With more than 300,000 U.S. women facing surgery in the U.S. each year for pelvic-organ prolapse, a new study has concluded that the newer technique of supporting the internal organs with a mesh trampoline produces better short-term success, but complication rates are higher.
The study, in the May 12th New England Journal of Medicine, comes at a time of growing popularity for the mesh surgery, which involves specialized kits, compared to the older method of stitching sagging organs back into place with an anterior colporrhaphy.
“Despite their widespread use, none of the marketed kits have been comprehensively evaluated in comparative trials,” said the research team, led Dr. Daniel Altman of the Karolinska Institute in Stockholm.
“I think the mesh advocates will find strength in our study and I think mesh opponents will similarly find strength for their arguments, looking at the complication rates,” Dr. Altman told Reuters Health in a telephone interview.
Surgeons have sought a better repair method because women who receive traditional surgery typically face a 40% risk of recurrence.
In the randomized multicenter trial, 189 women had colporrhaphy and 200 had their vaginal walls supported with a Gynecare Prolift Anterior Pelvic Floor Repair System mesh kit by Ethicon, a Johnson & Johnson subsidiary that was not involved in the study.
Just under 16% were having the surgery because an earlier attempt had failed.
At the one-year mark, 60.8% who got mesh repair were free of any prolapse compared to 34.5% among the women in the colporrhaphy group (P<0.001).
Dr. Altman said the success rates were relatively low because the researchers were very strict about what constituted a success. Not only did patients’ organs need to be repositioned, but “the patient must have no sense of bulging and protrusion. When you say that, the success rates drop.”
However, the trocar-guided mesh surgery took longer (52.6 vs. 33.5 minutes, P<0.001) and resulted in more blood loss (84.7 vs. 35.4 mL, P<0.001) and more cases of bladder perforation (3.5% vs. 0.5%, P=0.07).
And at the one-year mark, women who had the newer surgery were more likely to report new stress urinary incontinence (12.3% for mesh treatment vs. 6.2% for colporrhaphy, P=0.05).
The incontinence “could be due to damage to the urethra and supporting structures, but it could also be that the procedure is too effective. It overcorrects the bladder base and it lifts it up a little too much,” Dr. Altman said. “These changes are so small, it’s easy to overcorrect.”
Because the study, by the Nordic Transvaginal Mesh Group, involved 53 clinics in Finland, Norway, Sweden and Denmark, it represents all types of settings.
“I think our study reflects real practice compared to other studies,” Dr. Altman said.
N Engl J Med 2011; 364:1826-1836.
— Gene Emery0