Clinical trial identifies women most likely to benefit from vaginal mesh surgery
Certain women with vaginal prolapse are most likely to benefit from undergoing vaginal mesh surgery, a technique that has become controversial and is the focus of numerous lawsuits. The findings, which are published early online in Ultrasound in Obstetrics & Gynecology, provide valuable information regarding who should and should not be considered candidates for the surgery.
Vaginal prolapse—when pelvic tissues weaken and the vaginal canal may protrude through the vaginal opening—affects roughly 10% to 20% of women. A significant number of patients require repeat surgeries to correct this recurring issue. They often undergo sacrospinous vaginal colpopexy—which involves attaching the vagina to surrounding tissue in the abdomen to hold it in place—or a surgical procedure that inserts a net-like implant called a vaginal mesh.
While studies suggest that vaginal mesh may reduce recurrence rates, it also has been linked with significant complications. (Indeed, vaginal mesh is the focus of a number of ongoing lawsuits.) To justify the potential complications associated with mesh use, it's important to identify women at high risk of prolapse recurrence.
Research suggests that a condition called levator avulsion is a major contributor to the development of pelvic floor prolapse and to its recurrence after surgery. This condition occurs when a woman suffers from an injury to the pelvic floor muscle during vaginal childbirth.
This information led Kamil Svabík, MD, PhD, of Charles University and General University Hospital in Prague, and his colleagues to compare sacrospinous vaginal colpopexy with vaginal mesh in patients with post-hysterectomy prolapse and levator avulsion, as diagnosed by ultrasound imaging.
The randomized clinical trial included 70 women: 36 underwent vaginal mesh surgery and 34 underwent sacrospinous vaginal colpopexy. At the one-year follow-up, ultrasound examinations revealed that there was one recurrence in the vaginal mesh group (2.8%), and 21 recurrences in the sacrospinous vaginal colpopexy group (61.8%). Dr. Svabík noted that despite the study's small size, the team was able to achieve significant results.
"By assessing patients prior to receiving treatment using pelvic floor ultrasound imaging, we are able to identify women who will benefit from vaginal mesh implantation over a conventional approach and dramatically reduce the risk of repeat surgery," said Dr. Svabík. "This is a win/win situation for our patients and for understanding the reasons behind varying success rates of conventional or less traditional treatments."