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Research & Innovation, Family Health

Transvaginal Mesh: What Women Should Know

BY CARRIE MACMILLAN June 19, 2019

One option to treat a pelvic floor disorder was pulled from the market, but others remain.

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What is surgical mesh?

Surgical mesh is a net-like medical implant that is used to provide support when repairing weakened or damaged tissue. Most surgical mesh comes from synthetic (man-made) materials or animal tissue. It is used in a variety of medical procedures, including hernia repair and heart stents.

The type most often used to treat pelvic floor disorders is made of the synthetic polypropylene. For pelvic organ prolapse repair, the mesh graft is placed to reinforce the weakened vaginal wall. This is different than the way it is used for stress urinary incontinence, in which a thin strip is placed to support the urethra.

When did mesh start appearing in pelvic floor surgery?

Polypropylene mesh has been used for abdominal hernias since the 1950s. Historically, pelvic organ prolapse was repaired with “native tissue,” or attaching the prolapsed organ to a surrounding ligament or muscle with stitches. Although this is still a good option for many women, some women don’t have enough—or strong enough—native tissue, Dr. Rickey explains. Also, this technique is not always effective long-term, Dr. Harmanli notes.

So, in the 1970s, gynecologic and urologic surgeons began to experiment with mesh, cutting it themselves and inserting it through abdominal incisions. In the 1990s, a minimally invasive approach—making an incision in the vagina to insert the mesh in an effort to shorten recovery time—was developed.

Meanwhile, the FDA approved the first pelvic mesh for stress urinary incontinence (the midurethral sling) in 1996. In 2002, the first mesh for transvaginal repair of pelvic organ prolapse was approved. It was around that time when manufacturers began marketing kits that included surgical tools and mesh for transvaginal prolapse procedures, the first of which received FDA clearance in 2002.

What pelvic floor surgeries use mesh?

It is important to note that the FDA has only stopped the sale and distribution of devices containing mesh used for the transvaginal repair of pelvic organ prolapse.

Two common pelvic floor surgeries that use mesh and are not affected by the FDA announcement are as follows:

  • Transabdominal mesh to treat pelvic organ prolapse: This minimally invasive surgery is done by making a small incision in the abdomen or laparoscopically (small incisions near the navel and using a camera) and inserting the mesh to support organs. “This technique has existed for more than 30 years and is well studied and safe. Women should not be afraid of this,” Dr. Harmanli says.
  • Midurethral sling procedure: This surgery is the most common one used to treat stress urinary incontinence. A surgeon makes three small incisions (one in the vagina, two above the pubic bone) and places a narrow strip of synthetic mesh under the urethra to lift and support it along with the neck of the bladder. “This is the safest and least complicated procedure a woman can have for urinary incontinence,” Dr. Harmanli says. “There are approximately 20 years of high-quality data supporting this surgery. The risks are very minimal, and when there is a complication, it can be corrected with another surgery, but that is hardly ever needed.”

What is the problem with transvaginal mesh surgery for pelvic organ prolapse?

Transvaginal prolapse repair is a more complicated surgery, especially compared to the straightforward sling procedures to treat urinary incontinence, Dr. Rickey says.

The complex nature of the surgery, Dr. Harmanli adds, requires specialized training. The kits (mentioned above) were heavily marketed to general Ob/Gyns and urologists who didn’t necessarily have the required skills, Dr. Harmanli says.  

What are other options for pelvic floor disorder treatment?

There are a number of nonsurgical options that can address pelvic organ prolapse and stress incontinence, including physical therapy to strengthen the pelvic floor and devices called pessaries that are made of silicone and can be placed into the vagina to hold the organs in place. Patients can often self-manage the pessaries, meaning that women can place and remove the pessary themselves as needed.

But when such methods don’t work for women, surgery may be helpful. Until a better product is designed that can be used transvaginally for repair of pelvic organ prolapse, Dr. Harmanli says he will continue to perform the procedure through the abdomen (laparoscopically) for women with severe prolapse. “For cases that are moderate or for women where we can’t easily go through the abdomen, we will offer transvaginal repair using native tissue,” he explains.

What should women do if they have concerns?

Drs. Harmanli and Rickey say they have received numerous phone calls from past and current patients anxious about the news they have been hearing about pelvic mesh. If a woman was treated transvaginally with mesh for pelvic organ prolapse and has no complaints, she shouldn’t worry and does not need to take any action, Dr. Harmanli says.

“The word ‘mesh’ shouldn’t scare women,” Dr. Rickey adds. “There are other options to treat these disorders, and mesh is but one tool in a tool box with many others. Any treatment is a shared decision between doctor and patient, and we discuss the benefits and risks very carefully.”

Click here to learn more about Yale Medicine's Urogynecology & Reconstructive Pelvic Surgery Program.