I couldn’t even begin to imagine going through that. The Essure story was tragic and very difficult to watch. #The bleeding edge hip replacement movieI hope every Orthopedic surgeon sees the movie or gets data on those implants. I found the cobalt-steel hip replacements to be of greatest interest, as I suspect this is considered benign and there are likely many patients suffering right now and don’t know why. Thank you for sharing, I would not have seen it otherwise. meet somewhere in between a 510k and PMA. Personally, for higher risk devices, I would advocate for a 510k with a conditional approval, with tight post market surveillance rules and only final approval once the post market data has been assessed, i.e. The same is true for the people working for the regulators and we need to accept the limitations that they need to operate with. We also need to accept that we don’t always have the scientific knowledge nor the test methods nor the prior knowledge to fully identify each and every risk, and also not the knowledge to satisfactorily address each and every question that may come up, without it turning into a major project. However, we also need to keep things in perspective and not have a knee jerk reaction which will end up with increasing barriers and having smaller companies with exciting and vital new innovations going bust because they are waiting forever to have their product scrutinised to the nth degree by the FDA or other regulators. For some of us old timers, we are probably not too surprised that things may go wrong and that motivations of people in the industry are not as honourable as we would like to think. Thanks for bringing the documentary to all the industry insiders’ attention. Attempting to surgically remove the spring lije device from the patients fallopian tubes can cause the Essure device to snap, break and migrate into other areas of the pelvic and abdominal cavity - deeply troubling. The sygical removal process of the spring-like Essure birth control device is tragic. By placing the "burdan" of monitoring the approved medical device upon the device manufacturer is fundamentally flawed. The section of the documentary dealing with the "Essure" birth control device is self evident of a broken medical device approval and monitoring process. The video testimonials from doctors and patient reviving this device were compelling The neurologic damage being caused by "cobalt toxicity" is deeply troubling. "The Bleeding Edge" disloses incidents of sevvere adverse effects of Hip Replacement materials made from "cobalt steel." The FDA 510(k) Functional Equivalency Medical Device approval process is broken because a new medical device can achieve FDA approval even if the 510(k) medical device petition is predicated on a formerly approved, dangerous, FDA recalled medical products. Amy DeWinter, I was shocked by he NetFlix documentary "The Bleeding Edge."
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