Surgeons have found that plastic mesh can make certain pelvic repairs much easier, and surgical mesh has been widely used to repair hernias and reproductive tract problems such as uterine prolapse (dropped uterus).
How Safe Is Surgical Mesh?
Over the last several years, however, the FDA has become aware that these devices may lead to serious complications including organ perforation, urinary difficulties and excessive bleeding. When used for pelvic organ prolapse, transvaginal mesh can contribute to infection, nerve damage and bleeding.
The FDA has just announced that surgical mesh will be reclassified as a high-risk device. Manufacturers will now have to submit safety data that until now has not been required for this kind of plastic mesh.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm
