TVT Mesh Settlement Talks Continue, Lawsuits Could Top 50,000

Richmond, VAThere are already in excess of 30,000 TVT sling lawsuits in the pipeline that a federal judge, before whom such lawsuits have been consolidated, is trying to move along. But as unwieldy as that number already seems, experts predict that number could swell to more than 50,000.

“The liability seems pretty clear on these cases, so settlement makes sense,” said Carl Tobias, a professor of product-liability law at the University of Richmond in Virginia, in an interview with Bloomberg News (9/30/13). “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion-dollar settlement.”

Transvaginal mesh was until recently a much-ballyhooed, new-age response to Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), two medical conditions common to middle-aged women who have borne children. Historically, drooping pelvic organs were wrestled back into place with a transvaginal sling fashioned from a patient’s own harvested tissue and stitched into place by way of invasive surgery.

The advent of laparoscopic, or “keyhole” surgery, coupled with the capacity to insert a transvaginal mesh device and deploy it inside the abdomen, changed the face of transvaginal sling surgery. Incisions were smaller, healing more rapid and patients spent less time in the hospital, freeing up beds.

However, the reality has proven a vast departure from theory for many patients, after thousands of reports detailing transvaginal mesh complication that has included mesh piercing the vaginal wall or becoming hopelessly intertwined with vital organs. Many a transvaginal mesh lawsuit has been filed, with plaintiffs complaining of severe pain and mobility issues. Many have undergone surgery to have the problematic mesh removed. For others, removal is not possible.

While TVT mesh manufacturer Johnson & Johnson is not part of current talks, other manufacturers are: they include C.R. Bard, Endo Health Solutions Inc., Boston Scientific Corp. and two other companies. US District Judge Joseph Goodwin in Charleston, West Virginia, has been quoted as saying he is trying to push these lawsuits through the system as quickly as possible, and acknowledges to Bloomberg that settlement discussions are ongoing. In a September hearing, Judge Goodwin referenced the “mountain” of vaginal sling lawsuits. “I’m going to keep the bulldozer moving to deal with these cases,” he said at the time.

The Bloomberg report noted that C.R. Bard has settled some TVT side effects cases after coming out at the losing end of two recent bellwether trials. Judge Goodwin, according to Bloomberg, presided over the first federal trial with regard to the Bard Avaulta Plus vaginal mesh this past August. That trial ended with a jury award of $2 million to the plaintiff, who sued C.R. Bard claiming her vaginal sling damaged her internal organs.

Following a requirement last year by the US Food and Drug Administration (FDA) for manufacturers of trans vaginal mesh products to study their products post-market, C.R. Bard pulled their Avaulta products from the market altogether.

As settlement talks continue, the FDA continues to receive reports of TVT side effects ranging from internal organ damage to infection and pain during intercourse after the mesh shifts and protrudes through the vaginal wall - creating a hazard for both partners.