FDA Pulls All Vaginal Mesh Products Off the Market
Posted on 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.