News

ACOG-AUGS Says Limit Use of Mesh for Prolapse


 

From Obstetrics & Gynecology

Debilitating pain, abscess formation, and other serious complications associated with the use of vaginal synthetic mesh for pelvic organ prolapse surgery have been addressed in a joint statement issued by the American College of Obstetricians and Gynecologists and the American Urogynecologic Society that recommends the development of a national patient registry for “all current and future vaginal mesh implants.”

Other recommendations in the statement include reserving the use of vaginal mesh in the surgical repair of pelvic organ prolapse (POP) to women at high risk “in whom the benefit of mesh placement may justify the risk.” These women include those with recurrent prolapse – particularly of the anterior compartment – and those with medical comorbidities that “preclude more invasive and lengthier open and endoscopic procedures,” according to the statement which appears in the December issue of Obstetrics & Gynecology (Obstet. Gynecol. 2011;118:1459-64). The statement is an opinion of the Committee on Gynecologic Practice (Committee opinion #513).

Based on the currently available but limited data, a “small but significant” group of women who undergo mesh-augmented vaginal repair of pelvic organ prolapse experience “permanent and life-altering sequelae, including pain and dyspareunia, from the use of vaginal mesh,” according to the statement. The estimated complication rates range from less than 1%-15%, but could be higher.

Some women with complications need additional surgery to attempt to correct the problem, but “unfortunately, some women will continue to have pain even after corrective surgery because complete removal of the mesh may not be possible,” Dr. Cheryl B. Iglesia, the former chair of the committee, said in a written statement issued by ACOG.

“For this reason, it's important to understand that, in many cases, POP can be successfully treated without mesh, and women and their doctors really need to weigh the risks and benefits before deciding on a course of action,” added Dr. Iglesia, director of Female Pelvic Medicine and Reconstructive Surgery at Washington (D.C.) Hospital Center.

In an interview, Dr. Iglesia said that other patients for whom the benefits of using mesh may justify the risks include those with recurrences after a traditional vaginal repair using native tissue without mesh, those with more advanced stages of prolapse who have comorbidities and are not good candidates for an abdominal procedure and anesthesia, and a woman with a collagen vascular disorder.

The ACOG-AUGS recommendations reflect some of those made by the Food and Drug Administration in a July 2011 safety communication updating the complications associated with transvaginal placement of surgical mesh for POP, which was an update of a 2008 Public Health Notification about these complications (“FDA Warns of Risks With Transvaginal Mesh” August 2011, p. 1). whe first surgical mesh product intended for the repair of POP was cleared by the FDA in 2001, based on the agency's review that concluded the product was “substantially equivalent” to surgical mesh used for hernia repairs, without any clinical data. Surgical mesh products are currently regulated by the FDA as a class II device, which requires the manufacturers to show that the product is substantially equivalent to a similar product already on the market. Clinical trials are required for clearance of devices that are regulated as class III devices, and the ACOG-AUGS statement notes that the FDA is considering whether to reclassify mesh products intended for vaginal repair of POP to a class III device. In that case, clinical trials would be required before a product would become available.

The joint statement also recommends that complications and total reoperation rates for recurrence of complications should be reported as outcomes for prolapse surgical techniques, and surgeons should undergo training for each specific surgical mesh product before using it in surgery. In addition, new mesh products “should not be assumed to have equal or improved safety and efficacy unless clinical long-term data are available,” and patients “should provide their informed consent after reviewing the risks and benefits of the procedure, as well as discussing alternative repairs.”

The statement also says that ACOG and AUGS support the development of a registry “to provide surveillance of all currently available and future vaginal mesh implant products,” and describes “rigorous” clinical trials that compare the effectiveness of synthetic mesh and native tissue repair, with long-term follow-up of patients as “ideal.”

Most of the outcomes data for vaginal placement of synthetic mesh for POP are case series and prospective cohort studies, and smaller studies “document good short-term success in the hands of individual surgeons, but longer follow-up procedures performed by surgeons from multiple centers is lacking,” the statement points out.

Next Article: