A jury has awarded a California woman $5.5 million for complications and injuries she suffered as a result of being implanted with transvaginal mesh devices. The case was the first personal injury claim involving transvaginal mesh to go to trial.
The plaintiff, a 53-year-old resident of Bakersfield, California, had two polypropylene mesh devices made by C.R. Bard implanted in 2008 to treat her occasional urinary incontinence. Instead of improving her condition, however, the transvaginal mesh cut into her colon and surrounding tissue.
The plaintiff underwent eight surgeries and nine additional procedures to remove the mesh, but surgeons haven’t been able to fully remove the device, and the plaintiff’s tissue continues to grow through the fine mesh fabric.
C.R. Bard eventually halted sales of its Avaulta mesh device on July 1, 2012, but the move came too late for many women who had been implanted with the device and, like the plaintiff, experienced complications.
Transvaginal mesh devices are now the subject of hundreds of lawsuits, which have been consolidated into four Multidistrict Litigations (MDLs) against mesh manufacturers C.R. Bard, American Medical Systems, Boston Scientific, and Johnson & Johnson’s Ethicon. The transvaginal mesh MDLs are pending in U.S. District Court for the Southern District of West Virginia.
In July 2011, the U.S. Food and Drug Administration issued a safety alert to health care providers and patients, saying it is unclear whether using transvaginal “mesh is more effective than traditional non-mesh repair” and that the products could put patients at a higher risk of complications than more conventional forms of surgery.
The FDA said the complications associated with transvaginal mesh weren’t linked to a single brand of mesh.
“Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication,” the FDA’s advisory states.
When transvaginal mesh erodes or breaks apart, it can cause excruciating pain in the pelvic area, bleeding, infection, and damage to surrounding organs and tissue. Mesh erosion can also cause painful sexual intercourse or an inability to engage in sexual intercourse.