FRANKFORT, Ky. (WTVQ) – Attorney General Daniel Cameron announced Tuesday a multistate settlement with medical device manufacturer Boston Scientific Corporation, resolving allegations of deceptive marketing of transvaginal surgical mesh devices for women.
The settlement requires Boston Scientific to pay $188.6 million to 47 states and the District of Columbia. Kentucky will receive $2,934,694 million.
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor 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.
The complaint alleges that Boston Scientific misrepresented the safety of these products by failing to disclose potential serious and irreversible complications. The settlement requires Boston Scientific to cease misleading advertising and modify their marketing, training, and clinical trial materials to comply with the following 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 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 mesh is implanted inside the body;
- Refrain from representing that surgical mesh does not potentiate infection or does not increase the likelihood of infection;
- Refrain from representing that surgical mesh repair is superior to native tissue repair unless such representations are supported by valid scientific evidence.
- Inform healthcare providers of significant complications when providing training regarding procedures for insertion and implantation;
- Maintain policies requiring that its independent contractors, agents, and employees who sell, market, or promote mesh are adequately trained to report patient complaints and adverse events to the company.
Clinical Trial Reforms
- When submitting a clinical study or clinical data regarding mesh for publication, disclose the company’s role as a sponsor and any author’s potential conflict of interest;
- Refrain from citing any clinical study, clinical data, preclinical data, research, or article regarding mesh for which the company has not complied with the disclosure requirements in the injunction;
- Include a sponsorship disclosure provision requiring consultants to contractually agree to disclose in any public presentation or submission for publication any sponsorships by Boston Scientific related to the contracted-for activity;
- Register all Boston Scientific-sponsored clinical studies regarding mesh with ClinicalTrials.gov.