Apparently, the FDA felt it had to respond to the points made in the excellent Netfix documentary "The Bleeding Edge" by Writer/Director Kirby Dick and Amy Ziering. If you haven't seen it please take the time and make sure to bring a box of tissues. These wonderful filmmakers and the brave subjects bring to light the power of the Medical Device Industry (worth $40 Billion with a B) over our the FDA. The subjects of the film from the orthopedic surgeon poisoned by metal from his own hip replacement to the thousands of women suffering unrelenting never-ending pain from the metal wire contraceptive device Essure, illuminate that the FDA miserably failed to protect innocent patients from manifest threats to body and soul of people throughout this country and the world.
On March 8, 2019, Kaiser Health News exposed a secret mountain of reports of malfunctioning medical devices regulated by the FDA which were virtually hidden from the public, doctors, and patients. https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/ "Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy" according to Christina Jewett of Kasier Health News. In particular, Ms. Jewett found at least one device, with life threatening implications, a surgical stapler had 10,000 reported malfunctions which were not found in the relied upon data base. In fact, only 100 such malfunctions where found during that time.
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