Vaginal Mesh Use for Prolapse Repair Drops After 2011 Warning

Marcia Frellick

December 22, 2015

Since the US Food and Drug Administration (FDA) issued a second warning in 2011 against surgically implanting mesh for treating pelvic organ prolapse (POP), use of the vaginal mesh decreased in New York from 30% to 23% in 2013, new data show.

Findings from the study by Art Sedrakyan, MD, PhD, from the Department of Healthcare Policy and Research, Weill Medical College of Cornell University in New York City, and colleagues were published online December 21 in JAMA Internal Medicine.

Prior research showed that after the first FDA mesh warning in 2008, use of the mesh actually went up from 21% in 2008 to 30% in 2011.

The difference is likely a result of the wording of the warnings, the authors suspect. In the first warning, physicians were asked to get extra training in using the mesh and to be aware of the risks. In the second warning, in 2011, the FDA questioned the benefit of the mesh over traditional POP repair and said complications were "not rare," noting that there had been 1503 mesh-related events recorded by the end of 2010, an increase of five times the number recorded on January 1, 2008.

"Although other explanations are possible," the authors write, "we believe that the stronger language in the 2011 [US Food and Drug Administration] warning is at least partly related to the decline in mesh use and has implications for future risk-communications policy, suggesting that stronger regulatory warnings can influence physicians' use of potentially unsafe medical devices."

The researchers used data from the New York Statewide Planning and Research Cooperative System, which contains records of all surgeries in the state.

They found that the annual number of repairs for pelvic organ prolapse decreased from 6960 in 2011 to 5757 in 2013. The use of mesh after the 2011 FDA warning declined from 30% (95% confidence interval [CI], 29% - 31%) to 23% (95% CI, 22% - 24%) in 2013.

They also found that most of the decline after the 2011 warning occurred in low-volume centers compared with high-volume centers (from 25% [95% CI, 23% - 27%] to 15% [95% CI, 13% - 16%] vs from 37% [95% CI, 35% - 39%] to 34% [95% CI, 32% - 36%]; P < .01), as well as in nonacademic centers (from 29% [95% CI, 27% - 30%] to 20% [95% CI, 18% - 21%] vs from 32% [95% CI, 31% - 34%] to 27% [95% CI, 25% - 29.0%]; P < .01 for academic centers).

Higher-volume and academic centers may have more procedures with higher severity and may also be more comfortable because of physicians' experience with using mesh, the authors speculate. The greater decline in the low-volume, nonacademic centers may also be related to lower tolerance for litigation as the number of lawsuits and amount of awards increases.

FDA's 510(k) Approval Pathway Flawed, Experts Say

In an accompanying commentary, Vanessa L. Jacoby, MD, from the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, and colleagues say the study findings add to the evidence that the FDA's 510(k) pathway to approve moderate-risk medical advices is flawed.

Under this process, the manufacturers do not have to go through clinical trials, but must demonstrate "substantial equivalence" of the structure and function to an existing, legally marketed device.

The FDA approved vaginal mesh for POP because it was substantially equivalent to mesh for abdominal hernia repair, "an entirely different surgery performed on tissues with characteristics disparate from those in POP repair," the commentary authors write.

They add that the study highlights that substantial use of mesh persists "despite serious risks and the initiation of 49,000 federal lawsuits against manufacturers," adding that gynecologists began reporting complications to the FDA soon after the 2002 approval, including erosion into the vagina, severe pain, and dyspareunia.

The authors advocate for the FDA requiring evidence from comparative clinical trials before an implantable device is used in surgical practice, rather than relying on postmarket voluntary reporting to determine safety.

The study was funded in part by the National Institutes of Health and the US Food and Drug Administration. The authors have disclosed no relevant financial relationships. One commentary coauthor reports funding from Astellas Pharma US via contracts with the University of California, San Francisco, to conduct research unrelated to transvaginal mesh. The other commentators have disclosed no relevant financial relationships.

JAMA Intern Med. Published online December 21, 2015. Research letter extract, Commentary extract


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