Update 4/16/19: “The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately.” (It certainly took the FDA long enough).
Have you seen The Bleeding Edge?
It’s a Netflix documentary from the filmmakers behind The Invisible War and The Hunting Ground, Kirby Dick and Amy Ziering, and film producer Amy Herdy (See here for the trailer).
If you haven’t seen The Bleeding Edge, please do. It focuses on women and men harmed by medical devices approved by a broken regulatory system that lines the pockets of corporations like Bayer and Johnson & Johnson at the expense of the health and safety of the American people. The faulty medical devices featured in this film include Bayer’s Essure contraceptive, DePuy’s ASR hip implant, the Da Vinci surgical robot, and Johnson & Johnson’s transvaginal mesh.
As you may remember, I wrote a novel about transvaginal mesh.
My novel, Amelia Elkins Elkins, is a retelling of Jane Austen’s Persuasion that focuses on the impact of a failed medical device on the Elkins family, a modern version of the Elliots, who are thrust into a lawsuit that brings the title character into contact with her ex-partner, a modern version of Frederick Wentworth.
For the book, I researched the real-life litigation, the painful factual allegations of the injured women, the laughable evidence the companies touted to support the implantation of transvaginal mesh into people, and the loophole the companies used to get the FDA to approve their defective product. The Bleeding Edge discusses this loophole in detail, so I won’t spoil it for you here.
I highly recommend watching this documentary and then doing something proactive about the proliferation of unsafe medical devices in the United States.
Max at Litigation and Trial, an attorney who represents people injured by medical device companies (to the extent Congress and the courts still give us a right to sue), has listed a few steps you can take to protect us from unsafe medical devices.
Contact your Representative and Senators in Congress and tell them:
(1) you saw The Bleeding Edge and you are concerned about medical devices;
(2) you want them to pass a bill fixing the 510(k) loophole in the Food, Drug, and Cosmetic Act, like what would have been done by H.R. 3847, the SOUND Devices Act of 2012;
(3) you want them to pass a bill like H.R. 2164 that will allow victims to bring lawsuits against “premarket approved” medical devices;
(4) you want them to regularly hold hearings about the FDA and its decisions, to ensure it is always acting in the best interest of patients; and
(5) for Senators, you want them to only confirm judicial nominees that respect your Seventh Amendment right to a jury trial.
To find out more, check out his post (linked above), and please, watch the documentary. Thanks.