November 26, 2018
A health scandal in the works? Implants are not or little controlled in France.
Little or no checks on prostheses and implants in Europe
It is a potential new health scandal that is emerging in France, but also in several Western countries. An international collective of journalists (ICIJ, including The world and Radio France are partners for France) investigated, and discovered that the implants and prostheses were only weakly controlled.
According to the survey carried out by the ICIJ, theThe bodies responsible for certifying implants and prostheses are content in the vast majority of cases to study a file submitted by the manufacturer. Moreover, these organizations, far from being independent, or public, are in fact private companies which charge certification to manufacturers who request them. Difficult, therefore, to bite the hand that pays you …
Implants, prostheses: in the United States, controls are more stringent
The ICIJ investigation began three years ago, when a Dutch television journalist succeeded in obtaining certification for a vaginal implant, by submitting a dossier with the technical specifications of a … mandarin net! The sequel revealed that the problem was the same all over Europe. Unlike the United States, or the Food and Drug Administration (FDA), a public authority, is responsible for issuing marketing authorizations.
In France, the ANSM, the National Medicines Safety Agency, took several months to communicate a file detailing the incidents involving prostheses or implants. A file full of errors, which considerably underestimates the volume of incidents or accidents involving prostheses and implants. At the scale of France, the range is therefore very wide: between 18,000 and 200,000!
Fortunately, the European legislator has planned to strengthen the regulations by 2020. But on that date, however, implants will still not be treated as medical devices … The ICIJ published a database on November 25, 2018 allowing patients to consult the incidents listed on implants and prostheses, with the model and the name of the manufacturer.
Jean-Baptiste Giraud
