Abstract
February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinion on how to evaluate the risks and benefits of these devices.
The committee was asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit-risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. As there was no sufficient reply of the manufacturers on April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016 (FDA 2019).