April 16, 2019
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 failed to provide reasonable assurance that the products are safe and effective.
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 seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (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 required 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 convened an advisory panel to solicit input from experts on how to evaluate the safety and effectiveness of surgical mesh for transvaginal repair of POP.
As reported by Medscape Medical News, the panel recommended 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.
The FDA agreed with these recommendations, and because the manufacturers did not provide the required data in their PMAs, the FDA declined to approve them.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we 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 required to continue to follow women already enrolled in their "522" postmarketing studies.
Women who have had transvaginal mesh placed for the surgical repair of POP are advised to continue with annual and other routine check-ups and follow-up care. Women who are satisfied with their surgery and are not having complications or symptoms do not need to take any additional action. Women who experience complications or symptoms, such as persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex, should speak with their healthcare provider.
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