Pharmaceutical

New study finds transvaginal mesh offers no advantages but plenty of risks

mesh1 New study finds transvaginal mesh offers no advantages but plenty of risksA thorough review of the surgical methods used to repair pelvic organ prolapse (POP) conducted by the Cochrane Collaboration, found that there is no clear advantage in using transvaginal mesh over more conventional “native tissue repairs” in correcting pelvic organ prolapse and its complications.

The review, presented at the International Urogynecological Association’s 2012 annual meeting in Brisbane, Australia, found that transvaginal mesh “also carries with it an increased risk of intervention in the short term.”

According to lead author Christopher Maher, MD, the “downside” of using transvaginal mesh includes “increased perioperative morbidity, post operative stress urinary incontinence (SUI), increased complications, primarily mesh exposure, and operations to correct this.”

“There is clearly a downside to mesh interventions,” Dr. Maher added. According to the study, conventional “native tissue” repairs have “significant advantages over mesh,” including “lower operating time and less intraoperative blood loss.”

For the study, Dr. Maher, a physician with the Wesley Private Hospital and Royal Brisbane Women’s Hospital, and his team analyzed 54 randomized, controlled trials involving 5,775 women with the goal of updating a 2010 study.

Among their findings, Dr. Maher and his team found that conventional surgical methods (anterior colporrhaphy) to repair POP were associated with reoperation rates nearly twofold lower than the placement of transvaginal polypropylene mesh. They also found a 1.75-fold lower rate of operation for conventional SUI correction compared with use of mesh devices.

The study also assessed use of transvaginal mesh in the posterior and apical areas of the vagina and found no evidence that the mesh devices were effective in those repairs either, stating “posterior colporrhaphy fascial repair remains the gold standard.”

A posterior prolapse occurs when the wall of fibrous tissue (fascia) that separates the rectum from the vagina weakens, allowing the vaginal wall to bulge. This condition is also called a rectocele because usually the front wall of the rectum bulges into the vagina.

Dr. Maher said that transvaginal mesh kits have been “marketed aggressively since 2003-2004” for prolapse, yet in eight years’ time only two randomized, controlled trials have been conducted, and those “show no advantage and plenty of downside” to their use.

According to Renal & Urology News, “Dr. Maher pointed out that this summer Johnson & Johnson withdrew transvaginal prolapse mesh products from the market in the United States and is planning to halt their sales worldwide. This follows 2009 and 2011 FDA alerts warning of serious complications from transvaginal mesh for POP repairs. Lawsuits have been filed against most companies that market transvaginal mesh due to allegations that women have been harmed by these products.”

Sources:

Renal & Urology News
Encyclopedia of Surgery