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The American Urogynecologic Society fights back against transvaginal mesh bans


 

The American Urogynecologic Society is pushing back against attempts to ban transvaginal mesh surgery in the treatment of pelvic floor disorders.

In a recent position statement, officials at the American Urogynecologic Society (AUGS) voiced their strong opposition to restrictions on the use of transvaginal mesh surgery when performed by qualified, credentialed surgeons. The policy statement comes after a state medical organization, a health care system, and a medical malpractice company have considered or adopted bans on the use of transvaginal mesh for pelvic organ prolapse or stress urinary incontinence.

Dr. Anthony Visco

"We really feel that the best decision making is left between the patient and her physician without outside interference," Dr. Anthony G. Visco, AUGS president and division chief of urogynecology at Duke University, Durham, N.C. said in an interview.

Rather than an across-the-board ban, AUGS is urging hospitals to do a better job in assessing the competence of the surgeons performing these procedures.

"Instead of a ban on mesh, I think hospitals and health systems should adopt strict credentialing guidelines so that qualified surgeons are performing these procedures," Dr. Visco said.

Some hospitals have already adopted guidelines issued by AUGS that outline how to credential and audit surgeons who perform transvaginal placement of surgical mesh for pelvic organ prolapse and sacrocolpopexy for pelvic organ prolapse, he said. AUGS also recommends that hospitals form a group of pelvic floor reconstructive experts who can review cases and complications in both mesh and nonmesh prolapse repair. Additionally AUGS has released an informed consent toolkit that it recommends to hospitals to help standardize the process of reviewing risks and benefits with patients.

The use of transvaginal mesh to treat pelvic organ prolapse and stress urinary continence has been controversial in recent years as reports of adverse events from the devices have mounted. In July 2011, the Food and Drug Administration issued a safety notice warning that serious complications associated with surgical mesh for the transvaginal repair of pelvic organ prolapse are "not rare." The surgery may expose patients to greater risks without the benefit of being more effective than traditional nonmesh repairs, the FDA wrote.

The agency advised physicians to obtain specialized training for each mesh placement technique and to be vigilant about potential adverse events including mesh erosion and infection. In the same 2011 notice, the FDA said it was still evaluating the impact of transvaginal mesh in the treatment of stress urinary incontinence.

While the FDA has not acted to remove these devices from the market, it has ordered manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to look at the safety and effectiveness of surgical mesh used for transvaginal repair of pelvic organ prolapse and mini-sling devices used to treat stress urinary incontinence.

In December 2011, AUGS and the American College of Obstetricians and Gynecologists issued their own statement recommending that pelvic organ prolapse vaginal mesh repair be reserved for high-risk cases such as women with recurrent prolapse or who have medical comorbidities that prevent more invasive endoscopic procedures (Obstet. Gynecol. 2011;118:1459-64).

The safety warnings from the FDA don’t warrant a ban on the procedure, Dr. Visco said. But enacting such a ban could have a number of negative consequences from limiting women’s medical options or limiting the ability of researchers to gather and analyze safety data, he said.

In certain cases, the use of transvaginal mesh for pelvic organ prolapse could be the patient’s best surgical option, according to AUGS. For example, patients with recurrent prolapse after a nonmesh, native tissue repair would be good candidates. Also, the use of transvaginal mesh might be preferred in patients with significant intra-abdominal adhesions because an abdominal approach would pose greater surgical risks.

Dr. Visco said he’s also concerned that news of bans on the procedure, combined with all the advertising about transvaginal mesh lawsuits, could lead some women to leave pelvic floor disorders untreated.

"I think patients are afraid," he said. "We’re worried that they’re so afraid that they may not even seek care."

Bans on transvaginal mesh surgeries could also put a stop to critical research on the products, according to AUGS. For instance, the Pelvic Floor Disorders Network, a clinical trials network funded by the National Institutes of Health, is preparing to launch a randomized trial of transvaginal mesh vs. nonmesh, native tissue repair for uterine prolapse.

And AUGS is building a national registry for pelvic floor disorders with the FDA, the NIH, and ACOG. The registry, which will include data from at least four major device manufacturers, is slated to launch later in 2013. Once the registry is up and running, surgeons will be able to track their outcomes and compare themselves to others.

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