Mesh Medical Device News Desk, October 4, 2016 ~ The American Urogynecologic Society’s 2016 PFDWeek (pelvic floor disorders) featured pre-conference workshops about the procedures still on the market to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but the undercurrent of pelvic mesh litigation was still on the minds of many.
The ethical considerations behind exploring new technology in minimally invasive surgery brought my husband and I to a Tuesday morning session, September 27, Advances in Laparoscopy and Robotic Reconstructive Pelvic Surgery. The course faculty was Kevin J. Stepp, MD, of the Carolinas Healthcare System in Charlotte, Andrew Sokol, MD of George Washington University Hospital and John Miklos, an Atlanta area urogynecologist were on the panel.
Up for discussion was abdominal sacral colpopexy (ASC), considered the Gold Standard of pelvic surgery, now that most of the major pelvic organ prolapse (POP) meshes have been taken off the market.
Does robotic surgery offer a novel improvement to traditional surgery? What are the responsible and ethical consideration for exploring a new technologies in minimally invasive surgery, especially considering 100,000 lawsuits that have been filed against polypropylene pelvic mesh?
A sacral colpopexy is prolapse of the top of the vagina downward, not uncommon after a hysterectomy. The procedure can use mesh, porcine (pig), cadaver fascia or tissue from the patient. The goal of the abdominal surgery, which can be done laparoscopically, is to replicate the natural anatomic support normally presented by the uterosacral and cardinal ligaments.
The panelists agreed – they are getting more requests to do the procedure without mesh but biologic products, the data shows, doesn’t work as well, said one.
Then there is the concern about intestinal and urinary tract injuries from trocars, used during the procedure, as seen in the Baggish report, said another.
The sacrospinous ligament fixation is surgery that restores the uterus or vaginal vault to its natural position in a woman who has had a hysterectomy. The stitches can be permanent or absorbed over time.
An estimated 11 percent of women will require one of these surgeries in her lifetime says the IUGA, International Urogynecological Association.
Robotics promise the latest and greatest technology that some doctors will turn to but each machine costs roughly $2 million plus annual maintenance. Many will jump on the technology bandwagon like driverless cars, but even with robotics, not everyone is of the same skill set, warned Dr. Miklos.
In a power point presentation, Miklos said early adapters are driven by image, ego, the institutional culture, a risk taker personality and the promise of financial gain. Later adapters are generally more conservative, risk adverse, and have less financial reason to adopt a new process or product.
Dr. Miklos was an early adapter and the first to bring the TVT (tension-free vaginal tape) to the U.S. from Sweden. Even though today he has misgivings, he still supports the use of TVT mesh for incontinence, but many who followed were challenged by the steep learning curve.
“It’s important you identify your forte and extrapolate and utilize to the best of your ability to meet the needs of your patients.” Patient first and your reputation follows, he said.
He reminded the urogynecologists present that surgeons and industry have a responsibility to patients to recognize and understand the complications associated with such a device so a patient can be treated in a more timely fashion and minimize needless suffering.
Later in the day another discussion, Mesh Graft Use in Pelvic Reconstructive Surgery, led by Drs. Lucente and Cassidenti, was supposed to focus on surgical options.
Instead, a defense lawyer was present. Lisa Floro is the Associate General Counsel for Urology Care for Coloplast, a manufacturer based in Denmark that makes healthcare products and is one of seven mesh manufacturers facing 2,550 product liability lawsuits in federal court in Charleston, WV.
It was her job to describe the “Cycle of a Mass Tort” to the doctors present. There were no plaintiffs’ attorneys to lend balance to her claims. And the two doctors on the panel are currently consultants to Coloplast, among other mesh makers.
As an observer who understands the plaintiffs side after reporting on nine pelvic mesh trials, the lack of the other side of the story appeared to be a tangible example of how bias seeps into industry-supported instruction.
In the changing litigation landscape, both panelists had lost lucrative consulting dollars. According to trial testimony, Dr. Lucente was a preceptor for many doctors in training, including Ethicon, maker of the Prolift mesh for POP which is no longer on the market.
Dr. Cassidenti was working with American Medical Systems as a consultant and trial expert, but AMS was sold to ENDO International, which decided to close down its mesh division, Astora Women’s Health and with it, his preceptorship. See a background story here.
On more than one occasion, Dr. Cassidenti blamed pressure from plaintiffs’ attorneys for closing AMS.
“What can we do to keep products that are very helpful to our patients?” he asked. Currently only Restorelle by Coloplast and Uphold by Boston Scientific remain on the market as a treatment for POP.
“He is loose on his rulings,” said Coloplast’s Floro, referring to federal Judge Joseph Goodwin who is overseeing the MDL in West Virginia. She was referring to some rulings that had gone in the favor of the defense, and some that had not. Of the 20 trials so far over pelvic mesh, defense has won six after juries looked at both sides.
Dr. Cheryl Iglesia from Washington D.C., said she is getting questions from her patients who want to sue and ask who to go to. “What do I say to that patient?” she asked Ms. Floro. “I don’t know what to say. I didn’t know if there was a website that was reputable,” she asked.
Another women in the audience chimed in, “Are any reputable?”
“We do see a decrease in advertising in pelvic mesh litigation. The plaintiffs’ bar has move on to other litigation, Xarelto, talc, Volkswagen,” said Floro, who cynically compared pelvic mesh litigation to consumer fraud class action lawsuits filed over products such as Nutella where claimants can get a coupon for $5 for their trouble since the product was falsely marketed as healthy.
One doctor suggested women were “looking for a payout,” as a reason for the 100,000 plus lawsuits against seven mesh manufacturers. Another doctor said women are coming into her office proudly displaying a check they were awarded as part of mesh litigation.
Cassidenti asked “Do you think when the industry gravy train is over, will they come after the physicians?”
Women who fly across the country to have their mesh removed return to their primary physician and that is a problem, opined another urogynecologist. AUGS is working on removal guidelines so that women no longer have to seek removal experts who live long distance.
Dr. Lucente suggested a woman came to him with pain after a cross country mesh removal odyssey, only to receive a shot and then she was okay.
Dr. Donald Ostergard, one of the founders of AUGS, who was first to suggest to the early adapters that “mesh is not inert,”stood up and asked if anyone know about Boston Scientific and allegations it smuggled counterfeit mesh resin into the U.S. from China when it could no longer buy resin domestically.
The doctors hadn’t hear anything.
“Tell us about it, Don.”
Dr. Ostergard suggested that Boston Science mesh made after 2012 might contain a substandard mesh and that Scotland had stopped selling it, all of it.
“Emotion, Fear and an alarming reaction gets way in front of the facts of science,” suggested Dr. Lucente, comparing mesh to the morcellator medical device that grinds up the uterus and sometimes fibroids masking deadly and aggressive uterine cancers. ###