Transvaginal Mesh: Safety, Complications and Your Legal Options
Transvaginal mesh treats pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Complications such as pain, erosion and revision surgery led to an FDA ban on transvaginal mesh for POP. Lawsuits continue into 2026.
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What Is Transvaginal Mesh?
Transvaginal mesh is a synthetic, net-like surgical material that helps support weakened or damaged pelvic tissue. It has been used to treat both stress urinary incontinence and pelvic organ prolapse.
- Stress urinary incontinence (SUI)
- A condition where physical movement or activity, like coughing, exercising or sneezing, causes involuntary urine leakage. When transvaginal mesh is used to treat SUI, it is sometimes called a bladder sling.
- Pelvic organ prolapse (POP)
- A condition where organs like the bladder, bowel, uterus or the top of the vagina drop from their normal position and bulge into the vagina. This can be due to weakened pelvic muscles.
The mesh is implanted through the vagina during surgery, which is why it is called “transvaginal” mesh. Once in place, it acts as a sling or hammock, allowing your body’s tissues to grow into tiny holes within the mesh for added strength and stability.
When Did Surgeons Start Using Transvaginal Mesh?
Surgeons have been experimenting with mesh since the 1970s, but it wasn’t until the 1990s that doctors developed the transvaginal mesh technique. This technique shortened patient recovery time after surgeries.
In 1996, the FDA cleared the first pelvic mesh device for urinary incontinence treatment. By 2002, it had approved several vaginal mesh kits for pelvic organ prolapse.
Since then, the agency has issued several safety communications for risks associated with transvaginal mesh. Lawsuits against manufacturers have led to more than $8 billion in settlements for approximately 100,000 women.
Why Transvaginal Mesh Became Controversial
Transvaginal mesh became controversial due to thousands of complication reports, leading to safety concerns and regulatory actions. The FDA issued warnings from 2008 to 2019, then ultimately banned transvaginal mesh for pelvic organ prolapse in 2019. However, surgeons continue to treat stress urinary incontinence with mesh.
In a 2026 study published in Gynecology and Minimally Invasive Therapy, scientists found that a certain type of minimesh was a safe and durable option for POP repair. However, the FDA has not changed its stance on vaginal mesh.
Settlements are currently estimated at about $8 billion, since some payment amounts aren’t publicly available. Women have been filing these lawsuits for years. If you’ve been impacted by mesh complications, you can still speak to a lawyer and file a transvaginal mesh lawsuit.
Transvaginal Mesh Complications and Side Effects
Transvaginal mesh complications can range from less severe issues like pain to serious concerns such as mesh erosion, which causes the mesh to poke through surrounding tissues.
- Erosion or exposure of vaginal mesh
- Infection
- Mesh contraction, which is when the mesh shortens and causes tightness or pain
- Pain during sex
- Pain in the pelvis or vagina
- Vaginal bleeding or discharge
One SUI mesh recipient, Donna Miser, told Drugwatch she suffered from severe complications such as pain during sex, bloody discharge and a knife-like pain in her vagina. She has had to endure multiple surgeries to find relief, and she told us the experience has changed her life and left her depressed.
For complications specific to SUI slings, see our Bladder Sling Complications page.
FDA Warnings, Mesh Reclassification and Market Withdrawal
The FDA’s warnings for transvaginal mesh span from 2008 to 2019. This includes reclassifying mesh to require additional safety studies and removing certain meshes from the market.
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2008
After receiving over 1,000 reports of complications from transvaginal mesh, the FDA issued its first public health notification. The warning highlighted risks like discomfort during intercourse, erosion, infections, organ perforation, pain and vaginal scarring, but these complications were described as rare.
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2011
The FDA updated its warning, stating that complications from transvaginal mesh were not rare. Newly identified risks included bleeding, emotional distress, recurrent prolapse, urinary problems and vaginal shrinkage. The agency also considered reclassifying mesh from a low to moderate-risk Class II device to a high-risk Class III device.
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2016
The FDA reclassified transvaginal mesh for pelvic organ prolapse repair from Class II to Class III. This reclassification requires more rigorous premarket approval and is the strictest device review process.
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2019
The FDA ordered all manufacturers to stop selling and distributing transvaginal mesh for POP repair in the U.S. The agency concluded that manufacturers had not adequately demonstrated that their mesh products were safe and effective.
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2024
Based on available data for mesh slings for stress urinary incontinence, the FDA recommended that medical providers receive proper training for the surgery and advise patients of the risks and benefits.
The FDA’s regulatory actions mean that transvaginal mesh for POP is no longer marketed or available in the U.S. However, mesh slings are still used for stress urinary incontinence. The agency hasn’t released any updates on these regulatory actions since 2024.
Boston Scientific’s ProteGen Sling is the only mesh product that has been officially recalled. Other transvaginal mesh products were withdrawn by manufacturers after the FDA’s 2019 POP ban.
What To Do if You're Experiencing Vaginal Mesh Complications
If you’re experiencing mesh complications, you should talk to your doctor. You can also contact a lawyer if you’re interested in filing a lawsuit. Here are three easy steps:
- See a urogynecologist, as they specialize in pelvic floor or urinary incontinence issues. Your medical provider may recommend imaging or tests. In some cases, you may need an examination under anesthesia to see if your mesh is causing problems.
- Keep all of your medical records, especially if you want to file a claim.
- Get a free case review through Drugwatch to see if you qualify for a lawsuit.
Thousands of cases have settled, but the litigation is ongoing in 2026. Lawyers continue to accept new cases.
Frequently Asked Questions About Transvaginal Mesh
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