March 23, 2021
Carson City, NV – Today, Nevada Attorney General Aaron D. Ford announced a multistate settlement
with Boston Scientific Corporation (BSC) to resolve allegations of deceptive marketing with its
surgical mesh products for women. The settlement requires BSC to pay $188.6 million to 47 states
and the District of Columbia to resolve allegations that it deceptively marketed transvaginal
surgical mesh devices to patients. Nevada’s share of the settlement is $2,198,979.
“Consumers need to be able to make informed decisions about their health, and the best way for them
to do this is to know all possible risks,” said AG Ford. “My Bureau of Consumer Protection is
holding Boston Scientific Accountable for not disclosing the dangers posed by these surgical mesh
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 because of 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.
The complaint alleges that Boston misrepresented the safety of these products by failing to
disclose the full range of potential serious and irreversible complications caused by mesh,
including chronic pain, voiding dysfunction, and new onset of incontinence.
The settlement provides comprehensive injunctive relief. The terms of the settlement require BSC to
make the following changes:
• For marketing materials intended for consumers, describe complications in understandable
• 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; and
• 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; and
• 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
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
• 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; and
• Register all Boston-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
In addition to Nevada, other states participating in the settlement include: Joining this
multistate settlement are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,
Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,
Maine, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New
Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma,
Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont,
Virginia, Washington, Wisconsin, and the District of Columbia.
A copy of the complaint
and the stipulated judgment
submitted for court approval is attached.