Attorney General Jennings announced Monday a settlement with Boston Scientific Corporation (Boston), a medical device manufacturer, to resolve allegations of deceptive marketing of its transvaginal surgical mesh devices for patients. The multistate settlement follows a 2019 settlement with Johnson & Johnson, Ethicon, Inc. and a 2020 settlement with C.R. Bard, Inc. for similar conduct.
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in patients 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 patients were implanted with the devices and thousands 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.
“Today’s settlement holds Boston Scientific accountable for their failures,” said Attorney General Jennings. “My office will continue to work to ensure that Delawareans can rely on manufacturers’ assurances as to the safety and effectiveness of medical devices.”
The settlement provides comprehensive injunctive relief. Under the terms of the settlement, Boston is required to implement several reforms:
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 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;
Training Reforms:
- 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 related to the contracted-for activity;
- Register all Boston-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
Boston has agreed to pay a total of $188.6 million to the 48 states and the District of Columbia. Delaware will receive $1,386,237 of this amount, which will be placed in the Consumer Protection Fund. The matter was handled for Delaware by Deputy Director of Consumer Protection Regina S. Schoenberg.
A copy of the Cease and Desist Order by Agreement is here.