In 7-year study, failure rate for pelvic organ prolapse surgery gradually increased
TUESDAY, May 14, 2013 (HealthDay News) -- The success of a common surgery for pelvic organ prolapse -- a painful and distressing condition affecting many women -- lessens over time, according to a new study.
Abdominal sacrocolpopexy is a procedure used to relieve the problem. It involves stitching a piece of mesh on the top of the vagina and attaching it to a strong ligament from the back of the pelvic bone. This surgery helps to support the pelvic organs.
But the new study found that with each passing year, the rate of pelvic organ prolapse surgery failure increased. The rate of mesh erosion (the primary material used to provide support) reached 10.5 percent by seven years after surgery.
The study also found that the risk of urinary incontinence rose with each year after the surgery.
"This is the longest follow-up of a common operation for women with pelvic organ prolapse. We found that pelvic organ prolapse and urinary incontinence rates increased gradually over follow-up," said study author Dr. Linda Brubaker, a professor of obstetrics and gynecology and urology at Loyola University Medical Center.
Even though surgeons might define a procedure as a failure, many of the patients did not. Only about 17 percent of women had additional pelvic floor surgeries, according to the study.
Pelvic organ prolapse leads to surgery in 7 percent to 19 percent of women, according to study background information. Normally, muscles, ligaments and connective tissue keep all of the pelvic organs where they're supposed to be. But, weakness or tears in these supportive tissues can allow pelvic organs, such as the uterus and vagina, to protrude through the vaginal opening.
This can lead to problems with pelvic organs, according to the American Urogynecologic Society. For example, if the bowel is protruding, constipation or fecal incontinence can result. If the bladder is affected, urinary incontinence may occur.
As to why these surgeries might fail, Brubaker said, "surgeries don't stop time. Women continue to age and the underlying biology continues. Patients may gain weight, too," added Brubaker, who is also dean of the Loyola University Chicago Stritch School of Medicine.
Results of the study are published in the May 15 issue of the Journal of the American Medical Association.
Each year, as many as 225,000 American women have surgery for pelvic organ prolapse, the study authors noted. However, very little long-term follow-up data is available on the success of these procedures, Brubaker said. Most studies only follow women for two years.
The current study included seven years of follow-up. Abdominal sacrocolpopexy isn't the only procedure available for pelvic organ prolapse, but it is commonly used. And, in more recent years, the surgery is being done laparoscopically, so it's less invasive.
The mesh used during the procedure has evolved over time as well. Brubaker said that some of the types of mesh used at the start of this study are no longer in use due to possible complications. The U.S. Food and Drug Administration recently cautioned surgeons about the potential for complications from using surgical mesh for pelvic organ prolapse, and suggested that surgeons use alternatives, such as stitching wherever possible. The agency said that mesh didn't appear to provide any greater benefit to the alternatives.
But, Brubaker and her colleagues recruited patients for their study long before the FDA advisory, so many had repairs that included mesh. The study included 215 women. Of these, 104 had pelvic organ prolapse surgery, along with an additional procedure to stop urinary incontinence. The remaining 111 women just had abdominal sacrocolpopexy.
No matter what the procedure, the failure rate gradually increased each year following surgery. For example, the probability of surgical failure where a patient was experiencing symptoms again in women who had the dual procedure was 14 percent at two years, 21 percent at four years and 29 percent at seven years, according to the study.
Women who had the dual procedure were less likely to have urinary incontinence than women who just had pelvic organ prolapse surgery.
Brubaker said there are other surgical techniques available now that don't involve mesh. However, the different surgeries haven't been studied in head-to-head trials, so it's difficult to know which might be best. There are also nonsurgical options. And, Brubaker said that if a woman is overweight, losing even a small amount of weight can help relieve some symptoms.
In an accompanying editorial, Dr. Cheryl Iglesia wrote that, as with face lifts or hernia surgery, "operations for pelvic organ prolapse also may be vulnerable to the normal wear and tear of aging and activities of daily living. Although imperfect, surgery for pelvic organ prolapse is generally safe and effective, and relief of bulge symptoms is associated with high patient satisfaction."
Iglesia is an associate professor of obstetrics and gynecology and urology at Georgetown University School of Medicine, and the director of urogynecology at MedStar Washington Hospital Center in Washington, D.C.
Her advice to women experiencing pelvic organ prolapse? "Go to a surgeon who you can have a legitimate conversation with about treatment options. Talk about what happens if you don't do anything. Talk about nonsurgical options. Talk about the different types of surgeries and their risks. Look for someone with a high experience rate with more than one procedure. Don't go to a one-trick pony," she said. "Find out if mesh will be used, and if you'll have an anti-incontinence operation done at the same time."
Learn more about pelvic organ prolapse from the U.S. National Library of Medicine (http://www.nlm.nih.gov/medlineplus/pelvicsupportproblems.html ).
SOURCES: Linda Brubaker, M.D., professor of obstetrics and gynecology and urology, Loyola University Medical Center and dean, Loyola University Chicago Stritch School of Medicine; Cheryl Iglesia, M.D., associate professor of obstetrics and gynecology and urology, Georgetown University School of Medicine, and director of urogynecology at MedStar Washington Hospital Center, Washington, D.C.; May 15, 2013, Journal of the American Medical Association