FOR IMMEDIATE RELEASE: July 15, 2011
Wendy Waldsachs Isett, AUA
FDA ISSUES NEW SAFETY COMMUNICATION ABOUT THE USE OF MESH TO TREAT PELVIC ORGAN PROLAPSE
On July 13, 2011, the U.S. Food and Drug Administration (FDA) issued a new safety communication about the use of mesh for pelvic organ prolapse (POP) surgery. This warning is an update of a previous FDA warning that was issued in October 2008. Based on continuing adverse event reports that have been received by the FDA since the initial warning in 2008, the FDA now states that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. In addition, the FDA conducted a systematic review of the published literature from 1996-2011, and concluded that transvaginal POP repair with mesh does not improve symptomatic results or quality of life when compared with non-mesh repairs, and that mesh used for POP repair introduces risks that are not present in traditional non-mesh surgery. Mesh erosion and contraction (shrinkage) were identified as specific complications which can result in pelvic pain, dyspareunia, bleeding and infection.
The FDA then issued new recommendations, which state that healthcare providers should:
Importantly, the FDA explicitly states that the announcement only pertains to the use of transvaginal mesh for POP, and does not concern the use of mesh for the surgical treatment of stress urinary incontinence.
This announcement reinforces the importance of discussing the potential for these complications with prospective patients prior to performing POP surgeries that utilize mesh, and of documenting that discussion in the patient's medical record.
For more information, the FDA report can be viewed here: