Transvaginal Mesh Trials Continue, Next Bellwether June 11

Washington, DCJust days before the first bellwether transvaginal mesh lawsuit begins trial on June 11, lawsuits keep rolling in as women continue to be troubled by transvaginal mesh complication.

One of the latest lawsuits was filed April 30 in US District Court for the Southern District of West Virginia, Charleston Division. The plaintiff in the case, according to a PRWeb Newswire release (5/7/13), received a Polyform Synthetic Mesh product in April 2010. The plaintiff, who hails from New York, alleges she was injured by the device. The lawsuit is Case No. 2:13-cv-09644 and joins the pending cases in multidistrict litigation In Re: Boston Scientific Corp. Pelvic Repair Products Liability Litigation, MDL No. 2326.

Among the allegations cited by this most recent plaintiff is loss of consortium with her husband. The latter issue has proven to be heartbreakingly common, given the propensity of transvaginal mesh to migrate, or shift somewhat from its original point of insertion and placement, becoming interwoven with organs or other sensitive tissue and sometimes perforating vaginal walls.

This makes sexual intercourse between partners difficult or dangerous and, in some cases, completely impossible. One plaintiff reported her fiancé called off their engagement, after intercourse was no longer possible due to the perforation of a transvaginal sling through the vaginal wall.

Transvaginal mesh evolved from similar products historically used for abdominal hernia repair, but are now used for conditions such as Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP), two conditions common to middle-aged women who have previously borne children. The previous standard was to harvest a woman’s own tissue to fashion a sling, then stitch the sling into place as part of a major surgical procedure to harness shifting organs.

The TVT sling, in contrast, was conceived to allow for a faster, less invasive repair, requiring less healing time.

However, in the years since TVT mesh has become the latest gold standard for such repair, scores of women have been reporting grievous complications that have produced pain, and have negatively impacted health, lifestyle, the capacity to earn a living and even relationships.

Vaginal sling lawsuits have become so commonplace that there are no fewer than five MDLs: In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325; In Re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, MDL No. 2326; In Re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2187; and In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327.

The roughly 30 manufacturers of vaginal sling products have been mandated by the US Food and Drug Administration (FDA) to undertake post-market testing to further study the safety and efficacy of TVT sling surgery using transvaginal mesh. To that point, the FDA has pretty much stated that TVT side effects are so widespread that the agency no longer considers TVT mesh as a first treatment option, and may not necessarily be the safest option for most women.

The bellwether trial that begins June 11 is not the first TVM lawsuit to go through the courts. Earlier this year, transvaginal mesh complication plaintiff Linda Gross was awarded $11.1 million. Bloomberg News (2/28/13) reported that Gross’ trial was the first of some 4,000 cases involving the Gynecare Prolift to go to trial.

Meanwhile, a Joint Status Conference was scheduled for May 23, with regard to the thousands of transvaginal sling lawsuits pending in the US District Court for the Southern District of West Virginia.

In spite of all these inglorious and tragic TVT mesh events, the FDA is content to continue to issue health and safety advisories as needed, and to require no fewer than 33 manufacturers of transvaginal tape sling products to continue post-market studies. However, the FDA has not signaled it is prepared to take these products off the market.