Hidden Harm
Kaiser Health News revealed that, for nearly 20 years, the FDA struck deals with medical device makers to keep millions of malfunction and injury reports out of a trusted public database relied upon by doctors, researchers, and patients for information about injuries, deaths or malfunctions linked to breast implants, surgical mesh, artificial knees and hundreds of other medical products. Instead, the FDA allowed companies to submit these reports to an internal database so obscure that it was unknown to safety experts, doctors, and even a recent FDA commissioner. As a result of this reporting, the FDA published its entire hidden database online in June 2019, revealing 5.7 million device-related injuries or malfunctions for the first time.
Read more about the story behind the investigation in this piece by The Journalist’s Resource.
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