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At AAGL’s 50th Global Congress on MIGS, Peter L. Rosenblatt, MD, and Cheryl B. Iglesia, MD, FACOG, debated the use of native tissue repair and transvaginal mesh in pelvic reconstructive surgery.
The outcomes of native tissue repair versus mesh augmented repairs became the topic of much debate over the past several years. The Food and Drug Administration (FDA) removed vaginal mesh kits from the market, which then refocused attention on the outcomes of native tissue repairs. In a debate on Monday, November 15, Rosenblatt and Iglesia presented evidence to determine the superior method in pelvic reconstructive surgery.
Rosenblatt began the debate, asserting his position on vaginal mesh. His first argument discussed a prospective analysis in Female Pelvic Medicine & Reconstructive Surgery, in which researchers presented 5-year results of robotic sacrocolpopexy, defining success as no retreatment with surgery or pessary, no pelvic organ prolapse (POP) beyond the hymen, no apical descent greater than -5, and no POP symptoms. They had a success rate of almost 90% and there were no mesh related complications. His point being that this is where the industry came from. It used to be a salvage procedure, when you were out of options.
He went on to cite a randomized controlled trial in JAMA where women with significant prolapse were randomized to sacrospinous ligament fixation, or uterosacral ligament suspension, which are the 2 primary methods of native tissue repair for POP. The primary outcome was defined as: no apical descent greater than 1/3 into the vaginal canal or anterior or posterior vaginal wall beyond the hymen; no vaginal bulge symptoms; and no retreatment for prolapse at 2 years. They found that, 2 years after surgery, neither method was superior to the other. “Do you know any other surgical subspecialty that would tolerate a failure rate of 40% to 50%?” Rosenblatt said.
He went on to describe the tumultuous relationship between transvaginal mesh and the FDA, beginning at the end when the FDA told the last 2 manufacturers of pelvic mesh—Coloplast and Boston Scientific—that they had to pull these from the market. Things hit the fan, Rosenblatt said, in 2011 when the FDA released a statement that mesh use in transvaginal POP repair introduces risks not present in native tissue repair. Specifically that, in a 3-year period, they received about 15 thousand additional complaints of erosion, infection, pain, dyspareunia, urinary problems, recurrent prolapse, bowel, bladder, and blood vessel perforation. Rosenblatt deemed this misleading in the scope of all POP surgeries in 2011.
In January 2012, the FDA told 33 manufacturers of prolapse and incontinence products to conduct post-market surveillance studies. However, the FDA decided not to wait until the findings were published to tell the last two manufacturers to take their products off the market, claiming that the manufacturers had not demonstrated reasonable assurance of safety and effectiveness.
At this point, Cheryl B. Igelsia, MD, FACOG, issued her rebuttal in support of native tissue repair. She cited numerous studies, including a paper by the Pelvic Floor Disorders Network that showed significant quality of life improvement after 2 years. “The bottom line is that these techniques should not be abandoned for mesh procedures, and the native tissues are considered the gold standard,” Iglesia said. She continued with her experience in a tertiary care center. “Patients are more willing to accept failure from a prolapse repair over a mesh-related complication,” she said.