITE: KKA 245424 – 245426

Document #364
09/23/82
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE

Dr. Charles Vinnik letter to Robert Rylee, Dow Corning, regarding a patient who experienced severe reaction to the gel in a ruptured Silastic implant. Dr. Vinnik states, “Review of the sections by the same pathologist who has reviewed all of the silicone injection material with me over the past twelve years shows this reaction to be as marked a reaction as we ever saw with the silicone injections. I believe this proves the point that ‘pure silicone’ can cause severe foreign body reactions in susceptible individuals.”
CITE: M 780645 – 780649. NOTE: See 12/06/83 entry. M 780641 – 780644, for the second letter written to Rylee regarding this same patient.

Document #365
11/05/82
FRAUD/MISREPRESENTATION

L. Smith, Dow Corning, memo regarding implementation of a complaint system “Direct Response” program. She states that the reviewer should “not say anything on the form that you do not want the complainant to know.” There will be a separate form to write on which will not be provided to the complainant.
CITE: KKA 236497.

Document #366
12/17/82
TESTING

Letter to Dr. Goldwyn from Rathjen regarding receipt of clinical data, “the quality of documentation is self explanatory. Absolutely unacceptable! I suspect the validity! … There is no room for friendships here. He has embarrassed you and me, he has disregarded the Protocol, ignored the reputation of his colleagues and the A.S.P.R.S.”
CITY: DCC 106003897, Exhibit to MDL Rathjen Deposition.

Document #367
00/00/83
SILICA

Researcher N. Kossovsky studies the surface morphology of explanted mammary prostheses and reports that the surface was covered with embedded spheres and surrounded by pits. Kossovsky suggests these surface anomalies may be the result of the “grazing” of silica filler particles from the envelope of the prosthesis by phagocytic cells. CITE: M 790186 – 790193.

Document #368
01/26/83
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
RUPTURE
TESTING
CONCEALING FROM FDA

Dr. Nirmal Mishra, staff toxicologist at the FDA, presents the FDA’s reasons for this recommendation which include: gel migration, granulomatous foreign body reaction, loading of the reticuloendothelium system, unknown subsequent disposition in the body with little epidemiologic or experimental data on effects.
CITEP KMM 120705 – 120729, Exhibit 3 to Harris County Rathjen Deposition. DUPLICATE; M 100083 – 100143.

Document #369
02/02/83
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
Stark, Dow Corning, memo to Marlar, Rathjen, Steinberg, Jakubczak, Weyenberg, Lentz and Hobbs reporting that “the number and type of abnormalities noted with the 360 fluid studies in rabbits, i.e., classic cyclops condition of the eyes, clubbing of extremities, ankles bent in the wrong direction, were all indications of potential birth defects related to silicones: and the “this issue is of paramount importance. It has relevancy to the safety of all silicone applications and must be resolved ASAP.
CITE: DCC 17042386 – 17042387, Exhibit to California Lentz Deposition, Exhibit 93 to Bennett Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KKA 22785 – 22786.

Document #370
02/03/83
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – PRODUCT LABELLING

G. Jakubczak, Dow Corning, memo to Milt Hinsch regarding revisions to the package insert for the Silastic implant. Jakubczak suggests routing all comments on inserts to Jim Matherly, Chick Burda, Harvey Steinberg and Marcia Marsh since this is a “very high potential liability product.” Jakubczak suggest adding language on silicone bleed – “Silicone bleed from a gel filled mammary has been identified in surrounding tissue.”
CITE: KMM 301297 – 301301. NOTE: Need to cross check the final package insert to see if Jakubczak’s suggestions were incorporated.

Document #371
02/17/83
TESTING

Hobbs, Dow Corning, memo to Lentz stating that data produced 15 years ago would likely produce adverse publicity because the data does produce doubt, the laboratories producing the data can easily be criticized relative to their performance standards and the studies involved would likely not withstand validation.
CITE: DCC 204005659 – 204005660.

Document #372
04/01/83
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory patient no. 29 follow-up. The patient developed rheumatoid arthritis in the back and shoulders and has an over active thyroid.
CITE: B 1453 – 1454, Exhibit 14 to Harris County Rathjen Deposition, Exhibit to MKL Rathjen Deposition.

Document #373
04/05/83
DOCUMENT DESTRUCTION

C. Burda, Dow Corning, memo to J. Matherly regarding the “severe status of record keeping by TSS&D” on Slapstic II Lot History Records. Burda states, “Tim Pinto and I encountered a serious problem of HX master records being incomplete and/or missing.” When “Attempting to determine the number of Silastic II implants distributed by Dow Corning the following conditions have been encountered. Master HX records have not been properly prepared and recorded. Many … are not available for lots processed by the plant. Supportive records and/or references are often not provided.” There is also a four page listing of irregularities found in at least 56 lot history and device master records including the reject cause tally does not reconcile with the quantity rejected, incomplete and missing information in the records, sizes combined in a single lot, and implants unaccounted for. “The HX master record is (a) suitable document for device manufacturing work. But it has not been used properly. As the records indicate people using it do not use it as a serious GMP type document. The management of the HX system is totally missing as written by failure to check and approve each lot. Furthermore it appears no audit was ever performed to check if HX lots were ever completed and records returned…. There are no exceptions for failure to comply to good manufacturing processes.”
CITE; D 4924 – 4929. NOTE: Dow Corning has cited to lot history records in responding to inquiries from the FDA and Physicians about problems with implant shells. Specifically, Dow Corning Claims that the lot history records show that there was no problem with the particular lot in question. See, e.g., 06/21/82 entry.

Document #374
04/20/83
COHESIVENESS – LIQUID COMPONENT OF GEL

Gene Jakubczak and Tom Brown of Dow Corning recommend rejection of loose gel HH0223099 (Drums 1,2) (Used in Silastic II Mammaries) as “unsuitable for sale.” The lot of gel passed all lot acceptance requirements but it was atypical gel. The recommendation is based upon their observations that the gel “appeared sloppy,” that some Slapsti II units “failed catastrophically,” and others failed ASTM cohesivity tests. “Gel fell en masse from envelopes…. Gel appeared to ‘flow’ and when manual attempt to squeeze from envelope was made, no tendency to spring back into the envelope was noted upon release.’ (emphasis added). Further, “On the basis of the risk which would be posed to a patient having one of these units implanted, prudence requires their rejection. The ease with which gel may be displaced from the shell (as evidenced in the hang test) is sufficient cause for concern.”
CITE: F 726 – 727. DUPLICATE: DCC 800441416 – 80041417.

Document #375
05/03/83
COHESIVENESS – LIQUID COMPONENT OF GEL

Dr. Vinnik writes to Robert Rylee, Dow Corning Wright, regarding a Dow Corning silicone gel implant “which does not appear to conform to your own minimal specifications with respect to gel cohesion.” The attached Operative Report notes “THE GEL ON BOTH SIDES APPEARED TO BE DEFECTIVE, BEING EXCESSIVELY THIN AND RUNNY.”
CITE: KMM 3885 – 3891

Document #376
07/20/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

C. Lentz, Dow Corning, memo to D. Weyenberg discussing staffing needs to conduct toxicological studies. He writes, “The work we do has a wide range of urgency connected with it. On one end of the range is the work that must be done now and on the other end is work which needs to be done some time but can be put off for now …until it reaches the ‘must be done now’ stage.” Lentze states that Dow Corning’s current mode is that the toxicology department is understaffed or “inadequately’ staffed, that they are “borrowing” pathology and veterinary skills from Dow Chemical and that Dow Corning has “no resources available to do long term studies or fundamental information type studies.” Lentz urges Dow Corning to immediately hire two people to meet Dow Corning’s “here and now obligations.” A long term (2 year) state of the art study on the health effects, including carcinogenic potential of implanted silicone gel “must be done. Dow Corning no longer has the option of not doing or delaying the study.’

Lentz adds, “Commencement of a gel implant study is overdue and at this time we would not be able to convincingly demonstrate due diligence in pursuing knowledge.”

One of the recipients of the memo, Forrest Stark, writes a handwritten note back to Lentz at the top of M 420069: “Bringing appropriate professionals in house has my wholehearted support. I still think that a reorganized TOX within HES could give us efficiencies.”
CITE: M 420068 – 420072, Exhibit to Harris County Boley Deposition, Exhibit 7 to Zimmer Deposition, Exhibit to Rylan Deposition, and Exhibit 19 to Harris County Zahalsky Deposition.

Document #377
08/09/83
ACKNOWLEGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Memo to Rathjen from Isquith regarding Immunological Research Proposal, “It has long concerned me that our knowledge in this area is virtually nil and should not be. … Knowledge from such a study … could be a tremendous asset in better understanding tissue reaction to silicone implants.”
CITE: KMM 205513 , Exhibit to Isquith Deposition and Exhibit 65 to MDL Rathjen Deposition.

Document #378
08/25/83
ACKNOWLEDGEMENT OF NEED FOR TESTING

Weyenberg, Dow Corning, memo to C. Lentz. J. Cooper, Rylee, Stark, Steinberg, and Ziarno regarding a toxicity evaluation of silicone gel.

“Will you please take the leadership in the preparation of a definitive proposal for a chronic tox study on gel implants? Please consider the options of a study conducted within our TOX Department versus and externally funded study. The proposal should include the options and your recommendations on scope, expense (including APS) and timing for the study–A proposal which can be used by the Health Care Group and the RDES function for decisions on funding this project.
CITE: M 420067.

Document #379
09/15/83
ACKNOWLEDGEMENT OF NEED FOR TESTING

Boley, Dow Corning, memo to J. Matherly regarding “Biological Safety Testing Of Gel For Implants.” He states the “only gel to my knowledge that has had long-term implant testing performed on it” is X-3-0885 (Sylgard 51). “Gel Q7-2218 only has tissue cell culture data available for it. Therefore, if we are to continue to sell this material as “medical Grade,” immediate action should be taken to bring it into compliance with the business definition of Medical Grade.”

“It is my opinion the Q7-2167/2168, Q7-2150/2146, and X-3-0885 are similar enough in formulation such that testing performed on one gel is applicable to the other two… we have no valid long-term implant data to substantiate the safety of gels for long-term implant use…. Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.
CITE: F 838 – 839. duplicate: M 170034 – 170036; M 580061; KMM 380518 – 380520; KMM 140198: KMM 386581: KMM 483550 – 483552; KFD 1655 – 1658: KKA 1. NOTE: In 1983, Dow Corning is till complaining of no long term testing and no real safety data.

Document #380
09/23/83
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Jim Matherly, Dow Corning Wright, memo to Jim Cooper and Jerry Zoarmp. Regarding Biological Testing of Gel For Implants Matherly states that:

“Within the past two months, we have received inquiries relating to a broken gel testicle and a broken mammary, as well as from Cox-Uphoff and Ruthton Corporation. To our embarrassment, we were unable to provide more than tissue culture and heavy metals analysis. Furthermore, our product literature on these gels imply that safety testing to qualify them as implant materials does exist and can be obtained readily from Dow Corning.”

Matherly notes an added rationale for the safety of the implants is the assumption the gel is contained in an envelope. “This supposes that ruptures do not occur or are removed quickly… (but) experience has shown this later statement to not be accurate….” Matherly concludes “Only inferential data exists to substantiate the long-term safety of these gels for human implant applications.” He also points out the “data produced by IBT is … generally suspect in the industry due to their poor laboratory practices.”
CITE: m 170037 – 170038. DUPLICATE: F 854 – 855: m 430215 – 430216: F 838 – 855: KMM 483548 – 483549: KKA 4 – 5; KMM 27693 – 27694; KMM 361961 – 361962: KMM 329306 – 329309: KMM 380521 – 380522.

Document #381
09/26/83
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – PRODUCT LABELING
TESTING
TISSUE REACTION

Boley, Dow Corning, memo to Marlar, Rylee, Wessel, Cooper, Rathjen and Hobbs with copies to Lentz, Stark and Steinberg regarding “Repeat of Dr. Heggers Published Procedures Claiming Antigenicity Of Silicone Gel.” Boley wanted to repeat the study with an outside laboratory but the estimated cost of $20,000 was too much. He states: So Economically, I find it difficult to justify expending much time and money on this matter. For the present, I believe it may be adequate to begin updating our product data sheets to read “low-sensitization” or “minimal sensitization” rather than “non-sensitizing.” The issue of sensitization of silicone polymers will eventually be resolved by the medical community with or without our help. Therefore, perhaps the appropriate course is to wait. In any event, the sensitization potential of silicones will be extremely low or non-existent and therefore, should have little economic impact on Dow Corning.”
CITE: KMM 337395.

Document #382
09/30/83
COHESIVENESS – LIQUID COMPONENT OF GEL
TESTING
KNOWLEDGE OF GEL BLEED

Dow Corning “Investigation of Q7-2167/2168 Formulation Parameters Which Might Influence Gel Cohesivity And Bleed” by Joan McMahon, Randall Sweet, and Virgil Metevia. They discuss that in mid-1982, Dow Corning Wright’s TS&D requested the Medical materials Department of Dow Corning to address issues of gel cohesivity and bleed with Q7-2159A (the gel used in Silastic and Silastic II), which is the catalyzed version of Q7-2167/2168 gel.

Thirty (30) mammaries were taken from inventory and tested. 23.3% (7 of 30) failed the cohesivity test. Mammaries within the same lot passed while others in the same lot failed this test. Some has excessive bleed and some did not. There was little area where the gel would be cohesive and still fall in the specification range of 75-300. Data showed the specification could be brought to 50-150 and still likely pass the ASTM F703-81 gel cohesivity test. The responsiveness of 50 penetrations was not considered to be objectionable. Gel bleed is already known to be a problem.
CITE: KKA 121630 – 121669. DUPLICATE: KKA 88488 – 88495; KMM 270149 -270162; KMM 173990.

Document #383
10/05/83
FRAUD/MISREPRESENTATION

Bruce Reuter, Dow Corning, memo to the Territory Managers and Sales Representatives regarding Natural Y breast implants. Reuter lists Natural Y’s claims about polyurethane implants and cites to medical publications which disprove their claims. Reuter criticizes Natural Y for not having supporting references for its claims. He states that, “The contracture free claim is a joke! We have had reports of infection, pre-operative rupturing and contracture from around the country.” Additionally, Reuter states, “Have you felt a Natural Y prosthesis. There is no envelope around the gel, just an easy peel off foam coating. The FDA is going to move mammaries from Class II to Class III because of the concerns with gel bleed and here is a mammary that is a gel bleed time bomb.”
CITE: KKH 56082 – 56087. DUPLICATE: D4503

Document # 384
12/06/83
COHESIVENESS – LIQUID COMPONENT OF GEL
TISSUE REACTION
RUPTURE
GEL MIGRATION

Dr. Charles Vinnik writes to Robert Rylee, Vice President of Dow Corning Wright, regarding an enclosed pathology report showing that a patient has had a considerable silicone reaction to the mammaries extruded material. Dr. Vinnik states that he will not “assume liability along with Dow Corning for a defect in the silicone gel.”

“The silicone gel, as demonstrated to Mr. Reuter and Mr. McGuire, and as seen and commented on by Mr. Matherly, Ms. Duel, Mr. Jakubczak and others at Dow Corning was in fact lacking in cohesion. Various theories were postulated as to why this gel was not cohesive and thus reacted as migratory gel within this patient’s body producing considerable inflammation, foreign body reaction and discomfort. Nonetheless, all of these theories are moot as there has never been any representation to the medical public or the lay public that in any way, shape or fashion does the silicone gel change its physical characteristics once implanted in the human body with or without the intact shell…. There would be no requests to you for compensation for this patient’s problem were the gel cohesive. If the gel was cohesive, she would have no problem…. I think (this) points up the fact that there should be some type of a liability insurance scheme with impartial analysis which would appropriately compensate people for products which are defective. I keep using the word ‘defective’ with respect to the silicone gel as there is yet to be any hard scientific evidence to show that what happened in this patient’s case is anything other a defect in manufacture
CITE: KKA 246750 – 246753. DUPLICATE: KKA 152422 – 152425; M 780641 -780644.

Document #385
12/13/83
CONCEALING FROM FDA
TISSUE REACTION
KNOWLEDGE OF GEL BLEED

FDA: “The FDA inspects Dow Corning’s Hemlock plan and lists numerous violations in the complaint reporting system. The investigator notes that Complaint MD 1081 dated 04/21/81 showed a “giant cell reaction with imbedded silicone particles.” Dow Corning failed to follow-up this complaint and get more information. Also, there were numerous complaints about implants being “greasy” and Dow Corning had failed to respond to them. Other violations included production records, oven records, “dirt & debris on top of packaged sterile mammaries,” and other problems with sterility in the dipping room and manufacturing process.
CITE: FDA 17098 – 17137.

Document #386
12/27/83
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – PRODUCT LABELING
TISSUE REACTION

Lentz memo to Marlar with copies to Boley, Cooper, Hobbs, Rathjen, Rylee, Steinberg and Wessel regarding Marlar’s 11/21 memo about “plans to change the silicone gel product literature to indicate some degree of sensitization…. I would like you to delay a final action on this plan until a group representing a broader product responsibility in the corporation has had a chance to discuss the subject and reach a conclusion. I believe this is essential because the major component of gel is polydimethylsiloxane. This material is used in a very broad spectrum of products and consequently a variety of human exposure does occur. For example, PDMS is used in a variety of personal care products, such as skin lotions. If your literature suggests silicone gel causes some degree of sensitization, there is significant potential for implicating other PDMS products.”
CITE: KMM 336678

Document #387
02/06/84
KNOWLEDGE OF LIQUID SILICONE DANGERS
TISSUE REACTION
RUPTURE
SILICA

Dr. Charles A. Vinnik writes to Gene Jakubczak of Dow Corning regarding a pathology report from a patient whose implant lost its shell integrity. The pathologist found some silicone material engulfed by macrophages. “The type of reaction seen here is very similar to that in which liquid silicone is ingested by phagocytes converting them to foreign body giant cells and ‘foamy macrophages’.” (emphasis added). One of the rationales given by Dr. Vinnik for this reaction is, “The factor X within the shell of the implant. the reaction … sustained is very similar to those which I have seen rarely over the years associated with faulty polymerization of the shell and/or filler. It is possible that the birefringent particles described by the pathologist (was) silica used as the filler material in the implant shell…. These findings have been reported by Wilflingseder and Brown with the silica particles confirmed by scanning electron microscopy.” Dr. Vinnik hopes that Dow Corning will do more than its “usual casual, perfunctory and useless analysis….”
CITE: M 490041 – 490045. DUPLICATE: KKA 246784 – 246785

Document #388
02/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Holmes, Dow Corning, memo to Rathjen regarding “S.H. Miller Study Protocol.” Holmes states: “It seems almost inconceivable that we do not know more about the human immunological response to silicone at this point….” He states that the study is “certainly needed” and that Dow Corning should support it.
CITE: KMM 205503, Exhibit to MDL Rathjen Deposition.

Document #389
02/29/84
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION
COHESIVENESS – LIQUID COMPONENT OF GEL

E. Frisch, Dow Corning, memo to R. Dumas, G. Jakubczak, and S. McGuire referring to a visit with Dr. Vinnik. Dr. Vinnik stated that many of Dow Corning’s implants were “defective with thin spots causing them to be easily ruptured…. The gel in removed implants has lost its cohesiveness, and suggested that biodegradation may be occurring.” Frisch claims it is not Dow Corning’s envelopes and gel which are the problem, but that implant manipulation “would probably result in localized stressing of some areas of the implant, particularly if there were a thin spot, or if the stretching were uneven such that it created an aneurysm. The subsequent manipulations would probably stretch these areas resulting in progressive weakening and ultimately rupture….” There is no machine that duplicates this kind of manipulation that is commonly recommended by doctors to prevent capsular contracture.
CITE: KMM 259750 – 259751. DUPLICATE: DCC 80030963 – 80030966.

Document #390
03/14/84
COHESIVENESS – LIQUID COMPONENT OF GEL
TISSUE REACTION

Dr. Charles Vinnik, Dow Corning, letter to Gene Jakubczak, Dow Corning, regarding an implant which had lost its shell integrity. “(T)he patient did have a silicone reaction exterior to the intact capsule….” He states that Dow Corning’s gel was “greatly inferior” to other manufacturer’s gel because of its “looser consistency.” Bruce Reuter, Dow Corning’s National Sales Manager, writes at the top of the letter, “I think we should cut Dr. V. loose!”
CITE: DCC 242051086 – 242051087

Smoke/Fire Document #391
03/30/84
TESTING

Abstract of Dow Corning study of “Tissue Cell Biocompatability of Dow Corning 200 Fluid, 65 cs” states that, “The test material was evaluated for cytopathic effect by placing the material in direct contact with a confluent monolayer of human embryonic cells…. A distinct cytopathic effect was observed by the test material in both initial and retesting of the samples.”
CITE: 38813 – 38821. DUPLICATE: KKH 59302 – 59320.

Document #392
04/16/84
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING

Letter to Miller from Rathjen re the March 28th letter covering prospective breast study,. In July, patients will receive an examination for their 12 year follow-up.
CITE: KMM 205496 – 205497, Exhibit to MDL Rathjen Deposition.

Document #393
04/18/84
TESTING
GEL MIGRATION

Linda Veresh, Dow Corning, “Final Report on Dow Corning 382 Elastomer, skin sensitization test; the original report is dated 1982. Two of the guinea pigs died with no cause determined but the implants had migrated and whitish lesions and granular particles were found on the lung, ventricles of the heart, spleen and liver. In addition, hemorrhagic spots were found on the cerebrum.
CITE: T 11768 – 11817

Document #394
04/23/84
DOCUMENT DESTRUCTION
COHESIVENESS – LIQUID COMPONENT OF GEL

Reuter, “Dow Corning, memo to Wessel regarding C. Vinnik’s runny gel complaints. “These escapades are costly! The price tag on this one is greater than $3,000.00 and we settled another claim for $5,000.00 late in 1983. … P.S. Please read memo then destroy. Do not keep for files.”
CITE: KKH 76226. DUPLICATE: M 490088.

Document #395
04/26/84
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION
TISSUE REACTION

Handwritten note to Jakubczak, Dow Corning, that Wessel called regarding Dr. Barker. “Please call Dr. Barker re two sentences Jim thinks should be deleted to reduce product liability. 1. Chronic inflammatory cells caused by gel. 2. Gel causes contracture. Jim feels above does not reflect the truth.”
CITE: M 500016. NOTE: “Dr. Barker was writing an article about capsular contracture with silicone breast implants.

Document #396
05/09/84
KNOWEDGE OF SYSTEMIC DISEASE

Eldon Frisch, Dow Corning, memo to Bill Boley, Marcia Marsh, and Jim Wessel concerning Baxter Travenol’s presentation at the biomaterials Meeting. The poster presentation demonstrated a cell culture method Baxter developed for assessment of immunotoxicity. Frisch states that Baxter “tested a number of materials, including silicones, and have found that many, if not most, plastics and elastomers elicit an immunotoxicity reaction. … This may be of interest in the alleged case of human adjuvant disease.”
CITE: KMM 37828.

Document #397
05/21/84
KNOWLEDGE OF SYSTEMIC DISEASE

Frisch, Dow Corning, letter to Dr. John Madden (cc to Boley) regarding a female hydrocephalic patient described in an attached abstract entitled “Evidence For Immune Response to Silastic Implants” by Michael R. Wasserman. The described patient experienced an alleged immune response to silicone elastomer.
CITE: DCC 10005769 – 10005770.

Document #398
06/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up for patient no. 8. She developed arthritis in 1978, 6 years post-implantation.
CITE: B 1084 – 1085, Exhibit 11 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition.

Document #399
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 48. Five years post-implantation she was diagnosed with idiopathic thrombocytopenia purpura.
CITE: B 727 – 750, Texas Exhibit No. 8, Exhibit to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #400
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 26. The patient developed arthritis in her fingers.
CITE: B 1401 – 1403, Exhibit 12B to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #401
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 47. The patient developed urinary bladder papiloma and a palpable node in the left axilla.
CITE: BL 676 – 709, Exhibit 17B to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #402
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 36. The patient developed rheumatoid arthritis in the upper extremities.
CITE: B 1584 – 1586, Exhibit 16 to Harris County Rathjen Deposition, and Exhibit To MDL Rathjen Deposition. DUPLICATE: DCD 173003868 – 173003869

Document #403
07/09/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 31. The patient developed discoid lupus in 1982.
CITE: B 1516 – 1517, Exhibit 15 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #404
07/10/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Gregory follow-up of patient no. 50. The patient had minor arthritic changes in her hands.
CITE: B 804 – 805, Exhibit 18 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #405
08/01/84
IDENTIFICATION OF CHEMICALS

Joint Research Agreement For Identification Of Agricultural Chemicals between Dow Corning (signed by Weyenberg) and Dow Chemical (signed by P. Gehring). Dow Chemical produces and sells pesticides, herbicides,
insecticides, acaricides, nematocides and fungicides and has developed expertise in perceiving structural-activity relationships in non-organosilicon compounds. Dow Corning has expertise in the synthesis and manufacture of organosilicon compounds referred to as silicones. The parties will work together to “identify commercially salable organosilicon compounds and formulations therof with biological activity as pesticides in the agricultural chemical field…: Dow Corning appoints Dr. John Ryan as its representative: Dow Chemical appoints Dr. Yulan Tong. The Joint Research Program will begin with 1 or more meetings between the designated representatives. Dow Chemical will disclose the type of pesticides it seeks to develop and the kinds of chemical structural groups that DOW believes impart desired agricultural chemical properties. The parties may select compounds for screen tests by Dow Chemical. The designated representatives shall generate a plan for conduct of the Joint Research Program. The information developed under this program shall be kept confidential for 10 years.
CITE: DCC 2001173 – 2001192.

Document #406
08/14/84
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH – THICKNESS
RUPTURE

R. Dumas, Dow Corning, memo to G. Jakubczak and others regarding “Project Report – Complaint Analysis, Plastic Surgery.” Dumas details the number and types of complaints received on mammary implants and notes that the most common complaints for the gel-saline units were of a greasy surface and post-op deflation from pin hole leaks. Upon inspection, it was determined that the pin holes were caused by “burs on the wire screen in the wash area…. Many of the pin hole leaks examined suggested origination from this source.” Dumas states that, “The appearance of some of these units made me sympathize with one surgeon stating that he believed we were soaking the units on (in) Mazola oil before shipping. Since this bleed appears to be inherent in the current design of the product a standard response has been developed to answer (sic) this type of complaint.” (emphasis added). NOTE: design defect.

The most typical complaint for the Silastic II is post-op suture or rupture during insertion. “The tear propagation (sic) noted with the ruptures was found to be of a much less degree compared with the standard gel product…. There is an indication that there may be more susceptibility to rupturing during insertion than that found with the standard gel unit.”

Dumas noted that most of the complaints concerning the standard gel mammaries (sic) were of the “ease of tear propagation (sic). In addition non-uniformity of the envelope was noted along most tears examined, suggesting thickness variation to be a contributing factor to the rupture.” NOTE: manufacturing defect.

Dumas’ overall recommendations are that Dow Corning needs to develop a more uniform envelope thickness on all products, reduce bleed characteristics, and increase stress resistance in the Silastic II.

Dumas also documents the practice of sending returned implants to TS&D from the Medical Plant in mail envelopes via the plant mail. “Many of the units arrived in a smashed condition making analysis extremely difficult. Imagine trying to analyze a mammary flattened like a pancake inside a gel soaked mail envelope.”
CITE: KKA 119771 – 119774.

Document # 407
08/27/84
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Operative report of a Gregory patient indicates a “tingling numbness which radiates up and down both legs. The point of onset varies each time; it may start in the groin, thigh or calf region but always involves both legs” She was diagnosed with aortofemoral stenosis.
CITE: B 1017 – 1019, Exhibit 10 to Harris County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition.

Document #408
09/24/84
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION

Dr. Muller sends a letter to Dow Corning Valbonne regarding a rupture in situ. When he performed the explantation, he found only gel and no envelope. “In our opinion, this result is very critical.” He requests information from Dow Corning.
CITE: M 460195. NOTE: Dow Corning does not respond to the substance of Dr. Muller’s inquiry for three years when, after considerable letter writing, Jakubczak answers him in a letter dated 08/13/87.

Document #409
10/22/84
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Devries and Siddiqui, Dow Corning, report the results of the “Acute Oral Toxicity Study of Diphenylmethylsilanol In “Rats, “TX-84-0110-03. Signs of toxicity exhibited by rats include lethargy, tremors, slight ataxia and coma which terminated in death. The authors conclude that diphenylmethylsilanol is “slightly toxic” when ingested on an acute basis targeting the central nervous system.
CITE: T 29120 – 29165. DUPLICATE: CGS 1321 – 1322. NOTE: Refers to complaint CGS 1306 -1319.

Document 410
12/07/84
KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

Veresh, Dow Corning, report on the “Ninety-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System.” The pathologist noticed the presence of “a mild to moderate eosinophil infiltrate in the intramuscular and subcutaneous Q7-2218 implant sites in Rabbit #1564 at 30 days, and a trace eosinophil infiltrate at an intramuscular Q7-22l8 site in Rabbit #1570 at 90 days. Dr. Geil noted that the presence of eosinophil in a tissue response is considered indicative of an allergic response.”
CITE: T 39610 – 39704.

Document #411
01/02/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Frye memo to C. Lentz regarding “1984 accomplishments.” There is inconclusive daphnia data/D4 data. Frye also notes the “concerted year-end efforts to respond to the ITC recommendations for further testing of D4 for environmental fate and ecological impact. We might also include our efforts to head off publication of VanDerPost’s silanol nonsense in a highly respected journal. It should at least qualify as ‘fire prevention’ effort where I would also classify our correspondence relating to Shin Etsu Hondotai’s allegations of cyclosiloxane insecticidal (sic) properties and the Hutzinger et al manuscript alleging absorption and bio-transformation of a series of cyclic and linear oligomeric methylsiloxanes. Our Kyoto presentation was also an attempt to prevent silicones in aquatic sediments from being improperly categorized as ecologically threatening materials.”
CITE: FRY 364 – 366, Exhibit 2 to Ryan Deposition.

Document #412
01/08/85
TESTING

J. Cooper, Dow Corning, memo to C. Lentz, R. Rylee, H. Steinberg and K. Yerrick concerning “Biosafety Testing Concerns.” There is an apparent shift by the FDA to require animal lifetime, device carcinogenic potential testing for all new implant applications.

If we operate from the premise that lifetime carcinogen testing is required, our only approved materials are HP Elastomers, the mammary shell material (MDF0077) and MDX44515 (a peroxide catalyzed elastomer) all of which were tested in rats for two years.

Most of our claims to date have been based on a two-year dog study (five materials). However, a dog study must continue for seven years to qualify as lifetime testing. The materials used in the two-year dog test would not be approved under the lifetime test criteria. These include Adhesive A, MDF 0372 Tubing, MDF 0355 Foam Elastomer and MDF 0382 Elastomers….

Heaven forbid, is it possible the FDA will require such testing for each combination of materials for each application? This must be vigorously opposed. (emphasis added). Cooper also urges Dow Corning to conduct a study of the effects of the human immune system of silicone gels, fluids, and elastomer particles.
CITE: M 170062 – 170065. DUPLICATE: F 751 – 754; KKA 160337 – 160341. NOTE: In l985, Dow Corning is complaining about the FDA requirements which they can not meet.

Document #413
01/29/85
ACKNOWLEDGEMENT OF NEED FOR TESTING

A.J. Isquith, Dow Corning, memo to W.F. Boley with recommendations for Dow Corning Q7-2159A gel basic genetic toxicology screening. “It is important to recognize that the tests outlined are capable of measuring genetic potential of chemical toxicity. The tests would not detect cancer potential due to hormonal imbalance (example, effect of estrogen or 2,6-cis diphenylhexamethylcyclotetrasiloxane) or cancer caused by chronic tissue destruction related to the geometry or physical state of an implanted material (solid state carcinogenicity).”
CITE: F 853, Exhibit 12 to Isquith Deposition, Exhibit to Harris County Boley Deposition, and Exhibit 19 to Harris County Zahalsky Deposition. DUPLICATE: M 170040 – 170041; M 580052. NOTE: See 03/07/85 entry.

Document #414
02/19/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Malczewski and Cooper of Dow Corning Health Care Group Research submit a Project Proposal titled “Investigation of the Effects of Silicone Fluids, Gels and Particles on the Immune System.” Proposed is an immunotoxicology program involving “a series of animal tests and in vitro tests designed to assess the risk of adverse immunological sequela associated with the presence of silicone materials in the human.” The authors note that silicone materials are causally linked to three different immunology-related disease states. First, a direct immunological sensitizations to implanted silicone material involving an immediate systemic response which is not correctable by explantation. Finally, the presence of silicone material in the lymphatic system may suppress the immune response to pathogenic organisms and tumor cells. Animal studies suggest that silicone materials modify the immune system both by eliciting a specific immune response and by nonspecifically enhancing or suppressing the immune system. Further, many recent clinical reports in the medical literature suggest that silicone materials elicit or modify the immune system. More sensitive testing methods by some researchers finding an immune response to silicone materials may explain conflicting reports by others who do not. Accordingly, proposed is a comprehensive screen of the immunotoxicity potential of silicone fluids, gels and particles. More than five series of sensitive in vitro tests will access nonspecific suppressing or enhancement of individual immune cell populations, as well as evaluate cell-mediated and antibody-mediated immune response to specific antigenic stimulation. Test will also evaluate the ability of animals to resist proliferation of pathogenic bacteria and tumor cells. Different species of animals will be used in the implantation studies to account for interspecies variations. Expected benefits from this testing include:

1. An assessment of the real risk potential for an immunological response to silicones.
2. An awareness of immunological problems that may erupt so that they can be engineered around if possible.
3. Five or six publications in literature to defuse the current wave of negativism toward silicones.
4. Possible ability to evaluate suspected human silicone sensitivity cases.
5. Data available for defense in lawsuits. NOTE: handwritten entry states “or prove guilty.”

The authors estimate a recourse requirement of “6 effort years…expended over a 3 year period,” and that “Health Care Group Research currently has adequate people skills and resources to conduct this work.
CITE: KMM 386643 – 386659, Exhibit to LeVier Deposition, Exhibit 21 to Harris County Hayes Deposition, Exhibit to Boley Deposition, Exhibit 12 to Popoff Deposition, and Exhibit to Isquith Deposition.

Document #415
03/07/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

B. Boley, Dow Corning, responds to A. Isquith’s memo of 01/29/85 on “Genetic Toxicology Screen of Dow Corning Q7-2159A Gel.” Boley states, “There is currently no valid carcinogenic test data on the silicone mammary gel Q7-2159A. I recognize that short term in vivo and in vitro mutagenicity tests are no substitute for a 2-year animal carcinogen study…. I feel the Health Care Business has an obligation to do what it can to assess the carcinogenic potential of this material…. Without this testing, I think we have excessive personal and corporate liability exposure.” (emphasis added”.

Boley authorizes tests such as the Ames Test, InVitro Forward Mutation Test, In Vitro Chromosome Aberration Test, and In Vitro Transformation Assay Test. According to Isquith’s memo of 01/29/85, this is the “minimal testing” that would meet the FDA guidelines.
CITE” M 170039, Exhibit to Harris Country LeVier Deposition, Exhibit to Peters Deposition, Exhibit to Boley Deposition, Exhibit to Isquith Deposition, and Exhibit 20 to Harris County Zahalsky Deposition. DUPLICATE: F 851; M 580051; DCC 17016611 – 17016613. NOTE: see 01/29/85 entry.

Document #416
03/12/85
TESTING
GEL MIGRATION

Dow Corning Health Care Group Research Report 150 by Boley and Bejarano entitled “Fate of Q7-2159A Gel Injected Sub-dermally In Rats: Macro Observations.” Fibrous tissue can infiltrate Q7-2159A gel and partition it into many smaller masses. The disappearance of 50% of the gel from the injection site is of concern. Whether the gel migrated or was trapped in capsular tissue is unknown.
CITE: DCC 800311717 – 800311729, Exhibit 9 to Bejarano Deposition, Exhibit to Frisch /Deposition, and Exhibit 32 to Zimmer Deposition. DUPLICATE: F 160 – 175; KMM 297691 – 297705.

Document #417
03/26/85
SHELL STRENGTH – THICKNESS
RUPTURE
MISCELLANEOUS – PRODUCT LABELLING

Dow Corning receives a complaint report MD2402 for an implant that ruptured necessitating removal. Dow Corning states, “Gel mammary rupture not covered by labeling.”
CITE: CO 3106 – 3112

Document #418
04/10/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

R. Steele, Dow Corning, memo to G. Hignite regarding subjects discussed at a Health Care Business Board Meeting, Steele notes that the mission of the Health Care Business Board is on “internal profitability issues.” One subject dealt with a presentation made by Bill Boley to the Executive Committee about a research study of the effects of silicone on the immune system. “The benefits of such a program would be to test for the real potential of immunological response to silicones…. Hopefully, we can diffuse any negativism that might exist toward silicone through publication of this data. This study would also give us the basis for an ability to potentially evaluate the sensitivity of individuals to silicone materials. Finally, the data would be available for defense in litigation
proceedings.”
CITE: F 842 – 846.

Document #419
04/11/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Boley, Dow Corning, Memo to Hobbs, Lentz and Cooper regarding “HCB” Research Immunotoxicology Program.” Boley states that the Health Care Business has approved research on immunotoxicology. Handwritten notes indicate that Al Munson, University of Virginia, is involved.
CITE: KMM 386642, Exhibit to LeVier Deposition, Exhibit to Boley Deposition, Exhibit 5 to Harris County Burchiel Deposition, and Exhibit to Isquith Deposition.

Document #420
04/30/85
GEL MIGRATION
TISSUE REACTION

Krystyna Pasyk, M.D., University of Michigan, writes a report to Dow Corning concerning pathological analysis of three slides of lymph nodes from women’s tissues who were implanted with silicone breast implants. “All three slides show similar microscopic changes – hyperplasia of the lymph node sinuses with infiltration of foamy histiocytes and foreign-body reaction most probably to silicone.”
CITE: T 31093 – 31108.

Document 421
06/04/85
MISCELLANEOUS – PRODUCT LABELLING

Art Rathjen, Dow Corning, Memo to Duel, Jakubczak, Rigas and Wessel regarding the “Revised SILASTIC II Product Insert.” Attached is Rathjen’s handwritten changes and comments to the product insert. Rathjen states in the cover memo:

It isn’t a matter of semantics. It’s a matter of being articulate, precise. In the Health Care Businesses, there probably isn’t a more important or meaningful document than this one currently under revision. I think it is important enough that each sentence should be studied and analyzed as it relates to the sentence proceeding it and the one following it. Some sentences are way too long. They ramble. There is an overdose of repetition. Some subjects are out of order or sequence. I wouldn’t have spent the time nor the effort on this revision if I didn’t feel it was important.

CITE: KMM 232474 – 232480, Exhibit to MDL Rathjen Deposition.

Document #422
06/30/85

Boley memo to Cooper, Lentz.
CITE: KMM 386490 – 386491. (TO BE SUPPLEMENTED).

Document #423
07/17/85
ACKNOWLEDGEMENT OF NEED FOR TESTING

“A complaint from Dr. Muller is handled through Dow Corning Valbonne. Wilfried, a sales representative, inquires why no one has responded to Dr. Muller’s prior complaints and inquires. “Prof. Muller is seriously considering publishing those bad results which probably is one of the least desirable things which should happen to us here in Germany. It once more underlines the necessity to give a scientific watertight answer to problems if and when they occur. I do regard this case as serious as it could potentially damage our image here in the market and moreover could potentially do us further harm.”
CITE: M 460190.

Document #424
07/30/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Boley, Dow Corning, memo to Cooper, Lentz, Rylee, Weyenberg, Yerrick, DeVries, Hobbs, and Siddiqui regarding “Summary of Meeting with IIT Research Institute to Discuss Immunotoxicology Testing of Silicone Materials.” He identifies seven issues which Dow Corning must decide including “The major business issue of whether Dow Corning should commit to immunotoxicology testing of silicone materials.” (underlined portion -emphasis in original). IIT Research Institute proposes to research adjuvant disease, immune sensitization, and immune suppression. Boley is “convinced that immunological testing of at least some silicone materials used for medical applications is appropriate.”
CITE: KMM 386490 – 386491.

Document #425
08/08/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning Study titled “Thirty-Day Implant Study of Dow Corning Q7-2218 Silicone Gel System” by Bejarano. He states:

Mild encapsulation of the gel by fibrous tissue was evident in nine of the ten test animals by unaided visual observation. Fibrous tissue encapsulation of the U.S.P. polyethylene control sites was not evident. Microscopic evaluation of tissue sections of the intramuscular implant sites revealed a greater cellular response to the Q7-2218 gel than to the U.S.P. polyethylene control. In addition, increased numbers of eosinophiles were evident at the Q7-2218 gel implant site.

The presence of eosinophiles at the Q7 2218 gel implant site suggests the possibility of immunological sensitization to a component of the gel formulation. Additional studies are required to either substantiate or disprove the possible sensitization potential of this silicone gel.
CITE: T 31514 – 31571, Exhibit to Boley Deposition and Exhibit to Isquith Deposition. DUPLICATE: KKH 40082 – 40139.

Document #426
09/05/85
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – PREP PROGRAM
RUPTURE
RUPTURE – CLOSED CAPSULOTOMY
SHELL DEGRADATION
TISSUE REACTION

Dr. Garry Brody writes to Rylee, Dow Corning Wright, complimenting him on his “unique plans for replacing broken implants. Not only should this be effective in controlling litigation but it also ought to be an excellent marketing tool.” “Brody is referring to the PREP warranty program Dow Corning recently announced. Attached are Brody’s comments on the patient brochure. He states, “I really do feel it hits the mark with just the right balance between what the manufacturer needs to tell the physician and to transmit to the patient without discussing the medical side of things.”

Brody enclosed sample questions and answers about silicone breast implants. The proposed answers including statements such as:

“Reports of serious or life threatening problems directly related to the implant itself are rare. There is no evidence that there is any relationship between breast implants and cancer.

All silicone materials will shed tiny microscopic amounts of material which are picked up by the body’s scavenger white blood cells and filtered by the lymph glands in the arm pits.

The gel filled implants tend to bleed tiny amounts of gel which travels the same routes. This very minute quantity of silicone that escapes the implant and travels in the body appears to be harmless.

Occasionally, closed capsulotomy can cause bruising, bleeding or even rupture of the implant.”
CITE: KMM 41248 – 41261

Document #427
09/11/85
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE
MISCELLANEOUS – PRODUCT LABELLING

Dr. Charles Vinnik letter to Bruce Reuter, Dow Corning Wright, concerning another implant which had lost shell integrity and the gel was “terribly runny.” He states, “I am forced to believe Gene and Lois’ hypothesis of the physical disruption of the gel by prolonged contact with tissue fluids and fat. Inasmuch as this is not generally known by my colleagues, I feel that your company has both a moral and legal obligation to make this information available through your representatives and in your literature. I am loathe to publish my series of cases as I feel that it may open a Pandoras Box. I do feel, however that rapid dissemination of this information is very necessary to protect your company and my colleagues.”
CITE: M 240116 – 240117. DUPLICATE: KMM 4625 -4626; KKH 1086 – 1087; DCC 242051124.

Document #428
09/23/85
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION

D. Weyenberg memo to J. Cooper, Dow Corning, regarding an “immunomodulation Study.” Weyenberg outlines the objective of the study:

What is the potential for silicone gels and fluids intended for disposition in the body, and which migrate and persist indefinitely in the body, to cause or contribute to clinically significant disorders? Where does the material accumulate: Where would theory predict it to accumulate? What might be the impact of certain accumulations? Are there elimination mechanisms? Does it migrate from any initially deposited site? The phenomenon of silicone migration within the body is very central to any of these questions, and I am bothered by our apparent lack of knowledge of this phenomenon and the low emphasis on phenomenon in our potential program.
CITE: KMM 369357, Exhibit to Weyenberg Deposition.

Document #429
10/01/85
EMBOLISM
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS – COMPLICATIONS
SHELL DEGRADATION
TISSUE REACTION

In an Infor-Med, Natural Y discusses the recurring problems of painful fibrosis and implant distortion associated with the standard smooth silicone implant. “The dangerous implications of ongoing fibrosis, accompanied by cell anoxia, vascular impairment and pain, have been consistently documented by microbiologists and histologists as being precursive to cancer. Additionally, the hazards of free silicone, well documented in silicone injections, are leading to more granulomas and silicone gorged lymph nodes.” The memo also describes more specific and

basic areas of concern: “Smooth surfaced polymers, because of their disruptive effect on cell products, are generally regarding as unsuitable for long term implantation…. Early design smooth silicone breast prostheses — commercially available until the mid 1970’s were vulnerable to extreme gel bleed and volume loss…. Possibility of embolism.” CITE: MEI 4230 – 4233.

Document #430
10/10/85
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Study titled “Characterization of C-U Silicone Elastomer Shells.” The use of plastic embedding significantly enhances our ability to resolve the presence of silicone gel as well as those cells involved in the response. Plastic embedding provides retention of the interface between the fibrous capsule and the foreign body. The silicone gel is removed from the immediate locality and taken to the periphery of the capsule where one can only assume it is then transferred to the reticuloendothelial system as observed with similar materials used in other clinical situations A significant difference in degree of cellularity, number of lymphocytes and cells at the interface is noted when gel implants are compared to the extracted implants. It is my impression that the use of silicone gel prostheses represents a significant risk to the patient. The literature suggests that individuals can develop an allergic and immunologic reaction to silicone gel and oil. It would behoove us to develop in an expeditious fashion a non-permeable silicone shell with subsequent replacement of the gel with another polymer system.
CITE: CUI 300317 – 300414, Exhibit 11 to D. McGhan Deposition, Exhibit to Oppelt MDL and Harris County Depositions, Exhibit 7 to Harris County Pool Deposition, and Exhibit to MDL Pool Deposition.

Document #431
10/10/85
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION

John Conrad, Territorial Manager for Dow Corning Wright, reports that a very loyal customer has switched to using Surgitek products. The reason for the switch is that the doctor, Dr. Mobley, experienced 6-7 post-op loss of shell integrity with Dow Corning implants including one where the “shell has been eaten away by something.” There was no evidence of a shell whatsoever. Conrad requests follow-up by Dow Corning Wright.
CITE: KMM 425114.

Document #432
10/17/85
SHELL STRENGTH – THICKNESS
SHELL DEGRADATION

Clauss, Dow Corning Valbonne, memo to Frisch regarding Dr. Muller. Dr. Muller complained that the envelope has disappeared and suggests that there was a chemical dissolution of the envelope by the gel, that the body Metabolized the envelope, or that the envelope migrated. Clauss states that the first and second hypothesis “seems for me, according to our silicone behavior knowledge, the most credible.”
CITE: M 460185.

Document #433
12/04/85
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED

Matherly sends a confidential memo to Jakubczak, Dow Corning, regarding “Dow Complaint MD2579.” In it, he states that, “The claim is really extraordinary in that it alleges that gel volume has been lost while envelope integrity is maintained.” Matherly then suggests “We probably should include a carefully constructed professional statement (from you or Lois) that would discount weight loss from an intact envelope.” He also discusses the investigator’s inability to find any other problem with the prosthesis, “He, I don’t believe, meant to convey the message that I think is obvious here, and which seems to be very dangerous in that it implies something he didn’t observe.” Matherly says he is seeing enough problems in the Complaint Analyses that he is scheduling a meeting in January to review concerns and provide training.
CITE: KKH 38544.

Document #434
12/05/85
SHELL STRENGTH – THICKNESS
RUPTURE

Eldon Frisch, Dow Corning, memo to Thiess and Wessel regarding “Rupture of Gel-Containing Mammary Implants.” Frisch states, “In about 1974, Dow Corning modified the implant in response to competitive pressure by making the envelope thinner and the gel softer and more responsive.” He concludes that “the potential for rupturing implants was quite well known, based upon the information provided by Weiner, Talcott, Bloomenstein, and Vistnes. I have always taken the position that any reasonable person would realize that a gel-containing breast implant is a rather fragile, delicate implant, somewhat analogous to a water-filled balloon
CITE: DCC 240000969 – 240000970.

Document #435
12/09/85
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION
TESTING
TISSUE REACTION

Study by Siddiqui, Stanton and Kolesar titled “Pharmocokinetic Profile Of Dodecamethylpentasiloxane In Rats Following Oral Administration,” TX-85-0131-08. On the basis of the total recovery in the urine, expired air, and tissues and assuming no biliary excretion of L5, it is safe to conclude that approximately 25% of the administered dose was able to absorb from the gastrointestinal tract of the Sprague-Dawley rat.
CITE: T 32215 – 32226.

Document #436
02/11/86
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Ken Yerrick, Dow Corning, memo to Boley, Cooper, Hayes, Rylee, C. Lentz and Weyenberg regarding immunotox Studies.” Yerrick states:

It is my understanding that as a result of the recent visit by Jack Dean we are proceeding with the development of protocols to investigate the effects of silicones on the immune system. From my discussions with Lentz and Boley it is also my understanding that Dean agreed to act, in the future, as an expert witness should the need arise. Of course, he will agree to do this if he is given the opportunity to approve the protocol. I believe we should follow this approach as we proceed with the study. I recognize there are some 1986 budget issues, i.e., no funds budgeted for this project.
CITE: KMM 329406.

Document #437
04/18/86
SHELL STRENGTH – THICKNESS
TISSUE REACTION
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS

W. Boley, Dow Corning, memo to J. Vallender, J. Cooper, and G. Jakubczak, responding to a ruptured mammary implant complaint from Drs. Weiss and Cohen. Boley states that he is a toxicologist and is not competent to give medical advice. Responding to the finding of granuloma with “entrapped globules of silicone,” Boley states that:

The extent and duration of this response to silicone gel has not been well characterized…. The assumption can be make that the gel will behave similarly to the fluid. Animal tests on PDMS (polydimethylsiloxane) fluid suggest that the granuloma response should be self-limiting and resolve with time. However, it was recently stated to me by one experienced clinician that he did not believe this response would resolve itself in humans. I think the answer to the question is, that at this time we do not know what the clinical sequel (sic) will be.
CITE: KMM 202743. DUPLICATE: DCC 204000522.

Document #438
04/22/86
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

H. Ratajczak, R. Thomas and J. Fenters, IIT Research Institute, letter to W. Boley, Dow Corning, Proposing research protocol for “Tests of Potential Immunomodulation by Polydimethylsiloxane Gel.” Study is estimated to take two years with the final four months used to prepare the final report.
CITE: KMM 369361 – 369377.

Document #439
04/29/86
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

In an Infor-Med, Jackie Markham, Natural Y Surgical Specialties, claims that there is overwhelming agreement among ASAPSs members that the less exposure of silicone to the lymphatic system the better because it means less of a load on the immune system. Surgitek and Dow Corning are accused of dumping and “fire-saleing” high-bleed mammary implants which they had advocated for years on the market.
CITE: MEI 4237 – 4239.

Document #440
07/08/86
SHELL STRENGTH – THICKNESS
RUPTURE
FRAUD/MISREPRESENTATION

Clauss in Valbonne, memo to Matherly and others at Dow Corning concerning Dr. Muller’s five ruptured implants. Dr. Muller would like answers to the cause of the ruptures, the potential consequences of a rupture, the statistics for ruptures, and whether Dow Corning recommends that patients be followed up to check implant integrity. Clauss states that he understands the response “must be carefully prepared on the legal point of view.”
CITE: M 460180. DUPLICATE: M 460196.

Document # 441
08/06/86
RUPTURE – CLOSED CAPSULOTOMY
SHELL DEGRADATION
TISSUE REACTION

Outline of issues and answers regarding breast implant contracture in which the occurrence of capsular contracture is termed “logical, rational, predictable, and entirely explainable.” It is noted that, since fibrous tissue is merely scar tissue, “fibrous tissue encapsulation cannot be prevented, even with the ‘best’ biomaterial.” Treatment can include daily manipulation, open or closed capsulotomy, initial placement of implant beneath pectoralis muscle, use of certain bioreactive materials, placement of implant in an oversized surgical pocket, and partial deflation of implant when capsule has matured. Three theories for prevention are identified: use of biodegradable covering (such as porous polyurethane), use of a porous coating, and use of shape retaining implants.
CITE: KKA 16168 – 16174.

Document #442
03/20/86
MISCELLANEOUS – COMPLICATIONS
TISSUE REACTION

Complaint Report MD 2692 stating that a lymph node was removed and biopsied finding a foreign substance that was later identified as silicone. The diagnosis was lymphadenitis.
CITE: COM 1348 – 1357. NOTE: This was originally listed as “08/20/86” on Plaintiff’s Trial Exhibit List.

Document #443
10/14/86
MISCELLANEOUS – SALES

Reuter, Dow Corning Wright, writes a “Dear Plastic Surgery Resident” solicitation offer.

As you approach that point in your career when you are planning to set up your practice, DCW wants to help you offset some of the expense of getting started. When you open your practice, we will provide you with 5 free pairs of Silastic II mammary implants and a 50% (up to maximum of &10,000) discount on all DCW plastic surgery products during your first year in practice.

CITE: M 370227 – 370234.

Document #444
11/05/86
SHELL STRENGTH – THICKNESS
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE

Dr. Charles Vinnik writes to Gene Jacubczak, Dow Corning, regarding the gel implant failures Dr. Vinnik has seen and “whether or not the gel changes within a patient or we are just dealing with a variation in the spectrum of gel cohesiveness used during the manufacturing process.” He also notes that during routine mammography screening, he is discovering a loss of implant shell integrity “far more frequently in the general population than has been anticipated….”
CITE: DCC 242051156.

Document#445
11/11/86
KNOWLEDGE OF LIQUID SILICONE DANGERS
RUPTURE
TESTING
TISSUE REACTION

M. Bejarano and W. Boley, Dow Corning, perform an internal study on “Dow Corning Q7-2159A Gel Injected Subcutaneously Into Rats” which concluded that the gel caused an increasing inflammatory response and tissue in-growth into the gel, “partitioning it into numerous smaller masses…. It is reasonable to assume that a similar response may occur in humans.” This test resulted from the concern over the fate of gel if the prosthesis ruptured.
CITE: KMM 270273 – 270283. DUPLICATE: KMM 278641 – 278650.

Document #446
00/00/87
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
MISCELLANEOUS – SALES

Dow Corning document titled “DRIVING FORCE: PROFITABILITY AND CONSOLIDATION. MAJOR OBJECTIVE: PROFITABILITY – EVERYTHING CURRENTLY BEING DONE OR BEING PROPOSED IS DESIGNED TO IMPACT THIS OBJECTIVE.” (emphasis added). The key objectives are to increase sales in 1987 for the Silastic II by 25%. To accomplish this, Dow Corning Wright plans to use the Battelle study and P.R.E.P. program and focus its sales efforts to “targeted key accounts for conversion to SILASTIC II.” Also, “Continue close working relationship with PSEF, ASPRS, and ASAPS for obvious political benefits.”
CITE: KKA 71925 – 71948.

Document #447
00/00/87
FRAUD/MISREPRESENTATION

Dow Corning advertisement: “Silastic Mammary Prostheses.” The advertisement states: “When you use the Silastic Mammary Prosthesis, you know all possible precautions have been taken:”

“At least 207 tests-from raw materials to finished product-all for your professional protection.”

“19 years of clinical experience.”

“A half of a million mammary implants since 1962.”

“FDA registered and inspected manufacturing facilities.”

“And, if our prosthesis costs a few dollars more, think of it as your malproduct insurance.”

CITE: M 700030. DUPLICATE: M 370055.

Document 448
01/00/87
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
SHELL DEGRADATION
SILICA
TISSUE REACTION

Z. Glaser writes a brief article or report entitled “Chemistry of Silicones used for breast implants and other soft tissue applications.” Glaser discusses the composition of silicone breast implants, gel migration and bleed, and degradation of silicone by the body. He cites two cases where gel migration into the lymph nodes was noted and an “acute serum-sickness-like reaction” occurred 24 hours past implantation, both instances were from intact implants.
CITE: M 780070 – 780073. NOTE: See 01/00/85 entry. See 07/25/88 entry; possible attachment to M 780066 – 780069.

Document #449
01/16/87
COHESIVENESS – LIQUID COMPONENT OF GEL
RUPTURE
GEL MIGRATION

Dr. Charles Vinnik writes to Bruce Reuter, having expressed all of the following thoughts to you, Bob Rylee and Gene Jakubczak for years now.

I feel like a broken record, having expressed all of the following thoughts to you, Bob Rylee and Gene Jakubczak for years now.

Bruce, you will recall that when you first started working for Dow Corning you observed surgery with me and observed an implant being exchanged. The original Silastic implant that was removed from the patient that you observed had gel which literally ran to the floor. We all observed it–it was far from cohesive, having the consistency of approximately 50 weight motor oil. Preceding that incident, and subsequent to that incident, there have been numerous implants which I have returned to the company … all delineating the problems that I have been having with the gel…. I have begged that the returned products be compared with the original lot samples … to determine if there is indeed any change in the gel. It is amazing to me that apparently nobody has done this very simple test.

(emphasis added). Vinnik also complained about the lack of meaningful analysis given to complaints and returned implants. “What really has burned me is the fact that on many of these reports when I received them, there are gratuitous self serving statements wherein the evaluator obviously speculates that somehow or other the patient has, at my direction, abused the implant.” Dr. Vinnik questions the cohesivity of the gel in recent implants stating, “Imagine my disappointment and shock when I found the gels were not what they were represented to be.” He recommends a “thicker more cohesive silicone gel … a much softer gel” be used than what is used in the SILASTIC II.

Loss of shell integrity is also an increasing problem on older prosthesis. “Loss of shell integrity is discovered on mammography when in fact it is clinically not evident…. I am hesitant, particularly with the poor quality of cohesion of some of the silicone gels that we have encountered to allow patients that I discovered to have lost implant shell integrity to keep those implants in place…. I do not want to have the responsibility of problems with respect to migratory gel on my hands as was the case with the many, many cases that McGhan accumulated…. It is amazing to me that apparently nobody has done this very simple test.
CITE: F 674 – 678. DUPLICATE: DCC 80031352 – 80031354.

Document #450
01/16/87
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by LeVier to Frye, Lane, LeVier, Skinner, Hobbs, Rylee and Stark titled “Organosilicon Insect Toxicants,” report number 6053, series number 10030. A selection of linear siloxanes, siloxane copolymers and cyclic siloxanes were found to posses toxicant activity against crickets, alfalfa weevils, feline fleas and bovine lice. The mode/mechanism of toxicity was not determined. Cost and lack of chemical reactivity preclude use of these structures as agricultural insecticides.
CITE: DCC 2010235 – 2010283

 Document #451
02/02/87
TESTING
TISSUE REACTION

Rasmussen’s monthly report for February, 1987, to Ruhr reporting the deaths of ten more animals due to moribund condition in the Two-Year Gel Implant Study – M8518-0, bringing the total number of deaths to 48. Also, “thirteen animals are presently living out of a total of 21 which are or have exhibited masses associated with the gel implant.”
CITE: KMM 315219 – 315221

Document # 452
02/09/87
TESTING
SILICA
TISSUE REACTION

Siddiqui reports to Dow Corning regarding a 1987 study of anal leakage when rats are subjected to polydimethylsiloxane fluids. The test materials are Dow Corning 1500 antifoam, a 50/56 mixture of Dow Corning 200 fluid and Dow Corning 112 compound. The positive control is 50 cs of Dow Corning 200 fluid. Siddiqui observes 1) a definite loss in body weights with all treated animal, 2) mushy. light-green stools in the animals treated with the mixture of Dow Corning 200 fluid and Dow Corning 112 compound at 5 or 8 gl kg/day doses and 3) soft and oily feces in the animals treated with Dow Corning 1500 antifoam at 5 and 8 kg/day doses. The rats showed gastric endemic and slight intestinal irritation. The report concludes that the material containing small amounts of silica in polydimethylsiloxane fluids does not significantly improve the results of anal leakage previously obtained in the laboratory.
CITE: T 34186 – 34323.

Document #453
02/23/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
SHELL DEGRADATION
TESTING
TISSUE REACTION

Robert LeVier, Dow Corning, memo to Hayes, Rylee, Stark, Thiess, Weyenberg, and Yerrick regarding the “Medtox Project Final Report.” Seven numbered copies of the Medtox Report were issued to the seven individuals
listed above. The final report replaces the 12/31/86 interim report. Levier asks each of the recipients to “Please discard the interim report dated December 31, 1986. (KMM 298339).

The purpose of the Medtox project was to formulate a consolidated understanding of all internally funded safety studies of silicone material relevant to the Health Care Business and to relate the findings to current safety issues as presented in the literature, by the physician community and in litigation. LeVier reviewed four sources of information: the Corporate Toxicology File 1949 – present, the DC 360 Fluid NDA 2702 file 1974, the Medical Research Report File 1980 – present, and the Corporate Mainframe Reference List 1957 – present. The report will generate a database for Dow Corning to search and will be available to the Legal Department. The first and earliest report LeVier noted was a 1949 publication. He also located and identified in the appendix 110 reports. The studies through 1963 were primarily related to antifoam compounds and emulsions used in antigas formulations. Thereafter, the studies were conducted to qualify materials. “Studies in the 1980 – 1986 period are primarily directed toward requalification of materials that have been in use for some time.”

Levier concludes that the reaction at the implantation site is an acute inflammation progressing to chronic inflammation characteristic of a mild foreign body response and that there is no evidence of systemic toxicity.

LeVier does note, however, that:

Two studies indicate that PDMS injected S.Q. or I.P. in very large quantities (5 to 62 ml/animal) in mice and rats is disseminated broadly and polymer is microscopically visible as deposits in tissue. It is likely that these deposits are the end-stage result of phagocytic transport and aggregation of polymer….

Several teratology studies in rats and rabbits have shown a positive but low incidence of skeletal defects and increased fetal resorptions.

LeVier acknowledges that silicone fluid and silicone elastomers can be found in macrophages and multinucleated giant cells. “The greater incidence of macrophages and giant cells is more characteristic of a chronic inflammatory state than usually seen around elastomer implants in the absence of abrasion particles.” He notes that the silicone fluid migrates and is transported to regional lymph nodes. Further, LeVier concludes that:

The implantation site reaction to silicone gel, particularly in the form of a fabricated mammary prosthesis, is similar to that produced by fluid polymer. In the case of free silicone gel the distribution compared to fluid polymer resides in the cohesiveness of the gel…. In the case of free gel, progressive gel subdivision by connective tissue septa is superimposed on encapsulation of the entire gel mass.

The analyses of the internal studies indicates that there are notable deficiencies among the reports. LeVier classifies these as “Nuisance Issues” and “Substantive Issues.” The nuisance issues include that the study designs are outdated, the studies are of limited utility, the variety of systemic histopathologic findings is broad, and the majority of the studies were conducted by IBT and FDRL. “Both of these companies are known to have falsified data in the time period relevant to the studies conducted for Dow Corning.” He does not think it likely that any of Dow Corning’s studies were falsified, but he does not state the basis for this belief.

Regarding the substantive issues, LeVier states:

There are two specific deficiencies of importance that tend to limit the utility of the long-term studies in particular.

1. The histopathology of the reticuleondothelial system (RES) including liver, spleen, lungs, lymph nodes and bone marrow was not examined carefully or systematically in any long-term study. Therefore, little information is available from these studies with regard to migration of implanted materials nor with regard to target tissue effects. Such an examination is rarely part of a formal toxicity study but the absence of such an evaluation is often cited as a criticism.

2. None of the studies incorporate a critical assessment of physiologic effects induced by the local inflammatory reaction. Nor is the nature of the local reaction assessed in detail. Thus, no information is available with regard to effects on the immune system, for example.

In discussing the limitations of the prior studies, LeVier admits that there are no studies in which the inflammatory reactions were described and classified according to “criteria employed by researchers expert in the study of inflammation nor have any studies been designed to detect the range of systemic effects that could attend a chronic inflammatory state…. Presently, there are insufficient data to effectively understand cause and effect relationships or to defend silicones against the broadening claims of HAD stimulation.:

In discussing what corrective measures should be taken. LeVier recommends that Dow Corning should not replicate any of the studies that were flawed and outdated. He states:

Replication of existing studies for the sole purpose of correcting nuisance problems would be very costly and would consume several years before results could be available. Some problems such as too few animal per group and too many implants per animal could be corrected but it is improbable that the spectrum of unrelated pathologic events could be materially influenced. It is such pathologic events that are used to claim systemic toxicity caused by silicone implants. The course of action (corrective measure) that is recommended is to develop sound arguments in support of the validity of existing studies.

(emphasis added). LeVier also discusses the immunopotentiation of silicone and notes that “if immunopotentiation is prolonged in response to PDMS, then the probability may be increased that silicone has an adjuvant like effect of sufficient duration to promote development of auto-antibodies in susceptible individuals.”
CITE: KMM 298296 – 298339. NOTE? The interim Medtox report is dated 12/31/86. NOTE: Includes LeVier memo sending attached Medtox report to D. Hayes, R. Rylee, F. Stark, G. Thiess, D. Weyenberg and K. Yerrick.

Document #454
02/24/87
COHESIVENESS – LIQUID COMPONENT OF GEL

Bruce A. Reuter, International Marketing Manager at “Dow Corning Wright, responds to Charles A. Vinnik, M.D.’s letter of 01/16/87 regarding gel biodegradability and problems with gel cohesivity. He states, “Biodegradability implies a change in chemical make-up as opposed to physical change. Using this definition, it can be said, categorically, that silicone does not biodegrade as a result of contact with body tissues. We do know that silicone gel can be physically broken down into smaller particles either mechanically or by manipulation in the presence of water or body fluids.: Thus, “It is the combination of gel in contact with body fluids and manipulation which causes the physical breakdown.

With regard to gel cohesivity, Reuter states that the gel undergoes a physical change when it is in contact with body fluids. It becomes less cohesive. Reuter disagrees with Dr. Vinnik’s contention that Dow Corning Wright’s “quality assurance testing is more rigorous than the exercises” Vinnik prescribes. “Our quality assurance testing is a single episode under controlled conditions as opposed to a daily manipulation which varies in force from patient to patient…. There is no quantitative clinical data to determine how much concentrated stress an implant can take in a confined space before fatigue occurs, nor are there any currently accepted scientific methodologies to test this phenomenon in situ.”

In response to the clinical trials on the Silastic II that Dr. Vinnik participated in, Dow Corning Wright has decided not to computerize and analyze the data. The study is considered closed. Dow Corning Wright is also developing a thick gel high profile teardrop prosthesis but “no formal evaluation is planned.”
CITE: M 420161 – 420166.

Document #455
02/24/87
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE
FRAID/MISREPRESENTATION

Steinberg, Dow Corning counsel, submits information to the FDA regarding the Two-Year Gel Implant Study of Dow Corning 360 Fluid and the findings of malignant lymphoma.
CITE: KMM 491863 – 491912.

Document #456
03/24/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

W. Boley, Dow Corning Wright, memo to Brodhagen, Frisch, Jakubczak, and others regarding “Summary of H.E.S. Testing Activities In Support Of Health Care Businesses For February.” The first immunotoxicology testing by Dow Corning is scheduled to begin on April 27. 1987 (25 years after Dow Corning first sold breast implants). The protocol was sent to Dow Corning for approval.
CITE: M 170187 – 170191.

Document 457
04/01/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED

Dow Corning Quality Assurance Department Report 0058 by Sharon McCoy entitled “Factors Affecting The Integrity And Stability Of Q72159A Mammary Gel And Intermediates.” The objectives of the study were to identify causes of gel penetration drift, identify causes of gel depolymerization and determine feasibility of using SiH to vinyl ratios to predict final gel penetration values. (OOT 41655) On the issue of depolymerization of the gel, she states that “Potassium in Ql-0043 appears to cause depolymerization in the finished product Q7-2159A when levels exceed 1.75 ppm, taking test repeatability into account” (Id.)
CITE: Hancock Deposition, Exhibit to Olson Deposition, and Exhibit to Isquith Deposition. OOT 41654 – 41676, Exhibit to Harris County Burda Deposition, Exhibit to Petraitis Deposition, Exhibits 11 and 27A

Document 458
04/10/87
TESTING
FRAUD/MISREPRESENTATION
MISCELLANEOUS – PRODUCT LABELLING

I.G. Hignite, Dow Corning, records the minutes of the “Health Care Businesses Board Meeting Minutes – 04/07 – 08/87” The Board decided to proceed on Talmadge Holmes’ proposal to acquire 1,250 case histories from Dr. Ben Gregory. Dow Corning plans to computerize the data and publish a paper on the findings. Also, LeVier presented the results of his Medtox final report which showed that “there can be acute to chronic inflammation and mild foreign bold reaction” from silicone breast implants. He claims there was no indication of systemic reaction. The immunotoxicology testing is now to begin in September 1987. LeVier noted that Dow Corning has “not been able to define how to design experiments that measure antibody formation from silicones.” Also, the Health Care Board reported that legal counsel recommended that Dow Corning settle the Stern case because of “incomplete information on our implant package inserts….” Dow Corning recommends a review of all other package inserts to bring them up to date.
CITE: F 817 – 822.

Document #459
04/13/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWDEDGE OF SYSTEMIC DISEASE

John Ludington, Dow Corning, memo to Gene Jakubczak. Ludington states:

It has recently come to the attention of Executive Management of Dow Corning Corporation that preliminary indications from a current study, indicate adverse effects of Dow Corning medical grade silicone gels placed into the body of highly sensitive test rats. Our scientific assessment is that this does not represent a human health concern….

A committee is formed comprised of Reed, who will be the President and Chairman, Jenkins who will be the legal counsel to the committee, Rylee, and Stark. He directs the committee to “make appropriate recommendation for future action in light of Dow Corning’s legal and ethical responsibilities. This investigation is a top priority matter.” Ludington cautions persons not to speculate about these matters with anyone else.
CITE: KMM 302536 – 302537, Exhibit to Ludington Deposition, Exhibit to Reed Deposition, Exhibit to Stark Deposition, Exhibit 23 to McKennon Deposition, and Exhibit 26 to Zimmer Deposition.

Document #460 & 461
06/11-12/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING
TISSUE REACTION

An expert panel was convened at the request of Dow Corning Corporation to review and discuss the chemical and biological data base on silicone gel products along with the relevant medical data. The purposes of the panel were to provide an opinion as to whether any of the information reviewed indicate a significant risk to human health and suggest additional work which could be undertaken to further support the safety of these gel products.

The panel expressed the opinion that the findings of sarcomas at the implant was predictable and consistent with the mechanism of foreign body tumorigenesis. The panel found that the study finding increased malignant lymphoma was flawed in terms of conduct, diagnosis and reporting. “Because of these problems, the panel determined that no definitive conclusions could be reached on the basis of the study. The panel members did, however, recommend that additional safety data in the form of a chronic bioassay in a non-rodent species … and further studies to elucidate the mechanism of solid state tumorigenesis in rodents should be undertaken.” Specifically, the panel recommended that Dow Corning conduct a seven-year dog study. The panel recommended that the tissue be re-examined by another pathologist and that the data from this study be re-evaluated after this work is completed.
CITE: KMM 362273 – 362277 and DCC 267360013 – 267360331 and DCC 267420044- 267420289, Exhibit 8 to Zimmer Deposition (draft). NOTE: Dow Corning never did the seven-year dog study suggested by the panel. DUPLICATE: KMM451887: KMM 366396 – 366712.

Document 462
07/06/87
COHESIVENESS – LIQUID COMPONENT OF GEL
GEL MIGRATION

Dr. Charles Vinnik writes to Robert Rylee, Dow Corning, concerning recurrent problems with gel cohesivity and “runny” gel in Dow Corning implants. Gene Jakubczak promised Dr. Vinnik that Dow Corning would compare gel specifications on implants returned for evaluation. “Sadly, despite the fact that I had sent a number of patients’ samples back … there has never been any description of comparison of the returned gel samples with the original gel standards that were supposedly retained by your company…. The problem either emanates from the top, or that people under you are operating contrary to our explicit agreement….” He continues, “I can only draw the conclusion that there is a deliberate attempt at evasion with respect to the level of cohesivity of the gels used in the original silastic prostheses dating from approximately 1077. I might further add that the cohesivity of the Silastic II prosthesis is not as good as I would like it to be … compared with one of your competitors…. The safety factor in terms of patients not having problems associated with migratory gel and all of those legal implications to you from that problem is enormous.”
CITE: M 490090 – 490091.

Document #463
07/06/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Weyenberg and Gehring letter to Shilling regarding joint research agreement for identification of agricultural chemicals – modification of item 10 (changing agreement from 3 years to 4) and amendment specifying subsidiaries of the parties may receive info exchanged under their agreement and may be employed to conduct work on the program.
CITE: DCC 2001190 – 2001191.

Document #464
08/05/87
TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning summarizes data concerning a Two Year Gel Implant Study in rats conducted by Industrial Bio-Test Laboratories using the old gel – MDF 0193, and responsive gel – Q7-2159A. Dow Corning claims there were deficiencies in the original report such as improper tabulation and evaluation of tumor findings including malignant lymphomas. Hughes Research and Development was asked to review the data and tissue samples and, in their second report, found a treatment-related increase in the incidence of malignant lymphoma. Dow Corning refuted this conclusion claiming that the increase in lymphoma was “stress related viral induced but no basis to substantiate our opinion.” Dow Corning subsequently conducted an internal study. An independent panel of experts convened by Dow Corning reviews all data and finds that the implant site sarcomas identified in the studies are predictable due to “solid state” carcinogenesis in rats, a phenomena which allegedly poses no significant risk to human health.
CITE: KMM 491869 – 491881.

Document #465
08/13/87
SHELL STRENGTH – THICKNESS
RUPTURE – CLOSED CAPSULOTOMY
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
GEL MIGRATION
TISSUE REACTION

Jakubczak, Dow Corning, sends Dr. Muller a lengthy response to his questions about implant rupture. He states that a hypothetical cause of rupture which may be possible but about which he does not have direct knowledge of is “Excessive force created when closed capsulotomy is being performed.” Also, in the event of an implant rupture, gel can migrate and complications include “enlarged lymph nodes, scar formation, inflammation, granulomatous foreign body reaction, presence of foamy histiocytes, silicone mastopathy, nodule formation, or other difficulties…. The long term physiological effects of uncontained gel are not completely known.”

Jakubczak states that Dow Corning has been tracking the rate of ruptures since the gel-filled implants were introduced to the market. “The rate (Of rupture) is less than ).1% for gel filled product. The gel-saline product is slightly less than that for gel product. The SILASTIC II mammary implant, to the best of our knowledge, is in the ballpark or slightly less. For the specific time period of the last 1970’s our data indicates that the rate of rupture was the same.”
CITE: M 460204. DUPLICATE: KKH 75863 – 75871. NOTE: Jakubczak did have direct knowledge of ruptures occurring with closed capsulotomies. Also, Dow Corning did not track rupture rates like he represents in this letter.

Document #466
09/21/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
TESTING
TISSUE REACTION

Talmadge Holmes, epidemiologist at Dow Corning, memo to Dillon, Hobbs, Jenkins, LeVier, Ruhr, Rylee, Stark, Steinberg and Zimmer regarding an epidemiological study on the relationship of cancer and silicone breast implants. Holmes notes that the Deapen study “was limited in that there were only 6.2 average years of follow-up per person and no data were collected regarding known breast cancer risk factors.” A proposal for additional epidemiologic investigation into the relationship between silicone gel used in mammary implants and cancer is attached.
CITE: KMM 387394 – 387397, Exhibit 29 to Zimmer Deposition.

Document #467
09/24/87
ACKNOWLEDGEMENT OF NEED FOR TESTING

Eldon Frisch, Dow Corning, memo to Hayes, Dillon, LeVier, and Thiess regarding a proposal from Nir Kossovsky to study noninfectious inflammatory reactions in human tissues collected at autopsy from patients with all types of implants. Frisch notes that Kossovsky has testified as an expert for plaintiffs in silicone implant litigation and states, “In my opinion, the study he wishes to conduct would be highly worthwhile from a scientific standpoint, and may confirm that there are problems with all types of implant materials, but I am uncertain of its value to Dow Corning and thus have had a problem identifying just why Dow Corning should fund this work.”
CITE: DCC 240001004, Exhibit to Dillon Deposition, Exhibit to Frisch Deposition, Exhibit to LeVier Deposition, and Exhibit 5 to Harris County Burchiel Deposition.

Document #468
11/03/87
KNOWLEDGE OF LIQUID SILICONE DANGERS
GEL MIGRATION
KNOWLEDGE OF SYSTEMIC DISEASE

Dan Hayes, Dow Corning, memo to Frisch, Hobbs, LeVier, Steinberg, the DCW Business Board, Rylee, and Stark regarding the Dow Corning Wright Keratosis Program. Hayes asks, “What is the best approach to deal with silicone migration in this application? How do we approach the immunology issues that have been raised in literature in recent years?”
CITE: DCC 251000386 – 251000387

Document #469
11/17/87
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Complaint Report MW 2030 submitted to Dow Corning regarding a Silastic implant. The patient developed “bronchospastic asthma of allergic nature” related to the silicone. The patient has leakage from her nipples which is suspected to contain silicone. Dow Corning agrees to devise a test to detect whether the discharge was silicone. CITE: KKH 72651

Document #470
12/15/87
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Note from Winton, Dow Corning, regarding conversation he had with Don Linkert about the falsification of cure oven charts. He quotes Linkert as saying that they had gotten low on inventory and there was pressure to get product out the door. Winton claims that Linkert told him that there was some discussion about the problem and the QA department’s hassling over atypical situations such as oven cycles. Winton quotes Linkert as saying that he was aware that a second chart could be run with nothing in the oven and substitute that chart for the original. Winton claims that Linkert responded to this suggestion by saying: “do what you have to, but I don’t want to know about it.” Mike Mitchell was fired earlier in the year for falsification of documents.
CITE: DCC 80062087 – 80062088. DUPLICATE: DCC 17015132

Document #471
12/31/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DESEASE

Eldon Frisch, Dow Corning, outlines the “Keratosis Program” and the biological tests needed. Biological assay data is needed for “defense against litigation…. Because of the findings from silicone gel implant studies, both internal and regulatory requirements for assurance of the biological safety of subdermal silicone fluid will be particularly critical and demanding.”

Frisch states that the “must time-consuming and expensive study will be an assay of carcinogenic potential” as will reproductive and developmental toxicity assays. “Prior studies will not suffice” since they were inconclusive. Both studies showed increases in skeletal deformities and increased in utero mortality rates in animal reproduction studies. Also, the Dow Corning internal study, Frisch claims, is “distrusted scientifically and was of questionable statistical design.”
CITE: KMM 407480 – 407482.

Document #472
00/00/88
SHELL STRENGTH – THICKNESS
MISCELLANEOUS – PRODUCT LABELLING

Dow Corning Territory Strategy Sheet by Bill Fargie states that, “I need to increase anxiety level of surgeons re: litigation and broken shells. Most of board certified (surgeons) in my territory are beginning to see alarming number of implants with ‘loss of shell integrity’…I need label revision on all Plastic packaging – everything confusing and difficult.” CITE: KAA 64021.

Document #473
01/00/88
KNOWLEDGE OF SYSTEMIC DISEASE
FRAUD/MISREPRESENTATION

Hayes, Dow Corning, writes Dear Doctor letter regarding immunological reactions to silicone. He encloses a position paper. The position paper criticizes the research done by the Japanese by claiming that fluids used were often adulterated and by claiming that the adjuvant concept is broadly misunderstood. The paper gives a brief description of the research that has been done on the problem and then states:

Unfortunately, all animal studies reported to date have been founded upon incomplete experimental designs, and interpretations and speculations that extend well beyond the support that can be provided by the data.
CITE: KMM 122710 – 122712. DUPLICATE: MD 145633 – 145635.

Document #474
01/22/88
KNOWLEDGE OF LIQUID SILICONE DANGERS
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Frisch, Hobbs, LeVier, and Steinberg, Dow Corning, author a report “keratosis Program Team Report.” One of the issues this team has identified is to negotiate an IDE program with the FDA that would allow Dow Corning to do only short-term evaluations of silicone fluid injections for keratosis” without the requirement for extensive clinical and laboratory studies.” The silicone to be injected is Dow Corning 360 Fluid. The team assumes that, “Prior studies sponsored by Dow Corning (carcinogenic, reproductive and developmental) will not suffice. The protocols and designs of prior studies were not adequate by today’s standards, and in some studies the findings left unanswered questions.”

The team notes that bioassays which must be addressed include carcinogenic, pharmacokinetic and immunologic. “Immunologic studies are not on the FDA general list and are not included in projected costs, but because of the current flurry of publications alleging immunogenic reactions to silicones FDA may want these studies done. Internally, evaluation of the immunogenic potential of silicone fluids is currently being planned, and it is believed these data would apply to 360 fluid even if the fluid involved in the study were 200 fluid.”

Furthermore, the team states:

FDA will probably require adequate data to assure safety prior to allowing the clinical investigation to proceed. FDA’s concerns will most likely center on carcinogenicity and reproductive/developmental toxicity issues. Dow Corning currently has neither human nor animal data to address these issues in a statistically valid, scientific fashion. The reproductive/developmental toxicity issue could perhaps be temporarily waived by not including women who may have children, but this still leaves the carcinogenicity issue unresolved.

CITE: KMM 407502 – 407540.

Document #475
02/01/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
SHELL STRENGTH – THICKNESS

Letter from Franklin Wilder, The Hartford, to Greg Thiess, Senior Managing Attorney at Dow Corning, about a woman who struck her breast when slipping at a grocery store, allegedly causing one or both implants to rupture. Wilder questions, “Is there a standard for rupture force? The reason for this question is that it is foreseeable that a woman may hit her breast, or suffer some trauma and this force imparted to the implant. (sic) Has Dow Corning performed any studies along these lines?”
CITE: KKM 42522. Note: See 02/04/88 response

Document #476
02/04/88
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA

Harvey Steinberg, in-house legal counsel for Dow Corning, memo to the File regarding the “GMP Records Review.” This document is the basis for Griffin Bell’s finding in his October 12, 1992 report that Dow Corning falsified oven temperature charts, and has a typed note at the top: “Attachment I, APPROVED FOR PUBLIC DISSEMINATION ON OCTOBER 12, 1992.” Steinberg writes that”

In late Fall, 1987, Sandy Brondstetter, a sister of a mammary area employee, advised her supervisor,

Ken Montague, that dummy over (sic) cure charts were being made in the mammary area. Brondstetter and Montague investigated and found, under a desk blotter in the mammary area, an actual chart evidencing an interim oven shutdown for a lot where a chart for a cycle not exhibiting any such shutdown had been submitted with the lot history record….On December 1, at a meeting with T. Bartolo, Boone and Winter were advised that Bartolo were completely unaware of any problems with the cure ovens that would lead to anybody even having a need to be concerned about charts, at least since the new controllers and recorders were installed in late 1986 or early 1987. He admitted that with the old equipment there were a number of problems with the recorders with the result that a substantial number of problems with the recorders with the result that a substantial number of the curing charts evidenced atypical curing cycles and required management review and clearance. Bartolo admitted that he had personally prepared mocked-up charts to submit in place of the actual charts where, based on his technical knowledge of the limits of the cure cycle, he could conclude that the product had actually been cured a fully sufficient amount of time even if outside of the SOP/specs for the product. His knowledge of cure cycle was based upon his co-authoring the TS&D reports documenting that intermediate interruptions do not interfere with the proper cure of the silicone materials where the total cycle time, at the specified cycle temperature, is achieved. He repeated that, to the best of his knowledge, this practice stopped with the installation of the new equipment.

*** The investigation reasonably established that the cure ovens would kick off in the middle of a cycle an average of about once a week (four times a month) whereas an actual review of the mammary charts showed only 3 out of 104 lots as anything other than a perfect. non-interrupted cycle. Of those 3, none represented a substantial intermittent downtime (e.g. overnight) as did the chart discovered hiding under the desk blotter. A subsequent review of an additional 84 mammary chart turned up only 2 less than perfect samples. In contrast, a review of cured non-mammary silicones showed about 20% of cure runs evidencing over shutdowns, a number consistent with the once-a-week expectation.

The memo also states that Les Schnoll reviewed the lot history records for 1985-1987 and that all lots passed the test evidencing proper gel cure. Schnoll also reviewed the complaint trends and found no unusual events or activities. ” Based on the above, it was concluded that all product fully met quality standards and the issue was merely a personnel and documentation concern.” Dow Corning suspended for 30 days all implicated individuals and supervisors and gave them stern warnings and lectures on the importance of documentation.
CITE: DCC 105000001 – 105000003.

Document #477
02/04/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
RUPTURE
SHELL STRENGTH – THICKNESS

Greg Thiess, Senior Managing Attorney at Dow Corning, Letter to Frank Wilder, The Hartford, about a breast implant case filed against Dow Corning. Thiess states, “With respect to your question concerning any Dow Corning studies on the force that a mammary implant could withstand once placed inside of the female breast, Dow Corning has done no such studies.”
CITE: KMM 42521. Note: See 02/01/88 entry.

Document #478
03/25/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Board of Directors’ meeting showing a report that early test results show that D4 has a toxic effect on daphnia in low concentrations and that further testing is planned.
CITE: DCC 101003623 – 101003626, Exhibit 10 to McKennon Deposition, and Exhibit to Weyenberg Deposition.

Document #479
05/02/88
MISCELLANEOUS – ORGANIZATIONAL SURVEY

“Dow Corning Organizational Survey.” “Our manufacturing technology lags 10 years behind state-of-the-art with regard to control and automation. This is especially apparent if you compare the Midland plant (oldest DC plant) with some of the European plants.” With regard to Dow Corning’s commitment to quality, the comment is made that, “Managers say ‘improve quality,’ but don’t show any interest. They need to ‘walk the talk.;” Also, “We should emphasize permanent fixes rather than temporary ones … usually the emphasis is to do things as quickly as possible, especially when it comes to changing over the use of equipment.”

A comment from Production and Manufacturing was, “Good quality programs, but NO follow-up. We’ve made the same suggestions for fixing problems for the past two years and we see nothing being done to fix the problem…. Dow Corning does not accept the fact that quality costs money….” A criticism voiced is the “over-emphasis on profitability,” the constant emphasis on sale/profits/results,” the pressure for quantity over quality, and an emphasis on “political savvy” instead of qualifications to get ahead.

Also, employees complain about “Ineffective decision-making process: bureaucratic, with blurred responsibilities, CYA (‘cover your ass’) effect. Politics, game-playing, ‘good old boy’ network.”

“SOPs … are outdated, never been written or written by people who do not do the work. Lack of quality standards for products, which results in different interpretation of what is a good product and what isn’t. Often engineering and lab do not agree so it is left up to the operator to take responsibility and make a judgment call about continuing to run the line.”

On the topic of Dow Corning’s reactive, short term focus, the RDE&S Professionals write, “We have too much short-term thinking and fire-fighting, especially from TS&D and marketing. This detracts from long-term, fundamental research.”
CITE: KMM 247952 – 247965.

Document #480
05/11/88
TESTING DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Eldon Frisch, Dow Corning, memo to Bauer regarding “Animal Implant Reactions To Breast Prostheses.” He encloses the 11/29/68 study in dogs conducted by Food and Drug Research Laboratories which he has redacted
Frisch states:

A large number of materials were tested in this single study. Thus, when information pertinent to all materials and all animals is considered the report is rather confusing, difficult to interpret, and can easily be misrepresented to a jury as happened in the Stern case. Accordingly, all data not pertinent to the four dogs who received SILASTIC 372 elastomer (the envelope material) and the miniature breast implants and the control animals have been removed. Data were deleted by covering the copy with paper or tape, and nothing has been added.

CITE: KMM 200817 – 200862.

Document #481
05/23/88
TESTING
TISSUE REACTION

PATHCO Inc. reports to Dow Corning on a “Two-Year Gel Implant Study (B7811) In Sprague Dawley Rats.” Gels MDL 0193 and Q7-2159A were implanted subcutaneously in rats at Industrial Bio-Test Laboratories.

Microslides were prepared by Hughes Research and Development. The study was evaluated histopathologically by Hughes R&D. At the request of Mark Zimmer, Dow Corning, PATHCO Conducted a complete wet tissue audit and histopathologic evaluation of the study.

Evidence of toxicity/carcinogenicity for all four silicone gels tested was restricted to the implant site. All four gels were associated with the presence of mesenchymal neoplasms in at least on sex. Gel 1208 was associated with neoplasms in both sexes, Gel 1209 with neoplasms in males only and Gels 1210 and 1211 with neoplasm in females only. Dysplasia of the capsule of the implant, and apparent preneoplastic lesion, was seen with all four gels in females and with Gel 1208, 1209, and 1210 in males. Other lesions associated with all four gels were fibrosis of the capsule, the presence of extracapsular gel, and inflammatory changes both within the capsule and in the immediate extracapsular tissues.
CITE: R 14267 – 144314.

Document #482
07/25/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – ORGANIZATIONAL SURVEY
TESTING

Letter agreement between Dow Corning (signed by Weyenberg) and Dow Chemical (signed by Perry Gehring) regarding the 08/01/84 Joint Research Agreement for Identification of Agricultural Chemicals. Dow Corning proposes this agreement be extended and additional 3 years.
CITE: DCC 2001192.

Document #483
07/25/88
GEL MIGRATION
TESTING
TISSUE REACTION

FDA: An internal FDA review of the epidemiological study involving 3,000 women in California by Dr. Dennis Deapen and his colleagues, Pike, Casagrande, and Brody, to determine if breast implants increase the chance of developing cancer, concludes there were “numerous sources of errors, biases and methodological limitations.” Also:

“this study has not contributed greatly to our understanding of the relationship between breast implants and the risk of breast cancer. Furthermore, it is known that silicone can migrate to other body sites away from the site of implantation. Even with all the biases inherent in the study design, the authors did note a higher number of observed cases of cancers at other sites than expected (24 observed versus 15.8 expected). Based on these results and the fact that silicone can migrate to other sites, the authors should have addressed this issue by including cancers at other sites, instead of limiting their study to only breast cancer.
CITE: M 780066 – 780069; Attachment 3 to Staff Report prepared by the Human Resources and Intergovernmental Relations Subcommittee on Government Operations, December, 1992, p. 9. NOTE: See 05/10/89 ENTRY. See 00/00/00 (M 780074 – 780078), 00/00/87 (M780070 – 780073), 08/17/89 (M 780079 – 780090) and 08/03/88 (M 780056 -780063 entries; possible attachments to this document. DUPLICATE: M790025 – 790029

Document #484
08/09/88
TESTING
CONCEALING FROM FDA
KNOWLDEDGE OF SYSTEMIC DISEASE

FDA: M. Stratmeyer, Acting Chief, Health Sciences Branch of FDA to Director, office of Science and Technology, memo with attached report regarding analysis of Dow Corning data on carcinogenicity of silicone gels. “As you will see, the conclusion of this report is that silicone can cause cancer in rats; there is no direct proof that silicone causes cancers in humans; however, there is considerable reason to suspect that silicone can do so.” The FDA Reviewer finds that patients were studied for an average of 6.2 years which is “probably too short to detect breast cancer… considering that the latency period for foreign body carcinogenesis in humans appears to be in the range of 20-30 years.”
CITE” M 780055. DUPLICATE: FDA 29449 – 29457.

Document #485
09/23/88
TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Dr. Selwyn, Statistics Unlimited, Inc., prepares a “Statistical Analysis for Two-Year Gel-Implant Study of Q7-2159A and MDF-0193 in Sprague Dawley Rats (M8518-0)” for Dow Corning which concludes that “Carcinogenesis is noted in mammary gels in significant amounts.” (KMM 388066 – 388150: KMM 2726331 – 272637). Histopathological analysis demonstrated “increased incidences of fibrosarcomas at the implant site which were highly significant for both the Q7-2159A group and the MDF-0193 group, and in both sexes.” Incidences of non-neoplastic findings were statistically greater in the Q7-2159A group males than in the control group for the following: “chronic capsular inflammation, implant site dysplasia, fibrous capsule at the implant site, implant site necrosis, extracapsular gel, acute and chronic pyelitis, necrosis in the liver, seminal vesicle secretion (reduced or absent), stomach necrosis, and thymic region hemorrhage.”
CITE: KMM 388067 – 388150. DUPLICATE: KMM 272631 – 272637.

Document #486
10/21/88
TESTING
TISSUE REACTION

Dow Corning Report 153 concerning “A Two Year Gel Implant Study Of Dow Corning Q7-2159A and Dow Corning MDF-0193 In Rats.” “Implantation site-associated mesenchymal tumors (i.e., sarcomas) were seen in both silicone gel treatment groups at an incidence of 23-24%. The sarcomas were associated with the connective tissue capsule of the implanted materials and the majority were fibrosarcomas.” The study also found “depressed” survival rated among male rats implanted with Q7-2159A and those implanted with MDF-0193. “The biologic relevance of the observation is unknown.” Dow Corning claims the sarcomas are explained by the “Oppenheimer effect” – solid state carcinogenesis.
CITE: P 17215 – 17390. NOTE: See 03/00/88 and 08/15/88 entries. Silicone gel does not have the same smooth characteristics as the implants used in the tests which gave rise to the “Oppenheimer effect” theory. DUPLICATE: KKP 136919 – 13626; T 15805 – 15926.

Document #487
11/28/88
ACKNOWLEDGEMENT OF NEED FOR TESTING
MISCELLANEOUS – COMPLICATIONS
SHELL DETERIORATION
SHELL STRENGTH – THICKNESS
TESTING
TISSUE REACTION

LeVier, Dow Corning, memo to Hayes, Rylee, Rusk and Stark regarding gel tox studies. LeVier states that the following actions should be taken:

Large volume studies designed to evaluate a possible chemical tumorigenesis effect but solid state tumore will not necessarily be seen in this study because of the large volumes doses used. Envelope studies designed to obtain 2-year implantation data in the rat on both components of the Silastic II shell.

Threshold determination and material comparison studies designed to estimate the gel volume/surface area threshold for initiation of the solid state effect of non- silicone materials under state of the art experimental conditions.

LeVier also gives dosage parameters for rats and mice.
CITE: DCC 267420828 – 267420829.

Document #488
12/14/88
TESTING
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE
ACKNOWLEDGEMENT OF NEED FOR TESTING
SILICA

John Yan, Mentor, reports on his trip to Dow Corning. He notes that Dow Corning uses the Statistical Process Control Method to assure product reliance. Mark Zimmer, Dow Corning’s veterinarian, presents Dow Corning’s

internal study on the two-year rat study. (No reference is made to IBT’s or Hughes Research findings nor to other “expert” panel and their recommendations.) “Dow Corning found the test animals to develop dysplasia, chondrosarcoma, fibrosarcoma, and sarcoma…. (T)hey found a 52% incidence of site related tumor formation with the rats and 24% incidence with the female rats.” Yan notes that Dow Corning purchases all of its fumed silica from Cab-o-Sil.

Yan also notes that, “At present, teratogenicity, immunological, and pharmacokinetic studies have not been initiated on the gel.” (emphasis added). Dow Corning did not share with Mentor the Master File for the Gel.
CITE: MMD 167731 – 167733.

Document #489
01/06/89
MISCELLANEOUS – SALES

Weigel and Thiess, Dow Corning, author “Facts You Should Know About Product Liability And Dow Corning Corporation.” The document states:

OVERRIDING IMPACT: PRODUCT LIABILITY IS A COST OF QUALITY WHICH HAS A SIGNIFICANT EFFECT ON THE COMPANY’S PROFITABILITY.

PRODUCT LIABILITY COSTS ARE INCREASING…AND WE HAVE INDICATIONS THAT OUR LIABILITY COSTS ARE HIGHER THAN OTHER COMPANIES IN SIMILAR BUSINESSES.

THE PRODUCT LIABILITY TREND IS DIRECTLY CONTRARY TO DOW CORNING’S EXPERIENCE WITH WORKERS COMPENSATION AND PROPERTY INSURANCE COSTS WHERE OUR STRONG PREVENTION PROGRAMS HAVE LED TO COSTS WELL BELOW INDUSTRY AVERAGES.

SINCE 1978, DOW CORNING’S GLOBAL SALES HAVE INCREASED 174%; PROFITS HAVE INCREASED 141% AND PRODUCT LIABILITY PREMIUMS INCREASED 571%. IN THE U.S. AREA IN 1988 IT TOOK $57M IN SALES AT CURRENT ROS TO PAY ITS SHARE OF THE PREMIUM.

IN 1978, TOTAL PRODUCT LIABILITY PREMIUMS PAID GLOBALLY BY DOW CORNING WERE $1.4M (40% OF THE TOTAL INSURANCE PREMIUMS PAID). PRODUCT LIABILITY PREMIUMS IN 1987 WERE $8.0M, WHICH REPRESENTS 59% OF THE TOTAL PREMIUM….

SINCE 1978, INTERPRETATION OF THE U.S. STANDARD OF STRICT LIABILITY HAS BECOME INCREASINGLY LIBERAL; THUS, PUNITIVE DAMAGE AWARDS HAVE RAPIDLY ESCALATED. IN RECENT YEARS JURIES HAVE INCREASINGLY FOUND ALMOST ANY FAILURE IN A PRODUCT TO CONSTITUTE A DEFECT FOR WHICH DAMAGES CAN BE AWARDED. FAILURE TO WARN HAS BECOME A MAJOR SOURCE OF LIABILITY FOR ALL BUSINESSES.

CITE: KKA 41392 – 41393.

Document #490
03/01/89
TESTING
TISSUE REACTION
DNOWLEDGE OF SYSTEMIC DISEASE

Siddiqui, Kolesar, Zimmer, and Hobbs, Dow Corning, report on “A 90-Day Sub-Chronic Inhalation Toxicity Study Of Octamethylcyclotetrasiloxane (D4) In The Rat.” Exposure resulted in slight growth retardation and lower food consumption in females. There was also an increase in liver weights that was statistically significant, leading the authors to conclude that “these data indicate that D4 has an effect on the liver.”
CITE: T 40150 – 40276, Exhibit 34 to Zimmer Deposition. DUPLICATE: KKP 15029 – 12155.

Document #491
03/27/89
TESTING

Eldon Frisch, Dow Corning, responds to the request by Emanuel Horowitz of the Johns Hopkins University for industry technical data and standards on medical grade, implantable silicone.

There is no general agreement on the standards for implant grades of silicone elastomers, nor for other applications. Unfortunately, other than allowing everyone to say a standard has been written,

ASTM F604 “Silicone Elastomers Used in Medical Applications” is hardly worth the paper it is printed on. I would like to see it revised, and believe I improved the language of Section 1.4 on biocompatibility when it was last reviewed, but I also know that attempting to make the major revision needed would create a lot of controversy, many negatives, and approval would be difficult.

CITE: DCC 17043724 – 17043727

Document #492
04/17/89
ACKNOWLEDGEMENT OF NEED FOR TESTINGMISCELLANEOUS COMPLICATIONS
TESTING
TISSUE REACTION

Dow Corning Report 82 by H.M. Mehendale entitled “Evaluation of the liver Microsomal Enzyme Induction Potential of D-5.” In the University of Mississippi Medical Center study, sponsored by Dow Corning, D5 was administered orally to 24 female rats. “D5 was found to induce hepatomegaly with recovery after cessation of dosing. The enlargement appeared to be due to a net enlargement in liver mass. D5 was found to be an inducer of drug metabolizing microsomal enzymes and to resemble phenobarbital in this regard. However, D5 differed from phenobarbital in that it decreased the P-450 hemoprotein content of the microsomes.”

CITE: P 15182, Exhibit to Isquith Deposition. DUPLICATE: F 433 – 460.

Document #493
05/22/89
SILICA
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

LeVier, Dow Corning, memo to Birdsall, Steinberg and Groh regarding “Risk Assessment: Carcinogenic Potential Of Silicone RTV Elastomers And Foams Containing Celite Super Floss Or Celite 315 Fillers.” Attached is the first draft of a risk assessment overview necessitated by the recent discovery that the supplier of silica had been using cristobalite and other crystalline silicas in materials that comprise the elastomer. LeVier states:

“The majority of health care elastomer products employ amorphous silica as the reinforcing filler. These fumed amorphous fillers have been shown by X-ray defraction analysis to contain no crystalline fraction. However, RTV’s in the form of elastomers and foams are based on older tin catalyzed formulations that use Manville Celite Super Floss (CAN#: 68855-54-9) or Cilite 315 (CAN#:61780-53/2) as the reinforcing filler (MSDS’s attached). These silicas are generically classified as flux calcinated diatomaceous earth. It has recently been learned from the silica manufacturer that Celite Super Floss contains up to 63% cristobalite and Celite 315 contains up to 23% cristobalite. Cristobalite and other crystalline silicas have been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic for humans.” (emphasis added).”

The products affected by this discovery include 382 Medical Grade Elastomer which was discontinued in 1987:
“for economic reasons related to additional safety testing required to investigate the availability and effects of stannous octoate catalyst degradation products (the subject of a 1987 Risk Assessment)…. This product was sold to many other manufacturers and individual physicians…. Dow Corning has also recently licensed the 382 technology to the World Health Organization (WHO) for the purpose of manufacturing and selling a contraceptive vaginal ring. Dow Corning’s supply position in the later application has not yet been fully defined. The cristobalite component in these materials ranges from about 10 weight percent to 30 weight percent. The highest concentration of crystalline silica occurs in 382 Medical Grade Elastomer.”

LeVier reviews the Dow Corning data on stannous octoate RTV formulations and concludes that “there are no long-term animal implantation data available.” The human data from inhalation studies of silica show that “crystalline silica can increase the incidence of lung cancer…. There is sufficient evidence for carcinogenicity of crystalline silica to experimental animals. There is limited evidence for the carcinogenicity of crystalline silica to humans.” LeViers risk assessment conclusions are that:

1) Unmodified crystalline silicas including cristobalite-containing silicas are probably carcinogenic for humans via inhalation exposure. The probability that crystalline silicas are carcinogenic for humans via parenteral exposure is less certain but existing animal data indicates that such silicas administered parenterally may be carcinogenic for humans….

4) The effect of in situ plasticizer treatment of Celite silicas on their possible carcinogenicity is unknown except on a theoretical basis. Theoretical considerations lead to the prediction that treated crystalline silicas could be less carcinogenic than unmodified crystalline silicas….

6) “An (sic) life-time rat study of the potential carcinogenicity of treated Celite silicas cannot provide unequivocal proof that such silicas cannot be carcinogenic for humans.
CITE: KKA 1601 – 1608

Document #494
09/08/89
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Patricia Lang, a consulting toxicologist, writes to Birdsall, Dow Corning, with copies to Stark, Ovsenik, Frith and Benson enclosing her assessment of Dow Corning’s toxicology laboratory and its efforts to comply with Good Laboratory Practices (GLP). Lang states:

“In the last two weeks it has become apparent that though some actions are being implemented to bring HES into compliance, the general feeling within the lab is one of chaos. This can be explained, at least in part, by the fact that there is no management with a full understanding of laboratory function to give direction, and get things implemented. Until now, the three consultants you hired, Charles Frith, Barry Benson and myself, have been trying to take the place of management, with very limited success. The only real progress to date has been in educating some of the personnel in general theory behind Good Laboratory Practice regulations. This does not mean that these people are trained, just educated to some degree…. With the pressures put on the already-too-few people to generate SOP’s in the past two weeks (especially the ones for Zybion), I was hearing many comments indicating that these documents will be generated haphazardly, without respect to whether they are accurate or not. Because the department has so much breadth and so little depth, there are not natural double-check systems to assure that either bad science or poorly thought out procedures (let alone poorly written sets of instructions) do not get put into place…. Since there is so much work to be done to bring the lab into compliance, any SOP’s which get approved in the new system, will have to be followed for a long time before anyone has time to rewrite them. They should be correct and complete the first time.” (DCC 80112044)

Under the “Personnel” section, Lang notes that:

“The consultants you hired were TRYING to take the place of a manager of toxicology. Because they were not part of the group, and only had the ear of Brian Hobbs (who apparently was given the authority to make decisions which should not have been his to make), they were not able to do the job that is needed to be done. As stated several months ago, IT IS ESSENTIAL THAT A GOOD MANAGER OF TOXICOLOGY BE HIRED IMMEDIATELY. The Dow Corning management style is not conducive to running even an adequate toxicology laboratory.” (DCC 80112045) She goes on to note that Dow Corning’s toxicology department has serious problems working its Xybion computer system, that it hasn’t been maintained and that inexperienced persons are operating it. (Id.) Further, she notes many problems with formulation of policies on scientific issues:

“At the present time, the WRONG people are making decisions (in some cases the WRONG decisions) which impact upon the science being performed. The policies which I am addressing include, BUT ARE NOT LIMITED TO, use of Room Log Books for entry of study information, secondary review of raw data or calculations, assurance of room conditions (light cycle, temperature and humidity), health check by veterinarian prior to study assignment, proper anesthetization procedures for animals, training procedures for various tasks (as necropsy, weighing organs, ect.), supervision of weekend activity, and authority of study directors to assure proper study conduct. This list is far from complete.” (DCC 80112045 – 80112046) Lang notes that the pathology procedures need a “complete overhaul.”

She states”

“Documentation is extremely poor at present, and no one in HES fully understands the requirements in this area…. A plan must be written to bring this group up to industry standard as soon as possible. Just getting this department into compliance will take several months….” (DCC 80112046)

CITE: DCC 80112043 – 80112071, Exhibit to Isquith Deposition (used by Dow Corning).

Document #495
11/15/89
KNOWLEDGE OF LIQUID SILICONE DANGERS

E. Frisch, Dow Corning, memo to B. Lipscomb regarding the “keratosis IDE” and the information necessary to convince the FDA that the material is safe. He notes that the FDA’s position is that animal studies are useful for safety while clinical studies are only useful for efficacy. Frisch acknowledges that Dow Corning’s “primary focus has been on efficacy,” even with the clinical studies. “Safety data … are scant and based on superficial external examination of the injection site” that does not include any detail or blood chemistries, urine analysis, liver function studies, or examination for lymph node enlargement. Key studies needed are carcinogenesis pharmacokinetics, developmental and reproductive toxicology, and immune response. Frisch notes that LeVier has a copy of a 9 page letter from the FDA to the Ortho division of J&J rejecting their IDE application for cosmetic uses of silicone fluid. CITE: KMM 407633 – 407634.

Document #496
12/04/89
CONCEALING FROM FDA
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

515(B): Dr. Jack Fisher (ASPRS) informs “All Members of BIRAC, Old and New” about progress report since ASPRS convention in San Francisco. He notes four concerns of the PSEF Board of Directors and those of BIRAC: 1) that manufacturers had written the RFP and they thought Colton was going to do this; 2) concerned that all southern California bidders would be excluded; 3) concerned that one manufacturer stated that it would only fund two issues from a longer list that PSEF wanted studies; and 4) concerned and “disappointed that the study does not address the connective tissue issue…. Based on our very best clinical judgment and scientific understanding, we believe that CT disease issue will forever loom until we meet it head on.” (emphasis added). PSEF is also deeply concerned about the reporting requirements – the potential delays in notification of study results. PSEF believes “these restrictions to be an infringement of academic freedom and a potential embarrassment to foundation (PSEF).”
CITE: KKA 43763 – 43769A

Document #497
01/31/90
TESTING
TISSUE REACTION
KNOWLEDGE OF SYSTEMIC DISEASE

Crofoot, Stanton, Siddiqui, and Zimmer, Dow Corning, report on “A 14 – Day Subchronic Oral Gavage Study With Hexamethylcyclotrisiloxane In Rats.” Oral administration of the test material, D3, “may produce increases in liver weight at dose levels as low as 100 mg/kg and perhaps as low as 25/kg in the male rat….” The authors state that the “toxicologic significance of the liver weight increases cannot be made.”
CITE: T 37322 – 37409, exhibit 36 to Zimmer Deposition.
DUPLICATE: T 37447 – 37490.

Document #498.
02/08/90
SHELL STRENGTH – THICKNESS
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD

Jim Curtis memo to John Dillingham, both of Dow Corning, regarding deficiencies in the stocking and shipping process at the Arlington plant. He states:

“I can tell you that the stock here in Arlington is mixture of old and new units. Eight year old SILASTIC II units are in a bin with 2 month old units. And the people that pull the implants from the bins to fill orders tell me that they will pull any, with no attention to the lot number (production date). When I asked why we had eight year old implants, I was told that many implants are returned from territory stock and mixed in the bins with the new implants…. If the system goes unchanged, the customer will develop the perception that our implant quality is very inconsistent.

CITE: KKA 5640. NOTE: A listing of the useable life and shelf life for Dow Corning products is located at KKA 097708 – 097710.

Document #499
02/08/90
MISCELLANEOUS
MISCELLANEOUS – ORGANIZATIONAL SURVEY
SILICA

Burda, Dow Corning, prepares a “Product Structure Of Silastic Mammary Implant (1964 To The Present)” in which he lists all of the products Dow Corning has manufactured and their component parts. Contains charts that show silica content and corporate and manufacturing organization.
CITE: DCC 17007927 – 17007993.

Document #500
02/19/90
CONCEALING FROM FDA

515(b) Lois Duel writes to other manufacturers suggesting that the epidemiology studies be funded only by manufacturers, and that ASPRS be excluded. She claims the basis for this position is the “need to preserve the confidential nature of the study content as its supports PMA submissions by sponsoring manufacturers.” Duel further suggests that ASPRS and PSEF play a modified role such as PR efforts.
CITE: MEX 28736 – 28738.

Document #501
07/331/90
KNOWLEDGE OF LIQUID SILICONE DANGERS
CONCEALING FROM FDA
ACKNOWLEDGEMENT OF NEED FOR TESTING

Dow Corning’s “Summary of Pre-clinical Testing Relevant To The Keratosis Project And Indications For Additional Studies.” There is no testing of extracts, hemolysis, mutagenicity for 360 Fluid (although the author notes that this should have been done since “such testing is brief and inexpensive”), skin irritation for DC 360 Fluid, Sensitization, 90-Day implantation study of 360 Fluid, and no long term studies. The author also reviews the chronic exposure toxicology files and states:

“A series of five studies (1968-1976) in the rat and dog involve the injection of relatively large volumes of DC 360 Fluid, 350 cs at subcutaneous, sublantar and intramuscular sites for periods of one to two years. These studies provide evidence of a limited local inflammatory reaction and instances of fatty necrosis at the injection sites. These findings are expected. Unfortunately, none of these studies conform to GLP regulations and, more seriously, none of the wet tissues, blocks or slide preparations have been retained. There is another series of reports of fluid injection experiments conducted by Dr. Ashley and by Dr. Rees (1964-1972). These latter studies are of virtually no utility. They suffer from the same deficiencies as the other long-term studies and, in addition, no protocols or in-life data can be retrieved.

On at least two occasions the FDA has indicated that existing chronic data are insufficient to support the use of PDMS in small volume injection applications. Most recently (April, 1988), the FDA informed Ortho Pharmaceutical that a rat carcinogenicity study must be completed before initiating clinical trials related to the treatment of facial wrinkles with injected PDMS. The bottom line is that there are no specific long-term pre-clinical safety studies conforming to GLP’s to support development of a product to treat keratosis.

A 2-year study in the rat has not yet been requested. Such a study cannot be started in HES until about April 1991. The objective of a life-time rat study is to assess the long-term local reaction as well as systemic toxicity including carcinogenicity.”

With regard to special testing on polymer distribution, nine in vivo distribution studies of PDMS have been conducted between 1956 – 1985. “All of the animal studies tend to show a low level ubiquitous distribution with the highest concentrations found in lymphatic tissue.”

With regard to immunotoxicity, the author states:

“A study was done in 1974 to look at the immune adjuvant activity of a number of organosilicone compounds and polymers including several viscosities of DC 200 Fluid…. This is not a well-structured nor GLP-conforming study but it is unlikely that a repeat will be needed.”

With regard to teratology and reproductive effects studies, the author claims that there are no adverse effects from PDMS on reproductive capacity in the rat or primate. The summary also lists a cost estimate for conducting additional studies and a list of the present studies in the Toxicology Files.
CITE: KMM 407282 – 407282.

Document # 502
08/13/90
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE
DOCUMENT DESTRUCTION

FDA: B. Levier, Dow Corning, memo to R. Dieck and L. Duel regarding Statistical Analysis of Neoplasm Data from 2 Year Gel-Implant Study of Q7-2159A and MDF-0193 in rats stating, “but the sum of hepatocellular adenomas and carcinomas is within only one or two tumors of being statistically significant…. Our argument… may still be plausible but it is weakened by these findings… (and) I think it would be imprudent to test this issue with the FDA.” A handwritten note at the bottom of the memo states “Please discard this memo after reading
CITE: KMM 451517 – 451525.

Document #503
08/20/90
CONCEALING FROM FDA

Woodbury, Dow Corning, memo to R. Dieck, C. Dillon, L. Duel, R. LeVier, H. Steinberg, regarding comment by Roscoe Moore, FDA, at the 1990 Data users Conferences that manufacturers purposely overestimate device prevalence because it allows them to underestimate complication rates.
CITE: KMM 402702, Exhibit to Dillon Deposition, Exhibit 13 to Woodbury Deposition.

Document #504
09/06/90
DOCUMENT DESTRUCTION
CONCEALING FROM FDA

FDA: W.L. Miller, Dow Corning Wright Marketing, telex to Lutz and Schmitz regarding the MSI Questionnaire during the period of 01/01/90 to 03/27/91. He states that, “The FDA continues to exert tremendous influence on the ways in which we manage our business. As a result, the questionnaire which we developed would be required to be included in the submission package when MSI is presented for P.M.A. review by the FDA. Even if the results of our evaluation are very product/D.C. positive such a document could raise many questions and potentially impact our successful completion of the PMA process. THEREFORE I MUST ASK YOU TO DESTROY ALL COPIES OF THIS DOCUMENT WHICH CURRENTLY EXIST IN YOUR FILES. A NEW DOCUMENT HAS BEEN CREATED, AND HAS ALREADY BEEN SENT TO DUSSELDORF VIA FAX FOR DISTRIBUTION.”
CITE: KKE 1315.

Document #505
10/09/90
SHELL STRENGTH – THICKNESS
FRAUD/MISREPRESENTATION

Dr. Flowers sends a letter to Doris Michelson, Dow Corning, regarding complaint Report MW 3416. Dow Corning claimed that a slit developed in the implant “in response to wear and stresses that were greater than the implant’s design limits.” Dr. Flowers believes it is the same fold flaw phenomenon as that which caused near 100% deflation rates in McGhan implants between 1977 and 1979. He believes the deflation problem is caused by folding, which in turn causes fiber fatigue and later fracture and slits. He blames inadequate pre-market testing and is distressed about Dow Corning’s complaint analysis process. He states that, “What alarms me most of all, and that which I find totally unacceptable is the identical ‘finding’ which contains two fairly lengthy sentences, word for word identical with the earlier patient. This obviously is a company approved ‘finding’ that is ‘rubber stamped’ in an effort to decrease company liability and conceal the true significance of the findings.”
CITE: KMM 498693 – 498696.

Document #506
10/17/90
SHELL STRENGTH – THICKNESS
MISCELLANEOUS – RECKLESS/ONSCIOUS DISREGARD

Dave Kinne memo to Glenn Dennis, both of Dow Corning, regarding an inspection of the dipping process for making envelopes. For the week of October 8, 1990, “49% to 87% of the units inspected and passed may actually be non-conforming” and should not have been accepted. Kinne states:

“These statistics are disturbing at best and give further weight to arguments in favor of shutting down and addressing our problems. At the very least they should serve to get the actions that have been recommended for the past several months executed and provide some tangible support to my quality efforts.
CITE: KKA 19032 – 19036.

Document #507
12/06/90
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE

Robert Rylee, Vice President and General Manager of the Health Care Business of Dow Corning, sends a “Dear Doctor” letter. Rylee states that Dow Corning “voluntarily” submitted information to the FDA including a “summary list of 750 bio-safety studies and full reports of more than 30 toxicology studies…. The list included all of our studies; none were withheld.” Rylee discusses recent media attention and a 11/27/90 decision by a district court in Washington D.C. ordering Dow Corning to make public this bio-safety data.

Dow Corning cites the need for confidentiality as the reason it is appealing the district court’s order.

Rylee also states that there have been recent reports of immunological responses to silicone breast implants. “Suspected immunological response is a controversial subject because there are so few cases available for study. A review of the global literature indicates that out of more than two million women with silicone mammary implants, only about 40 have been reported to have a form of rheumatic/connective tissue disease. Some form of scleroderma has been reported in 14 implanted women with a latency of about 10 years, and so-called human adjuvant disease HAD) has been reported in 13 implanted women with a latency of about 7 years.” He concludes by states that based on Dow Corning’s 25 years of experience in silicone breast implants has demonstrated the “reasonable safety and efficacy of these devices.”
CITE: M 370276 – 370277, Exhibit to MDL Rathjen Deposition. DUPLICATE: M 690014 – 690014A.

Document #508
12/10/90
FRAUD/MISREPRESENTATION
DOCUMENT DESTRUCTION

Woodbury and Delongchamp, Dow Corning, memo to various Dow Corning employees regarding U.S. breast implant prevalence. The “figure of 2,000,000 women in the U.S. with breast implant does not appear to be supportable or reliable.” Woodbury and Delongchamp claim that the prevalence rates are “roughly 250,00 to 800,000. These figures translate to a prevalence rate of about 4 to 8 per 1000 adult white women in the United States.”
CITE: KMM 403370, Exhibit 2 to Woodbury Deposition. DUPLICATE: KMM 489617.

Document #509
12/12/90
FRAUD/MISREPRESENTATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA

Dow Corning “Epidemiology Update” on post-surgical complications in breast augmentation notes that internal customer complaints based on Dow Corning Wright data probably “substantially underestimates true incidence rates. The number of complaints reported underestimates the true number. And, product sales, used as a denominator in rate calculations, likely overestimates the number of women who have been implanted.”
CITE (KKA 1971: KMM 396712).
CITE: KKA 10971 – 10972, Exhibit to Dillon Deposition, and Exhibit 4 to Woodbury Deposition. DUPLICATE: KMM 396712; KKA 155318 – 155322. NOTE: Regarding the Micro Surfaced Implant (MSI), the report notes the principal outcome of the clinical trial in progress is “excessive capsular contracture.”

Document #510
12/12/90
DOCUMENT DESTRUCTION
FRAUD/MISREPRESENTATION

Woodbury and Delongchamp, Dow Corning’s Medical Research Services, memo concerning the National Center for Health Statistics, 1988 Device Survey, Attached materials provide findings based on 142 documents from the FDA funded Device Supplement to the National Center for Health Statistics (NCHS) 1988 National Health Interview Survey. Woodbury and Delongchamp conclude that in the U.S. there are 544,000 implanted breast devices and 320,000 women with breast implants (4.2 per 1000 adult white population). Also, 25.9% of the devices had some problems, equaling 30.3% of the women. Within 5 years of implantation, 13% of sampled women had a replacement, with 17% having a replacement by 10 years. Device defect, failure or malfunction was reported for 11% of the women, and defect or malfunction being the reason for replacement in 30% of replaced devices.
CITE: DCC 80011571 – 80011597, Exhibit to Dillon Deposition, Exhibit to LeVier Deposition, Exhibit to Harris County Rylee Deposition, and Exhibit 3 to Woodbury Deposition. DUPLICATE: KMM 333323 – 333349. NOTE: This is the document that Rylee and Thiess are alleged to have requested Dillon and Woodbury to destroy because it would be damaging to Dow Corning.

Document #511
12/14/90
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS

Hazleton memo to various personnel regarding the establishment of a Steering committee Team to manage the evolving issues and communications surrounding the biosafety of D4 and other small molecule dimethyl materials. The team will be comprised of Bill Cavanaugh, Barie Carmichael, Chuck Dillon, Deb Zellner, Doug Wernecke, Mark Zimmer and Jack Pulley.
CITE: No Bates Number; Exhibit 3 to Boley Deposition, and Exhibit 33 to Zimmer Deposition.

Document #512
12/20/90
DOCUMENT DESTRUCTION

Dillon, Dow Corning Corporate Medical Director, memo to Swanson, Dow Corning Corporate Ethics Committee, stating:

“I am writing to report a recent incident and to request a formal review by the DC Corporate Committee on Ethics. I make this request because I feel that this episode represents a violation of corporate, professional, and commonly accepted business ethics.

The specific incident occurred on Friday, December 14th at 5:15 PM. Greg Thiess, a senior litigation attorney in the corporate legal department approached Mary Ann Woodbury, a research scientist of my staff in her DC-1 office. He asked that she destroy all copies of a memo she circulated two days previously. The memo contained a data analysis of a recent National Center for Health Statistics Survey of Surgical Device complication rates, and the overheads for a presentation to the Reed Committee on mammary implant issues that summarized the overall scope and current status of Epidemiology projects for the Health Care Business’s (sic) mammary implant products.

Mary Ann asked me to join them in her office and Greg repeated his request to both of us. Greg stated to us that he was acting at the specific request of Robert Rylee II, Vice President and General Manager of the Health Care Business who was very angry with the memos, and that he had spoken with Mr. Rylee on this subject earlier by telephone. He also stated that from his personal viewpoint, the information contained in the memos would compromise projects that he was then working on in Dow Corning product liability litigation and be adverse to the company if publicly revealed. I directed Mary Ann not comply with the request and stated to Greg that to do so would in my opinion be unethical conduct.

I feel that this is a serious example of misconduct requiring formal review. I am concerned that these documents may be sought out and destroyed. Also, I am concerned that the incident, if not amended, may lead to others that would threaten the integrity of my department, its employees, their ability to provide valid scientific evaluations to management, as well as their careers in the company.
CITE: DCC 80090119, Exhibit to Dillon Deposition, Exhibit to Duel Deposition, Exhibit to Freeman Deposition, and Exhibit 5 to Woodbury Deposition. DUPLICATE: DCC 80090589.

Document #513
01/11/91
DOCUMENT DESTRUCTION

Yerrick, Dow Corning, memo to Dillon and Woodbury regarding the Code of Conduct meeting. Yerrick states:

“I hope you feel your concerns were heard and understood; and more importantly they will be acted upon in a sincere manner. You have my commitment to do so. I understand that you may have some skepticism about the outcome but that’s OK because we need that to determine our success.

I, and others, appreciate your candor in bringing forward the issue as a generic problem to be evaluated. It was the right thing to do.”
CITE: KMM 486118, Exhibit 8 to Woodbury Deposition.

Document #514
01/16/91
FRAUD/MISREPRESENTATION
DOCUMENT DESTRUCTION

Woodbury, Dow Corning, responds to Yerrick’s memo of 01/14/91 stating, “I have just returned from being off sick. I tend to still be skeptical, as a result of other things that I know Bob Rylee has done.”
CITE: KMM 486119, Exhibit 9 to Woodbury Deposition.

Document #515
01/22/91
CONCEALING FROM FDA
DOCUMENT DESTRUCTION

Lois Duel, Dow Corning, memo to Bailey Lipscomb and others regarding the “January, 1991 Monthly Report.” Under the heading of “Technical Communications,” Duel notes that she “spent MANY days reviewing, filing and/or trashing retained documents in my files. Major progress was made, but there is more to do.”
CITE: KKA 37643 – 37646.

Document #516
01/22/91
FRAUD/MISREPRESENTATION
TESTING

515(B): Dr. Cherup sends a letter to ASAPS returning a research grant. She reports that she did not get any cooperation from Dow Corning and Mentor and that they “more or less told me that they did not want their textured silicone implants involved in any studies over which they were unable to have direct control. They explained to me that they had other studies ongoing with other researchers characterizing their implants, but they admitted to me that they had direct control over these studies.” She states that she does not want to add to the “the mound of already existing information wrought by studies which are biased as being supported by one company or product or another.”
CITE: MD 120461 – 120463.

Document #517
01/28/91
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Zimmer, Dow Corning, memo to Co-Producers Technical Committee and Co-Producers Steering Committee regarding documents to review for February technical committee meeting. Zimmer states that the draft reports of the previous morphometrics and DNA studies indicate that it is fair to say that D4 causes hepatocellular hyperplasia and that no evidence of hypertrophy was evident. He also enclosed morphometrics and DNA assay protocols for a 2-year rat bioassay and for cell replication studies.
CITE: DCC 260000566, Exhibit 39 to Zimmer Deposition.

Document #518
01/29/91
COHESIVENESS – LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED

FDA: Department of Health and Human Services pharmacologist, Hoan My Do Luu, letter to Dow Corning and Dan McGunagle of the Breast Implant Task Force regarding Appendix A and B, supplements to PMA P910039A (Silastic II H.P.) and P910040A (Silastic MSI single lumen silicone gel-filled mammary implants). The letter deals with the summary of extraction data for Dow Corning Silastic shells, gels and patches. Luu states that “the reporting of low amount of cyclics (less than 2% wt) in the summary report is misleading because the company selectively reported only two of the 17 cyclics found in the components’ extracts. The firm selectively reported the amount recovered for cyclic tetrameter (D4) and pentameter (D5) as total volatile cycles. Other shortcomings were found in the methodology protocols used such as incomplete extraction in ethanol, ethanol: CH2CL2 and saline, lack of controls and validation of the methodology…. The reporting of no detectable siloxane residues in saline extracts was questionable.” See original document for additional questions regarding Dow Corning’s reporting.
CITE: FDA 12281 – 12290. NOTE: See entries of 12/20/91, 02/05/92, 02/06/92 and 03/13/92.

Document #519
02/28/91
CONCEALING FROM FDA
DOCUMENT DESTRUCTION

FDA: Eldon Frisch, Dow Corning, memo to Garry Brody, M.D. regarding letters from the FDA on the use of silicone fluid on hypodermic needles. Frisch states;

“I have found the letters from FDA that have served as a basis for the use of silicone fluid on hypodermic needles and syringes for many years. I have removed all references to Dow Corning just in case these letters somehow find their way back to FDA. I have been asked by some of the individuals at FDA about the basis for silicone fluid being used on syringes and needles, and have never produced these letters. There are some who believe that if FDA cannot identify how it came about that fluids were allowed on syringes and needles then it is difficult for them to rescind the approval.”

(emphasis added). Attached are two documents – a letter from Philip Sheeler, FDA, in which all names of individuals and companies have been redacted, and a second letter from William Jester, FDA, in which all names have also been redacted.

CITE: DCC 17037526 – 17037528.

Document #520
03/12/91
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE REACTION

Stark, Dow Corning, memo to Lentz regarding the proposed modification of future D4 testing programs. Stark states that the morphometric and DNA studies are technically sound and correctly interpreted, the ovary weight issue must be resolved, pharmocohinetics and additional metabolism data are imperative before we embark on reproduction, teratology, and chronic studies, and cell replication studies must precede chronic studies. Stark encloses an outline of the proposed D4 research plan.
CITE: DCC 260000706 – 260000716, Exhibit 42 to Zimmer Deposition.

Document #521
03/15/91
FRAUD/MISREPRESENTATION
CONCEALING FROM FDA
KNOWLEDGE OF SYSTEMIC DISEASE

Woodbury, Dow Corning, letter to Gary Brody, M.D., regarding National Health Statistics Survey. Woodbury states:

Factors which may influence the accuracy of prevalence estimates:

–Primary data collection methodology.
–Statistical design of sampling plan.
–Specific data collection methodology within a given primary data
collection method.
–Survey participation bias.
–Completeness or representativeness of data upon which estimates are based.
–Analysis Method.
–Willingness of respondent to disclose information or knowledge and illingness to disclose for a proxy respondent.
–Device replacement rates and frequency of replacement.
–Permanent removal rates.
–Mortality patterns for implanted patients.
–Device inventory and wastage for marketing based estimates.
–Subjective estimates of surgery rates by surgeons within surgeon surveys.

The letter includes an attachment containing a comments by R. Delongchamp, Dow Corning, stating:

“The observation of serious disease among women with cosmetic implants is expected simply because all women eventfully die whether or not they have an implant. As the numbers of women with implants increases, this fact makes it inevitable that at least one woman with an implant will succumb to even the rarest of diseases. An assessment that the implant caused the disease is unwarranted.”

The letter also includes attachments presenting survey data.
CITE: KMM 403500 – 403530, Exhibit to Harris County Rylee Deposition, Exhibit 17 to Woodbury Deposition. DUPLICATE: KKA 102860 – 102880.

Document #522
05/01/91
ACKNOWLEDGEMTN OF NED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by Ruhr and Hoffman titled “Progress Report: A Chronic Implant Study In Rats With Dow Corning Q7-2423 and Q7-2551 Elastomers,” Dow Corning Tox file 3810-10 and 5194-8. These silicone elastomeric materials comprise the envelope for the Silastic II and silastic MSI mammary prostheses.

Four groups of 60 male and 60 female rats each are incorporated into the study design. There is a sham operated control group, a U.S.P. polyethylene control group, and one group for each of the elastomers.

Statistical analysis will be performed on body weight and food consumption data; organ weight; and appropriate clinical pathology data.
CITE: P 19120 – 19163, Exhibit 21 to Zimmer Deposition, Exhibit 5 to Bejarano Deposition, Exhibit 1 to Bey Deposition, and Exhibit 36 to McKennon Deposition.

Document #523
06/04/91
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – PRODUCT LABELING
TESTING

J Curtis sends a telex to L. Duel, Dow Corning, regarding animal study data for the PMA submission, “I was not privileged to its duration and discovered its incompleteness during preparation for the PMA…. Is LeVier’s response not a problem for us. Doesn’t John Gauger utilize some of the data from these ‘incomplete’ studies as the basis for product claims in ‘labeling’ (i.e. product advertising)?”
CITE: KAA 57.

Document #524
06/19/91
KNOWLEDGE OF GEL BLEED
TESTING

Varaprath, Dow Corning, report on internal Dow Corning Wright study entitled “Composition(al) Analysis of Mammary (Implant) Gel Bleed.” Analysis states:

“Silicone gel bleed was collected from mammary implants fabricated with and without a fluorosilicone barrier interlayer using accelerating conditions to collect significant quantities via a short period of time (not in in-vivo simulation). The -prostheses used in the test were 1) Low Profile Round (LPR) Design High Performance (H.P.) Mammary Prosthesis with no fluorosilicone barrier, and 20 SILASTIC II LPR H.P. Mammary prosthesis which contain fluorosilicone barrier interlayers. The test method for gel bleed collection is documented by the author. The fluorosilicone barrier was shown to reduce the amount of gel bleed by approximately a factor of 20 (i.e., 837.3 + or – 64.9 mg. without barrier vs. 44.3 + or – 5.6 mg. barrier). After collection, the gel bleed was analyzed using different spectrochemical techniques to determine its composition (i.e., sivinyl and Si-H were detected by infrared spectroscopy, platinum by atomic absorption spectroscopy, and molecular distribution by gel permeation chromatography). The molecular weight distribution of the LPR samples was relatively close to the reference material, Q7-2317, while the SILASTIC II samples exhibited significantly lower molecular weight distribution that the reference. The Sivinyl content of the LPR samples averaged 156. + or – 13.5 ppm; SILASTIC II samples averaged 100.0 + or – 7.0 ppm; and Q7-2317 was 9.8 + or – 7.4 ppm. Infrared and atomic absorption spectroscopy did not detect Si-H or platinum.”

Adverse effects are listed as N/A.
CITE: FDA 33559 – 33569.

Document #525
06/24/91
FRAUD/MISREPRESENTATION

Hall, Dow Corning, memo to Gary Anderson, Campbell, Carmichael, Biggs, LeVier, and Jenkins regarding the “DCC Committee.” Hall states:

It has been two weeks since we had the great session with the BOD at which time they pointed out some of the problems we were facing and suggested ways we might get beyond them. This communication is intended to simply summarize where I feel we are.

The issue of cover-up is going well from a long-term perspective. We are moving rapidly ahead on our press conference, and all things appear to be in place for that with the exception of the University of Michigan study being finalized….

The number one issue in my mind is the establishment of networks. I believe we have made no progress in the two weeks. Obviously, this is the largest single issue on our platter because it affects not only the next 2-3 years profitability of DCC, but also ultimately has a big impact on the long-term ethics and believability issues. If we do not win this one, or at least minimize the financial impact that people are able to achieve, you can forget about whether we have done all these other things correctly….

It has become obvious to me that what is at risk here is somewhere between $50 million and $500 million. Right now, I think we are losing the time race badly in this critical area, and I believe that the amount of money we are going to lose is increasingly rapidly since we are not going to be in a position to divert the opposing forces into the directions we want soon….

The place we have the biggest hole still missing and two weeks behind from the time we got the word from Keith McKennan (sic), is in this whole arena of getting a patient grass roots movement going.
CITE: KKA 332805 – 32806.

Document #526
09/13/91
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS
TESTING
TISSUE REACTION

FDA: Letter from the FDA to B. Lipscomb, Director of Clinical and Regulatory Affairs for Dow Corning Wright. Dow Corning Wright submitted 229 studies to the FDA in its PMA for the Silastic II Mammary Implant H.P. and the MSI Mammary Implant H.P. but the FDA states, “we believe that the PMA lacks information needed to show that there is reasonable assurance that the device is safe and effective for its intended use.” The FDA then lists “major deficiencies” in the PMA including lack of specific data on rupture testing, tear resistance testing, abrasion resistance, gel bleed performance testing, pharmacokinetic/biodegradation studies, mutagenicity testing, manufacturing information, and clinical and non-clinical investigations.
CITE: m 780258 – 780265. DUPLICATE: M 780092 – 780100: M 780101 -780103; KKA 178597 – 178604.

Document #527
10/09/91
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
TESTING

FDA: FDA Materials Research Engineer, Lawrence D. Coyne, Ph.D., issues a memorandum titled “Dow Corning single and Double Lumen Silastic II and Silastic MSI Breast Prothesis: In-Depth Review of Gel Bleed Testing.” He reviews eight Dow Corning reports of gel bleed permeation testing, two of which provide useful information:

“The bleed consists of approximately 80% compounds of low molecular weight (=5300) in the range of, although lower than, the linear (i.e., uncross-linked) polydimethylsiloxane compound found in the original gel fill. Approximately 4% is composed of components of very low molecular weight (=525) which may correspond to unreacted or deliberately added dimethylcyclosiloxanes. The remainder, approximately 16%, is of much higher molecular weight (=245,000) and probably arises from unreacted or degraded parts of the cross-linked material found in either the gel or the shell material. It is vital that a thorough and adequate extraction of the original gel fill and shell be performed so as to resolve the origin of these detected bleed products!”

Also noted is that for simulating in vivo gel bleed, use of mineral oil rather than saline as solvent in testing is better and proper, since it: “represents more realistically the in vivo state in which large concentration gradients outside the shell are maintained by the turnover and replenishment of body fluids possibly with the assistance of some active transport process. These conditions do not exist in a static in vitro experiment employing a very poor solvent such as saline.”

The writer particularly criticizes a Dow Corning bleed study due to:

“the complete lack of chemical or molecular weight distribution analysis of the bleed product. The importance of determining the identity of the bleed product, in addition to its total accumulated weight, cannot be overstated. The barrier layers of these “low-bleed” devices may in reality be much more efficient at retarding the passage of components of higher molecular weight, but be relatively permeable toward potentially more hazardous low molecular weight linear and cyclical molecules. The chemical analysis of this study is not nearly thorough enough. Concentrations of unreacted functionalities as a useful quantity, but even more important is the complete identification of the lower molecular components, which would be expected to pose the most significant health risk.” CITE: DCC 241000088 – 241000101.

Document #528
10/27/91
DOCUMENT DESTRUCTION
SHELL STRENGTH – THICKNESS

Morris, Dow Corning, memo to Kinne regarding the monthly report. “Mandrel repair has maintained a 50% success rate. There are now approximately 500 Mandrels in the repair loop. The number is continuously growing! The mandrel repair team cannot keep up with the rate of damage.” She also states that she is a member of recently formed “Document Investigation and Review Team (D.I.R.T.)… All documentation and paperwork is being created/edited.” She also reports that:

“there were several major losses this month. Some of the most significant were 98 units lost due to lack of final cure, 16 units were rejected because of rotocoat malfunction, 71 envelopes were lost due to a high fill level in the tank, and 27 envelopes were dipped on the wrong profile.
CITE: KKA 22700.

Document #529
12/20/91
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH – THICKNESS
TESTING

FDA: Lawrence Coyne, Material Research Engineer for the FDA, provides an in-depth review of Gel Bleed and Mechanical Testing submitted in Dow Corning’s 12/13/91 Amendment (Volume 1) concerning Single and Double Lumen Silastic II and Silastic MSI Breast Prostheses, PMAs P910039A and P910040A. One notable deficiency in the testing is “the absence of any reported values for the total energy to rupture.” Also:

a. Tensile Strength Testing
Coyne’s “examination of the raw data for ultimate elongation reveals that a number of inordinately low elongation values were simply disregarded in calculating average values of this property.” As such, Dow Corning’s calculations were artificially high, within ASTM F703 guideline; however, inclusion of all data would have brought the mean average down to “a clearly unacceptably small and highly fluctuating value.” Coyne attributes the low values to poor manufacturing quality control leading to “chemical differences within the shells.”

b. Patch/Valve Tensile Testing

Significantly lower values of ultimate elongation and tensile strength in the patch material and the shell material in the vicinity of the patch would appear to indicate the higher probability of device rupture in these areas.

Finally, Coyne finds Dow Corning’s gel bleed study unacceptable, as it “does not include any chemical or molecular weight characterization of the gel bleed products…. Also, contrary to what might be expected, the bleed rates were higher in terms of a weight basis for the firm gel as opposed to the soft or responsive gel.”
CITE: FDA 12423 – 12431.

Document #530
12/30/91
FRAUD/MISREPRESENTATION

FDA: FDA sends a Warning Letter to Dow Corning Wright instructing them to take immediate action to eliminate dissemination of false and/or misleading information concerning the safety of breast implants. Examples of false statements made regarding the following subjects are:

1) Implant Safety – “Scientific data and research show that breast implants are 100% safe…. After thirty years of study conducted with patients, there have never been health problems with implants or silicone…. Breast implants are safe.”

2) Gel Bleed – “a minute amount of gel, less than half a teaspoon, which doesn’t go anywhere.”

3) Rupture – “…results from a traumatic incident… such as being hit in the chest with a two by four…. It (rupture) has happened less than 1% in 2 million women.”

4) Migration – “It is not possible for the silicone to go to the internal organs because it is not specifically possible for the silicone to get into your spleen, kidneys, etc.”

5) Autoimmune disease – “It must be a genetic glitch… Silicone breast implants have never been linked to autoimmune or connective tissue disease in any studies ever done.”

6) Cancer – “There is no increase in breast cancer from implants, if anything it is less.”

7) Capsular Contracture Complications. – “But remember, you can have complications when you have a baby, yet people do it all the time.”

CITE: M 780626 – 780628. DUPLICATE: KKA 39985 – 29987; FDA 16233; FDA 50509 – 50512; DCC 242061180 – 242061182; DCC 242010055 -242010057; DCC 242051629 -242051631: M 780626 – 780628: DCC 17006751 -17006753; DCC 242031792 – 242031794.

Document #531
01/08/92
KNOWLEDGE OF LIQUID SILICONE DANGERS
EMBOLISM

FDA: Hoan-My Do Luu summarized the adverse effects associated with the use of injectable liquid silicone fluid. The short term effects are swelling, erythema, pain, edema, pigmentation, slight rubbery of the skin, discoloration of the skin and embolism. Long term effects are severe inflammation, granuloma, dermal and subcutaneous atrophy, pain, migration or disappearance of the injected material, lymph node hypertrophy, dermatitis, calcification, human adjuvant disease and breast cancer.
CITE: FDA 12449

Document # 532
01/27/92
TESTING
FRAUD/MISREPRESENTATION
KNOWLEDGE OF LIQUID SILICONE DANGERS

M. Zimmer memo to the “substantial Risk Evaluation Committee” regarding his conclusions reached after reviewing some of the previous teratology studies on Dow Corning silicones. His conclusions differ from the conclusions reached in the initial reports.

In some studies, after reevaluation of the data, it has been determined that the original interpretation of the data was incorrect.

First, he notes increased skeletal defects which “may be due to a direct effect of the test material. This conclusion differs from that on the report….” Second, “an increase in dead fetuses and a decrease in live births were seen at all doses of 360 fluid…. This conclusion differs from that in the report…. The finding of dead fetuses in the treated groups were related to treatment.” Third, “There is evidence of material toxicity based on maternal body weights” in albino rats. “The study demonstrates material effect at 1000 mg/kg but has no fetotoxic or teratologic effect at any dose.”

Zimmer also notes that the conclusions in File No. 1059-5 that polydimethylsilozane does not cause adverse reproductive teratologic and mutagenic effects is incorrect. (emphasis added).
CITE” KMM 452794 – 452802.

Document #533
02/11/92
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS LOBBYING

Zellner, Lutz, McClintick, Rothhaar and Clary, Dow Corning, memo to Parr, Yerrick and Anderson regarding D4 issue definition and actions. The authors present an overall communication plan that is split into two phases. Phase I is to disseminate the most recent information regarding the orally administered, range-finding study on rabbits. Phase II is to assure a state of DC preparedness to effectively meet any/all future D4-related events and provide a mechanism for periodically updating customers regarding D4 study plans and results. The authors enclose a schedule for each phase.
CITE: DCC 260000852 – 260000854, Exhibit 43 to Zimmer Deposition.

Document #534
02/12/92
DOCUMENT DESTRUCTION
CONCEALING FROM FDA

Greg Thiess, Dow Corning, memo to Jim Jenkins regarding Dillon’s memo regarding document destruction. Thiess does not want memo released publicly to the FDA for a number of reason. He states:

“First, it is difficult to understand how Dillon’s complaint could be relevant in any way to the FDA’s investigation or its further inquiries, primarily because the document R. Rylee sought to be withdrawn or destroyed as inaccurate was not, in fact, withdrawn or destroyed. The request initiated by Rylee and transmitted by me was, simply stated, refused….

Second, I do not wish for my character to once again be drawn into question by the release of such an irrelevant document, particularly where the facts of the incident (in my opinion) showed that I was the victim of an apparent long simmering dispute between Messrs. Rylee and Dillon and a childish unwillingness or refusal of them to communicate about needed epidemiological studies, creation of internal documents, etc. Moreover, if the unfounded allegation of Dillon is released, how am I to answer the charge without, in effect, releasing confidential communications to me by a representative (Rylee) of my client, made to another representative of my client (Dillon)?

Third, I remain as concerned today as after the Committee meeting that the Committee never actually reached a decision about the supposed improper conduct. As I said at the meeting of my conduct, or that of R. Rylee for that matter, did not breach any DCC code of conduct or any applicable rule of professional conduct for lawyers.”
CITE: DCC 80021872, Exhibit to Dillon Deposition, Exhibit to Reed Deposition, and Exhibit 15 to Woodbury Deposition.

Document #535
02/13/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Klykken, Dow Corning, memo concerning “Differentiation Of Foreign Body Reactions And Immune Granulomas.” Klykken gives a brief overview of foreign body reactions – which he claims are a “normal wound healing response” – and immune reactions to the implant which could range from “mild, fleeting symptoms to severe disruption of immunoregulatory functions and premature removal of the medical device.” He claims that Dow Corning scientists “have failed to demonstrate any linkage between these implant materials and immunological sensitization.”
CITE: M 850018. NOTE: Eldon Frisch, Dow Corning, admitted in memos dated 11/15/89 that Dow Corning had not done any immunological testing but needed to do so.

Document #536
02/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING

Joan Hatfield, Dow Corning Australia, fax attaching several documents, notably:

a. Dow Corning 02/10/92 press release announcing the release of “15 reports of scientific studies and 94 internal, non-scientific company documents.’ In the release, Rylee admits implants are not risk-free. Tylee quotes Dr. Calman of the United Kingdom Department of Health stating: “There is little evidence on links between silicone gel implants and autoimmune disease.”

b. McKennon 02/11/92 letter expressing regret that the “10 or so most painful memos” to be used against Dow were taken out of context, “to discredit Dow Corning,” often without concern for any responsive documents or memos. Also, McKennon feels that “many of Dow Corning’s critics are applying 1990’s standards to 1970’s memos and studies.” McKennon also states that he has been assured that all of the information known to Dow Corning which might be relevant to their deliberations has already been provided to the FDA.

CITE: DCC 267010007 – 267010014.

Document #537
03/02/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS – COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH – THICKNESS
STERILIZATION/CONTAMINATION
TESTING
TISSUE REACTION

FDA: FDA inspects Dow Corning Wright’s plant from January 13 to March 2 and finds various examples of MDR reportable silicone breast implant complaints that were not reported to the Food and Drug Administration.

Examples include leaking mammary envelopes, ruptured mammary implants, implant deflations, capsular contracture complaints, inflammatory reactions, infections, gel bleed, an inadequate program in place for monitoring and controlling the levels of microbial and particulate matter in the controlled rooms, improper validation of the envelope curing oven, inadequate calibration program and MDR reports not filed in a timely manner.
CITE: M 780802 – 780813.

Document #538
03/09/92
COHESIVENESS – LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION

Lutz, Dow Corning, memo to Clary, McClintick, Klykken, Rigas, Roghhaar and Zellner regarding position statement on gel bleed and D4 – review and comments. Comments regarding bleed include bleed of silicone fluid is commonly associated with mammary implants and has long been recognized by surgeons as a characteristic of silicone gel-filled breast implants. The amount of bleed is largely dependent on the molecular weight of the silicone material. The comments regarding D4 include that it is contained in minute quantities in the silicone gel-filled mammary implant and Dow Corning and other manufacturers believe D4 is safe for use in its intended applications and in no way affects the safety of silicone mammary implants.
CITE: KMM 452997 – 453002, Exhibit 44 to Zimmer Deposition.

Document #539
03/13/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Memos updating latest D4 study results. One study showed that pregnant rabbits will stop eating and show a significant weight loss. Non-pregnant rabbits will do the same. Another study has shown that there are effects on certain internal organs, organ effects can be expected whenever there is significant weight loss. It is believed that Dow Corning’s exposure guidelines and work practices for D4 continue to provide adequate protection for all employees.
CITE: DCC 17030046 – 17030047, Exhibit 15 to Zimmer Deposition, and Exhibit 4 to Boley Deposition.

Document #540
03/13/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH – THICKNESS
TESTING

FDA: The FDA cites deficiencies in Dow Corning, Mentor and McGhan’s PMA test data on chemical extraction studies, in-vitro gel cohesivity, valve competence, joint integrity, tear resistance, and tensile strength. Include internal FDA memos dated 03/13/92 and 03/18/92 from Lawrence Coyne explaining in detail the reasons for the PMA denials.
CITE: FDA 12567 – 12607. NOTE/ FDA 12519 – 12535 may be an attachment to this document.

Document #541
02/13/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH – THICKNESS
TESTING

FDA: The FDA, in a summary of safety and effectiveness data, cites deficiencies in Dow Corning’s, Mentor’s, and McGhan’s PMA test data on chemical extraction studies, in-vitro gel cohesivity, valve competence, joint integrity, tear resistance, and tensile strength.
CITE: FDA 12519 – 12535. NOTE: May be an attachment to FDA 12567 -12607.

Document #542
03/13/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Harrison memo to S&T plant personnel regarding an update of D4 study findings.
CITE: DCC 17030046 – 17030047, Exhibit 15 to Zimmer Deposition.

Document #543
04/24/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
MISCELLANEOUS – PRODUCT LABELING
TESTING
TISSUE REACTION

Rothhaar, Dow Corning, memo to Product Safety and Regulatory Compliance Staff regarding D4 material safety data sheets and labels. Rothhaar states that there is a moratorium on changes to material safety data sheets and labels for products containing D4 and D5. The reason for this moratorium is because the increased liver seen in some test animals exposed to D4 is believed to be an adaptive response rather than a true toxic effect and it is appropriate to retain the current 10 ppm industrial hygiene exposure guideline.

New products will not show D4 listed in the MSDS unless the D4 contributes to the product being a physical hazard and if not listed, no statements regarding the liver effect information and no mention of the IHG will be included in the MSDS but will be listed if it is determined to be hazardous. In any case the label for the product will not include any health hazard warnings relating to D4. There will be no potential liver effect statement on the label.
CITE: DCC 260000772 – 260000774, Exhibit 53 to Zimmer Deposition.

Document #544
06/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

McGunagle memo to Johnson and Kalins regarding the significance of Dow Corning studies omitted from their PMA’s.
CITE: FDA 30537 – 30539, Exhibit to LeVier Deposition, Exhibit 21 to McKennon Deposition, Exhibit 10 to Harris County LeVier Deposition, and Exhibit to Issquith Deposition.

Document #545
06/24/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

FDA: Daniel S. McGunagle, Task Leader for the FDAs Breast Prosthesis PMA Review Team, memo stating that studies were omitted from Dow Corning’s PMA. Dow Corning’s PMA does not contain information significant to the determination of the safety and effectiveness of breast implants. McGunagle lists eleven specific studies that Dow Corning had failed to Mention or submit. These provide a factual basis for the FDA’s concern regarding silicone-filled breast implants. Further, he notes that:

“The content of the withheld documents can be said to show a pattern. Intelligent people, familiar with this material, and anxious to obtain agency approval would recognize that these studies would draw more inquiry and justify further investigation into the safety of these devices. It is reasonable to assume that such people would not want this to happen and, being in a position to control the content of the PMAs, would leave these studies out to improve the chances for PMA approval.”

CITE: FDA 51245 – 51247.

Document #546
07/14/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Memo from Forrest Stark to the Environment, Health & Safety (EHS) Board which consists of Gary Anderson, Bey, Crossman, Foglesong, Harrison, Lacefield, LeVier, Pulley, Weyenberg and Yerrick. Copies of the memo were sent to D. Anderson, Bassani, Birdsall, Churchfield, Dover, Frye, Grupp, Haberer, Hayes, Hazleton, Hoover, Jenkins, Kabbe, Ludington, Marciniak, McCormick, Nishio, Parr, Pfuehler, Reed, Rothhaar, Skinner, Snedeker, Steinhoff, Ziarno, Roth, Zimmer and Groh. The memo discusses “Environment, Health & Safety Board Meeting Minutes Meeting Held June 30, 1992.”
CITE: DCC 17003795 – 17003829, Exhibit 18 to Zimmer Deposition. NOTE: This contains overhead presentations on D4 which are very interesting.

Document #547
09/07/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

Dow Corning lists “Clinical Immunology Proposals…and finds worthy of serious consideration:

1. Barrett Noones’s silicone as an antigen and =/-presence of specific antibodies; specific T-cell stimulation; Dow Corning states that this “becomes important in the light of the recent Goldblum article”;

2. Walter Peter’s cytokines in implanted individuals. He has already started screening individuals and Myron Harrison, Dow Corning, has asked him to combine this clinical study with Laurence Rubin’s proposal on serologies on implanted women to look for markers of autoimmune disease.

3. James Sanger’s proposal to study the presence or absence of humoral antibodies contiguous to implants or in case of rupture.

4. Kimber White’s (study on the potential immunogenicity of silicone elastomers and elicitation of humoral or cell-mediated responses.

5. Daniel Ladin’s and David Fivenson’s study hyupothesis that T cell activation occurs at the site of capsular formation and that peripheral blood lymphocytes have the same oligocloanality.

6. Howard Smith’s study on indiciduals who are being explanted and claims to be seeing differences in some biomarkers levels.

7. Marianne Frieri”s clinical immunology focusing on cytokine and growth factor assessment in breast implant patients.

8. Robert Winchester’s and Jane Morse’s characterization on the clinical features, auto-antibody profile, lymphocyte phenotypes, and HLA groups of women who are symptomatic post implant.

9. Nemecek Young’s clinical research with emphasis on immunology and genetics.

10. Sudha Agarwal’s and Marc Liang’s study on immune response to silicone implants.

11. John Varga’s clinical studies.

12. Jeffrey Brown’s rupture detection via MRI.

13. M.A. Atassi’s clinical immunology and animal studies of the immune system.

CITE: DCC 267011492 – 267011512.

Document #548
10/19/92
ACKNOWLEDGEMETN OF NEED FOR TESTING
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING

Minutes of the Substantial Risk Evaluation committee Meeting. The committee considered the risk associated with D4 and determined that the single high dose had a toxic effect on the tested animals and therefore the other observations are not necessarily indicative of an immune system effect, insufficient data is available to determine a dose-response relationship but there is no reason to suspect that actual exposure to D4 would cause the effects noted, the method of exposure in this study is not expected in real-world situations so the risk of these results being seen in actual exposed populations is slight, and even if people exposed to D4 had similar effects as noted in the study there is no substantial risk because the effects would be transient or reversible and not result in serious effects.

CITE: DCC 281061443 – 281061450, Exhibit 47 to Zimmer Deposition.

Document #549
12/31/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS – LOBBYING
RUPTURE
TESTING
TISSUE REACTION

The Committee on Government Operations (John Coyners, Chairman, Henry Waxman, et al.) writes a report which includes a scathing critique of the FDA’s failed regulation of silicone breast implants while ignoring their own scientists recommendations and the manufacturers’ failure to do any long term safety studies. Silicone breast implants should have been banned due to lack of safety evidence in all manufacturers PMA’s. The article covers all areas of this issue.
CITE: PSSC Medical Articles CD, J 3968 – 4022.

Document #550
12/09/92
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – ORGANIZATIONAL SURVEY

Bey memo regarding industry associations, silicone health council (SHC) history, SHC/GSPA meeting objectives – D4 program, Dow Corning position SCH/GSPA meeting November 9012, 1992 – D4 program, global silicone producers association – committee chairs and current members, and SCH/GSPA meeting results – D4 program.

The Silicone Health Council was founded in the mid-1970’s by Dow Corning, General Electric and Union Carbide. It was managed via the Industrial Health Foundation at the University of Pittsburgh. Wacker Silicones and Rhone Poulenc joined SHC in the 1970’s. In the 1980’s, SHC was affiliated with SOCMA, Wm. Smock, Director. In the 1990’s, Shin-Etsu Chemical, PCR, Huls, and Goldschmidt joined SHC.
CITE: DCC 17003711 – 17003719

Document #551
01/07/93
COHESIVENESS – LIQUID COMPONENT OF GEL
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEIOUS – COMPLICATIONS
TESTING

Zellner, Dow Corning, memo to Area S&T Directors regarding updates on D4 studies. Zellner states that studies indicate that D4 is safe for the use as a cosmetic ingredient, D4 has a very low toxicity level and that Dow Corning retain the Industrial Hygiene Guideline of 10 ppm for D4 and D5. Zellner insists that these studies were conducted by an independent group of scientists.
CITE: DCC 17005456 – 17005457,

Document #552
03/09/93
TESTING

Paul Klykken, Galbraith, Woodhiser, Duwe, Mudgett, Nash and Malczewski, Dow Corning, report which duplicates an original study performed by Dr. John O. Naim of University of Rochester. Both studies show that silicone is not biologically inert and therefore can cause autoimmune response.
CITE: DCC 267010511 – 2670010530. DUPLICATE: DCC 260000234 – 260000251.

Document #553
03/22/93
TESTING
KNOWLEDGE OF SYSTEMIC DISEASE

FDA: An FDA Talk Paper references two studies that show silicone gel can act as an antibody adjuvant. This supports the causal relationship between silicone gel-filled breast implants and autoimmune disorders.
CITE: BMS 68289 – 68291

Document #554
04/21/93
CONCEALING FROM FDA

Jim Jenkins, general counsel to Dow Corning, letter to Dr. Charles Vinnik agreeing to indemnify him whenever you are named as a defendant in lawsuits related to Dow Corning’s silicone gel-filled breast implants, except for claims of malpractice arising from surgery…. We are extending this indemnification to you because of the historical role you have played with respect to our products. In turn, you have agreed to cooperate and work together with us in defending this litigation.”
CITE: DCC 80071933 – 80071934, Exhibit to Duel Deposition, Exhibit 116 to Burda Deposition, and Exhibit to MDL Rathjen Deposition.

Document #555
06/14/93
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by Crofoot, Kolesar and Evans regarding an acute and repeated dose inhalation toxicity study with Dow Corning Z-6228 silane in albino rats.

The results of this study indicate that Dow Corning Z-6228 most likely will not present a significant acute inhalation hazard. However, repeated exposures may cause injury of respiratory tract under the conditions of this study. It is recommended that further toxicological studies be conducted to investigate the effects of long-term exposure. CITE: DCC 411000178 – 411000230 (Temporary Dow Corning Bates Number 178 -230); Exhibit 7 to Bejarano Deposition; Exhibit 6 to Bey Deposition, and Exhibit 22 to Zimmer Deposition.

Document #556
07/20/93
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS – COMPLICATIONS
TESTING
TISSUE REACTION

Study by Kolesar, Hoffman, Crofoot, Kowalski. Siddiqui, Evans and Groh regarding a two-week repeated dose inhalation toxicity study of hydrogen chloride and selected chlorosilanes in albino rats.

The results of this study showed no differences between gaseous hydrogen chloride and Me3SiC1, Me3SiC13, and MeSiC13. However, microscopic examination revealed mineralization in the kidneys of females exposed to HSiC13. Whether or not this lesion represents an earlier age-related predisposition to development is not known.
CITE DCC 411000141 – 411000157; Exhibit 6 to Bejarano Deposition; Exhibit 7 to Bey Deposition, and Exhibit 23 to Zimmer Deposition.

Document #557
09/01/93
TESTING
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE

Malczewski, Woolhiser, Mudget, Duwe, Galbraith, Nash and Klykken, Dow Corning, report on “A Humoral Adjuvancy Study In The Rat Of Dow Corning Silicone Gel (Q7-2159a) Preparations And Mammary Gel Bleed.” All three sheared mammary gel/BSA preparations demonstrated comparable antibody responses to the positive FCA/BSA control and were significantly greater than that of the non-adjuvant control at 4, 6, and 8 weeks post-immunization. The ability of sheared silicone gel preparations to elicit an adjuvant response does not appear to be a preparation-dependent phenomenon under the conditions of this assay. The adjuvancy potential of mammary gel may not be primarily dependent on the preparation technique. Mammary gel bleed did not elicit an adjuvant response following i.m. administration. The antibody levels generated from this group were equivalent to the non-adjuvant control at all time points measured.
CITE: OOT 48639 – 48655, Exhibit 9 to Klykken deposition in Harris County.

Document #558
11/24/93
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

Study by Busey titled “Audit Report For Dow Corning Corporation Project Number 7088 – A Life-time Implant Study With Dow Corning Q7-2159A In Rats.” The raw data did not appear to have been reviewed in a timely fashion. Deficiencies were detected in the accountability and identification of the animals on study. Raw data was deleted for no apparent reason. Records for the receipt, distribution and archiving of the control article were not present or were incomplete. Records for the transfer of samples, namely blood samples, within the laboratory were not present. Some of the maintenance records for the balances used on this study were not present. The printed protocol and its amendments were incomplete with regard to identifying personnel assigned to the study, specifically the current study director and pathologist.
CITE: DCC 411000615 – 411000765, Exhibit 10 to Bey Deposition, Exhibit 45 to Zimmer Deposition.

Document #559
01/25/94
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

Study by Busey titled “Audit report For Dow Corning corporation Master Schedule Number M8616-0 EPL Project Number 287-005-Biodurability And Tissue Compatibility Of Optimized 55- and 70- durometer H.P. Elastomers.”

No data were present documenting how or where the control samples of each test material were selected and stored control samples were inconsistently used. Some samples were not tested within 48 hours of implant retrieval as specified by the protocol. The test material receipt log does not document the receipt of the DeMattia Bars. There are no precise test article accountability records. There were several inconsistencies among the daily observations, veterinary records and material removed records concerning the loss and re-implantation of implants. The animal daily observation records indicate that daily observations were not recorded after 9/16/87 as specified by the protocol. No dogs were sacrificed at the 6 month interval. There were no environmental records. There were no raw data documenting the histologic preparation of the capsule tissue collected at necropsy. No raw data were present documenting the collection or preparation of the tissue samples for transmission electron microscopy. CITE: DCC 411000580 – 411000614, Exhibit 11 to Bey Deposition, Exhibit 46 to Zimmer Deposition.

Document #560
05/25/94
TESTING
TISSUE REACTION

Study by Kolesar, Evans, Hoffman, Siddiqui and Heffel regarding a 14 day repeated dose inhalation toxicity study of Dow Corning X1-6145A additive in albino rats.

No apparent treatment-related clinical signs were observed in animals exposed to 50 ppb of the test material. Statistically significant decreases in body weight were observed in body weight were observed in males exposed to 100 and 200 ppb and females exposed to 200 ppb. Relative liver, kidney, and adrenal weights were increased in males in the 200 ppb group. Also, relative liver weights were increased in females in the 200 ppb group. All lesions in the lung and other organs examined microscopically were considered agonal or spontaneous and unrelated to test article exposure.
CITE: DCC 411000001 – 41000140; Exhibit 8 to Bey Deposition, Exhibit 8 to Bejarano Deposition, and Exhibit 24 to Zimmer Deposition.

Document # 561
06/29/94
FRAUD/MISREPRESENTATION
MISCELLANEOUS – RECKLESS/CONSCIOUS DISREGARD
TESTING

Mast, letter to Bejarano regarding the inappropriate actions he took in connection with his responsibilities in Dow Corning’s Health and Environmental Sciences Laboratory; four animal studies; tissue taken from one particular animal and characterized the tissue as being taken from other animals. Bejarano’s early retirement has effectively positioned him to avoid the severe disciplinary actions warranted by his misconduct. Dow Corning cannot overlook the harm that has been done to it and people who depend upon it.
CITE: BEJ 393, Exhibit 15 to Bejarano Deposition

Document #562
08/15/94
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
TESTING

Dow Corning study titled “A Chronic Implant Study in Rats with Dow Corning Q7-2423 and Q7-2551 Elastomers: Audit of Pathology Materials” by Experimental Pathology Laboratories, Inc. The report states:

“The results of the initial slide/block comparison of 20% of the animals revealed several identification discrepancies between the slides and blocks and several slides with missing blocks.”

“This audit revealed several discrepancies in the conduct of the histology phase of the study.”

“The detailed findings from the audit of the blocks and slides and supporting documentation are presented in Appendix A. In addition to the cutting of duplicate slides, a variety of other discrepancies were noted in the identification and histologic preparation of the slides on this study.
CITE: DCC 411000769 – 411000965, Exhibit 4 to Bey Deposition

All documents may be ordered from the National Breast Implant Depository in Birmingham, Alabama.

Enkele krantenkoppen hierover:

Data Raises New Concerns on Breast Implant Safety

Papers show Dow Corning knew