The Food and Drug Administration (FDA) recently halted sales of surgical mesh devices used for transvaginal repair of pelvic organ prolapse (POP).
In this condition, the muscles and tissues that support the pelvic organs (uterus, bladder, rectum) weaken or loosen, causing them to drop or press into or out of the vagina. The main symptom of pelvic organ prolapse is (seeing or feeling) a vaginal bulge, and it can can co-exist with other conditions such as urine leakage or problems with bowel movements, making it difficult to lead a normal life.
All of these issues fall under what’s called “pelvic floor disorders,” an umbrella term to describe problems that affect the ligaments, muscles, and tissues of the pelvis. Though 30 to 40 percent of women may have some degree of pelvic organ prolapse, about 3 to 8 percent of women have associated symptoms that may lead them to seek care.
The FDA’s move, Yale Medicine specialists say, has left some women confused and concerned—especially since there are several types of surgery used to treat pelvic organ prolapse, and the FDA decision affects just one approach—a transvaginal mesh procedure. This surgery involves making an incision in the vaginal wall and inserting mesh to help hold up the prolapsed (fallen) organs. (The goal is that a woman’s tissue grows into the holes of the mesh to create a supportive wall.)
The FDA said that the manufacturers of the devices used for this type of pelvic organ prolapse repair had not demonstrated a reasonable assurance of their safety or effectiveness by the FDA deadline. Complications reported in lawsuits against the manufacturers—which have resulted in nearly $8 billion in settlements to 100,000 women—include bleeding, pain, inflammation, and infections.
Importantly, the FDA did not place any restrictions on the use of mesh when the prolapse surgery is done through the abdomen. It also does not affect transvaginal use of mesh to treat stress urinary incontinence (SUI), commonly called a “sling” procedure. SUI is urine leakage that happens when women cough, sneeze, exercise, or lift heavy objects. It affects approximately 1 in 3 women and is caused by a weakened bladder sphincter muscle and other surrounding pelvic floor muscles, sometimes due to childbirth and aging, among other factors.
Yale Medicine obstetrician-gynecologists and urologists who subspecialize in female pelvic medicine and reconstructive surgery say they worry women will mistakenly think the FDA ruling involves all pelvic floor surgeries that use mesh.
“The transvaginal mesh used for prolapse is getting confused with the use of mesh slings to treat stress incontinence and laparoscopic procedures for pelvic organ prolapse,” says Leslie M. Rickey, MD, MPH, a female pelvic medicine and reconstructive surgeon. “Women should know that this has nothing to do with treatment for stress incontinence and that the pelvic floor surgeries we do are very well studied and safe. Even though this one procedure is off the table for now, there other good treatment options, both surgical and nonsurgical.”
“We need to educate women, especially those who have stress urinary incontinence, that this news from the FDA has nothing to do with the midurethral sling procedure,” he says, speaking of a common procedure that involves placing synthetic mesh to act as a ribbon of support under the urethra. “This is the safest, most effective, and least complicated surgery to treat stress incontinence and has revolutionized surgical management of the condition.”
And, Dr. Rickey adds, women who did have transvaginal mesh surgery for pelvic organ prolapse don’t need to rush to their doctor if it is working well for them—but they should always ask their physician about any concerns they might have. Below, we asked Drs. Rickey and Harmanli questions about mesh and pelvic floor disorders.
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.”