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Roughly 1 in 10 Americans, 32 million, have a medical device implanted – artificial hips, knees, shoulders, ankles, pace makers, stents, cataract lenses, surgical mesh, breasts, IUD’s, – are all just a part of a rapidly growing list. A study in JAMA Internal Medicine showed from 2008 to 2012, the FDA approved 400 implanted devices of moderate to high risk without any clinical testing. In 2015, the Food and Drug Administration received 16,000 reports of deaths associated with medical devices, yet one analysis estimated that only one percent of device-related deaths are reported to the FDA.
A recent article in The New York Times brings the dangers of medical implants into stark relief. In this case it was a metal-on-metal hip implant that almost killed Orthopedic Surgeon Dr. Stephen Tower. In 2006 Tower’s hip failed and he was implanted with a metal-on-metal ASR XL, made by Johnson & Johnson. It was an implant he was very familiar with, having specialized in implanting the very same joint and similar others in his patients. Dr. Tower’s own ASR implant was the beginning of a medical saga that has become all too familiar for other hip implant recipients. In his case The New York Times reported:
“Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.”