The FDA Safety Alert released during July 2011 on the subject of surgical mesh used in pelvic organ prolapse repair has one quality that makes it unique from typical FDA safety alerts on medical devices: Instead of singling out a product that has market approval under a certain brand name and by a specific company, the alert is a sweeping warning that covers all surgical mesh products used in pelvic organ prolapse repair. It’s hard to believe that all surgical mesh products operate in the same way – or that all of them lead to the same pelvic mesh problems. However, this FDA warning seems like a mere first step. The agency is currently reviewing the use of surgical mesh for other pelvic surgeries, and has not recalled any products yet. While the use of surgical mesh is still a legal option for pelvic organ prolapse repair, the Safety Alert does encourage uro-gynecologic surgeons to choose alternate repair methods if possible. Click here for more information.
