In March 2021, a coalition of 48 state attorneys general announced a $188.6 million Boston Scientific transvaginal mesh settlement resolving allegations that the company deceived patients and doctors about the safety of its surgical mesh devices used to treat pelvic organ prolapse and stress urinary incontinence.1https://www.scag.gov/ The agreement penalized Boston Scientific for its marketing conduct and imposed six years of compliance requirements, but it did not compensate injured women in most states. Patients hurt by the mesh had to pursue separate personal injury claims.
What the States Accused Boston Scientific of Doing
The investigation was led by California and Washington, with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas as co-leads. Thirty-nine additional states and the District of Columbia joined before the March 23, 2021 announcement.
The complaint’s core claim was a consumer protection one: Boston Scientific misrepresented what its polypropylene mesh could do and concealed complications that were serious and often permanent. The states pointed to specific statements the company made to doctors and patients, including that mesh complications were no different from risks in non-mesh pelvic surgeries, that a skilled surgeon could eliminate mesh-related problems, that the mesh would stay soft and flexible after implantation, and that it did not raise infection risk or trigger foreign body reactions. The company was also accused of claiming mesh repair was superior to traditional tissue repair without valid scientific evidence supporting that claim.
Where the $188.6 Million Went
The money was divided among the participating states, and in most of them it went into general funds as consumer protection penalties. California, a co-lead, received the largest known share at $19.3 million. South Carolina received $5.5 million.1https://www.scag.gov/ Michigan received roughly $4.4 million, and the District of Columbia received about $1.3 million. Allocations for most other states were not publicly disclosed.
Washington took a different path. Attorney General Bob Ferguson directed the state’s share of more than $8.8 million into a restitution fund for women who had received transvaginal mesh implants. Washington had built that fund with earlier settlement dollars from Johnson & Johnson ($9.9 million) and C.R. Bard ($2.38 million), and by March 2021 had already distributed more than $11 million directly to affected women. Every woman implanted with transvaginal mesh in Washington was eligible to file a claim, whether or not she had experienced complications and whether or not she had recovered anything through a separate personal injury suit.
Outside Washington, the settlement did not put money in patients’ hands. Women who were injured had to file their own lawsuits or participate in the parallel mass tort litigation.
What Boston Scientific Was Required to Change
The settlement locked Boston Scientific into a six-year compliance framework covering marketing, physician relationships, and research.
On marketing, the company had to disclose all significant and inherent mesh complications in consumer-facing materials, and describe those complications in plain language. It was barred from calling its mesh “FDA approved” unless that was accurate, and from claiming superiority over native tissue repair without supporting scientific evidence.
On physician relationships, training programs for health care providers had to cover the full range of known complications. Consultant and speaker contracts had to require physicians to disclose any financial support they received from the company. Boston Scientific also had to notify recent purchasers of any FDA safety alerts, recalls, or public health notices.
On research, the company had to register all sponsored clinical studies with ClinicalTrials.gov and disclose its role as sponsor along with any author conflicts of interest in published studies.
The Injuries Behind the Case
The devices at issue were permanent polypropylene implants, and the complications women reported were often severe and difficult or impossible to reverse.
Mesh erosion was among the most common problems. The mesh could break down and protrude through vaginal walls, sometimes extending into the bladder, urethra, or rectum and causing permanent organ damage. Chronic pelvic pain affected many patients, with women describing constant burning, stabbing, or aching that interfered with daily activities and work. Other reported complications included organ perforation requiring emergency surgery, painful intercourse, nerve damage causing permanent numbness or hypersensitivity, chronic infections from bacterial colonization on the mesh, and urinary dysfunction that was sometimes worse than the condition the mesh was implanted to treat.
Removal proved extremely difficult and sometimes impossible, a fact the states alleged Boston Scientific failed to disclose. More than half of patients experiencing erosion required multiple surgeries to attempt removal, and many of those procedures failed to extract all fragments. Between 2008 and 2018, the FDA documented more than 10,000 serious injuries, more than 800 device malfunctions, and 77 deaths associated with transvaginal mesh products across all manufacturers.
What the FDA Has Done About Transvaginal Mesh
The federal regulatory timeline tracks the states’ claims. The FDA first warned the public about serious complications from transvaginal mesh in October 2008, and issued an updated safety communication in July 2011. In January 2016 it reclassified transvaginal mesh for pelvic organ prolapse repair from Class II to Class III, the highest-risk category, requiring manufacturers to submit premarket approval applications proving safety and effectiveness.
Boston Scientific and Coloplast failed to meet that standard. In April 2019 the FDA ordered both companies to immediately stop selling transvaginal mesh for prolapse repair. The agency later reviewed follow-up data from Boston Scientific’s postmarket studies on two of its products, the Uphold Lite and Xenform, and concluded in August 2021 that neither had a favorable benefit-risk profile compared with traditional repair without mesh.
One boundary worth knowing: mesh slings used for stress urinary incontinence were not part of the market removal order and remain available, though with enhanced warning labels acknowledging risks such as erosion and the difficulty of complete removal.
If You Were Injured, the Attorney General Settlement Is Not Your Recovery
Because the $188.6 million settlement did not compensate patients outside Washington, women injured by Boston Scientific mesh have had to pursue separate claims. Boston Scientific faced roughly 54,000 federal lawsuits consolidated in multidistrict litigation (MDL No. 2326) in the Southern District of West Virginia under Judge Joseph R. Goodwin. That MDL was terminated in February 2021, with approximately 95 percent of cases resolved through settlement agreements. By the third quarter of 2015, Boston Scientific had already settled approximately 6,000 cases for a total of $457 million.
New cases are still being filed. In December 2025 a plaintiff sued in the U.S. District Court for the District of Massachusetts, alleging that Boston Scientific’s Obtryx II mid-urethral sling caused erosion, chronic pelvic pain, inflammation, and vaginal bleeding that required surgical removal. Individual settlement values for current cases reportedly range from $40,000 to $450,000 depending on the severity of the injury and the number of revision surgeries involved. Boston Scientific reported $194 million in litigation-related net charges for full-year 2025, compared with zero the year before, and said it could not predict the impact of future litigation charges with reasonable certainty.
Women considering a claim should know that the multistate settlement did not release Boston Scientific from personal injury liability, and eligibility, deadlines, and value depend on the specific product, when it was implanted, the injuries involved, and the statute of limitations in the state where the claim is brought.