Dangers of Vaginal Mesh Surgery for Incontinence May Be Overstated: Study

It found only 1 in 30 women will suffer a complication that requires a second procedure

Wednesday, September 9, 2015

WEDNESDAY, Sept. 9, 2015 (HealthDay News) -- Surgical mesh appears to be relatively safe for treating urinary incontinence in women, despite concerns raised by U.S. regulators, a new report contends.

Only one out of every 30 women who receive a synthetic vaginal mesh sling to treat stress incontinence will suffer a complication that requires a second surgery, according to a decade-long follow-up study of nearly 60,000 Canadian women.

"If a person has a sling in, 97 percent of them will do just fine and will have a good outcome potentially up to 10 years, in terms of their risk for future surgery," said study author Dr. Blayne Welk, an assistant professor of urology at Western University's Schulich School of Medicine & Dentistry in Ontario.

The researchers also found that women can greatly reduce their risk of complications by choosing a surgeon who performs these mesh implants on a regular basis.

"You want to go to someone who's doing this routinely," said Dr. Harvey Winkler, co-chief of the division of female pelvic medicine and reconstructive surgery at North Shore-LIJ Health System in Great Neck, N.Y. "When he's putting this sling in, it's just another day at the office for him," added Winkler, who was not involved with the study.

Stress incontinence occurs when tiny amounts of urine leak due to coughing, laughing, sneezing or other movements that place stress on the bladder.

The U.S. Food and Drug Administration has released several warnings in recent years related to the safety of vaginal mesh, according to background information in the article.

The mesh devices can cause pain, infection, bleeding, pain during intercourse and urinary problems, according to the agency. And surgery to remove or fix the mesh does not always clear up these symptoms.

Most recently, the FDA said in April 2014 it plans to reclassify surgical mesh as a "high-risk" device for fixing pelvic organ prolapse, in which weak or failing muscles allow pelvic organs such as the bladder, bowel and uterus to drop below their normal position and bulge (prolapse) into the vagina.

In the United States, more than 50,000 women have joined class-action lawsuits for complications resulting from incontinence and prolapse procedures involving surgical mesh, the researchers said.

Welk and Winkler argued that the FDA has done a poor job separating the risk of surgical mesh used for incontinence from the greater risk posed by mesh used to treat prolapse.

Surgical mesh is much more often used to treat incontinence than pelvic organ prolapse, Welk said. During this 10-year study, only about 5,000 women received mesh implants to treat prolapse, while nearly 60,000 received mesh for incontinence.

Winkler explained that incontinence treatment requires just a small strip of synthetic mesh that is inserted to support the urethra, while surgeons must use larger pieces of mesh to treat prolapse.

To assess the safety of mesh in treating incontinence, Welk's team tracked the number of Ontario women who needed a follow-up surgery to remove or fix a mesh implant. The study, which was published online Sept. 9 in the journal JAMA Surgery, included almost 60,000 women who had the procedure April 2002 through December 2012.

Overall, just over 1,300 women -- or 2.2 percent -- needed a follow-up surgery within an average of about a year after receiving a mesh implant for stress urinary incontinence, the findings showed.

By the end of the decade-long study period, there was a slightly more than 3 percent cumulative risk of complications, the investigators found.

Patients of "low-volume" surgeons were 37 percent more likely to require a follow-up surgery, when compared to women who received treatment by a surgeon who regularly performs this procedure, the researchers said.

However, Welk pointed out that the study's definition of a high-volume surgeon included doctors who perform an average of 17 sling procedures each year.

"It's not something where you have to do hundreds of these a year," Welk said. "That translates to one or two per month, which isn't out of the range of possibility for the average gynecologist or urologist."

The results show that incontinence surgery using the synthetic mesh is safe, and that women who have undergone the procedure can feel reassured, Winkler said.

"I have three friends of mine within a block of me who have the sling in," he said. "People should not lie awake at night worrying that the mesh is going to cause them problems."

However, the study did find that women who receive multiple mesh-based procedures for urinary incontinence had an almost fivefold increased risk of complications that would require a second surgery.

The study was supported by grants from the Ontario government and received no funding from medical device makers.

SOURCES: Blayne Welk, M.D., assistant professor, urology, Western University's Schulich School of Medicine & Dentistry, Ontario, Canada; Harvey Winkler, M.D., co-chief, division of female pelvic medicine and reconstructive surgery, North Shore-LIJ Health System, Great Neck, N.Y.; Sept. 9, 2015, JAMA Surgery, online

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