Boston Scientific (NYSE:BSX) has agreed to settle a transvaginal mesh class action lawsuit brought by women in Canada for $21.5 million, according to a report by the Canadian Press.
The proposed settlement involves about 325 women whose share of the money would depend on the severity of their medical issues, the news service reported. Final approval of the settlement is expected in June.
Complications reported from pelvic mesh include chronic inflammation, mesh shrinkage and embedding in scar tissue, infection, bleeding, pain during sexual intercourse, organ perforation, protrusion through the vaginal wall and urinary problems. Mesh manufacturers have paid millions of dollars in legal judgments and settlements.
Health Canada pledged to review the use of pelvic mesh implants for women with pelvic organ prolapse (POP) in July 2019, three months after the FDA banned its sale in the U.S. A recent long-term, observational study of 54,194 women implanted with transvaginal mesh to treat POP concluded that the FDA should have banned the product sooner than it did.
Boston Scientific is the only remaining company selling transvaginal mesh in Canada, according to the Canadian Press report, which said the company stopped marketing it as a treatment for POP in July.
Susan Vester, who had the device implanted in 2010, was the lead plaintiff in the case, which was certified as a class action in 2017, the report added. The attorney for Vester and her husband told the Canadian Press they were happy with the settlement. Boston Scientific did not immediately respond to a request for comment on the settlement.
BSX chief financial officer Daniel Brennan told investors last month that the company has now settled or is close to settling more than 95% of all known pelvic mesh claims, according to an earnings call transcript by Seeking Alpha. The company expects to pay the remaining $115 million of anticipated payments into settlement funds in 2020 to resolve the rest, Brennan added.