FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?

When the Food and Drug Administration (FDA) banned sales of all transvaginal mesh products for pelvic organ prolapse in April 2019, the ruling created a wave of confusion around a condition that’s often misunderstood. 

Pelvic organ prolapse, or POP, occurs when the muscles and ligaments supporting the vagina weaken, leading to a gradual “dropping” of the cervix, uterus, bladder, or rectum. The condition affects nearly one-third of all women, usually as they age or after childbirth.

Living with POP can be isolating and embarrassing. Symptoms include a feeling of pressure or a bulge coming out of the vagina, trouble urinating, incontinence, or discomfort during sex. Many women suffer for years before seeking help.

Some who have opted for transvaginal mesh surgery to fix their problem have encountered complications, including bleeding, pelvic pain, pain with intercourse and erosion of the vaginal wall.

The FDA ruling in 2019 effectively discontinued a procedure that sometimes didn’t result in safe and positive outcomes. In October 2022, after a 36-month postmarket surveillance study, the FDA determined again that the benefits of using surgical mesh to treat POP transvaginally do not outweigh the risks.

But the research doesn’t necessarily answer the question many women still have, which is: What do I do now?

At UT Southwestern, we have a team that specializes in female urology and pelvic floor disorders and we can help navigate this complex issue. Our section has never used transvaginal mesh kits to treat prolapse due to its tendency to create complications, but we have the expertise to treat mesh complications and remove vaginal mesh. And we specialize in a broad spectrum of effective and minimally invasive treatments to help patients suffering from POP.

A brief history of mesh: Slings vs. Transvaginal 

In the aftermath of the FDA ruling, “mesh” has become a four-letter word to most patients. But it’s important to remember not all procedures that employ surgical mesh are created equal.

The FDA ban only applies to transvaginal mesh for prolapse repairs, which means there are still safe surgical options for treating POP and incontinence. These include: