Many people believe that problematic transvaginal mesh has been recalled from the market.
While it’s true that a few of the more troubling meshes have been quietly and voluntarily removed from the market by industry, the majority remain and are sold and implanted every day.
How can that be considering the reports of complications, pain and permanence?
The answer might fall with the doctors who continue to use mesh.
These are polypropylene mesh implants used to treat incontinence and pelvic organ prolapse.
The formula hasn’t changed much.
Johnson & Johnson and Boston Scientific have their own proprietary name for their version of polypropylene mesh (PP) (Prolene and Marlex) but they are generally the same heavy weight mesh that is used to hold back a hernia.
Some biologics have evolved (pig, cow, and cadaver) but they not commonly used and are often composites that have a portion of them polypropylene.
Needless to say, that’s information women don’t often hear during informed consent. Nor do they hear the mesh is made of polypropylene, it can’t come out, you may have chronic pelvic pain, ongoing infections, painful sex, nerve damage from the blind procedure and a return of prolapse and incontinence.
In some women, a foreign body response incites a systemic autoimmune reaction. Oh, and we have no idea who will be affected this way.
Who would agree to sign onto that? So what ARE doctors saying to patients to convince them to have a PP mesh implant?
At Mesh News Desk, I’ve heard many things from recently implanted women and sad to say, doctors are still not providing true informed consent.
Women Are Told: Don’t Worry, Pelvic Mesh is a lot of Lawyer Hype
Though mesh cases are being settled, the multidistrict litigation amassed more than 104-thousand cases in federal court in Charleston, West Virginia beginning in 2012, more consolidated cases in one court that in any other mass tort.
Plaintiffs have filed defective product 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.
Industry trained anyone and everyone with an MD after their name who was looking for a payday – a greater return on medical procedures.
During trial, doctors have admitted they were expecting a huge jump in income by using pelvic mesh implants that everyone else was using. They were not told that up to 30% of their patients could have life-altering complications.
Women Are Told: The Bad Mesh Has Been Recalled
If you live in Canada, you are told the problems with mesh were just in the U.S., or that the problem has been resolved.
The truth is 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 “ahigher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
In other words it was defective.
But removal from the market does not mean forgotten.
To market a new medical device, first a manufacturer has to name a “predicate” that the new device resembles. That is part of the FDA 510(k) clearance to market that costs a few thousand dollars and takes about 90 days.
It is a fast-track to market that is the “least burdensome” on industry.
Boston Scientific’s ProteGen is the predicate for at least 60 other meshes that were marketed after it. Surprisingly, there is no mechanism within the FDA that sparks a review of subsequent medical devices based on a defective predicate.
In January 2012, after the FDA required manufactures to do post-market surveillance studies, some mesh makers quietly removed theirs from the market instead of undergoing expensive monitoring.
Gynecare Prolift Kit and ProliftM+ by Ethicon (Johnson & Johnson), Gynecare Prosima and Gynecare TVT Secur were quietly removed but not formally recalled.
Without an official FDA recall, the door remains open to reintroducing them to the market, again through the fast-track 510 (k) FDA clearance.
Women Are Told: Mesh has been used for 50 years without problems
This statement has been repeated to women by doctors wanting to implant pelvic mesh and at trial by the defense lawyers for manufacturers – Boston Scientific, Ethicon (Johnson & Johnson) and CR Bard.
The issue is the quantity and type of mesh.
That doctor or defense attorney is referring to polypropylene sutures which have been used for decades for sutures and hernia repair. Since pelvic organ prolapse was thought to be a hernia-like condition, mesh kits with large pre-cut, one-size-fits-all polypropylene mesh were developed.
Of course the quantity of the mesh for a small suture repair and a large mesh implant is not comparable.
As one mesh medical expert for plaintiffs has said, “The more mesh, the more mess.”
Unfortunately, the FDA has not issued any warning about the rate of complications for hernia mesh, though many suffer the same symptoms as pelvic mesh women.
Women Are Told: It’s Not Possible that Mesh is Causing Your Pain
The patient doesn’t have pelvic pain before mesh, then after her implant she is in excruciating pain. The doctor says it couldn’t be the mesh. It’s been placed correctly.
Until recently, studies did not even consider QOL (Quality of Life) as a factor to define the “success” of a mesh placement. Anatomical placement, in other words, mesh in the correct place defined a “successful” outcome.
Never mind that the woman may be unable to leave her bed because of the complications, much less work or care for children. Women were told if the mesh was in the correct place, it couldn’t be presenting you with a problem.
You might want to see a counselor, a psychiatrist or we could send you to pain management.
Countless women have heard that which only serves to add insult to their injury. ###
Jane Akre writes about mesh issues on http://www.MeshNewsDesk.com,your only online news resource since 2011 on mesh complications. I love writing about consumer issues and will help you tell your client’s story. email@example.com, 904-613-2828.
Interviewer and journalist has been turning her writing talents to legal news since she was a whistle blower some 20 years ago. She won her case against News Corp alleging she was fired for attempting to report news distortion to the FCC. The verdict was later overturned on appeal. Since then she has written consumer and personal injury news for a variety of major personal injury law firms. In 2011, Akre created the only website (www.meshnewsdesk.com) dedicated to exposing the transvaginal mesh mess which continues to this day. She loves interviewing lawyers who are working in the public interest! firstname.lastname@example.org