NOVEMBER 4, 2011 – Last July 13 when the U.S. Food and Drug Administration issued the most strongly warning notice yet about complications associated with surgical mesh – women listened. (see back story here). So did men with the same sort of polypropylene mesh for hernia repair as did women with mesh for stress incontinence.
The legal community listened and responded too with frequent ads on television announcing the FDA decision that complications from transvaginal repair of pelvic organ prolapse with synthetic mesh are not rare and that it was no longer clear that the use of mesh was more effective than tradition non-mesh repair. Hundreds of lawsuits have been filed and cases may be heard next year.
It sounded like a recall notice, but not quite. While surgical mesh complications have included pain, infection, bleeding, organ perforation, mesh shrinkage and the return of prolapse or incontinence, the FDA is still on the fence about the future of synthetic mesh. And while a recall is possible, it is not thought to be likely.
Now surgeons are listening too after patients come in with questions and demands to get the mesh out.
MDND talked to a number of pelvic surgeons who are fielding calls and visits from worried and symptomatic patients.
Donald R. Ostergard MD, Urogynecology & Reconstructive Pelvic Surgery, University Women’s Healthcare, U of Louisville, Ky
“We’re taking out mesh right and left for various types of problems and we’re going to see a lot more of it, “ Dr. Donald Ostergard says about synthetic surgical mesh.
“Mesh is the gift that keeps on giving. Erosion occurs, the vagina constricts and there is dysperunia, painful intercourse. You need multiple surgeries to get it out.”
Now at the University of Louisville, he and the residents and fellows are seeing cases of mesh complications that other physicians may or may not decide to remove.
“There is a complication rate is lower in incontinence tape is because there is so much less mesh put in – about ten percent. The more mesh the more complications” he says.
Dr. Ostergard has never been a fan of synthetic mesh.
“I gave a lecture to AUGS in 2006 on this topic and I was called a dinosaur who had his head in the sand about advances. As things have happened I feel vindicated. I wish this had been said some time ago. Polypropylene is not inert even though the manufacturers said it was inert.”
“It’s the biggest public health issue facing us now!”
Robert Moore, MD, Atlanta Center for Laparoscopic Urogynecology, Atlanta, GA
“Patients who had mesh for any reason, if it’s included or not in the FDA warning are seeing the commercials by lawyers and say ‘I’ve got to come see you and have it taken out because it’s been recalled by the FDA.’ Some think it’s infected, should I have it out?” he says he is asked.
Dr. Moore says as a regional center for gynecologic health in the Southeast, they’ve always seen a fair amount of complications but the FDA notification has stepped up patient awareness. The five-fold increase in complication rate that was noted by the FDA in July, has pitted more experienced surgeons against those who were sold on surgical mesh “kits” and their ease and convenience for a financial bonanza.
Dr. Moore blames some less experienced doctors for the complications.
“One of the issues that has come out from all of this is that surgeons have implanted mesh without experience and not knowing how to handle the patient or are sending them to someone who can handle it. We are seeing them and I tell them it’s not the mesh, it’s how it’s put in and by who and how it was attached.”
Still the patients are concerned and nervous and they don’t want it in he says.
“That’s their decision.” And a patient who doesn’t want mesh is not a good candidate for surgery because of the legal liability.
Dr. Moore says that is partially why he and partner Dr. John Miklos are using slightly less mesh even though he says they already had a “judicious use of mesh with proper informed consent” with about 80% of procedures done laparoscopically.
He says ultimately the FDA notice will be a good thing because the patient is more involved and asking more questions and the FDA will likely require a registry of all patients who have mesh implants.
The most challenging removals are those involving larger pieces of mesh such as Avualta, though he doesn’t want to mention one brand over another. And even without mesh a patient can have complications and pain he says. Dr. Moore does not believe some people are just “high responders” or in the “contaminated field” that introduces bacteria during a vaginal mesh implant. Even without mesh a patient can still have pain and complications, he says.
“It’s never been zero percent complications.”
Shlomo Raz MD, Urology, UCLA Health System, Los Angeles
With an busy schedule that any surgeon decades younger would aspire to, it is no wonder Dr. Raz is considered the “gold standard” of mesh removals. His administrative assistant, Elizabeth Vasquez tells MDND that Dr. Raz has four assistants and does 100 to 120 surgeries a month.
How has the practice changed since the July FDA health notification?”
“We’re being bombarded with people coming in with all kinds of complications that others have tried to remove but he can do it,” she says.
Vasquez says they fly in from all over the world. Recently women from as far away as Australia, Uruguay, Texas, the United Kingdom, New York, New Jersey, Florida, Iowa, North Carolina, friends, mother-in-laws and cousins all recommend Dr. Raz.
Dr. Raz is now booking for surgeries to be performed at the end of February. Vasquez says Dr. Raz sees 80 patients every Tuesday and Wednesday, 80 each day. He does surgeries Monday, Thursday, and Friday and that includes removing synthetic surgical mesh, averaging about 15 to 20 a month.
While some women come in for pelvic health testing, Vasquez says mesh has taken over any procedures.
“It may not be the mesh but how it was put in by another doctor. Before our patients came locally and we were not seeing as many severe complications.”
Despite the cost, many of the patients are self-pay meaning they may shell out anywhere from $30,000 to $50,000 for a surgery. An additional abdominal procedure that requires three to five days in the hospital can cost much more though the clinic tries to work with patients to contain the cost.
Vasquez says what the doctor values the most are the hundreds of personal letters that come in from patients finally relieved of a life of pain.
“He reads them all.”
Daniel Elliott MD – Urologic Surgeon Mayo Clinic, Rochester, MN
“At the Mayo Clinic we never used pelvic organ prolapse mesh so I’ve not seen a change at our practice since the FDA notification,” Daniel Elliott, MD tells MDND, but he also ads the clinic is fielding a huge number of telephone calls from women concerning mesh for various reasons whether they had it implanted to treat pelvic organ prolapse or incontinence. A couple of calls a week are coming into the Urology clinic that are mesh-related, he says “whether they express suffering from pain, erosion, or extrusion, or just a concern about having it removed.”
“We see a lot of patients coming in feeling they may have a problem from mesh that they thought was normal or were expected. We’re seeing a tremendous amount of concern.”
Dr. Elliott says the Mayo Clinic has innovated a surgical removal of synthetic mesh using lasers in additional to the traditional surgical removal, and procedure results will be unveiled at a national meeting. As other doctors have expressed, the more mesh, the more difficult it is to remove and the higher the chance of complications.
The Mayo Clinic in Rochester is averaging about 50 calls a week with concerns he says. “All they hear is FDA mesh and warning,” he says and they are doing a “huge number” of anti-incontinence procedures that are not part of the FDA’s warning which addressed specifically complications of mesh repair for pelvic organ prolapse (POP).
Throughout the Mayo Clinics, POP repair is done the old fashion way with sutures which Dr. Elliott says work as well as mesh. He says it was not an institutional decision by an independent decision by the doctors working throughout the Mayo system not to use synthetic mesh when a strong aggressive sales force push encouraged its use.
“The industry always pushes and its the job of the physician to push back. All they want to do is push a product. Independently we said “ ‘why’ ?”
With a suture costing $5, medical sales representatives pushing mesh added $1,500 to $2,000 to the cost of a procedure.
“Why do it if we don’t know if it will work or not? I was doing it for financial reasons. For $5 worth of stitches, I thought it was more of a gimmick for surgeons who weren’t adequately trained. All of us here, at Mayo, I speak for myself, we all have advanced level training for prolapse.”
Mesh is used for transabdominal repairs to treat pelvic prolapse which, Dr. Elliott adds, is not part of the FDA warning.
Peggy A. Norton MD, Chief of Urogynecology, Pelvic Floor Center, faculty University of Utah, Salt Lake City
Dr. Norton talked to MDND by email and was asked how if at all her practice has changed since the July 13 FDA warning of serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse.
“I am seeing more patients but WE NEVER DID VAGINAL MESH AT THE UNIVERSITY OF UTAH, (her emphasis) we are just taking care of other hospital’s complications. They are difficult patients (because they had a bad outcome, they are unhappy, and they are in pain) and if the world were a fair place, all mesh complications would be treated at the hospital where the mesh was put in originally. This would allow local hospitals to appreciate who is doing mesh, who has complications, who should be credentialed to put mesh in, and the overall risk/benefit ratio be appreciated.
“The mesh slings do have complications, but many, many more are done and the number of complications are both easier to take care of and more likely to completely resolve.
“The mesh for vaginal repair of prolapse is more difficult: fewer are done but the number of complications are higher, more difficult to remove, and some of those patients will not completely resolve the problem.”
Dr. M. Tom Margolis, Pelvic Surgeon/Urogynecologist, Bay Area Pelvic Surgery, San Francisco
How has the FDA notification of July 13th changed the practice of Dr. M. Tom Margolis of Bay Area Pelvic Surgery?
“The only thing that changed is people are coming in and saying whatever you do I don’t want mesh in there, to which I respond ‘Don’t worry I won’t put it in.’ ”
As far as calls for mesh removals, he says they are coming in from states all over the country and even as far away as calls from Great Britain. This has led to a removal or surgery to correct a complication of an additional two or three a month, at this point slightly more than before.
“The number of people contacting me has risen significantly and I’m not advertising. I get tons of calls and emails. Business has increased about 5% and I was doing 40 surgeries a week to begin with. I’m happy people are finding they can be treated and can have these problems corrected,” he said to MDND.
The biggest complication and removal problems are posed by the larger mesh kits he says.
“They continue to be challenging and they are hard to remove. The bigger the mesh, the bigger the mess,” he says pointing out the larger kits are the Apogee (AMS) here, Perigee (AMS) here, and the Avaulta (Bard) mesh kits.
Dr. Margolis does not implant surgical mesh transvaginally (through the vagina) because as he said to the FDA expert panel convened in September to consider whether to ban the medical device, the vagina is a “clean-contaminated field” that will always introduce bacteria, and the potential for infection.
He does use mesh laparoscopically for incontinence and occasionally uses biologics and sutures. #