What should an IFPM patient read in order to understand the FDA notification concerning pelvic reconstructive surgery utilizing mesh?
The U.S. Food and Drug Administration (FDA) issued an alert on October 20, 2008 relating to serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence, which each patient contemplating the surgery should read. Prior to undergoing the surgery, each IFPM patient must acknowledge that she was advised of the FDA alert. In addition, IFPM issued a position paper in response to the FDA alert, which is available from IFPM to its patients contemplating the surgery upon request to IFPM.
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