Netflix ’ s ‘ The Bleeding Edge ’ blasts medtech & FDA

Essure activist Angie Firmalino discusses surgeries with a nurse in Netflix’s ‘The Bleeding Edge.’ 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. 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. 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. Facebook group founder Angie Firmalino recounts her experience following removal of Essure. “Blood exploded out of me,” she says. “It looked like a horror scene.” Award-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. Her doctor told her that Latinas bleed more than other women. Fuentes’ husband left and she eventually lost her job due to excessive medical appointments. After she and the girls ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Blog Food & Drug Administration (FDA) Gynecological Metal-on-Metal Neurological Pre-Market Approval (PMA) Regulatory/Compliance AdvaMed Bayer British Medical Journal Intuitive Surgical JAMA Internal Medicine johnsonandjohn Source Type: news