The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing.
Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort.
However, the devices have been associated with serious complications. The FDA has even issued two separate warnings that complications with the mesh were not uncommon and that women should weigh the benefits against the risks. Complications include erosion into tissue and perforation into neighboring organs causing bleeding, pain, and infections. In many cases multiple surgeries were required to remove the device and some women have suffered lifelong consequences and even death.
“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. “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.”
The FDA will take comments on the proposed order for the next 90 days before deciding whether to reclassify the medical device as high-risk.
Source: Common Health