“We will continue to fight to get Essure off the market immediately,” they said. The E-Sisters say they are galvanized to do more to keep other patients from harm. But the firm said it would continue to allow gynecologists’ and obstetricians’ stockpiles of the metal coils to be implanted through the end of 2019. Shortly after release of the documentary – which included graphic X-ray photos of multiple Essure coils trapped in some women’s bodies that had either been misplaced, migrated out of Fallopian tubes, or broken into fragments while being removed – Bayer said it was pulling the device off the market by Dec. “We will continue to help women harmed by Essure,” ASHES told Medtech Insight. But spokeswomen for ASHES say that’s not fast enough to halt injuries to women from the device. Focus On Essure Stockpiling, Device Safety Billīayer announced July 27 (within days of release of the documentary on Netflix) that it will stop US sales of Essure at the end of this year. 13 statement responding to questions about their plans to leverage the documentary. “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.

(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. 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.

They tell Medtech Insight that they will continued to lobby Congress and US FDA to put more safety regulations and protocols into place for devices. Public health organizations including the Facebook group ASHES/E-Sisters, and the National Center for Health Research, are pushing for wider distribution of and a big impact from the “The Bleeding Edge” Netflix documentary.

Bleeding edge documentary