Implant makers and others obligated to tell United States regulators about harm arising from medical devices are significantly underreporting deaths, increasing the odds that dangerous products stay on the market for longer than they would otherwise, a new study concludes. The research, published online by the JAMA Internal Medicine journal last month and based on data from the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database, appears to corroborate a key finding from the International Consortium of Investigative Journalists’ Implant Files investigation. The study found that 23% of reports about patients with medical devices who died were class
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