A group of cringe-worthy product-liability lawsuits concerning transvaginal mesh (TVM) are moving forward.
Hundreds of women are suing TVM manufacturers—including Johnson & Johnson, American Medical Systems Inc. and Boston Scientific Corp.—claiming the surgical product, which is designed to support organs in the pelvic region that have shifted due to weakened or stretched muscles, often from childbirth, caused complications such as infection, incontinence, and abdominal, pelvic and vaginal pain.
This week, Southern District of West Virginia Judge Joseph R. Goodwin, who is overseeing the multidistrict litigation (MDL) comprising cases alleging TVM complications, chose the lead plaintiffs counsel for trial.
In July 2011, the Food and Drug Administration (FDA) warned consumers that there had been a rise in TVM-related injuries.
Many of the FDA-approved TVM devices in the MDL were based on a Boston Scientific product that the company voluntarily recalled in 1999. One lawmaker, Rep. Edward Markey, D-Mass., is pushing for legislation that would allow the FDA to refuse to approve medical devices based on products that have been or are in the process of being recalled. His bill also would require manufacturers to explain how their products are different from similar failed ones.