Surgical Mesh Manufacturer Misled Women about Product’s Safety
Contact: Charity R. Clark, Chief of Staff, 802-828-3172
Attorney General T.J. Donovan today announced that Vermont joined a multistate settlement with Boston Scientific Corporation (Boston Scientific) to resolve allegations of deceptive marketing of its surgical mesh products for women. The settlement requires Boston Scientific to pay $188.6 million to 47 states and the District of Columbia to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients. Vermont’s share of the settlement is $1,106,151.
“Boston Scientific’s misrepresentations denied women the ability to make informed decisions about whether to permanently implant surgical mesh into their bodies,” said Attorney General Donovan. “My office will continue to hold companies accountable for misrepresenting the safety and efficacy of their products.”
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. 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 coalition of attorneys general allege that Boston Scientific misrepresented the safety of their 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. In addition to paying the states $188.6 million, the settlement requires Boston Scientific to make marketing, training, and clinic trial reforms, including:
- Describing complications in understandable terms in consumer marketing materials;
- Disclosing significant complications, including the inherent risks of mesh in certain marketing materials;
- Refraining from representing that any inherent risks of mesh are risks common to any pelvic floor or other surgery not involving mesh;
- Refraining from representing that surgical mesh repair is superior to native tissue repair unless such representations are supported by valid scientific evidence;
- Informing healthcare providers of significant complications when providing training regarding procedures for insertion and implantation;
- Register all Boston Scientific-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
Attorney General Donovan is joined in today’s settlement by 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, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and the District of Columbia.
A copy of the complaint is here and the stipulated judgment submitted for court approval is here.