AG Racine Announces $188.6 Million Multistate Settlement with Medical Device Manufacturer Boston Scientific Corporation

District to Receive $1.2 Million in Case Alleging that Company Failed to Disclose Risks Associated with Surgical Mesh Devices   

WASHINGTON, D.C. – Attorney General Karl A. Racine today announced a multistate settlement with Boston Scientific Corporation (Boston Scientific) to resolve allegations that the company deceptively marketed transvaginal surgical mesh devices to patients. The company agreed to pay $188.6 million as part of the settlement that resolves claims under consumer protection laws. The settlement requires Boston Scientific to pay more than $1.2 million to the District and to market its products in a way that discloses potential complications. 

“The law requires that manufacturers inform patients and physicians of potential complications their products may cause,” said AG Racine. “When companies fail to do so and hurt patients, as Boston Scientific did, state attorneys general will hold them accountable.” 

Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions such as stress urinary incontinence and pelvic organ prolapse. These are common conditions faced due to a weakening in 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 people were implanted with the devices, and thousands suffered serious complications resulting from these devices. 

In April 2019, the Food and Drug Administration ordered Boston Scientific to discontinue the sale and distribution of all surgical mesh products in the United States because it determined that Boston Scientific did not demonstrate a reasonable assurance of safety and effectiveness for these devices. 

The settlement resolves allegations that Boston Scientific 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. As part of the settlement Boston Scientific must: 

  • Pay the states $188.6 million in penalties, including $1,287,532 to the District.  
     
  • Ensure that marketing materials accurately describe potential complications and risks: Boston Scientific must describe complications in understandable language in all marketing materials. In any marketing materials that address complications, Boston Scientific must include a list of agreed-upon complications.  
     
  • Implement training reforms that inform professionals of potential complications: Boston Scientific must disclose significant complications or inherent mesh complications in any training regarding proper procedures for mesh insertion and implantation. 
     
  • Reform its practices regarding clinical trials: Boston Scientific must disclose its role as a sponsor and any author‘s potential conflict of interest when it submits a study or clinical data for publication. Boston Scientific may not cite to any clinical study, clinical data, or preclinical data regarding mesh if it has not complied with these disclosure obligations. 
     
  • Comply with the District’s consumer protection laws.  

The District joined the investigation that resulted in today’s settlement, which was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas. The other states that joined the settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, and Wisconsin.  

How to Report Unfair Business Practices 
To report scams, fraud, or unfair business practices, contact OAG’s Office of Consumer Protection by: