The US Food and Drug Administration (FDA) today ordered the manufacturers of vaginal mesh products to stop selling and distributing their products in the US immediately, saying the companies fail to provide reasonable assurance that the products are safe and effective.
Reclassifying the devices
The three vaginal mesh devices available in the United States are Boston Scientific’s Uphold LITE and Xenform, and Coloplast’s Restorelle DirectFix Anterior. The companies have 10 days to submit their plan to withdraw these products from the market. Over the past several years, the FDA has see a significant increase in the number of report adverse events associate with the use of surgical mesh for transvaginal repair of POP.
As a result, the agency has taken a series of escalating steps, including reclassifying the devices from class II (moderate risk) to class III (high risk). As part of this reclassification, the manufacturers were require to submit premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the United States.
In February, the FDA convene an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP. the panel recommend that to support a favorable benefit–risk profile, surgical mesh should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh should be comparable to native tissue repair.
Better than surgery
The FDA agree with these recommendations; so because the manufacturers did not provide the require data in their PMAs, the FDA decline to approve them. In order for these mesh devices to stay on the market; so they determine that they need evidence; so that they work better than surgery without the use of mesh to repair POP.
That evidence was lacking in these premarket applications; also they couldn’t assure women that these devices were safe and effective long term,” Jeffrey Shuren, MD; director of the FDA’s Center for Devices and Radiological Health, said in the statement. The manufacturers are require to continue to follow women; so already enroll in their “522” postmarketing studies.
Women who have had transvaginal mesh place for the surgical repair; so of POP are advise to continue with annual and other routine check-ups and follow-up care. Women who are satisfy with their surgery; so are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms; so such as persistent vaginal bleeding or discharge; so pelvic or groin pain, or pain with sex, should speak with their healthcare provider.