The multi-state lawsuit accused the medical device manufacturer of failing to disclose the full range of potentially serious and irreversible complications caused by transvaginal mesh (TVM) to patients and the medical community. As well as paying this settlement, Boston Scientific has agreed to marketing, training and clinical studies reforms for its mesh devices. (For more information about Boston Scientific’s agreements, visit the attorney general of Delaware’s website where it details marketing, training and clinical trials reforms.)
Boston Scientific said that the settlement, which is not an admission of misconduct or liability, was in the best interests of the company and its shareholders,” according to Mass Device. “We are pleased to resolve this dispute and to continue focusing on delivering innovative products and solutions to physicians and patients.”
The FDA in April 2019 ordered Boston Scientific and the Danish company Coloplast A/S, the two last makers of transvaginal surgical mesh implants for pelvic order prolapse, to stop sales. The agency said that “Boston Sci and Coloplast failed to demonstrate an acceptable long-term benefit of mesh devices, compared to transvaginal surgical tissue repair without mesh and could not assure their safety and effectiveness. The mesh products…did not have a reasonable assurance of safety and effectiveness.”
Since they were approved two decades ago, vaginal mesh products have been linked to painful and life-altering injuries, from infections to erosion of the mesh into the vagina to organ perforation. Pelvic mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. Instead, transvaginal mesh became one of the medical device industry’s worst failures.
According to Boston Scientific’s recent annual reports, the company logged $330 million and $278 million in litigation-related charges in 2019 and 2020 respectively, with most of the changes related to transvaginal mesh products.
Hernia Mesh Litigation
READ MORE SURGICAL MESH LEGAL NEWS
Ethicon Physiomesh bellwether trials are slated for March, June and September 2021. Currently there are over 3,200 Ethicon abdominal mesh lawsuits pending in federal court. All the lawsuits allege that the medical device maker sold an unreasonably dangerous and defective product, which caused plaintiffs to suffer severe abdominal pain, infection, hernia recurrence, adhesions, perforations, erosion and other injuries associated with failure of the hernia mesh.