Attorney General Ford Announces $188.6 Million Multistate Settlement With Medical Device Manufacturer Boston Scientific Corporation


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 
devices.”
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:
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; and
•    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; 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 
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; 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.

 

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