FDA ban on transvaginal mesh: What does it mean for women facing pelvic organ prolapse?
October 17, 2022
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:
- Bladder or vaginal slings: They’ve been around since the 1990s and are still considered the gold standard for treatment for stress urinary incontinence. Made of synthetic mesh or human tissue, the sling acts like a hammock around the urethra, preventing it from opening during stresses on the bladder, like a laugh or a sneeze. It’s placed through a small incision in the vagina and for women worried about “leaking,” it’s an effective option. Most importantly, the FDA did not ban bladder or vaginal mesh slings and it is endorsed by most female urology specialists and urogynecologists.
- Abdominal or laparoscopic/robotic prolapse repair: Using a laparoscope or DaVinci robot, the surgeon enters the abdomen via five small incisions and inserts a mesh or tissue-based strip to hold the pelvic organs or vagina in place. The positioning and anchoring of the mesh has been deemed safe by the FDA and it is not associated with significant complications.
- Transvaginal prolapse repair using native tissue: The patient’s own tissue is used to raise the prolapsed organs and reconstruct the pelvic organ support. Multiple techniques exist and they are done transvaginally. It typically takes about 90-120 minutes, and there is no abdominal incision and no synthetic mesh implanted in the patient’s body.
Transvaginal mesh removal and repair
When transvaginal mesh “kits” were first approved by the FDA in 2002, the surgery was marketed as easy and effective, and it quickly became a popular choice for physicians and patients. At UT Southwestern, however, we steered clear of the procedure because it was prone to complications and its safety was never fully demonstrated by long-term research.
'The end of transvaginal mesh surgery, as mandated by the FDA, does not mean the end of effective treatment for pelvic organ prolapse. Our team is trained in the most advanced therapies, technologies, and techniques to successfully treat POP.'
About eight years ago, we began seeing more patients who had experienced complications from transvaginal mesh and wanted it removed or repaired.
Often times, the surgeon who put it in didn’t know how to fix it, patients told me.
And that’s another problem: Transvaginal mesh placed for prolapse is relatively easy to put in, but very difficult to remove because of the way it is anchored to bones and ligaments in the leg and pelvis. Removing all of it is nearly impossible.
Nonsurgical treatments for POP
The FDA ruling has put a spotlight on surgical options for POP, but UT Southwestern offers nonsurgical techniques for patients whose symptoms aren’t severe enough to warrant surgery. These include:
- Pessary, which is a specially fitted plastic “doughnut” that’s positioned similarly to a diaphragm and uses the strength of the pelvic muscles to support the vagina.
- Pelvic floor biofeedback and therapy helps strengthen or modify the pelvic floor by retraining muscles and employing manual therapy.
Related reading: ‘You are not alone.’ One patient’s story of life with a bladder prolapse
Getting your life back
The end of transvaginal mesh surgery, as mandated by the FDA, does not mean the end of effective treatment for pelvic organ prolapse. Our team is trained in the most advanced therapies, technologies, and techniques to successfully treat POP and we are dedicated to finding the right treatment for each patient.
We understand how isolating this problem can be. Patients often tell me they stay home because they’re worried about leaking or because of vaginal pressure and discomfort; they stop working out; they stop being intimate with their partner.
But when they get the proper treatment, they’re amazed at how different they feel. “You gave me my life back,” many say. “I feel like a woman again.”
It’s so rewarding to hear, and a reminder of why I do this job.
If you or a loved one is dealing with pelvic organ prolapse symptoms, you can schedule an appointment online or call 214-645-8300.