Illinois Attorney General issued the following announcement on Sept. 24.
Attorney General Kwame Raoul, as part of a bipartisan coalition of attorneys general, announced a settlement with C.R. Bard, Inc. and its parent company Becton, Dickinson and Co., requiring payment of $60 million for the deceptive marketing of transvaginal surgical mesh devices.
Raoul and the coalition 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, painful sexual relations, and recurring infections, among other complications.
“C. R. Bard sold these transvaginal surgical mesh devices, knowing that they could have serious, permanent side effects,” Raoul said. “The company’s actions caused women to experience painful and life-changing medical issues. The settlement holds C.R. Bard and its parent company accountable and ensures that any future patients are better informed about the use of surgical mesh products.”
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 sexual intercourse and voiding dysfunction. Millions of women were implanted with these devices without the public fully being informed that the use of surgical mesh involves the risk of these serious complications and is not proven to be more effective than traditional tissue repair.
Surgical mesh is a synthetic knitted or woven fabric that is permanently 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 and other factors.
C.R. Bard and its parent company, Becton, Dickinson and Co., have agreed to pay $60 million to the 48 participating states and the District of Columbia, with more than $1.64 million directed to Illinois. Although C.R. Bard stopped selling transvaginal mesh, the settlement provides injunctive relief, requiring both C.R. Bard and Becton, Dickinson and Co. to adhere to certain injunctive terms if they reenter the transvaginal mesh market.
Under the terms of the settlement submitted for the court's approval, the companies are required to:
Provide patients with understandable descriptions of complications in marketing materials.
Include a list of certain complications in all marketing materials that address complications.
Disclose complications related to the use of mesh in any training that includes risk information.
Disclose sponsorship in clinical studies, clinical data or preclinical data being published.
Comply with disclosure requirements before citing any clinical study, clinical data or pre-clinical data regarding mesh.
Require consultants to agree to disclose in any public presentation or submission for publication Bard’s sponsorship of the contracted for activity.
Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
Train independent contractors, agents and employees who sell, market or promote mesh, regarding their obligations to report all patient complaints and adverse events to the company.
Ensure that its practices regarding the reporting of patient complaints are consistent with FDA requirements.
Original source can be found here.