Thousands of women in the United States and many other parts of the world are alleging transvaginal mesh devices used to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are causing serious complications and permanent injury. In Australia and Canada, class actions against transvaginal mesh manufacturers could potentially become the biggest class actions those countries have ever seen. Likewise, in the U.S., transvaginal mesh litigation could become the largest case of product-injury litigation ever.
Beasley Allen attorney Leigh O’Dell, who is serving on the Plaintiffs’ Steering Committee for all Multi-District Litigation involving transvaginal mesh, says that the injuries linked to the mesh devices have become a public health crisis in the U.S.
“Thousands of women are experiencing embarrassing and life-altering problems, and many have undergone multiple surgeries only to have the mesh remaining, along with serious residual problems,” O’Dell said. “In light of the absence of clinical testing of the mesh in the female pelvis prior to the products being marketed, this crisis could have been avoided.”
A handful of medical device corporations, including Johnson & Johnson’s Ethicon, Boston Scientific, C.R. Bard, Coloplast, and Mentor, manufacture about 20 transvaginal mesh kits, which are designed to replace “native tissue repairs” and shore up prolapsed organs. Unfortunately, none of these devices were adequately tested before they were approved for market, and only after they were implanted in hundreds of thousands of women did the frequency and severity of their complications come to light.
Most of these complications involve erosion (also called mesh exposure, extrusion, or protrusion) brought about by what physicians call “compliance mismatch,” according to Australian urogynecologist Richard Reid, who is treating the lead plaintiff in Australia’s transvaginal mesh class action.
The fibrous polypropylene mesh acts like a cheese grater on the softer organs and tissues it contacts. This grating effect can rub a hole in the vaginal wall, or it may perforate the bladder or other organs, or shred surrounding tissue, resulting in intense pain, neuro-muscular problems, inability to walk, dyspareunia (painful sexual intercourse), vaginal scarring and shrinkage, bleeding, infection, and severe emotional distress often to the point of suicidal thoughts.
From 2008 to 2011, seven deaths were attributed to transvaginal mesh complications. Mesh complications may also arise when the device shifts out of place or breaks apart.
Tom Margolis, a Bay Area pelvic surgeon who specializes in removing transvaginal mesh, says that all transvaginal mesh kits are fundamentally flawed because they contradict the core principles of surgery. Dr. Margolis recently testified at a U.S. Food and Drug Administration meeting that passing a sterile, porous mesh device through the vagina for implantation violates the Golden Rule of surgery.
“You shall never implant a synthetic object in anyone’s body, anywhere, if it’s contaminated. To do so is to put the patient at serious risk of infection,” Dr. Margolis says.
The problems with transvaginal mesh are exacerbated by the difficulty of removing the devices when things do go wrong. The thin, fibrous mesh quickly becomes intertwined and incorporated with the surrounding tissue. Complete removal of mesh can be extremely difficult, if not impossible, requiring multiple surgeries over years. Mesh removal is also very dangerous because, as Dr. Margolis explained, it’s like trying to extract rebar from a hardened concrete slab without damaging the surrounding water mains and electrical cables.
The FDA issued its first transvaginal-mesh Public Health Notification in 2008 after detecting a pattern of adverse events in its post-market surveillance of the devices. From 2008 to 2011, the agency received 2,874 adverse event reports involving transvaginal mesh devices – a fivefold increase in just three years.
In 2011, the agency issued a stronger warning, saying that mesh failure rates could be as high as 10 percent, citing recent studies that found the devices may have ample risks without any apparent benefit. In 2012, the FDA ordered the manufacturers to test their devices for safety and efficacy. Any transvaginal mesh kits that failed could be removed from the market.
Of course, the FDA allowed these potentially dangerous products onto the market in the first place, and the growing mesh problem underscores flaws with the 510k approval process the agency relies on to expedite many medical devices to market. This system puts medical devices on a fast track through the approval process if they are substantially similar to already-approved devices.
According to Drugwatch, transvaginal mesh devices fast-tracked through FDA approval were based on a device that was recalled from the market years later due to serious structural flaws and other problems.
Ultimately, however, it is the manufacturer’s responsibility to test its products for safety and effectiveness before they seek government approval for them.
“We believe that litigation to hold manufacturers accountable is critical to the prevention of similar public health disasters in the future, and I feel very privileged to be a part of that process,” Leigh O’Dell said.
Australian Broadcasting Corporation
Medical Device News Desk
In These Times
U.S. Food & Drug Administration