Question 2031 — women

Summary

Mr. Joël Aviragnet draws the attention of the Minister of Solidarity and Health to the dangerousness of the Essure definitive sterilization method from the Bayer laboratory (class 3 device; high risk). 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. These springs are made of metals heavy allergens (nickel, titanium, chromium, iron, tin, platinum, iridium), and PET fibers (polyethylene terephthalate; endocrine disruptors in certain conditions). This method, initially presented as non-invasive compared to classic tubal ligation, is however contested. In fact, it causes numerous undesirable and very disabling effects in thousands of French women: extreme fatigue, muscle or joint pain, neurological disorders, abdominal pain, painful premenstrual syndrome, headaches, dizziness, shortness of breath or even heart rhythm disturbances. Failures in the practice, due to poor placement or migration of the springs out of the tubes, can also lead to unwanted pregnancies or organ perforations. The Bayer laboratory not having planned a protocol for removal, these women's only solution is to resort to major surgical intervention to extract these implants (removal of the tubes coupled or not with removal of the uterus). The lack of training of gynecologic surgeons in explantation leads to the presence of metallic fragments of implants left during the first operation and requires a second surgical intervention or even more. While Essure implants have already been withdrawn from the market in various countries such as Finland, the Netherlands and Great Britain, the temporary specialized scientific committee (CSST) of April 19, 2017 issued a favorable opinion on the continued marketing of implants, despite numerous gray areas. The ANSM was also informed on August 3, 2017 by the Irish notified body NSAI that this device was now subject to temporary suspension of its CE marking, as part of its renewal procedure. This suspension took effect from August 3, 2017 for a period of 90 days, i.e. until November 2, 2017. Also, in order to respect the precautionary principle and avoid an increase in the number of victims, he asks him to kindly make this suspension definitive and ensure that these implants are permanently withdrawn from the market.

Machine translation from French. The official text remains authoritative.

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