The NWHN Testifies for the Use of Better Evidence at the FDA

By Tessa Ruff In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone. The NWHN actively fought for the change, which also should have required manufacturers to submit thorough, randomized safety … Continued