An investigation leads to a settlement with a medical device manufacturer

INDIANAPOLIS – An investigation led by Attorney General Todd Rokita has resulted in a $188.6 million multistate settlement with a medical manufacturing company accused of deceptively marketing its transvaginal surgical mesh devices to patients. Indiana will receive $5,982,218 as a result of the settlement, in which 46 other states and the District of Columbia also participated.

Todd Rokita

“Women across the country have suffered serious health complications caused by surgical mesh devices, and I will continue to hold companies accountable that misrepresent or withhold information about the risks associated with the devices,” Attorney General Rokita said.

Boston Scientific Corporation allegedly misrepresented the safety of its surgical mesh products and failed to disclose the full range of potential serious and irreversible complications caused by mesh. Surgical mesh is a synthetic knitted or woven fabric that is implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors.

Although the use of surgical mesh poses a risk of such complications and is not proven to be any more effective than traditional tissue repair, millions of women have been implanted with the devices. Thousands are alleged to have suffered serious complications resulting from the devices.

The settlement provides comprehensive injunctive relief. In addition to paying $188.6 million, Boston Scientific Corporation must reform its practices related to surgical mesh, including its marketing, training, and disclosures regarding clinical studies.