As product liability lawsuits mount, several states are launching investigations into the sales of Boston Scientific Inc.’s transvaginal mesh products.
Earlier this year, we reported that hundreds of plaintiffs had filed lawsuits against Boston Scientific—as well as Johnson & Johnson and American Medical Systems Inc.—for pain, infection and other complications that their transvaginal mesh products cause. Surgeons have used such products for decades, primarily to treat hernias, but recently they have been using the mesh to treat pelvic muscle weakness associated with childbirth.
In a recent Securities and Exchange Commission filing, Boston Scientific disclosed that California and “several other state attorneys general offices intend to initiate a civil investigation into our sales of transvaginal surgical mesh products.” To date, the company is named in more than 2,500 lawsuits in which plaintiffs allege personal injury associated with its surgical mesh product.
Last summer, the Food and Drug Administration (FDA) said there had been a five-fold increase in reports of serious complications related to transvaginal surgical mesh products. In January, the agency ordered Boston Scientific and other mesh makers to conduct post-market studies of their products so regulators could better understand the safety and effectiveness of the products. The FDA is considering subjecting transvaginal surgical mesh to more scrutiny.
“In light of the recent regulatory guidance concerning transvaginal mesh devices, as well as the growing number of vaginal mesh lawsuits currently pending against Boston Scientific and other manufacturers, it’s not at all surprising that the marketing of these products has come under additional scrutiny,” Bernstein Leibhard, a plaintiffs firm representing individuals who have suffered injuries from the mesh products, said in a statement.
For more InsideCounsel coverage of the surgical mesh litigation, read: