, Volume 23, Issue 1, pp 11-13
Date: 16 Nov 2011

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

This is an excerpt from the content

Recently (July 13, 2011), the United States Food and Drug Administration (FDA) issued a document entitled “FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” [1]. This was stated as an update of a previous document issued on October 20, 2008, entitled “A Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat pelvic organ prolapse (POP) and SUI (stress urinary incontinence)”. Accompanying the recent FDA concerns was a 15-page document entitled “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse” which has a literature review identifying 27 key references [2].

The FDA’s aims in this update are to inform that: (1) “serious complications with surgical mesh for transvaginal repair of POP are not rare” (a change fro ...

Further contributions to this debate can be found at doi:10.1007/s00192-011-1581-2, doi:10.1007/s00192-011-1596-8 and doi:10.1007/s00192-011-1597-7.