The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny.
The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about medtech companies, the FDA and the European device approval system, a new International Medical Devices Database, resources for patients, and a list of its many international media collaborators. Investigators collected more than 8 million device-related health records over the course of the investigation, the majority of which came from the more than 5.4 million adverse event reports filed with the FDA over the past 10 years.
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