ATLANTA — State Attorney General Chris Carr said Georgia is part of a settlement 48 states and the District of Columbia agreed to with C.R. Bard Inc. and parent company Becton, Dickinson & Co. requiring payment of $60 million for deceptive marketing of medical devices.
“Failing to adequately inform patients and health care providers of the serious risks associated with these devices put the welfare of countless women in jeopardy,” Carr said of the transvaginal surgical mesh devices.
“This settlement sends a strong message that these practices are unacceptable and will not be tolerated.”
A news release stated thousands of women implanted with surgical mesh have made claims that they suffered serious complications resulting from these devices, including erosion of mesh through organs, pain during intercourse, and voiding dysfunction.
Although use of surgical mesh involves the risk of serious complications and is not proven to be more effective than traditional tissue repair, millions of women were implanted with these devices, the release stated.
The attorneys general allege that C.R. Bard misrepresented or failed to adequately disclose serious and life-altering risks of surgical mesh devices, such as chronic pain, scarring and shrinking of bodily tissue, recurring infections and other complications.
C.R. Bard and Becton, Dickinson & Co. have agreed to pay $60 million to the 48 participating states and the District of Columbia.
Although C.R. Bard stopped selling transvaginal mesh, the settlement provides injunctive relief, requiring both C.R. Bard and Becton, Dickinson & Co. to certain terms if they re-enter the transvaginal mesh market.
Under the terms of the settlement, the companies are required to provide patients with understandable descriptions of complications in marketing materials; list certain complications; disclose complications related to the use of mesh;
disclose sponsorship in clinical studies, clinical data, or preclinical data for publication; and refrain from citing studies or data regarding mesh.
The company also is required register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov; train independent contractors and others to report all patient complaints and adverse events to the company; and ensure that its practices on reporting are consistent with FDA requirements.
Joining Georgia in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, 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, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin, the release stated.