Despite the FDA’s warnings about health risks associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), use of the device is increasing, according to a study of POP patients in New York state.
At the same time, risks of reinterventions within 1 year and post-surgery urinary retention continue, said the authors of the study, which was published online in BMJ (June 2, 2015).
Researchers at Weill Medical College of Cornell University in New York analyzed a statewide database of nearly 28,000 women who had prolapse repair procedures in the state from 2008 to 2011. More than 7,300 women underwent prolapse repair with mesh and 20,653 had the procedure without mesh.
They found POP repair with mesh rose from 21% in 2008 to 30% in 2011. While more than 62% of the patients in the cohort were younger than 65 years, there were more 65-and-older patients in the mesh group than in the non-mesh group.
Although post-surgery complications were not common whether surgeons used mesh or not, researchers reported that mesh recipients were more likely than non-mesh recipients to have a reintervention within 1 year and to have urinary retention within 90 days.
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In subgroup analyses based on age, researchers found that younger mesh patients had a 66% increased risk of reintervention within 1 year, compared to non-mesh patients. Mesh use was associated with a 36% increased risk of developing in-hospital complications, such as urinary retention, among older patients.
"This study is addressing the real-world, population-based application of mesh as a medical device, and it yields a different profile for its safety—that mesh is not as safe as people believe it is," said senior author Art Sedrakyan, MD, PhD, in a Weill Cornell news release.
Despite these findings, Dr. Sedrakyan and colleagues said, mesh is not always dangerous and these and other results should not be taken to the extreme.
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But the FDA continues to send messages about mesh’s potential harm. The agency has issued proposals that would include the reclassification of surgical mesh used for POP from a moderate-risk to a high-risk, or class III, device.
“The authors present a manuscript which highlights the need and the benefit for patient registries for new surgical implants, such as what we’ve seen with the… POP mesh kits,” Daniel S. Elliott, MD, of Mayo Clinic, Rochester, MN, told Urology Times. “This current large-scale problem that we are dealing with shows the need to change how new surgical products are introduced to the market by industry, and then readily accepted by many surgeons and implanted in unsuspecting patients.”
While patient product registries help to fix the problem, they are not the entire solution, according to Dr. Elliott, who was not involved in the study.
“A registry occurs too late in the process to prevent complications. A registry only serves to alert the surgical community after the problem occurs,” he said. “My argument is that unless medical industry is forced to prove a product’s long-term safety prior to the release of a product (as with what occurred with POP mesh kits), then this whole mesh fiasco is doomed to be repeated. If the medical industry had been forced to definitely prove the long-term benefits of a new medical implant prior to release, and surgeons critically assessed all new products devoid of financial bias or incentive introduced by industry, then this whole POP mesh mess could have been avoided.”
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