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AdvaMed and the companies did not immediately respond to MassDevice’s request for further comment. The FDA, Bayer, Johnson & Johnson, and Intuitive Surgical declined to be interviewed for the film. When the filmmakers take aim at medtech lobbyists, AdvaMed president Scott Whitaker counters, “We want to make sure that new medical innovations get to patients and help save lives, improve the human condition, eliminate suffering and make this world a better place. They’re talking about … putting untested devices on the market. They’re not talking about stifling innovation. “Too often you hear people say, ‘Oh, you’re going to stifle innovation. “Just because you have a new technology doesn’t mean it’s innovation,” adds Redberg. “They wheel out patients and they say, ‘This person wouldn’t be alive today if it wasn’t for this innovative product,’” says Deborah Cohen, associate editor of the British Medical Journal. The filmmakers also slam the industry for its focus on innovation. “That’s how metal-on-metal hips got on the market.” “There’s a lot of problems with that 510(k) system,” adds Rita Redberg, MD, a cardiologist and editor of JAMA Internal Medicine. “So, the vast majority of devices today, regrettably, are regulated under this framework.” That exception became the rule,” Kessler says. “That provision, which was meant as an exception - in essence, a little loophole. Introduced in 1976 at the request of the medtech industry seeking speedier, less expensive approvals than required for a premarket approval or PMA, the 510(k) process allows for FDA clearance of “substantially equivalent” devices with less research. “The problem we have is, when it comes to medical devices, we built a system that doesn’t work.” “FDA does a credible job with the vast majority of products,” former FDA commissioner David Kessler says in the film. It dissects the 510(k) approval process, pointing out that predicate devices that have been recalled still count toward approvals. The film also includes criticism of the industry and the FDA by watchdog groups, doctors and former FDA officials. Tower, who had revision surgery with a plastic-and-ceramic hip, now speaks to groups of physicians on the hazards of metal hips. Orthopedic surgeon Stephen Tower blames high cobalt levels from his metal artificial hip for neurological problems and a mental breakdown. After she and the girls became homeless, Fuentes placed them in foster care. Fuentes’ husband left and she eventually lost her job due to excessive medical appointments. Her doctor told her that Latinas bleed more than other women. “It looked like a horror scene.”Īward-winning filmmakers Kirby Dick and Amy Ziering, of “The Invisible War” and “The Hunting Ground” also followed Ana Fuentes, a mother of four who says that she started wearing diapers to contain her excessive bleeding following implantation with Essure. It focuses on the efforts of women who had Essure implants to get the device off the market through Facebook groups, picketing of medtech conferences, and one-on-one conversations with physicians and lobbying members of Congress.įacebook group founder Angie Firmalino recounts her experience following removal of Essure.

The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial hips, and women whose surgeons used Intuitive Surgical’s da Vinci robotic arm to perform hysterectomies. Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. Essure activist Angie Firmalino discusses surgeries with a nurse in Netflix’s ‘The Bleeding Edge.’