This is a problem because, as this eye-opening documentary has proven, “what you don’t know can hurt you.” You can view the trailer for The Bleeding Edge below and watch the full documentary on Netflix. The medical device industry is, unfortunately, not transparent when it comes to the dangers of their products. ![]() This film has already changed policies and changed history.” Bayer continues to emphasize Essure’s safety and stated that they are dropping the product for “business reasons.”ĭirectors Ziering and Dick said in a statement about Bayer’s announcement, “This is exactly why we do this work. The film tells the stories of several women who suffered after receiving the implant but were never warned of the potential side effects. One of the products featured in the documentary, Essure is a coiled birth control implant that has caused serious health issues in many women. The documentary has not only pushed viewers to ask more questions about the devices they’re considering but is also exposing the industry and inspiring people to fight for change.Ī week before The Bleeding Edge was released, Bayer announced that it would stop selling Essure by the end of 2018. The problem with devices that are approved this way is that their effectiveness and safety are not properly tested before they reach the market, so patients aren’t warned of any potential risks until it’s too late. The method was created mainly to cut costs and establish an easier way for manufacturer’s to get new devices approved. The Bleeding Edge specifically takes issue with the FDA’s 510(k) pathway provision, which essentially allows a manufacturer to bypass clinical testing in humans and obtain approval for a device if they can prove that it is “substantially equivalent” to another device already on the market. “It’s a system that needs to be much more vigilantly regulated.” “Even if we take these five devices that we focus on the film off, the problem isn’t solved,” warned Ziering, the film’s producer. Products have become much more complex, however, the FDA’s research and testing procedures have been updated very little since they began regulating approvals in 1976. The filmmakers argue that the approval process new devices go through before reaching the American market is outdated and poorly regulated. Many of these individuals, and the documentary as a whole, place part of the blame on the U.S. Throughout The Bleeding Edge, the filmmakers interview a handful of doctors and patients who personally suffered from a medical device. “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.” Why Do Faulty Devices Get Approved? “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,” Academy Award nominated director Kirby Dick told the Guardian. While the film isn’t intended to be a thriller, the answer to this question is quite terrifying. In addition to investigating these hidden truths, the film includes heart wrenching stories of people whose lives have been forever damaged by a medical device, asking the question: “Does the ‘life-saving’ technology pushed by big corporations actually do more harm than good?” ![]() Released on July 27th, 2018, the documentary probes deep into the uncharted territory of the industry by examining poor regulations, corporate cover-ups, and profit-driven incentives that put unknowing patients in danger. “More Harm Than Good?” The Central Question Of The Bleeding Edge While The Bleeding Edge brings awareness to the dangers behind poorly researched products, countless individuals continue to suffer from the decisions of medical device manufacturers.Ī defective medical device lawyer can help you face these large companies to receive the compensation you deserve for the pain and suffering their products have forced you to endure. ![]() If you or a loved one have been injured by a medical product, you may be able to take legal action against the manufacturer. The Bleeding Edge focuses on five specific devices that have severely impacted the lives of thousands. The large industry is responsible for many defective medical devices including hernia mesh, hip implants, and IVC filters, all of which are known to have potentially life-threatening side effects. Why You Need a Defective Medical Device Lawyer When Facing the Horrifying Truths of the Big Medical IndustryĪ shocking Netflix Original documentary, The Bleeding Edge, exposes the dark underbelly of the $400 billion medical device industry in America.
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