Transvaginal Repair Surgery, 'Pelvic Mesh' Get Tighter Requirements: FDA

The U.S. Food and Drug Administration or FDA announced Monday, January 4, 2016 that it had come up with a more stringent data requirements when it comes to the use of surgical mesh devices in repairing pelvic organ prolapse (POP) transvaginally.

This move is taken by the health officials in order to address safety risks amid the numerous reports received by the FDA regarding complications involving the use of mesh for POP repair through the vagina. These complications include bleeding, organ perforation and urinary problems. according to NewsMax.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health.

"We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures."

The new policy given by the FDA is composed of two final orders for both the manufacturers and the public, according to a news release published in the FDA website. These orders aim to bolster the data requirements for surgical mesh in repairing pelvic organ prolapse (POP) transvaginally, or through the vagina.

The first order is about the re-classification of such medical tools from class II (moderate-risk devices) to class III (high-risk devices), while the second order will now force manufacturers to submit a premarket approval (PMA) application beforehand that will support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

According to an article from UPI, the pelvic organ prolapse occurs in women when the muscle and tissue in their pelvic floor are stretched, torn or weaken. This results to organs such as the bladder, bowel, or uterus to bulge into the vagina.

The FDA classified the surgical mesh as a moderate-risk device back in 2002 after doctors have started using it even before the 90s to repair prolapses transvaginally. But, as early as the 70s, gynecologists were already using the surgical mesh, but during that time, it was utilized for the repair of abdominal hernias.

"The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness," says the FDA.

"The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP."