Boston Scientific will pay $188.6 million to settle allegations that it used deceptive marketing practices to sell its transvaginal surgical mesh products to doctors and patients.
A coalition of 48 state attorneys general alleged in a complaint that Boston Scientific failed to sufficiently disclose risks associated with the mesh use and the safety and efficacy of the devices.
About 54,000 product liability cases or claims related to the products have been filed as of late Jan. 2021, with Boston Scientific settling over 96% of those cases, according to an SEC filing. The medical device manufacturer reported litigation-related net charges of $278 million in 2020 that included violations of state consumer protection laws, fraud, failure to warn and erroneous design claims. The settlement states that Boston Scientific does not admit to any wrongdoing or violation of law, regulation or liability.
The settlement includes several changes to company practices and disclosures, including describing complications in understandable terms and disclosing the risks of mesh in marketing materials. Boston Scientific also can't say that complications can be eliminated based on surgical experience; can't say that surgical mesh doesn't cause a foreign body reaction; and can't say that surgical mesh doesn't increase or introduce the potential for infection in the body.
The company also has to tell health providers about potential complications during training for insertion, and will have to disclose the company's role as a sponsor and any author's potential conflict of interest when submitting mesh-related clinical studies or data for publication.
The news on Tuesday comes nearly 15 years after vaginal mesh in 2004 was introduced into the market to treat pelvic organ prolapse, which had related side effects of permanent incontinence and severe discomfort. The devices had been used and still are used to treat urinary incontinence.
In 2015, a jury ordered Boston Scientific to pay a woman $100 million after finding the company failed to warn doctors and patients of vaginal mesh inserts that were poorly designed. That same year, the company paid $119 million to settle nearly 3,000 cases and claims.
Other mesh manufacturers have come under fire. In 2020, Johnson & Johnson agreed to pay $117 million in a settlement to 41 states and the District of Columbia over similar allegations involving the mesh devices.
New York Attorney General Letitia James said in a statement that the state will get over $6.3 million in settlement funds.
"While Boston Scientific was putting income before the health of people in need of care, women were put in danger," James said. " My office will never waver in its efforts to hold companies accountable for risking the health of its consumers."
