Notice: We Are Not Accepting New Cases. The transvaginal mesh lawsuit litigation has been substantially resolved. This page is provided for informational purposes. If you have recently experienced complications from a pelvic mesh device, please consult a licensed attorney in your state to determine whether any options remain available in your jurisdiction.

The transvaginal mesh lawsuit litigation stands as one of the most significant medical device mass torts in American legal history. More than 100,000 women filed claims against manufacturers of synthetic pelvic mesh implants, alleging that the devices caused catastrophic and often permanent injuries — including chronic pain, mesh erosion, infection, and debilitating complications during intercourse. By 2024, approximately 95% of all claims had been resolved, with manufacturers collectively paying more than $8 billion to injured women and their families.

This page explains what the litigation was, who the defendants were, how cases were resolved manufacturer by manufacturer, and where things stand today.

What Was the Transvaginal Mesh Litigation?

Transvaginal mesh refers to a synthetic surgical implant — typically made from polypropylene, polyester, or other synthetic materials — placed through the vagina to treat two common conditions in women:

  • Pelvic organ prolapse (POP) — a condition in which weakened pelvic floor muscles allow pelvic organs to press into or outside the vaginal wall
  • Stress urinary incontinence (SUI) — the involuntary leakage of urine during activities such as coughing, sneezing, or exercise

These are real and often debilitating conditions, and for many women, mesh repair was presented as the standard of care — an outpatient or short-stay procedure promising a quick recovery and durable results. For hundreds of thousands of women, that promise proved false.

Complications from transvaginal mesh implants were reported at alarming rates: chronic pelvic and groin pain that did not resolve, mesh eroding through the vaginal wall and into surrounding tissue, infection, perforation of the bladder or bowels, progressive scarring, and debilitating pain during intercourse. Perhaps most distressing, many of these complications were permanent. The mesh adhered to surrounding tissue and in many cases could never be fully removed — even through multiple revision surgeries.

The Regulatory Background: How These Devices Reached the Market

A central issue in the transvaginal mesh litigation was the regulatory pathway these devices traveled to market. Most pelvic mesh products were cleared by the FDA through the 510(k) premarket notification process — a pathway that does not require clinical trial data and that clears a device by demonstrating it is “substantially equivalent” to a predicate device already on the market. Plaintiffs argued that this process allowed manufacturers to bring products to market without ever conducting the long-term safety studies that would have revealed the complication rates their own internal data was showing.

The FDA’s own actions over time supported this narrative:

  • In 2011, the FDA issued a safety communication acknowledging thousands of adverse event reports involving pelvic mesh and cautioning that complications could be “serious.”
  • In 2016, the FDA reclassified surgical mesh for transvaginal pelvic organ prolapse repair as a Class III (high-risk) device, requiring manufacturers to submit applications for premarket approval — a far more rigorous standard than 510(k) clearance.
  • In April 2019, the FDA ordered the two remaining manufacturers of transvaginal mesh for prolapse — Boston Scientific and Coloplast — to stop selling the devices, concluding that they had failed to demonstrate a reasonable assurance that benefits outweighed the risks.

Seven MDLs — One of the Largest Mass Torts in U.S. History

As lawsuits proliferated, the U.S. Judicial Panel on Multidistrict Litigation created seven separate federal MDLs in the Southern District of West Virginia, each organized by manufacturer, and assigned all seven to Judge Joseph R. Goodwin — an extraordinary coordinated litigation structure. At the peak of the litigation, the combined dockets encompassed more than 100,000 individual claims.

Judge Goodwin oversaw an aggressive bellwether trial program, sending early cases to juries and allowing both sides to test their arguments before real jurors. The results were mixed — plaintiffs won substantial verdicts in some cases while manufacturers prevailed in others — but the cumulative picture that emerged from trials and discovery painted a compelling portrait of manufacturers who had minimized, dismissed, and in some cases actively suppressed evidence of the complications their products were causing.

How the Litigation Resolved — Manufacturer by Manufacturer

American Medical Systems (AMS) / Endo International — ~$2.6 Billion

AMS reached the largest settlement in the transvaginal mesh litigation. By 2014, the company had agreed to pay $830 million to resolve approximately 20,000 claims. In 2017, its parent Endo International set aside an additional $775 million to address approximately 22,000 more claims. Total payments reached approximately $2.6 billion — the highest aggregate settlement cost of any defendant in this litigation.

Ethicon (Johnson & Johnson) — Billions in Settlements

Ethicon faced claims involving products including the Prolift, TVT, TVT-O, TVT-Secur, and Gynecare mesh lines. After losing multiple bellwether trials — including an $11 million verdict in a New Jersey case in 2013 — Ethicon settled the overwhelming majority of its cases for confidential amounts. In February 2023, Ethicon paid $9.9 million to the state of Kentucky to resolve deceptive marketing allegations. The U.S. Supreme Court previously upheld a $302 million judgment against Johnson & Johnson in a California state attorney general case arising from the mesh litigation. As of late 2025, Ethicon was completing final case dismissals from its remaining MDL inventory.

C.R. Bard — Hundreds of Millions in Settlements

Bard settled hundreds of lawsuits for $21 million in 2014, followed by a group resolution of approximately 3,000 cases for around $200 million, and continued to settle claims in both the federal MDL and in New Jersey multicounty litigation. Bard’s federal MDL was substantially closed, with remaining cases transferred to state court proceedings.

Boston Scientific — $119 Million (2015) + $188.7 Million to 47 States (2021)

Boston Scientific settled approximately 3,000 transvaginal mesh lawsuits in April 2015 for $119 million, with additional settlements following in subsequent years. In 2021, the company paid $188.7 million to 47 states and the District of Columbia to resolve state attorney general allegations of deceptive marketing. In 2025, the Eleventh Circuit upheld a $26.7 million jury verdict against Boston Scientific — one of the last significant appellate rulings in the federal litigation.

Coloplast — $16 Million MDL Settlement

Coloplast resolved 2,821 lawsuits consolidated in MDL 2387 for $16 million, and the MDL was subsequently closed. In 2024, the Eleventh Circuit upheld a $2.5 million jury verdict against Coloplast in a case brought by a woman who suffered serious injuries from a Coloplast pelvic mesh device.

Cook Medical and Neomedic International

Cook Medical and Neomedic International resolved their smaller dockets separately outside the primary MDL settlement frameworks.

Where Things Stand in 2026

The federal transvaginal mesh MDLs are substantially closed, with approximately 95% of all claims resolved as of 2024. Manufacturers have collectively paid more than $8 billion to injured women and their families. Some limited individual litigation continues in state courts — particularly in New Jersey (Ethicon) and Massachusetts (Boston Scientific) — where individual scheduling tracks allow cases that were not resolved in the MDLs to proceed toward individual settlements or trial. A small number of appellate proceedings also continue.

The practical reality is that the mass tort era of transvaginal mesh litigation has ended. The firms that drove the largest volume of cases have closed their intake, and the remaining state-court activity represents individual case processing rather than any systemic unresolved docket.

Frequently Asked Questions

I had mesh surgery and never joined a lawsuit. Is it too late?

For most women, the window to participate in the federal MDL settlement programs has passed. Whether any options remain depends on your specific state, the manufacturer of your device, when your complications developed, and whether a state-court claim could still be filed within your jurisdiction’s statute of limitations. These questions require individualized legal analysis. Consult a licensed attorney in your state if you believe you may have a remaining claim.

My mesh is still in my body and I’m still having complications. What should I do?

Medical management of ongoing mesh complications is a separate question from your legal options. A gynecologist, urogynecologist, or pelvic floor specialist can evaluate your current symptoms and discuss whether revision surgery or other medical interventions may be appropriate. On the legal side, whether any viable claim remains depends on whether you previously filed a lawsuit, the current status of that filing, and the statute of limitations in your state.

How much did transvaginal mesh manufacturers pay in total settlements?

Transvaginal mesh manufacturers collectively paid more than $8 billion to injured women across seven federal MDLs. The largest single settlement came from American Medical Systems (AMS) / Endo International, at approximately $2.6 billion. Ethicon (Johnson & Johnson) settled the vast majority of its cases for confidential amounts; Boston Scientific paid $119 million in a 2015 MDL settlement plus an additional $188.7 million to 47 states in 2021; C.R. Bard paid hundreds of millions across multiple settlements; and Coloplast resolved its federal docket for $16 million.

What complications were caused by transvaginal mesh?

Reported complications from transvaginal mesh implants included chronic pelvic and groin pain, mesh erosion through the vaginal wall into surrounding tissue, infection, perforation of the bladder or bowels, progressive scarring, and severe pain during intercourse (dyspareunia). Many of these complications were permanent because the mesh adhered to surrounding tissue and could not be fully removed even through multiple revision surgeries.

Why did the FDA ban transvaginal mesh?

In April 2019, the FDA ordered Boston Scientific and Coloplast — the two remaining manufacturers of transvaginal mesh for pelvic organ prolapse repair — to stop selling their products. The FDA concluded that neither company had demonstrated a reasonable assurance that the device’s benefits outweighed its risks. The FDA had previously reclassified these products as Class III (high-risk) devices in 2016, requiring premarket approval rather than the less rigorous 510(k) clearance pathway most mesh products had used to reach the market.

Is mesh still being used in surgeries today?

The FDA’s 2019 withdrawal order applied specifically to transvaginal mesh used for pelvic organ prolapse repair — that category has been off the U.S. market since 2019. Mesh for stress urinary incontinence (mid-urethral slings) was not withdrawn and continues to be used in SUI surgery. Hernia mesh — a different product used for abdominal wall repair — also remains in use and is the subject of separate ongoing litigation.

What was the 510(k) process and why did it matter in this litigation?

The FDA’s 510(k) premarket notification process allows a medical device manufacturer to bring a product to market without clinical trial data, provided it can show the device is “substantially equivalent” to a product already on the market. Most transvaginal mesh products were cleared through this pathway. Plaintiffs argued that the 510(k) process allowed manufacturers to skip the long-term safety studies that would have revealed the complication rates their own internal data was already showing — and that the FDA’s eventual reclassification of these devices as high-risk confirmed that the original clearance pathway was inadequate.

About Carey & Danis LLC

Carey & Danis LLC is a national plaintiff litigation firm with offices in St. Louis, Missouri, focusing on pharmaceutical and medical device mass torts, consumer protection class actions, and data privacy litigation. The firm has represented clients in some of the largest coordinated litigation matters in the country. While we are not currently accepting new transvaginal mesh cases, our attorneys continue to investigate emerging medical device and pharmaceutical matters on behalf of injured patients nationwide. For information about other active cases, visit National Case Alert.

This page is provided for informational purposes only and does not constitute legal advice or create an attorney-client relationship. Prior results described herein do not guarantee a similar outcome in any individual case. Statutes of limitations and eligibility requirements vary by state. Carey & Danis LLC is a national plaintiff litigation firm. Attorney advertising.