Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath

The release of the U. S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 1824 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medicolegal activity, and statements from surgical societies. In summary, wellpublicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.