Pharmaceutical

Medical groups urge limiting use of transvaginal mesh

Serious injuries in women who have received vaginal mesh implants for the treatment of pelvic organ prolapse (POP) have spurred two medical groups to issue a joint statement saying that the mesh should only be used vaginally on high-risk women for whom the benefit may justify the risk.

The joint statement was issued by the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) just weeks after an expert panel for the Food and Drug Administration (FDA) held a hearing to investigate the safety of the devices and whether they should be banned. The committee raised concerns about the safety of the products but fell short of recommending their removal from the market. 

“Although many patients have no complications from surgical mesh placed vaginally, a small but significant group experience permanent and life-altering problems, including pelvic pain and painful sexual intercourse because the mesh erodes through the vaginal wall,” said Dr. Cheryl B. Iglesia, former chair of The College’s Committee on Gynecologic Practice.

“Unfortunately, some women will continue having pain even after corrective surgery because complete removal of the mesh may not be possible. 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.”

In July 2011, the FDA issued a Safety Communication saying the mesh was a continuous serious concern with nearly 4,000 complaints about the mesh since 2005, with the number more than doubling in the past two years. Given the growing number of adverse event reports, The College and AUGS also recommended that a national registry be developed in order to track outcomes for all current and future patients who receive vaginal mesh implants for the repair of pelvic floor disorders.

Source: Health Central