LITTLE ROCK — Arkansas Attorney General Leslie Rutledge announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations it engaged in deceptive marketing of its surgical mesh products for women. The settlement requires Boston 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. Arkansas will receive $2,776,500 from the settlement with Boston Scientific Corporation.
“Our mothers, sisters and daughters have been deceived by Boston Scientific Corporation, and now they must live with permanent damage to their bodies,” Arkansas Attorney General Rutledge said. “The settlement ensures impacted Arkansans’ voices have been heard and Boston Scientific will do no further harm to future generations in the state.”
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 the 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 potentially serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.
The settlement provides comprehensive injunctive relief. Under the terms of the settlement, Boston must comply with the following:
Marketing Reforms
For marketing materials intended for consumers, describe complications in understandable terms;
For certain marketing materials, disclose significant complications, including the inherent risks of mesh;
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 the 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 the mesh is implanted inside the body;