Mesh Medical Device News Desk, October 10, 2016 ~ It was a Wednesday afternoon course developed to meet the need for clarification among members of AUGS, the American Urogynecologic Society. The setting was its 37th annual conference held in Denver last week.
“Current Status and Future Potential for the Use of Mesh and Slings in Pelvic Reconstructive Surgery,” would be the only session that directly addressed the topic of how defective product lawsuits and trials have directly impacted urogynecologists in their treatment of patients, something we didn’t know at the time.
Dr. Dennis Miller, a urogynecologist from Milwaukee, moderated. Dr. Miller has been identified as the father of the Pinnacle pelvic mesh, now off the market, which he developed with Boston Scientific (BSC).
Geoffrey Cundiff, MD, an OB-Gyn Professor at the University of British Columbia was another panelist.
Charlie Khamis was scheduled to be there to provide “Industry Views,” but Charlie was a no-show. Khamis was with American Medical Systems as a project manager is now with Boston Scientific as the Director of Clinical Strategy, according to LinkedIn.
At the last minute he decided it was “not in their best interest to participate today,” said moderator Miller.
THE HYPE CYCLE
Dr. Miller blamed the 2010 “Hype Cycle” on a sudden increase in the number of complications with transvaginal mesh. The rush to litigation began when the FDA issued two warnings about mesh and its complications, first in 2008, then again in 2011, when the FDA said complications were “not rare.”
The best outcome of the multidistrict litigation (MDL) is that mesh overuse has been curbed, Miller suggested, the worst outcome of the MDL is that a more substantial number of women are suffering and living with symptoms of prolapse and incontinence. To illustrate his point, he showed a videotaped clip of a 2012 Depend commercial with spokesperson, Lisa Rinna.
What was unclear was how the size 00 celebrity, corseted into a bandage dress, relates to any mesh-injured plaintiffs. See video here.
Miller suggested if you “force people together there is probably more agreement than you think.”
That was not to be the case.
Potts began the session. He wore a crisp, grey suit and Carolina blue tie and looked like he was about to launch into an opening before a jury.
Potts told the crowd of approximately 20 doctors that he represents women who have been divorced or committed suicide due to complications from their mesh implants.
“That’s why I’m here today, I took an oath, like you took an oath, to protect our patients and clients above all else.”
Despite the sudden voluntary withdrawal of many pelvic meshes from the market, many remain and are still in use today, he said.
Potts shows a slide of what’s left:
Coloplast still has Altis, Aris, Axis, Restorelle, Supris and Suspend.
Bard has Ajust, Align, Alyte, Pelvilace.
Ethicon has Gynemesh, Prolene Soft Mesh, TVT-Exact, TVT Abbrevo, TVT, TVT-O.
Boston Scientific has Advantage, Lynx, Obtryx, Repliform, Solyx, and Uphold Lite.
American Medical Systems has shuttered its operation and no longer makes pelvic mesh.
The pelvic mesh trials center on product defects and are not focused on the action of the physicians, he assured the doctors present.
In fact, plaintiffs’ attorneys often have to defend physicians when manufacturers throw them under the bus, blaming the surgeon for complications with the allegedly faulty product. “He did it wrong,” is what manufacturers say in defense of their mesh product while it is the plaintiffs’ attorney whose expert will tell the jury the doctor did the procedure correctly, it was the product that was defective.
But the defense of doctors seemed to be lost on this crowd.
Potts shows a full screen on a study, Host response to synthetic mesh in women with mesh complications August 2016, American J Obstet Gynecol, a study into the macrophage, a key cell type that mediates foreign body response, in patients who undergo mesh excision surgery for pain after an implant. In some women with mesh complications, mesh induces a proinflammatory response that persists years after implantation.
Dr. Moalli, the lead investigator was sitting in the crowd. She corrected Potts; the study was about tissue degradation not mesh degrading, she said in a Woody Allen-Marshall McLuhan-like moment from the movie, Annie Hall.
Potts continued to explain that why, in 14 of the 20 trials so far, the juries have sided with plaintiffs:
The product was poorly designed because of its small pore size; there was little or no study before it was released; manufacturers misrepresented safety and efficacy; there was insufficient warning of the risk; manufacturers concealed knowledge of the potential of injuries from the FDA and other doctors; manufacturers knowingly used polypropylene resin mesh which is not intended for implantation according to its Materials Safety Data Sheet.
He said the polypropylene grade polypropylene is industrial grade, “used as carpet backing.”
Subpoenas have been issued by the Department of Justice, there is a grand jury gathered in Charleston, WV. and more than 96,000 lawsuits filed – all of that could have been prevented if there had been any clinical trials. But that was not the business model, he said.
How many meshes have been implanted in the US? While nobody knows for use there have been at least 3.5 to 4 million slings. In 2010 there were 100,000 meshes for prolapse implanted in a year. In all, more than five to six million women have been implanted with polypropylene mesh for incontinence or prolapse, according to Potts.
Potts warned physicians not to use the standard conflict of interest one-page forms. It’s too risky,” he said. Avoid conflicts of interest because juries love to hear that. “It makes their mouths water.”
“It’s just not the case the plaintiffs’ bar wants to remove all mesh. I don’t know anyone trying to shut down the manufacturers,” he assured the doctors whose society still supports the use of mid-urethral slings for incontinence.~ Derek Potts
Dr. Cassidenti asked why 60% of the lawsuits name slings as being defective. Because the vast majority of implants are slings for incontinence, Potts tried to explain.
“You have no credibility” shouted Cassidenti, now raising his voice and his very large presence in the room. Even though he was three rows back, his vehemence changed the tone of the conversation.
“It impedes progress” he continued.
Potts did not engage.
Dr. Miller appeared nervous. We are all trying to learn from each other, he said. “Try not to win the argument,” this is not a debate, he said encouraging kumbaya among those present. But that was not to be.
Cassidenti raised his voice again. “How many women are leaking urine because you terrorized them?”
Offering a brief respite was Dr. Geoffrey Cundiff, MD, from British Columbia. There was an explosion of new mesh kits that entered the market from 2000-2005, he said. “Everyone was in a rush to be on board.”
He had asked for safety and efficacy results on the new kits. Cundiff says he learned early not to put a mesh through the vagina. He did fascia slings.
If prolapse shows up early in a woman’s lifetime, it must be more serious and will likely need mesh, he concluded as a reason to keep mesh on the market.
Attorney Janet Nugent who represents C.R. Bard in transvaginal mesh litigation was dressed in a feminine red flowered dress. The mother of three came out strong.
“My stomach turns to see manufacturers pull their products from the market. I want the doctor and patient to make a choice and not a group of plaintiffs’ attorneys. That’s the bias I have,” she stated emphatically.
Nugent assured the group that the 510(k) clearance process is a “proven process” that works, and not a rubber stamp. Mesh has undergone biocompatibility testing and if the FDA is satisfied, the product is cleared for market. As far as the warning about not to implant polypropylene that comes with a MSDS?
(A Material Safety Data Sheet, that accompanies polypropylene resin. It’s Medical Application Caution states it’s not to be use for implantable medical devices. See one here on the right and below.)
“The chemicals used have been tested and proven safe and effective,” she said.
Of the $1 billion paid out so far for mesh settlements, they are “not an admission of liability. It’s a business decision.”
When asked if there was more litigation ahead that would name doctors with medical malpractice, she stated erroneously that the statute of limitations will “limit lawsuits.”
(Actually, tolling agreements in the mesh litigation have largely set aside statutes.)
Nugent said she’s heard certain language is put in an operative report for the benefit of a larger settlement at the behest of a woman’s law firm. Her law firm has taken depositions of medical funding companies and is trying to find out the source of the late night phone calls to women soliciting new cases.
As far as Boston Scientific and claims of counterfeit resin the company smuggled in from China, Nugent said she is “not aware of any health effects of the allegedly counterfeit resin.” And the FDA said don’t remove BSC mesh made after 2012, she reminded the group.
A doctor offered that pain isn’t always due to mesh; the patient may have had pain before the mesh, besides, mesh removals can cause pain. Even facing that reality, women are running out and getting removals, said another doctor in the group.
Dr. Vincent Lucente suggest patients are seeing this an opportunity. Three quarters of those patients requiring records had no measurable complaints that he could find.
Dr. Cundiff said until the litigation is concluded, “I can’t make them better.”
How many of the cases filed are legitimate? someone asked aloud.
“One hundred percent,” said Potts. ###