![]() “As far as medical device approval in this country, as depicted in 'The Bleeding Edge,' there is a great deal of work and change that needs to bring about stricter, and more thorough, approval processes,” the group’s founder Angie Firmalino and her fellow “ Essure Sisters” Amanda Dykeman, Amanda Rusmisell and Holly Ennis told Medtech Insight in a Sept. The effort ultimately mushroomed into a full-fledged, non-profit advocacy organization of thousands of similarly afflicted women searching for solutions to their Essure-related health issues, she says.ĪSHES leaders say they “intend to extend our advocacy work to focus on many different medical devices,” and have started working with advocates and other groups on a new platform called “Medical Device Problems.” ![]() In her online search for medical answers and physicians who might be able to remove the device, she launched a Facebook page for other women who had similar complaints. ![]() One, in particular, is ASHES, founded by Angie Firmalino, who had the Essure coils implanted several years ago after having her last child, but later starting experiencing pain, heavy bleeding and auto-immune system responses to the devices. The film has provided a high-profile platform to some grassroots patient groups that were formed based on personal experiences with medical devices. FDA's Jeff Shuren made the case that supporting innovation and protecting patient safety go hand-in-hand. Industry, US FDA Defend Innovation As A Force For Good By David Filmore Īt this year's MedTech Conference, AdvaMed said it will go the distance to defend industry against unfair attacks, and it downplayed assertions made in The Bleeding Edge documentary. (See sidebar, "Industry, FDA Defend Innovation As A Force For Good.") The device sector has pushed back against the film, calling it a one-sided "hit job" against the industry FDA is also critical of the film and defends its approach to protecting patient safety. The documentary premiered on Netflix in July and it has since captured significant media attention. ASHES leaders tell Medtech Insight they have started working with other advocates on a new platform called “Medical Device Problems.” In many cases, advocacy groups that initially formed around individual patients’ experiences with faulty hip replacements or painful encounters with pelvic mesh or the Essure implanted coils, are coming together and joining ranks to tackle other medtech safety issues. ![]() They plan to use the documentary as a platform to push for more thorough device oversight from FDA. The film targets four products, among others – Bayer’s Essure sterilization device, Johnson & Johnson’s ASR metal-on-metal hips and ProLift pelvic mesh products, and Intuitive Surgical’s da Vinci surgical robot – in an effort to illustrate how device manufacturers and FDA have leveraged the device regulatory system in the last 20 years to permit many novel medtech products to slip onto the market before thorough safety testing.īut participants in the film say they are not satisfied with talking about negative encounters they had with just a few medtech products that initiated their activism. Health groups including Advocating Safety in Healthcare, Essure-Sisters (ASHES), and the National Center for Health Research (NCHR), led by Diana Zuckerman, say they plan to use the documentary film "The Bleeding Edge," to educate the public on harms that can be caused by medtech.
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