Question 1318 — women

Summary

Mrs. Emmanuelle Anthoine alerts the Minister of Solidarity and Health to the dangerousness of the Essure definitive sterilization method, marketed by the Bayer laboratory. Indeed, Essure implants, 4 cm metal implants inserted into the fallopian tubes, locally create an inflammatory reaction (fibrosis) aimed at obstructing them, thus preventing any fertilization. Micro-implants are made of heavy metals allergens (nickel, chromium, iron, tin, platinum, iridium), and polyethylene terephthalate fibers (endocrine disruptors in certain conditions). This non-invasive, rapid and effective method of female contraception is, however, very controversial because it causes numerous undesirable effects in thousands of women: pain, hemorrhage, uncontrollable migration, perforation of organs, allergies, headaches, shortness of breath, heart rhythm disturbances. These side effects seriously handicap the personal and professional lives of these women. As the Bayer laboratory has not provided a removal protocol, it is necessary for these women victims of this device to undergo major surgery to extract these implants. The lack of training of gynecological surgeons in explantation leads to the presence of fragments metal implants left during the 1st intervention and require a 2nd surgical intervention or even more. These acts increase the risks due to the repetition of general anesthesia and invasive surgical procedures. Since July 2015, Essure has been under reinforced surveillance and since August 3, 2017, under temporary suspension of marketing as part of the CE marking renewal procedure. However, it is a definitive withdrawal from the French market which is requested as has been done in Finland, the Netherlands and even Great Britain since September 1, 2017. Also, she asks him if the Government intends to apply the precautionary principle without delay before withdrawing this product definitively from the French market.

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