Transvaginal Mesh Litigation – History, Settlements & Current Status

Lawsuits allege transvaginal mesh implants caused pain, mesh erosion and repeat surgery. The FDA has received reports of infection and organ perforation. Thousands of women have sued Johnson & Johnson and its Ethicon unit over the devices.

The litigation is at the settlement stage. State attorneys general settled with Johnson & Johnson and C.R. Bard. Boston Scientific settled a Canadian class action. A class action was also heard in Australia. No MDL is pending.

In 2019 the FDA ordered the last transvaginal prolapse mesh kits off the market. Other makers named in the litigation include Boston Scientific and C.R. Bard.

Latest Transvaginal Mesh Lawsuit Updates

September 25, 2020: Bard Agrees to Pay $60 Million to States

The Wisconsin Attorney General announced a deal with C.R. Bard and its parent, Becton, Dickinson and Company [1]. It was made by 48 states and the District of Columbia. The release calls it a pre-suit settlement.

The companies agreed to pay $60 million. The attorneys general allege deceptive marketing of Bard’s vaginal mesh devices. Injunctive terms apply if the companies return to the market.

March 4, 2020: Ontario Court Approves Boston Scientific Class Settlement

The Canadian Press reported, via CBC, a class-action settlement with Boston Scientific [2]. About 325 Canadian women with Boston Scientific transvaginal mesh implants will share $21.5 million. Ontario Superior Court Justice Paul Perell approved it.

Each woman’s share depends on the severity of her medical issues. The suit became a class action in February 2017. Boston Scientific stopped selling the prolapse devices in July 2019.

November 21, 2019: Australian Court Rules Against Johnson & Johnson Subsidiaries

ICIJ reported that 1,350 Australian women won a class action against Johnson & Johnson subsidiaries [3]. Federal Court Justice Anna Katzmann ruled the company engaged in misleading conduct.

The ruling said that in some cases complaints “were ignored altogether.” Compensation is to be set later, and Johnson & Johnson could still appeal. The class members had Johnson & Johnson mesh implants.

October 17, 2019: Johnson & Johnson Agrees to Pay Nearly $117 Million

The New York Attorney General announced a multistate settlement [4]. Johnson & Johnson and its subsidiary Ethicon will pay nearly $117 million over alleged deceptive marketing of transvaginal surgical mesh devices.

The state says an investigation found the companies did not disclose possible side effects. The deal covers 41 states and DC. New York State will receive $5,203,122.50.

April 16, 2019: FDA Orders Prolapse Mesh Off the Market

The FDA ordered Boston Scientific and Coloplast to stop selling and distributing their surgical mesh for transvaginal prolapse repair [5]. The order took effect immediately.

The products were Boston Scientific Uphold Lite and Xenform and Coloplast Direct Fix Anterior. The FDA calls it an order and not a recall. The makers then withdrew the devices.

March 7, 2019: Becton Dickinson Ends Bard Vaginal Mesh Sales Worldwide

ICIJ reported that Becton Dickinson, the parent of C.R. Bard, will stop making and selling vaginal mesh worldwide [6]. It would end sales in all remaining markets.

C.R. Bard had halted use of certain mesh products in the United States almost seven years earlier. It withdrew its Avaulta mesh in 2012. Becton Dickinson called the exit a business decision and not a safety concern.

January 5, 2016: FDA Reclassifies Prolapse Mesh to Class III

The FDA finalized its 2014 proposed orders. They moved mesh used for prolapse repair through the vagina into class III, the high-risk group.

Makers had to submit premarket approval applications by July 5, 2018. The FDA decided not to approve the applications from Boston Scientific and Coloplast. The April 2019 order to stop selling followed that decision.

July 13, 2011: FDA Issues Updated Safety Communication

The FDA updated its safety communication and published an analysis of serious complications from transvaginal mesh used for pelvic organ prolapse.

An FDA devices panel met on September 8 and 9, 2011. In January 2012 the FDA ordered postmarket studies of mesh. By February 17, 2013, it had issued 95 orders to 34 prolapse mesh makers.

October 20, 2008: FDA Issues Public Health Notification on Mesh

The FDA issued a Public Health Notification on serious complications of mesh placed through the vagina [7]. The mesh was used to repair prolapse of the pelvic organs and stress urinary incontinence.

In the past three years, the FDA had received over 1,000 reports from nine surgical mesh manufacturers. The notice called the complications rare but said they can have serious consequences.

What Is Transvaginal Mesh?

According to the FDA, surgical mesh is a medical device that gives extra support when tissue is weak or damaged [8]. The New York Attorney General says transvaginal mesh is a synthetic material placed through the vagina.

For pelvic organ prolapse, the mesh is placed for good to hold up a weak vaginal wall. For stress urinary incontinence, it supports the urethra or bladder neck.

Who May Be Affected?

Women who had mesh implanted through the vagina may be affected. That includes women with Johnson & Johnson, Boston Scientific, C.R. Bard or Coloplast products, such as slings and prolapse kits.

Johnson & Johnson stopped selling mesh implants for prolapse in 2012. It still markets devices for incontinence, according to CNBC in October 2019 [9].

The FDA asks anyone with persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex to tell a provider. Whether you qualify depends on your facts, so each case needs an individual legal review.

Reported Injuries or Damages

The FDA’s 2008 notification listed several problems. These include erosion through the vaginal lining, infection, pain, urinary problems, and prolapse or incontinence that came back. The FDA also reported perforation of the bowel, bladder and blood vessels during insertion.

In some cases, scarring and mesh erosion caused a big drop in quality of life. The FDA cited pain and discomfort, even during sex. Treatment included more surgery, some of it to remove the mesh.

The attorneys general allege that C.R. Bard did not disclose serious risks. They name chronic pain, scarring and shrinking of tissue, painful sex and repeat infections. Court findings are separate from these allegations.

In a 2014 study, Kasyan and colleagues followed 677 women who had mesh kits placed for prolapse (Central European Journal of Urology) [10].

Overall complication rates were 22.5% (152 of 677 women). The authors say the study’s main limit was a retrospective design, which looks back at past cases.

In 2021 and 2022, final FDA studies found results similar to native tissue repair after 36 months. The FDA still believes these devices add risks, including mesh exposure and erosion.

Recall and Regulatory Background

The FDA states that no approved mesh for repairing prolapse through the vagina is marketed in the United States. The FDA prolapse guidance says people without symptoms need no action beyond routine check-ups [11].

On July 13, 2018, the FDA ordered the maker of the last mesh for transvaginal posterior-compartment prolapse repair to stop selling.

The company withdrew its product. No transvaginal mesh MDL is pending before the JPML. The only mesh MDLs involve hernia mesh [12].

Evidence to Preserve

Keep any records that show what was implanted, when it happened and what followed:

• Product details, such as the brand, model, lot number or implant card from the hospital.
• Operative reports, along with the date and the hospital of your implant surgery.
• Medical records, scans and notes on complications, repeat surgery or mesh removal.
• Photos and symptom diaries that show how your problems changed over time.
• Bills, receipts and other costs you paid out of pocket for treatment.
• Letters, emails and notes from talks with your surgeon, the hospital and the mesh maker.
• Insurance or employer records that show the work you missed because of the mesh.

Filing Deadlines

Deadlines to file a claim exist, and they come from state law. They depend on where you live and on when the injury, the complication and the diagnosis happened.

If a deadline passes, a strong claim can still end. Talk with a lawyer promptly to learn which deadline fits your case.

Potential Compensation

A mesh injury claim may seek damages for medical costs, including revision or removal surgery. It may also seek pay lost to missed work, pain and suffering, and loss of quality of life.

On a February 2020 earnings call, Boston Scientific said over 95 per cent of known claims were settled or in the final stages. It expected to pay US$115 million into settlement funds that year.

Compensation amounts vary by case. Past results do not guarantee future outcomes. Your medical records and diagnosis help shape potential compensation.

Frequently Asked Questions

Is Transvaginal Mesh Still Being Used?

Transvaginal mesh is still used for incontinence slings. These slings remain a surgical option. The FDA’s April 11, 2024 evaluation found mini-slings as effective as traditional mid-urethral slings over 36 months. Side effects and re-surgery were similar in type and rate.

How Much Is the Transvaginal Mesh Settlement?

There is no single transvaginal mesh settlement amount. Washington settled a similar case in April 2019 for $9.9 million. The October 2019 Johnson & Johnson deal did not cover suits by California, West Virginia, Kentucky and Mississippi.

What Does the Research Say About Transvaginal Mesh?

An FDA panel reviewed research on transvaginal mesh in September 2011. It put the average mesh erosion rate one year after incontinence sling surgery at about 2 percent. Slings were reported to work for about 70 to 80 percent of women at one year.

Have Transvaginal Mesh Makers Admitted Liability?

Transvaginal mesh makers Johnson & Johnson and Boston Scientific have not admitted liability in the cases above. Johnson & Johnson said its settlement has no admission of liability or misconduct by Ethicon. Boston Scientific denied that its mesh caused the Canadian plaintiff’s problems. It said they came from pre-existing conditions.

References

1. https://urbanmilwaukee.com/pressrelease/ag-kaul-announces-60-million-multistate-agreement-with-c-r-bard/
2. https://www.cbc.ca/lite/story/1.5485362
3. https://www.icij.org/investigations/implant-files/australian-patients-win-in-closely-watched-mesh-class-action-against-johnson-johnson/
4. https://ag.ny.gov/press-release/2019/johnson-johnson-and-subsidiary-pay-117-million-settlement-after-endangering
5. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh
6. https://www.icij.org/investigations/implant-files/leading-manufacturer-exits-vaginal-mesh-market/
7. https://www.govinfo.gov/content/pkg/USCOURTS-ca4-15-01454/pdf/USCOURTS-ca4-15-01454-1.pdf
8. https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants
9. https://www.cnbc.com/2019/10/17/johnson-johnson-to-pay-117-million-to-settle-vaginal-mesh-litigation.html
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC4165670/
11. https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/pelvic-organ-prolapse-pop-surgical-mesh-considerations-and-recommendations
12. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-September-2-2025.pdf