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(Video 7) THE BLEEDING EDGE Official Trailer (2018) The medical device industry
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DavidWJones
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Published 4 years ago
A terrifying new documentary carries a stark warning that a nightmare has been lurking in the medical industry for decades and it might be in your body. The Bleeding Edge, which premieres on Netflix, examines the $400bn medical device industry responsible for products such as hip implants and robotic surgeons, through the lens of five products that have wreaked havoc on the lives of thousands.“A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals,” director Kirby Dick told the Guardian. “We felt it was very important that the public, doctors and policymakers know about this because right now medical device companies can get away with just about anything.”Dozens of people speak about issues that followed procedures involving medical devices, including women whose intestines fell out of their bodies after robotic surgery. Doctors, too, come forward afflicted by the unknown effects of some of these devices. 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.Tower, his friends and family knew he was in the throes of mental health crisis, but no one was sure why. 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 thought it might be related to his metal-on-metal hip replacement and had it redone. On the operating table, his surgeon found metal sludge seeping from the device before it was removed. “Within a month I had an incredible recovery in terms of my psychologic symptoms and ability to think,” Tower said.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.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.“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.
Keywords
bayermedical devicesfda 510k pathway for approving medical devices

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