FDA Reclassifies Vaginal Mesh as a High-Risk Device
Medical devices are among the most commonly litigated items in product liability lawsuits. To recover damages in a defective medical device lawsuit, the plaintiff must show that the device in question is unreasonably dangerous or that the device the plaintiff received suffers from a manufacturing defect that renders it unreasonably dangerous.
In one of its first actions for the new year, the U.S. Food and Drug Administration (FDA) has issued two orders increasing the regulation of transvaginal surgical mesh products used to treat pelvic organ prolapse (POP). The first order reclassifies transvaginal mesh used in POP procedures as a Class III device. Class II devices are those that generally involve moderate risks, while Class III devices are high-risk devices.