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Mesh Medical Device News Desk, June 30, 2016 ~ PART ONE, MYTH BUSTERS- What Women Are Told Today About Pelvic Mesh
One of the problems with pelvic mesh, and there are many, is that patients never receive true informed consent. What would informed consent look like?
Your doctor may say, this mesh is made of polypropylene, a polymer plastic, we anchor deep into your body. It can’t come out. We have no idea which individuals will have complications which that may include pelvic and chronic pain, ongoing infections, dyspareunia or painful sex, nerve damage, a return of incontinence or prolapse. We don’t know if you will be one that falls into the 30% complication rate. You will likely need additional surgery or surgeries to correct the problems or to remove the mesh.
How does that sound? Ready to schedule your appointment for surgery? In case you need more convincing, just catch a YouTube video of the procedure. That is more than most people can take.
We’ve heard many things from women newly implanted with pelvic mesh of them are untrue. So if you have been told you need surgery to treat stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and mesh is the answer, let’s bust some of the myths circulating about the procedures.
Myth #1- Don’t Worry- Pelvic Mesh is a lot of Lawyer Hype
To presume this is true would be to believe that more than 100,000 women in the U.S. have filed lawsuits because their lawyers are looking for a legal “payday” and the women are unwitting pawns in the scheme. Really? How disparaging of women and the legal profession. Fact: The women have filed lawsuits because there is indisputable evidence that the mesh manufacturers - Boston Scientific, Johnson & Johnson, AMS, CR Bard and the others - knew in advance that their mesh would have problems and they did nothing to stop the fast-track train to marketing. They trained anyone and everyone with an MD after their name who was looking for a payday - a greater return on medical procedures. At trials, doctors have admitted they were expecting a huge jump in income by using pelvic mesh implants that everyone else was using. Even the FDA is on record saying that pelvic mesh complications are “not rare” so shame on those doctors who are blaming lawyers and women.
Myth #2 - That Mesh Has Been Recalled
The Fact: Few meshes have been recalled although a few have been quietly removed from the market for “business reasons,” according to the manufacturer. The ProteGen sling, made by Boston Scientific, is an exception. Introduced in 1996, three years later, ProteGen was recalled because of “a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.” In other words, defective.
But removal from the market does not mean forgotten. To market a new medical device one needs to name a predicate and ProteGen is the predicate for at least 60 other meshes that were marketed after it. Sort of like saying our car is similar to the exploding Pinto, but don’t worry! BTW- There is no mechanism within the FDA to review meshes based on a defective predicate.
In January 2012, after the FDA required manufactures to do postmarket surveillance studies, some mesh makers quietly removed theirs from the market. Gynecare Prolift Kit and ProliftM+ by Ethicon (Johnson & Johnson) Gynecare Prosima and Gynecare TVT Secur. The Ethicon/Gynecare/Johnson & Johnson pelvic meshes quietly went away but were not formally recalled.
Myth #3- Pelvic mesh is FDA approved!
This is scary and untrue. Fact: The FDA does not approve mesh based on safety or efficacy. The FDA approves most medical devices for sale. Classified as Class II or moderate risk, the permanent implant is not required to undergo clinical trials (human testing) which would most likely have shown the complications such as mesh erosion, infection, mesh shrinkage, nerve entrapment, etc. The FDA’s own 510(k) approval process allows manufacturers to take the “least burdensome” route to approval, regardless of the fact that the “burden” then rests on the poor patient who discoverers after the fact that their device was marketed based on assurances from the manufacturer who has the most to gain by its marketing.