At the annual meeting of the American Association of Gynecologic Laparoscopists (AAGL), two leading urogynecologists debated the use of pelvic mesh versus native tissue repair in pelvic reconstructive surgery.
Dr. Peter Rosenblatt, a leading consultant for Boston Scientific, used to conduct the company's weekend cadaver clinics teaching doctors how to place polypropylene (PP) pelvic mesh. His position is that abdominal robotic sacrocolpopexy using mesh is a successful treatment.(Y-mesh is used in sacrocolpopexy).
Dr. Cheryl Iglesia is a member of AUGS (American Urogynecologic Society) who used to tout pelvic mesh procedures.
Dr. Iglesia came out on the side of native tissue repair, defined as using the existing patient tissue enforced with sutures.
In some cases, native tissue can mean harvesting one's own fascia to do an autologous repair.
Pelvic organ prolapse is a common problem for aging women and its predicted that by the year 2050, nearly one-third of women will be affected by at least one troublesome pelvic floor disorder. The estimates are that 200,000 surgical procedures are performed in the U.S. every year.
In 2010, Open Mesh sacrocolpopexy was considered to be the “gold standard” for the repair of high-grade POP, evolving from a suture only repair.
A major turning point in the history of pelvic mesh occurred when the U.S. Food and Drug Administration (FDA) issued its 2011 statement that mesh used for transvaginal POP repair has risks not present in native tissue repair.
That was a complete turnabout from the 2008 FDA statement that said the risks from the use of pelvic mesh were “rare”.
"The FDA determined that (1) serious adverse events are NOT rare, contrary to what was stated in the 2008 PHN, and (2) transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair." ~ FDA, Urogynecologic Surgical Mesh, July 2011
Eventually, the FDA received 15,000 additional complaints of mesh erosion, infection, pain, dyspareunia, recurrent prolapse and urinary problems, bowel, bladder, and blood vessel perforation.
By January 2012, the FDA ordered 33 mesh manufacturers to conduct post-market surveillance studies, the type that had not been done prior to FDA clearance and marketing. The manufacturers had failed to assure reasonable safety and effectiveness, evidenced by the additional complications.
Instead of waiting for the studies to be completed and published, in 2018, the FDA ordered the last two manufacturers of POP mesh to take them off the market, refocusing attention on native tissue repairs. See Mesh News Desk story here.
Previously, the kits had been marketed with no long-term efficacy data, no clinical studies, and no requirements for either. Instead, the FDA’s 510(k) clearance process allowed POP mesh kits to be sold based on the manufacturer's promises of safety and efficacy.
Dr. Cheryl Iglesia, in supporting native tissue repair, cited a study by Pelvic Floor Disorders Network showing a significant quality of life after two years of native tissue repair surgery. She actually called the native tissue repair the “gold standard” in a sharp reversal of AUGS calling the use of PP mesh the “gold standard.”
“Patients are more willing to accept failure from a prolapse repair over a mesh-related complication,” she said.
Rosenblatt cites the results of a 5-year study of robotic sacrocolpopexy (abdominal repair using mesh) and defined success as no treatment, no pelvic organ prolapse beyond the hymen, no POP symptoms, and no apical descent greater than -5. The success rate was almost 90% he said, with no mesh-related complications.
He cites another randomized controlled trial in JAMA. Participants had significant prolapse and were randomized into two groups - one with sacrospinous ligament fixation, and another with uterosacral ligament suspension. These are considered the two primary methods of native tissue repair for POP though the "Y" mesh is now used to suspend the organs.
After two years, neither was superior to the other.