Attorney General Gurbir S. Grewal announced today that medical device maker Boston Scientific Corporation will pay the State more than $3 million as part of a multistate settlement that resolves allegations that the company deceptively marketed its surgical mesh products.
The settlement requires Boston Scientific to pay a total of $188.6 million to 47 states and the District of Columbia to resolve allegations it failed to disclose multiple serious health risks associated with the transvaginal implantation of surgical mesh devices in violation of state consumer protection laws. New Jersey’s share of the settlement is $3.67 million.
“Every company that makes and sells healthcare products has an obligation to provide complete, accurate and clear information about those products, and to make required disclosures about any health risks associated with their use,” said Attorney General Grewal. “When companies fail to meet that obligation like Boston Scientific did in this case, they are abdicating their duty under the law and we will step in to protect New Jersey consumers.”
“Healthcare product manufacturers must be clear, and fair, in what they disclose about their products,” said Division of Consumer Affairs Acting Director Kaitlin A. Caruso. “When medical device companies offer misinformation or leave out critical information, they will be held accountable.”
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, common conditions caused by the weakening of the pelvic floor muscles as a result of childbirth and age, among 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 have been implanted with surgical mesh, and thousands allegedly suffered serious complications.
Today’s settlement resolves allegations that Boston Scientific misrepresented the safety of its surgical mesh products in violation of state consumer protection laws 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 agreement represents the third multistate settlement Attorney General Grewal has joined over the misleading marketing of surgical mesh and/or failure by companies to disclose risks associated with its use.
In addition to Boston Scientific, Attorney General Grewal has previously entered into multistate surgical-mesh-related settlements with Johnson & Johnson and C.R. Bard.
New Jersey’s total share from the three settlements is approximately $8 million, while the overall share to all participating states from the Boston Scientific, Johnson & Johnson and C.R. Bard settlements is $365.5 million.
In addition to the monetary terms of today’s settlement, Boston Scientific is required under today’s agreement to make the following reforms to its business practices:
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 above-mentioned disclosure requirements;
- 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.