An international survey conducted by more than 250 journalists around the world has revealed serious shortcomings in the control and monitoring of medical implants such as pacemakers, hip prostheses or even stents and valves.
A gigantic investigation called “Implant Files” conducted by more than 250 journalists in 36 countries, as part of the International Consortium of Investigative Journalists (ICIJ), revealed serious shortcomings in the monitoring of medical implants such as pacemakers, hip, knee and shoulder prostheses, stents, valves, breast prostheses or insulin pumps.
French Radio who, like The world and Cash Investigation, participated in this investigation, denounces the “incredible lightness” of the National Agency for the Safety of Medicines and Health Products (ANSM). Supposed to list all the incidents that have occurred with these medical implants since 1998 to guarantee reinforced control and monitoring of their proper functioning, it would seem that the database in question is dangerously incomplete.
“We can also wonder about the responsiveness of the health authorities”
“28,560 statements give no explanation of the nature of the incident. The rows of the table are simply empty”, denounce the journalists. “2,282 incident reports are not dated. It is therefore not possible to identify when the incident occurred. While reports are generally supposed to be made 48 hours after an incident, 7,398 reports were made a year or more after they took place. In one case, the statement was even made eight years after the incident!”
Journalists go so far as to question the responsiveness of the ANSM, which is supposed to detect any malfunctions of these implants and stop their marketing if necessary. “We can also wonder about the responsiveness of the health authorities, since 125,514 of these incidents did not lead to any decision”.
And for good reason. The number of incidents that have occurred due to these implants has increased all over the world. In the United States, they would have caused 82,000 deaths and 1.7 million injuries in ten years. In France, the number of incidents relating to these medical implants has doubled, with more than 18,000 cases in 2017 and around 158,000 incidents over the past ten years. disturbing data, recognized by Jean-Claude Ghislain, expert on the matter at the ANSM. “It is true that there are late declarations. It is clear that there is not yet a completely perfect reporting practice in France, and I do not know if it will be easily one day. .”
Scandals related to breast prostheses
These flaws make it possible to better understand how a health scandal such as that of the Poly Implant Prothèse (PIP) breast prostheses could have arisen. In France, 30,000 women (and more than 400,000 worldwide) were carriers of these fraudulent breast implants which recorded an abnormal rate of ruptures and the use of a gel “different from that declared when placed on the market “.
Recently, the ANSM has advised surgeons not to use breast implants with a textured shell. These materials have been linked to the development of anaplastic large cell lymphoma, a rare and aggressive cancer. 53 cases of anaplastic large cell lymphoma have been associated with breast implants (ALCL-AIM) declared to the ANSM between 2011 and July 2018. Among these 53 patients, five died, three of which were linked to progression of ALCL. For the other two patients, imputability remains uncertain. Could better maintenance of this famous database have prevented these incidents and deaths?
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