On July 13, 2011 the FDA published its second and much stronger public warning regarding the use of transvaginal synthetic mesh for pelvic organ prolapse. Dr. Margolis applauds the FDA actions because he has always held the strong position that transvaginal placement of synthetic mesh of all types for prolapse and stress incontinence was dangerous and could lead to surgical mesh complications. His position is based on core biologic principles of wound infection in contaminated fields (well known principles established in the surgical literature decades ago), his own review of the FDA MAUDE database which has reported mesh complications for almost a decade, numerous reports in the literature of major complications with mesh and his own personal experience removing mesh in scores of patients.
The FDA does not make these warnings lightly or without just cause. This is a strong statement and must serve as a warning to all potential surgical candidates that transvaginal synthetic mesh should never be used. If you are considering surgery, please instruct your surgeon not to use such systems.
To view the FDA warning please click on the following link: