Attorney General James Helps Secure Nearly $190 Million from Medical Device Manufacturer That Endangered Women’s Health
Consumers Misled About Safety, Effectiveness, and Potential Risks of Transvaginal Mesh Devices
NEW YORK – New York Attorney General Letitia James, as part of a coalition of 48 attorneys general, today helped secure $188.6 million from the medical device manufacturer Boston Scientific Corporation to resolve allegations of deceptive marketing of its transvaginal surgical mesh products that endangered the health of women. Today’s agreement will specifically provide New York with $6,346,944. A multistate investigation found that the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and by failing to sufficiently disclose risks associated with their use.
“We will never allow corporate profits to come above the health of New Yorkers,” said Attorney General James. “While Boston Scientific was putting income before the health of people in need of care, women were put in danger. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers.”
Transvaginal surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in women, such as stress urinary incontinence and pelvic organ prolapse. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors. Although use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of women were implanted with the devices and thousands of women are alleged to have suffered serious complications resulting from these devices.
The complaint — filed with today’s agreement — alleges that Boston Scientific misrepresented the safety of these products by failing to disclose the full range of potential serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.
Today’s agreement provides comprehensive injunctive relief, requiring Boston Scientific to:
- Describe complications in understandable terms for marketing materials intended for consumers;
- Disclose significant complications, including the inherent risks of mesh, for certain marketing materials;
- Refrain from representing that any inherent risks of mesh are risks common to any pelvic floor or other surgery not involving mesh;
- Refrain from representing that inherent mesh complications can be eliminated with surgical experience or technique;
- Refrain from representing that surgical mesh does not cause a foreign body reaction;
- Refrain from representing that surgical mesh remains soft, supple, or pliable after mesh is implanted inside the body;
- Refrain from representing that surgical mesh does not potentiate infection or does not increase the likelihood of infection; and
- Refrain from representing that surgical mesh repair is superior to native tissue repair, unless such representations are supported by valid scientific evidence.
- Inform health care providers of significant complications when providing training regarding procedures for insertion and implantation; and
- Maintain policies requiring that its independent contractors, agents, and employees who sell, market, or promote mesh are adequately trained to report patient complaints and adverse events to the company.
Clinical Trial Reforms:
- Disclose the company’s role as a sponsor and any author’s potential conflict of interest when submitting a clinical study or clinical data regarding mesh for publication;
- Refrain from citing any clinical study, clinical data, preclinical data, research, or article regarding mesh for which the company has not complied with the disclosure requirements in the injunction;
- Include a sponsorship disclosure provision requiring consultants to contractually agree to disclose in any public presentation or submission for publication any sponsorships by Boston Scientific related to the contracted-for activity; and
- Register all Boston Scientific-sponsored clinical studies regarding mesh with
Separately, but relatedly, in October 2019, Attorney General James and 41 additional attorneys general announced a multistate settlement that required Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for the deceptive marketing of transvaginal surgical mesh devices.
Additionally, in September 2020, Attorney General James and 48 additional attorneys general announced a multistate agreement that required C.R. Bard, Inc. and its parent company, Becton, Dickinson and Company, to pay $60 million for the deceptive marketing of transvaginal surgical mesh devices.
Joining Attorney General James in signing today’s agreement are the attorneys general of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and the District of Columbia.