MARLBOROUGH – Massachusetts Attorney General Maura Healey today, March 23, announced that her office has secured $2.8 million for Massachusetts as part of a multistate settlement with Boston Scientific Corporation (Boston Scientific) to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients.
This payment is part of a multistate settlement that requires Boston Scientific to pay $188.6 million in total to 47 states and the District of Columbia.
“This company’s deceptive marketing practices put profits over the safety and well-being of patients,” said Healey. “Along with a nearly $3 million payment to Massachusetts, this settlement requires that the company make significant reforms to ensure its practices conform with the law going forward.”
The complaint, filed in Suffolk Superior Court today, alleges that Boston Scientific misrepresented the safety of surgical mesh 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.
Boston Scientific’s headquarters is in Marlborough. Founded in 1979, Boston Scientific is a manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology.
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 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.
Along with the payments to states, the consent judgment, which is pending court approval, provides comprehensive injunctive relief. Under the terms of the settlement, Boston Scientific is required to reform its marketing of surgical mesh products and how it trains its sales and marketing employees.
The settlement also requires the company to register all of its clinical trials with the clinicaltrials.gov website and disclose its role in funding or sponsoring any clinical trial.
The investigation that resulted in today’s settlement and was joined by Massachusetts was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas.
Also joining this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.
For Massachusetts, this matter was handled by Assistant Attorney General Michael Wong of AG Healey’s Health Care Division.