Mijn ervaring met de Monobloc Hydrogel implantaten.

…….na heel veel mailen en schrijven besloot ik ook de LNE notified Body in kennis te stellen van het feit dat er nooit gewaarschuwd is voor Methyleen blauw totdat ik door mijn ervaring dit aankaarte bij de IGJ.

De : M.van Amersfoort [mailto:m.
Envoyé : lundi 5 septembre 2016 00:20
À : cofrac.fr; Medical GMED
Cc : @ansm.sante.fr; @ansm.sante.fr
Objet : complaint/questions

Dear sir/madam,

My complaint / questions are about the following issue:

Are the Monobloc hydrogel breast implants Arion approved according Directive 92 / 42EEC Annex 1 Section 7.4?  

Are you, as a Notified Body aware of the fact these implants contain an ancillary drug? Which can give serious interactions and/or allergies?

As a patient I have not been informed of the fact that there was a ancillary drug present in the implants which could enter my body through the envelope.

I experienced very rare CNS symptoms and want to know how much and in which form the methylene  blue was? 1% solution or powder?

My story
I had medical devices which gave me  many health problems.
The breast implants I received after breast cancer, contained a substance that caused an interaction with medication I used.
At  removal  (oktober 2012) of the Monobloc hydrogel implants  the blue dye/color which was inside the implants,  was disappeared, …leaked into my body.

At explantation they were yellow/brown.

Many health symptoms disappeared after removal  including severe skin rashes.

Upon inquiry it appeared that  this substance was  Methylene blue /  Methylthioninium chloride.
In the leaflet of medication paroxetine I used was stated,  not to use methylene blue.

At EMA Methylthioninium chloride is  known as drug associated with contra-indications and interactions:
Allergies;  not to use with  renal failure;  G6PD Deficiency and Methylene blue is known to have highly potent reversible MAO-A inhibitor activity at nanomolar concentrations.

The ANSM removed  a product FFP blood plasma from the market containing residues of methylene blue because of allergies. 

Although this is another route of administration,  this was only a residue of 8 µg / L.

The implants I had contained about 5000 µg/L .

I have lost precious years of my life, my work and even more frustrating nobody took this serious and even had to pay for my removal operation.

I am also concerned about other women, not only interactions and allergies but because Methylene blue can cause fetal harm when administered to a pregnant woman. An association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. Methylene blue is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Awaiting your answer.

With kind regards,

Marga van Amersfoort


Het antwoord wat ik dus kreeg van de Notified Body is een verwijzing naar de ‘consent’ waarin stond dat er methyleen blauw in zat.

Hier had ik notabene zelf voor gezorgd bij de IGJ.

Ik had zelf een klacht ingediend bij de IGJ over een stof die tegelijkertijd een medicijn is.

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