Will FDA Stance on TVM Mesh Trigger More Lawsuits?

Washington, DCA manufacturer that has been busy negotiating settlements for one of its other surgical mesh products is currently embroiled in a situation not unlike the Kugel Mesh mess with its Avaulta TVM vaginal mesh system. Kugel Mesh was manufactured by Davol Inc., which is a subsidiary of C.R. Bard, the distributor of the Avaulta mesh product often used in the treatment of pelvic organ prolapse (POP) and used for that indication by Bard.

TVM is short for transvaginal mesh, a product that has been used as a 'sling' to help rein in sagging pelvic organs that tend to droop into the vagina. The Bard Avaulta TVM mesh was, prior to 2008, a favorite for doctors who viewed the TVM sling as a worthy means of restoring pelvic organs to their original positions within the pelvis.

However, in 2008, the US Food and Drug Administration (FDA) began issuing alerts about the product—and this month went even further, suggesting that use of surgical mesh such as the Bard Avaulta product can put patients at risk.

Reported adverse reactions have included painful intercourse, pelvic discomfort and infection. Some TVM mesh patients have since had the pelvic mesh successfully removed, although not all can.

Of note is the FDA view that POP can be successfully treated without vaginal mesh, although the allegedly problematic mesh has not been taken off the market and doctors still have the ability to use the product on their patients if they see fit.

Still, the FDA announcement of July 13 is telling, given the agency's concern that the risks associated with the plastic TVM mesh may outweigh the benefits. While urging patients and surgeons to consider other options, the FDA noted that it intends to convene an expert panel in the fall to study and debate the efficacy and effectiveness—and the risks—of vaginal mesh.

At issue will be the risk/benefit ratio, and whether the product should be banned.

Jill Goodwin, a vaginal mesh patient who noted in comments published in the Boston Globe July 14 that there are days it's all she can do to even get out of bed, received a vaginal mesh product sold by C.R. Bard in 2008. A number of different companies manufacture the product, including Boston Scientific Corp.

The mesh sold by C.R. Bard—the Bard Avautla TVA mesh among them—is supplied to Bard by Covidien PLC, which manufactures the product. A spokesperson for Covidien was quick to point out that while Bard uses the Covidien mesh product for that indication, Covidien does not. Covidien's role is only in the supply of mesh to Bard for its TVM mesh line, including the Avaulta TVM vaginal mesh.

Experts note the tough FDA stance on vaginal mesh could result in an increased flurry of lawsuits. Attorneys representing plaintiffs litigating against a number of defendants noted in the Boston Globe that the mesh material was originally designed for hernia repair.