I am excited that The Bleeding Edge, a Netflix Original documentary from Academy Award nominated filmmakers Kirby Dick and Amy Ziering (The Invisible War, The Hunting Ground), will premiere Friday, July 27th! This documentary exposes the harm incurred by multiple patients resulting from four different medical devices covered by the 510k and Premarket Approval processes. The trailer for The Bleeding Edge was released by Netflix just last week.
The documentary touches on the Essure Problems Group's work on the Medical Device Safety Act (H.R. 2164). As you may know, this bill was introduced in the house in April 2017, by Congressman Brian Fitzpatrick. It is a bipartisan bill co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky, Congressman Peter DeFazio and the late Congresswoman Louise Slaughter. This bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices, including, but not limited to, Essure and Mesh devices. There are over 157 Class III medical devices on the market in the USA. Manufacturers of Class III medical devices currently enjoy federal preemption protection. This is due to the Riegel vs. Medtronic ruling in 2008, wherein the United States Supreme Court erroneously held that the preemption clause of the Medical Device Amendment essentially bars most state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval (PMA) from the Food and Drug Administration.
On July 20th, just one week before the release of The Bleeding Edge, Bayer announced it will be halting all sales and distribution of Essure. This announcement was celebrated by me and thousands of E-Sisters worldwide. Although this was a satisfying victory, there is still much work to be done. The Medical Device Safety Act of 2017 must be pushed through Congress!
I urge you to watch The Bleeding Edge and support me by co-sponsoring the Medical Device Safety Act (H.R. 2164) in the House, or introducing it in the Senate! It’s time to take a bold stand for medical device post-market safety and accountability!