![]() The same process is not required for medical devices. To approve a prescription drug, medicine must be tested in humans, the manufacturer must compile data on its effects and a panel of FDA scientists must give it final approval. “My great hope is you watch this film and then you are really, really, really careful and ask a lot of questions and do a lot of research.”Ī number of factors are responsible for the catastrophes captured in the film, but the documentary lasers in on the FDA’s 510(k) pathway for approving medical devices. “If we can’t change the laws and we can’t convince companies to put moral issues above profits, then all of us really have to be vigilant,” said The Bleeding Edge’s producer, Amy Ziering. Hundreds of thousands of people in the world may have been exposed to toxic metals from “metal on metal” hip implants, according to a 2012 joint investigation by the British Medical Journal and BBC Newsnight. Tower said he would never have believed neurological problems could come from orthopedic devices, if it wasn’t for that experience, and now tests the cobalt levels of his patients if they complain of having Parkinson’s or dementia-like symptoms. “Within a month I had an incredible recovery in terms of my psychologic symptoms and ability to think,” Tower said. On the operating table, his surgeon found metal sludge seeping from the device before it was removed. Tower thought it might be related to his metal-on-metal hip replacement and had it redone. So, Tower studied himself until he found the answer in a blood and urine sample: his levels of cobalt, a metal used in rechargeable batteries, were more than a hundred times higher than normal. Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. Stephen Tower, an orthopedic doctor profiled in the film, had developed a tremor and was having a hard time thinking when he decided to scrawl all over the walls and ceiling of a hotel room during a medical conference, eventually using soap as ink. ![]() ![]() Doctors, too, come forward afflicted by the unknown effects of some of these devices. ![]() Dozens of people speak about issues that followed procedures involving medical devices, including women whose intestines fell out of their bodies after robotic surgery. ![]()
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