Boston Scientific has agreed to settle transvaginal mesh claims from 47 states and the District of Columbia for $188.7 million. Last week’s settlement concludes a series of lawsuits accusing Boston Scientific of violating consumer protection laws by misrepresenting the safety and effectiveness of their transvaginal mesh products.
Boston Scientific agreed to change the way it markets transvaginal mesh, including disclosing significant complications and using everyday language to describe complications when marketing to consumers. The company agreed to stop making false safety claims, including:
- Surgical experience or technique can eliminate mesh risks
- Mesh does not increase the risk of infection or foreign body reactions
- Mesh stays soft and supple once implanted
- Mesh surgery is superior to simply repairing bodily tissues
Other changes include training representatives to report adverse patient events and adhering to ethical standards for clinical trials.
Boston Scientific said that the settlement was in the best interest of the company and its shareholders, and was not “an admission of misconduct or liability.”
The state attorneys general said on March 24 that transvaginal mesh is no more effective than traditional tissue repair and, in some cases, can cause the very problems it has been marketed to correct—plus more, including chronic severe pain according to Law.com.
Transvaginal mesh, also known as pelvic mesh, is a net-like implant used to treat issues such as incontinence, pelvic organ prolapse, and pelvic floor collapse. Transvaginal mesh is most commonly made out of polypropylene plastic, but can be made using animal tissue or a hybrid of multiple materials and has been the subject of thousands of lawsuits and a number of large settlements.
In 2020, Johnson & Johnson paid $344 million to settle lawsuits related to their Ethicon line of transvaginal mesh.
In 2019, MedTruth reported that the Food and Drug Administration stopped all transvaginal mesh sales from Boston Scientific and Coloplast, the last two companies still selling transvaginal mesh in the U.S. The agency cited a lack of evidence supporting the superiority of mesh surgery as well as concerns over safety and effectiveness.