Colorado to receive more than $2.6 million in settlement with surgical mesh manufacturer Boston Scientific Corporation
March 24, 2021–Attorney General Phil Weiser today announced Colorado will receive $2,606,605 in a multistate settlement with Boston Scientific Corporation for the deceptive marketing of its surgical mesh products for women.
The settlement, which was reached between the attorneys general of 47 states and the District of Columbia and the company, requires a total payment of $188.6 million. The attorneys general alleged that Boston Scientific deceptively marketed transvaginal surgical mesh devices to patients by failing to disclose the full range of potential serious and irreversible complications caused by mesh, including chronic pain, new onset of incontinence, and other complications.
“The deceptive practices of this irresponsible company impacted thousands of women, who now face lifelong complications,” said Weiser. “By requiring marketing, training, and clinical trial reforms in this settlement, we will help ensure that the company will be transparent and no longer cause women such harm.”
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. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors. Although 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 were implanted with the devices and thousands of women are alleged to have suffered serious complications resulting from these devices.
Under the terms of the settlement, Boston Scientific is required to cease deceptive marketing practices and implement training and clinical trial reforms, including the following:
- For marketing materials intended for consumers, describe complications in understandable terms;
- For certain marketing materials, disclose significant complications, including the inherent risks of mesh;
- 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; and
- Register all Boston Scientific-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
The money from the settlement will be used for reimbursement of the State’s actual costs and attorneys’ fees, and for future consumer fraud or antitrust enforcement, consumer education, or public welfare purposes.