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2270

Question 2270 — women

openFrance· National Assembly· FR

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Mr. Joël Giraud draws the attention of the Minister of Solidarity and Health to the difficult situation of women carrying the Essure definitive sterilization device produced by 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 composed of allergenic heavy metals (nickel, titanium, chromium, iron, tin, platinum, iridium), and PET fibers (polyethylene terephthalate - endocrine disruptors in certain conditions). This method, presented as non-invasive, compared to a classic tubal ligation, causes numerous undesirable effects in thousands of French women: extreme fatigue preventing them from carrying out the daily activities or carrying out professional activity, muscle and/or joint pain, neurological disorders, abdominal pain, painful premenstrual syndrome, headaches, dizziness, shortness of breath, heart rhythm disturbances. The German pharmaceutical company Bayer HealthCare recently announced that it was ending the marketing of permanent contraceptive implants. Essure in France. As the Bayer laboratory has not provided a removal protocol, victims of this device whose side effects seriously handicap their personal and professional lives must undergo major surgical intervention to extract these implants (removal of the tubes coupled or not with removal of the uterus). 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. The RESIST association (Mutual Aid, Support and Information Network on Tubal Sterilization), approved by the Ministry of Health, fights daily to support and accompany women victims of these Essure implants and, for some, victims of catastrophic removal surgeries. To reduce these risks, the RESIST association has requested the establishment of an Essure reference center and being by definition a common problem, the victims wish the creation of a central compensation system entrusted to ONIAM dedicated to the investigation of these cases. Also, he asks her to please make him know the Government's intentions regarding this particularly sensitive public health issue.

Machine translation from French. The official text remains authoritative.

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