An international survey carried out by 59 media, published on Sunday, denouncing the shortcomings of the control of medical implants (pacemaker, hip prosthesis…) in Europe, particularly in France, referring to incidents more numerous, difficult to quantify and to identify. This investigation, dubbed ‘Implant Files,” was conducted by more than 250 journalists in 36 countries, in the framework of the international Consortium of investigative journalists (Icij), of which those of the World, by Radio France and First Lines (producer of the program Cash Investigation) in France. At the end of their research, they argue that the number of incidents relating to ” medical devices (insulin pumps, pacemakers, breast implants, hip, shoulder or knee) is increasing everywhere in the world.
in The United States, which feature a collection of statements through a database of these incidents would have caused 82 000 deaths and 1.7 million casualties in ten years, and have been multiplied by five, according to estimates by the Icij. In France, according to figures from the national security Agency of the drug (MSNA), which maintains a directory of reports of materials, the number of incidents related to these implants have doubled in ten years, with more than 18 000 cases in 2017 and approximately 158 000 incidents in ten years, according to The World. In Belgium, some 3 800 “incidents” have been identified since 2013, but this count would be ” vastly underestimated “, according to The Evening.
Data bit entered
The data remain globally very incomplete and often confidential, according to the survey, making it impossible to count with precision the incidents and to know the brand and model of the implants placed, and, therefore, to find patients in case of a problem. In France, the “overall number” of devices marketed, for example, is ” not approachable “, recognizes Jean-Claude Ghislain, director, for emergency situations, scientific affairs and strategy, european Agency of the medicine MAN, as quoted by The World.
In France, where the health professionals must report these incidents to the authorities, this obligation would be little respected, while a new european regulation 2017 will simply ask the member States of the EU’ s” encourage ” the doctors to declare them, lament the authors. The survey also deplores the exchanges lack transparency between health authorities concerning these serious incidents, while a european database, Eudamed, should be online in 2020, but member States disagree on the degree of information they give.
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