The Implant Files are a globe-spanning investigation into the behaviors of the medical device industry. More than 250 journalists from 36 countries have been involved in the investigation, which started when Jet Schouten, an investigative journalist for Dutch Public Broadcasting, ran an experiment to see if she could get a mandarin net approved as a vaginal mesh, and nearly succeeded. The investigation has led to reports that a number of devices are approved without clinical studies, putting patients at risk.
We spoke to Katrin Langhans, who worked on the Implant Files for the Süddeutsche Zeitung about her part in the investigation and what the findings might mean for patients. Langhans says: “Even the…head of the (U.S. Food and Drug Administration) FDA once said that we in Europe are the guinea pigs of the whole world when it comes to medical devices.”
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