FDA Pushes Safety Improvement of Surgical Mesh Used for Transvaginal Surgery

The U.S Food and Drug Administration issued two proposals on Tuesday aiming to improve the safety and efficacy of surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). Once finalized, the device will be considered a high-risk device.

Surgical mesh was first used to treat abdominal hernias during the 1950s, before it became widely used for POP surgery in the 1970s. Surgeons cut the mesh on their desired shape prior to insertion in the vagina.

An earlier study conducted by the FDA revealed that, between 2005 and 2010, there were 3,979 incidents of death, injury and malfunction related to the surgical mesh. About 72 percent of these cases occurred between 2008 to 2010. This report pushed the agency to propose shifting the surgical mesh from Class II (moderate-risk) to Class III (high-risk) device category.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a press release. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

POP is a pelvic floor disorder that affects one-third of women in their lifetime on their bladder, uterus, vagina, rectum, and small bowel. POP is characterized by drooping due pregnancy or childbirth, obesity, constipation, pelvic cancer or hysterectomy. Symptoms vary depending on the organ affected - pressure in the pelvic area, lower back pain, pain during intercourse, constipation, difficulty urinating and spotting or bleeding of the vagina can all be indicative of potential POP cases.

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