Surgeons seem to have heeded a beefed-up warning from the U.S. Food and Drug Administration about using transvaginal surgical mesh when repairing pelvic organ prolapse, investigators reported online Dec. 21 in JAMA Internal Medicine.
In New York state, the use of mesh fell by almost 25% just 2 years after the FDA intensified its original warning, said Dr. Art Sedrakyan of Cornell University in Ithaca, N.Y., and his associates. “Although other explanations are possible, we believe that the stronger language in the 2011 FDA warning is at least partly related to the decline in mesh use,” they said.
A prior study by the investigators found that use of mesh actually rose by almost 50% during the 3 years after the original FDA warning, issued in 2008 (BMJ. 2015 Jun 3;350:h2685 doi: 10.1136/bmj.h2685). During that time, FDA received about 1,500 reports of subsequent adverse events, such as erosion through the vagina, pain, infection, organ perforation, bleeding, dyspareunia, vaginal scarring or shrinkage, and urinary problems, the investigators noted (JAMA Intern Med. 2015 Dec 21. doi: 10.1001/jamainternmed.2015.6595).
In 2011, the FDA responded by strengthening its original warning. Instead of urging physicians to be aware of risks and training in each technique in which they used mesh, the agency noted that mesh-related complications are “not rare” and emphasized that pelvic organ prolapse (POP) can be repaired without mesh. To examine the effects of that warning, the investigators analyzed a database of all surgical procedures performed in New York state during 2011-2013. They excluded patients who had undergone previous POP repairs and broke down trends by hospital type and size.
Total annual POP repairs dropped from 6,960 in 2011 to 5,757 in 2013, they found. After the new FDA warning, the use of mesh also fell – from 30% (95% confidence interval, 29%-31%) in 2011 to 23% (95% CI, 22%-24%) in 2013. The drop was significantly less dramatic in academic and high-volume hospitals, perhaps because surgeons there were more comfortable using mesh or were treating worse disease, the researchers said. “The higher rate of decline in the use of mesh by low-volume and nonacademic providers may be related to a lower tolerance for litigation related to sizable awards and growing numbers of lawsuits in outpatient settings,” they added.
The National Institutes of Health and the FDA partially funded the study. The investigators had no disclosures.