Pharmaceutical

Women should consider risks with transvaginal mesh

vaginal mesh sling Women should consider risks with transvaginal meshSurgical mesh plays a significant role in the successful management of certain pelvic floor disorders but women should be aware of the problems that can occur with the mesh and take measures to minimize their risk, recommends Dr. Lesley K. Carr, urologist at Sunnybrook Health Sciences Centre and associate professor at the University of Toronto’s Department of Surgery.

Transvaginal mesh is a device that is used to treat conditions such as stress urinary incontinence and pelvic organ prolapse. The mesh is used to shore up organs that have dropped, or prolapsed, causing symptoms such as urinary incontinence, pain during intercourse, and discomfort.

In 2011, the Food and Drug Administration (FDA) issued a safety communication warning that serious complications have been associated with the surgical mesh, in particular when used for the repair of pelvic organ prolapse. Complications included the mesh moving or eroding into the vaginal wall or other organs. Symptoms associated with these problems include a return of symptoms, incontinence, and pain resulting in disability. Many women required multiple surgeries to remove the mesh.

Transvaginal mesh is considered a moderate-risk medical device. Many of these devices were approved by the FDA through an accelerated program that allowed them to be approved for use without clinical trials to determine safety and efficacy if there were similar devices already on the market. The process has come under fire in recent years, and Congress is currently considering revamping the program to better ensure patient safety.

Dr. Carr says complications with transvaginal mesh can be reduced if surgeons are experienced, if the brand of mesh has been widely tested before coming to the market, and if the mesh is used in situations where the benefit outweighs the risk.

Source: CTV News