Vaginal mesh slings for incontinence fail in about 3 percent

0
58

(Reuters Health) – About one in 30 women who get a common type of vaginal surgery to address urinary incontinence will need repeat procedures within 10 years to remove or replace mesh slings inserted to prevent leaking urine, a study finds.

This risk is considered low, the authors note.

Patients fared best when they had slings inserted by surgeons who did the highest volume of these procedures. These patients were 37 percent less likely to need repeat procedures, the study found.

Women should make sure they know what their surgeon’s past experience has been, lead researcher Dr. Blayne Welk of Western University in London, Ontario said in an email.

Millions of women develop urinary stress incontinence when muscles and tissues that support the bladder weaken. Simple actions such as coughing, running or lifting heavy objects can put pressure on the bladder and cause urine to leak. The risk increases with age, obesity, and multiple vaginal childbirths.

In the U.S., an estimated one in seven women will get surgery for urinary stress incontinence during their lifetime, Welk and colleagues note in JAMA Surgery.

While long-term follow up of some of the first women to get the slings found few complications after more than 17 years, some previous research has linked the devices to chronic pain, fistulas, and mesh erosions into the urethra or vagina, the researchers note.

Treatment of these complications can require repeat surgeries to remove or replace the devices, a possibility that regulators in the U.S. and Canada have highlighted in warnings to consumers and advised surgeons to explain to patients considering these procedures. In the U.S., more than 50,000 women have joined class action lawsuits related to complications with vaginal mesh.

Given the warnings, Welk and colleagues set out to examine reoperation rates and to assess how the surgeon’s training and experience might influence the results. Overall, they looked at data on 59,887 women who had mesh slings implanted by nearly 1,000 different surgeons between 2002 and 2012.

After an average follow-up of five years, 1,307 women, or 2.2 percent, had needed a reoperation. However, when women were followed for 10 years, that rate rose to 3.3 percent.

In other words, Welk said, the risk of reoperation for mesh removal or revision 10 years after the procedure is one in 30.

The surgeons’ specialty – for example, gynecology versus urology – didn’t affect the outcomes of surgery, but their volume of cases did. When the researchers looked at surgeons’ total number of procedures, those in the top 25 percent outperformed the rest.

The authors admit that they were lacking data on the severity of pre-surgery incontinence, smoking history or type of mesh used in the procedures. The study also limited its analysis of complications to those serious enough to require repeat surgeries.

Many complications, while not life-threatening, can still affect a patient’s quality of life, said Dr. Quoc-Dien Trinh, who co-wrote an editorial with colleague Dr. Christian Meyer at Brigham and Women’s Hospital and Harvard Medical School in Boston.

The findings highlight the importance of seeking surgeons who have done high volumes of the procedure, Trinh said by email.

“This paper shows that there is merit in asking that question specifically in the context of mesh surgeries, and it has been shown to be a generally reliable metric of surgical quality of care,” Trinh said.

More complicated is the choice patients face when no surgeons close to home have done high volumes of these procedures, Trinh added. It may be easy to find a high volume surgeon in large cities, but in less populated areas it might mean traveling hundreds of miles.

“Ultimately, patients need to strike a balance between convenience and quality,” Trinh said.

SOURCE: bit.ly/1LXuCJT JAMA Surgery, online September 9, 2015.