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Attorney General Josh Stein Reaches $188.6 Million Multistate Settlement with Medical Device Manufacturer

For Immediate Release:
Tuesday, March 23, 2021

Contact:
Laura Brewer (919) 716-6484

(RALEIGH) Attorney General Josh Stein today announced a multistate settlement with Boston Scientific Corporation (Boston) that requires the company 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. North Carolina’s share of the settlement is $4,201,036.

“Doctors and patients deserve to have accurate, honest information when they are making decisions about medical care,” said Attorney General Josh Stein. “Boston Scientific deceived people to advance its own profits, and North Carolinians suffered real physical harm. I’m pleased that this settlement will help keep people safe by requiring the company to be more transparent about its products and their risks.”

Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat health conditions in women such as stress urinary incontinence and pelvic organ prolapse. These are common conditions women experience 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 alleges that Boston 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.

The settlement provides comprehensive injunctive relief, and Boston is required to:

  • Disclose and describe complications in understandable terms in its marketing materials.
  • Refrain from misrepresenting the risks of mesh implants.
  • Inform health care providers about significant complications when providing training on insertion and implantation procedures.
  • Ensure that contractors, agents, and employees who sell, market, or promote mesh are trained to report patient complaints and adverse events to the company.
  • Provide appropriate disclosures about sponsorship and conflicts of interest when submitting a clinical study or data regarding mesh for publication or presentation.

Attorney General Stein is joined in today’s settlement by the Attorneys General of California, Washington, Florida, Indiana, Maryland, Ohio, South Carolina, Texas, Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.

A copy of the complaint is available here.

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