Question 25802 — women

Summary

Mr. Alain Perea questions the Minister of Solidarity and Health on recent advances in establishing the lack of safety of Essure implants and on the significant deterioration in the state of health of women who carry them. The Essure medical device was placed on the French market in 2002 by the company Conceptus, acquired by Bayer Healthcare in 2013, with the aim of permanent contraception for women through hysteroscopic. For several years, a substantial number of women wearing the device, both abroad and in France, have experienced significant side effects, sometimes serious, including neuropsychiatric symptoms. The picture presented by these women was, in the majority of hypotheses, created quietly, over several months or even several years. It has had considerable negative repercussions on their lives, both family, professional and social level. The medical profession as a whole, taking into account both the diversity of the ailments presented and their time of onset, was unable to provide them with appropriate care. Very often, moreover, no underlying pathology capable of explaining the etiology of these symptoms and ailments could be diagnosed. The profound deterioration in the state of health of these women has not yet been able to subject to appropriate medical care. For many, the lack of identification of one or more medical causes for their complaints has led to a significant loss of credit and disrepute, both among their family, social and professional circles and among the medical profession. It generated, if not a rejection, at least an isolation which resulted in the development of self-medication behaviors added to attempts at habituation (mainly to pain, fatigue, reduced cognitive faculties). Thanks in particular to a significant number of materiovigilance reports, the National Medicines Safety Agency (ANSM) has implemented specific monitoring and reinforced surveillance of the Essure device. On August 3, 2017, the CE marking certificate of the device was temporarily suspended by the organization in charge of its renewal. The reasons for this suspension remain unknown. The Bayer company announced, on September 18, 2017, its decision to end the marketing of Essure in all countries, including France, with the exception of the United States. At the same time, the ANSM set up a temporary scientific committee, whose function was to decide, taking into account the new scientific data acquired, on the risk-benefit balance sheet. presented by the Essure device. In a report dated April 19, 2017, this committee failed to scientifically demonstrate the causality between the extra-gynecological symptoms presented by certain patients following implantation and their regression if not their disappearance upon explantation. The group of experts nevertheless noted that a body of evidence “argues in favor of the etiological role of the implantation of the device without be able, however, to establish proof” (report, p.9). The experts of this committee retained the hypothesis of galvanic corrosion and expressed their opinion on the plausibility of a causal link between the metals contained in the implants and disorders and symptoms other than locoregional. This is why the scientists and doctors authors of the report recommended carrying out “a macroscopic and microscopic analysis of the explants (from removals in former female carriers) and associated tissues, could provide elements of response to the uncertainties raised” and believed that “a characterization of the corrosion products could also be carried out on these explants” (p. 14). Since then, more than two years after these scientific recommendations, no study of this kind has been conducted by the national agency. The reasons for this absence are unknown. The deficiency of the national agency was made up for by certain victims who, after having undergone organ removal (uterus and tubes), had the tissues in contact with the implant and the implants themselves analyzed, at their own expense. One of them, also a surgeon, published the results of these analyzes in the daily Le Monde on July 24, 2019. The results are edifying. They establish that the device has considerably degraded in its body, at the level of the welding of the metal rod and the turns, by significantly releasing tin particles. Furthermore, blood biology shows in this patient a level of nickel in the blood almost three times higher than the norm before explantation and dropping spectacularly three months after explantation. The director of this laboratory, recently interviewed by journalists, confirmed these results by microscopic analysis of samples from other explanted patients. The scientific results he obtained, and which will give rise to a scientific publication in the coming weeks, confirm the degradation of the implant, at the level of its welding, and the release into the bodies of these women, in their tubes and uteruses, of significant particles, particularly tin. However, the toxicity of organic tin, particularly from a neuropsychiatric point of view, is known. The clinical picture that such intoxication is likely to cause is reminiscent of that which these women present. Taking into account these elements, he asks it, firstly, to know whether the reasons why the CE marking was suspended in August 2017 can be made public and secondly, in its capacity as supervisor of the ANSM, to communicate the reasons why the recommendations made by the scientific committee regarding the carrying out of macroscopic and microscopic studies of implants and associated tissues were not followed. He also asks him to make known his intentions regarding the establishment of a compensation fund backed by ONIAM for these victims and regarding the implementation of a medical care system since he is now demonstrated that victims of the Essure device suffer from poisoning, particularly from organic tin.

Machine translation from French. The official text remains authoritative.

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