Mesh Medical Device News Desk, July 27, 2018 ~ The fallout from lax federal regulation over medical devices and the harm done to patients, is the focus of a new documentary, The Bleeding Edge, which premiers today on Netflix.
Image: Scene from The Bleeding Edge
Mesh-injured Tammy Jackson, is followed through the film along with her family. Her pelvic mesh implant was among the medical devices, 95% of which are cleared for sale and marketing by a loophole in Food and Drug Administration safety, known as the 510(k).
Pelvic mesh, Essure birth control and metal-on-metal hips all entered the market after assurances from manufacturers that they were safe and effective.
Most medical devices are considered moderate risk or class II by the agency, even if they are to be implanted permanently. Unlike drug reviews, which involve clinical trials and years of research to assure safety, the FDA relies on the honesty and integrity of the device maker that theirs is similar enough to a device already marketed, even if that "predicate" device has been recalled from the market for problems.
"When it comes to medical devices, we built a system that doesn't work for proper regulation," says David A. Kessler, former FDA commissioner. Director Kirby Dick tells the New York Times that the multi-billion dollar medical device industry has exploited those flaws.
Tammy Jackson, the Bleeding Edge
The film looks at the revolving door between the FDA and the industries it oversees. Leave the federal agency, get a cozy job with industry, revolve back into a government position.
It's job security for the few, but at what cost?
Dr. M. Tom Margolis
Jackson is one of hundreds of thousands of women implanted with vaginal mesh, "which costs about $25 to bring to market, and they sell for about $2,000" says urogynecologist, M. Tom Margolis, MD.
Attorney Adam Slater who successfully represents hundreds of mesh injured women, also featured in the film.
At one time there were more than 104,000 defective product lawsuits filed in one federal court in the U.S. alone against seven mesh makers - Johnson & Johnson, American Medical Systems, Boston Scientific and C.R. Bard, among them. In the case of all of the medical devices mentioned in the documentary, there was no long-term data before the devices were put on the market.
Most pelvic meshes used to treat stress urinary incontinence (SUI) are still on the market, while the larger mesh, all polypropylene, used to treat prolapse, have been reclassified as high-risk or class III. That essentially means the bar is raised on proving safety. As a result, most prolapse meshes are no longer on the market.
No matter what medical device, when scientists, working for industry, voice internal dissent that the product is not ready for market, a plaintiff's lawyer says, "the marketing is always going to win out."
The film features Ana Fuentes, who was implanted with an Essure birth control device, made by Bayer. The mother of four is not unable to work because of the complications she continues to experience.
Angie Firmalino, Essure Problems
Angie Firmalino, who founded Essure Problems on Facebook, says even though Bayer announced last week it would remove Essure from the market, more work needs to be done. "That was a win," she tells MND.
Implanted in 2011 she started the Facebook group two years after she was implanted to warn friends.
It originated as a support group, but grew virally online as more and more women found each other and shared their experiences.
Public pressure was a deciding factor in the removal of Essure.
Essure problems took excerpts from the FDA's expert panel meeting and created YouTube Videos. "The more people saw the angrier they got," says Firmalino.
Then Erin Brockovich got involved and the Essure group sent volumes of emails to the FDA and continued to research data within the agency to come to the convincing conclusion that Essure should not have been marketing.
No word on how many women have been implanted with Essure. Bayer says 750,000 kits have been sold worldwide, but Firmalino says they don't know if that translates into women implanted.
Stephen Tower, a physician who was implanted with a chrome-cobalt prosthesis hip, was poisoned which led to a mental breakdown.
Conflicts of interest are addressed with an ominous warning the dangers of devices will grow over time. Medical companies paid doctors more than $2 billion in 2016 to use their implantable devices, says the film.
"The medical device industry has incredible power in Washington, D.C."
"They don't really care," says one patient.
"The only good thing is knowing I'm not alone," says Jackson. ##
See The Bleeding Edge Trailer here