![]() Scott Gottleib in February 2018 to discuss their health problems, provide years of data on Essure and request that he remove it from the marketplace. Through social media interactions, she identified and organized thousands of women into action, including participation in protests and meetings with US congresswomen sympathetic to their cause.įirmalino and other members of her organization met with FDA Commissioner Dr. The experience prompted her to search to see if other women had suffered similar problems or had mystery illnesses that were likely related to the product. When bleeding and other problems continued following the removal surgery, she returned for observation and describes a horrific scene in a hospital room when blood clots poured out of her. She reveals how these complications contributed to a breakdown in her marriage, the loss of her job, and even led her to surrender her children into foster care as she battled homelessness while waiting to receive disability benefits.įirmalino had Essure implanted and subsequently removed after one of the coils migrated into her uterus. With Fuentes, an accountant executive with four children, we watch as her decision to have a simple, surgery-free procedure brought about severe health issues. The film chronicles her own health problems attributed to the device and the guilt she feels for her role in promoting it to many other women and doctors. Avina, a former spokesperson for the product, worked as a nurse who participated in advocating the procedure and also chose to use it for her own sterilization. ![]() The filmmakers profile multiple women who have had the procedure, including Gaby Avina, Ana Fuentes, and Angie Firmalino. This scarring becomes a barrier preventing sperm from reaching a woman’s eggs. A metal and PET fiber coil device is inserted into the fallopian tubes to create scar tissue. Essure, a hysteroscopically-placed tubal implant is an alternative to surgical sterilization through tubal ligation. The main narrative arc of “The Bleeding Edge” tells the stories of women who have suffered serious health issues after receiving Essure birth control implants. In this article, I’ll discuss the contribution “The Bleeding Edge,” has made to the debate over faulty medical devices and report on some recent developments announced by the FDA and Essure’s manufacturer Bayer. Regular readers of the HSH blog may recall my colleague Renée Vinett’s article on this form of birth control and a related mass tort action. Focussing on patient stories of adverse events relating to medical products such as cobalt-joint replacements and hernia and vaginal mesh, “The Bleeding Edge” pays particular attention to an implanted permanent birth control device known as Essure. The film explores the $300-billion per year medical device industry and the American Food and Drug Administration’s (FDA) approval process. If you’re a Netflix fan who eagerly investigates new releases on the streaming service, you may have already come across a 2018 film called “The Bleeding Edge.” The title might lead you to believe it’s a horror movie, but it’s actually a superbly produced new documentary that is probably scarier than any horror movie we’ve seen.
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