The incidents are more and more numerous. An international survey carried out by 59 media and published this Sunday, November 25 warns of the multiplication of failures related to implants, whether breast, hip, shoulder or knee prostheses, stents, valves, pacemakers or insulin pumps. As part of the International Consortium of Investigative Journalists (ICIJ), the 250 journalists from 36 countries denounce shortcomings in the control of these medical implants in Europe.
In France, 158,000 incidents in 10 years
Called “Implant Files”, the study shows that the number of incidents is increasing all over the world, testifies The world. In the United States, they have caused 82,000 deaths and 1.7 million injuries in ten years, according to a collection of statements. According to ICIJ estimates, they have thus been multiplied by five. In France, the National Medicines Safety Agency (ANSM) records the reports. With more than 18,000 cases in 2017 and around 158,000 incidents in ten years, the number of incidents has doubled over this period.
But for most countries, the data remains incomplete and often confidential. The problems associated with implants are therefore difficult to quantify and identify, explain the journalists. While in France, health professionals must report incidents to the authorities, the obligation would be little respected. Only 1 to 10% of adverse effects would also be identified.
It is thus impossible to find patients who have faced problems, or to know the brand and model of the implants. Investigators also denounce the ease with which manufacturers can obtain the “CE marking”, allowing their devices to be marketed in Europe. They just need to request it from a private certification body of their choice, which they will remunerate.
“A zone of shadow and worry”
Medical devices represent “A zone of shadow and worry”, acknowledged the Minister of Health Agnès Buzyn. Asked in a report by Cash Investigation broadcast tonight on France 2, she believes that the category of implants “Is insufficiently regulated, it is an area of concern for the minister that I am”. When implants do not meet current health standards, they can cause severe pain, or worse be the cause of cancer.
Asked by France Inter this Tuesday, November 27, the minister nevertheless stressed that she wanted “Reassure the French, because faced with this European scandal, [le risque] is not equivalent in all countries ”, before adding: “France had implemented a lot of things, for example the obligation to register all medical devices for twenty years. We are almost the only country in Europe to have had an evaluation of virtually all implantable medical devices for years ”.
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