WEDNESDAY, May 11 (HealthDay News) -- In women, a vaginal mesh support is more effective for repairing a common type of pelvic organ prolapse -- which occurs when pelvic organs fall out of place -- than simply stitching the connective tissue in the vaginal wall muscle back together, finds new research.
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But the newer procedure comes with a higher rate of serious complications during the surgery, such as bladder perforation and pelvic hemorrhage, and adverse events after the surgery, including new urinary incontinence and pain during sex, according to the study.
"It's already fairly well-known that mesh procedures have higher complications. The likelihood of hitting something you don't want to hit, like the bladder, are higher when the surgeon can't visualize everything he or she is suturing. The flip side to that is the ability to create a better support," said Dr. Scott Chudnoff, director of gynecology at Montefiore Medical Center in New York City, who was not involved in the study.
"Both traditional and novel surgical treatments for pelvic organ prolapse have advantages and disadvantages," echoed the study's lead author, Dr. Daniel Altman, an associate professor and senior consultant at Danderyd Hospital and the Karolinska Institute in Stockholm. "It is therefore essential that the patient and doctor discuss their surgical options carefully before the type and extent of surgery is decided."
Pelvic organ prolapse occurs when the pelvic organs, such as the bladder and urethra, drop downward, often because of a weakness in the vaginal wall associated with childbirth, hysterectomy or menopause. This can cause the vagina to push forward, causing discomfort and even incontinence.
The standard procedure for repairing a pelvic organ prolapse is stitching together the area of connective tissue (fascia) where there is a weakness, according to Chudnoff. This treatment, he said, is called anterior colporrhaphy.
The novel surgery -- known as the transvaginal mesh procedure -- involves using a piece of synthetic mesh that has what looks like wings (called trocar) that are used to anchor the mesh. The trocar is pushed to a higher plane in the connective tissue, anchoring it more securely, and then sutured into place.
Discussing the novel operation, Chudnoff pointed out that the U.S. Food and Drug Administration issued a warning in the fall of 2008 about the high rates of complications with transvaginal mesh procedures.
Although the FDA allowed the devices to stay on the market, the agency recommended that physicians obtain specialized training in placing the mesh, that they watch patients carefully for signs of infection or erosion of the fascia around the mesh, and that they fully inform their patients of all potential complications.
But, the more traditional surgery has issues, too. According to background information in Altman's study, the risk of recurrence has been reported to be as high as 40% with anterior colporrhaphy.
The study involved 389 women in Sweden, Norway, Finland and Denmark. Researchers randomly assigned the women, who had a prolapsed bladder -- which occurs when weakened supportive tissue between the bladder and vaginal wall stretches so much that the bladder pushes into the vagina -- to one of the two procedures. Two hundred underwent mesh surgery, while 189 women had the standard surgery.
One year after the procedure, 61% of the women in the mesh group had no prolapse or only a slight prolapse, compared to 34.5% of those in the standard surgery group.
On the other hand, mesh surgeries required more time, and there was a greater risk of bladder perforation and pelvic bleeding during this procedure, according to the study. Bladder perforation occurred in 3.5% of women who had the mesh surgery, compared to 0.5% in the standard surgery group. Pelvic bleeding was also more common in the mesh group, with one woman losing up to 1,000 milliliters of blood.
Rates of new stress urinary incontinence post-surgery were higher for women in the mesh group -- 12.3% versus 6.3% in the standard surgery group, and more women in the mesh group reported pain during intercourse (7.3% versus 2%).
In the mesh repair group, six patients (3.2%) also had to undergo another surgery for mesh-related complications, and five underwent a new surgery to correct new stress incontinence, compared to one additional surgery for prolapse recurrence in the standard group.
Results of the study are published in the May 12 issue of the New England Journal of Medicine.
"Surgical treatment of pelvic organ prolapse should take into consideration a number of factors," including the patient's type and size of prolapse, previous pelvic surgery and gynecological history, and co-existing medical conditions, as well as the patient's lifestyle and daily activities, Altman explained.
"The study shows that use of a synthetic implant, placed using a standardized surgical technique, may improve outcomes of prolapse repair compared to traditional surgery," Altman said.
"The new method was, however, associated with higher rates of complications, which may occur up to one year after the operation. For this reason, the benefits of the implant-based method must be balanced against the higher rates of adverse events associated with this approach," he concluded.
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SOURCES: Daniel Altman, M.D., Ph.D., associate professor and senior consultant, Danderyd Hospital and the Karolinska Institute, Stockholm, Sweden; Scott Chudnoff, M.D., director of gynecology, Montefiore Medical Center, New York City; May 12, 2011, New England Journal of Medicine