Product liability lawsuits filed against manufacturers of transvaginal mesh products are mounting ahead of an approaching two-year statute of limitations in several states.
Six medical device makers – Boston Scientific, Coloplast, C.R. Bard, Ethicon/Johnson& Johnson, and Cook Medical Systems – are among the medical device makers who collectively face about 16,000 lawsuits filed by women and their families. The lawsuits blame transvaginal mesh products, used to correct pelvic organ prolapse (POP) and urinary incontinence, for serious and often debilitating injuries.
Many plaintiffs allege that the polypropylene devices eroded through the vaginal wall, perforated organs, caused vaginal scarring and shrinkage, bleeding, infection and pain. Many women suffering with mesh complications are unable to engage in sexual intercourse and find that their injuries put a strain on their relationship. Such injuries sometimes add enormous psychological and emotional dimensions of pain to the victim’s physical suffering.
In July 2011, the U.S. Food and Drug Administration (FDA) updated its 2008 safety communication warning doctors and patients about the potential risks of transvaginal mesh. The latest advisory warned that about 10 percent of women implanted with transvaginal mesh experienced mesh erosion within one year of surgery.
The FDA also said that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Mesh complications are compounded the difficulty in surgically removing the devices, which sometimes fragment and become irreversibly embedded in the body’s tissue. Women who need their transvaginal mesh devices removed sometimes have to undergo multiple surgeries, if removal is possible at all.
Lawsuits filed against transvaginal mesh makers in federal courts have been consolidated into six multi-district litigations (MDLs) in U.S. District Court for the Southern District of West Virginia.
Thousands of lawsuits have been filed in recent weeks in a push to file claims before state statute of limitations kick in. In addition to the state in which the mesh device was implanted, the actual deadline for claims depends a number of other factors, including the company that made the mesh device and the types of injury suffered.