Question 25447 — women

Summary

Mrs. Laurianne Rossi alerts the Minister of Solidarity and Health on the consequences of the installation of definitive contraceptive implants Essure, which concerns more than 170,000 women, as well as on the protocol for removing these implants. Essure is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age, composed of an expandable nitinol (nickel-titanium) spring and polyethylene fibers (PET). It is placed in the fallopian tubes by an obstetrician-gynecologist. Marketed in 2002, this implant had its marking withdrawn in August 2017, before being withdrawn from the European market from September 18, 2017. Many women with this implant have developed various symptoms, sometimes serious, which involve the carrying out of numerous consultations and examinations as well as the prescription of multiple work stoppages. Some women have notably been placed on disability due to the unexplained but real deterioration in their state of health. In order to remedy the health consequences of the Essure device, the National College of French gynecologists and obstetricians has developed a protocol for the explantation of the device and the decree of December 14, 2018 limited the practice of the act of explantation of devices for tubal sterilization at certain health establishments. However, the association Network of mutual aid, support and information on tubular sterilization (RESIST), approved by the Ministry of Health which helps, supports and informs implanted women, considers that it is necessary to better inform as soon as possible women who have had an Essure implant, of the serious lesions and side effects including they may be victims and the possibility of withdrawal available to them, in particular by inviting all health professionals concerned to recontact their implanted patients or by the creation of a national register. The association also believes that it is necessary to raise awareness among health professionals about removal as well as the protocol to follow since the health effects of Essure implants are very worrying. when removal damages the implant. It would also be necessary to specify the conditions for this removal by establishing a national explantation protocol common to all gynecologists, in order to limit the risks of breakage, dispersion of fibers within the human body and re-intervention. Consequently, it would like to know the additional measures it is considering to inform as soon as possible the more than 170,000 women who have had an Essure implant as well as the measures envisaged to increase professional awareness of compliance with a national withdrawal protocol and thus limit the dispersion of fibers in the human body and their health consequences.

Machine translation from French. The official text remains authoritative.

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