FDA Statements Regarding Transvaginal Surgical Mesh

Six years ago the FDA issued (on October 20, 2008) a Public Health Notification (PHN) regarding potential complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  The PHN provided recommendations and encouraged physicians to seek specialized training in mesh procedures, to advise their patients about the risks associated with these procedures, and to be diligent in diagnosing and reporting complications.

In the six years since the FDA issued this PHN, the following has taken place:

• On July 13, 2011, the FDA issued an update to the PHN in which it maintained that adverse events for POP mesh repair are not rare, as previously reported, and questioned the relative effectiveness of transvaginal mesh as a treatment for POP as compared to non-mesh surgical repair. Although the PHN made mention of mesh for use in SUI repair, the FDA did not address this SUI treatment approach and communicated that further evaluation would be required prior to releasing any statement in that regard.

• The update continued to encourage physicians to seek specialized training in mesh procedures, to consider the risks associated with these procedures when making patient prescribing decisions, to advise their patients about these risks, and to be diligent in diagnosing and reporting complications.

• On September 8 and 9, 2011, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to further address the safety and effectiveness of transvaginal surgical mesh. The panel examined the use of transvaginal surgical mesh products to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

• At the hearings held on September 8 and 9, 2011, representatives of the Transvaginal Mesh Device Manufacturers’ Working Group presented information to the FDA panel. This working group included representation by American Medical Systems, C.R. Bard, Boston Scientific, and Ethicon Women’s Health and Urology, in collaboration with the Advanced Medical Technology Association (AdvaMed) and Dr. Suzette Sutherland, a board-certified urologist focused in the area of female pelvic medicine and reconstructive surgery. We believe that this working group presented a very strong case for safety, efficacy, and continued classification of mesh as a Class II device to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

• The recent FDA panel hearings in September 2011 supported recommendations by the agency that it reclassify transvaginal surgical mesh products for POP to Class III (pre-market approval) and require manufacturers of existing products to conduct additional post-market surveillance studies. Regarding surgical mesh devices for treatment of SUI, the panel supported the agency recommendation that such devices remain in Class II. Regarding retropubic and transobturator slings, the panel supported the working group position that no additional post-market surveillance studies are necessary. Regarding mini-slings, the panel recommended pre-market studies for new devices and additional post-market surveillance studies.

• The FDA issued on January 3, 2012, requests for post-market surveillance studies of all previously approved and currently available vaginal mesh devices for pelvic organ prolapse (POP) and single-incision mini-sling devices with mesh for stress urinary incontinence (SUI). None of these devices were recalled and all remain available for usage in surgical procedures in women. These are all Class II 510K devices that had not required such data for their approval by the FDA. The FDA continues to assess whether to reclassify future vaginal mesh devices for POP from Class II to a stricter class III category. For more information, please visit the FDA’s update.

• The FDA safety update is intended to inform patients and healthcare providers about complications associated with surgical mesh. NAFC has formed a position statement that you may read here: NAFC Position Statement on the Use of Vaginal Mesh in Pelvic Surgery.

• Organizations presented information to an FDA advisory panel underlining case-specific details to patients with pelvic floor disorders. AUGS has also created a statement for patients who have undergone treatment using mesh or may be candidates for treatment. To view the AUGS/ACOG resources, please visit:

AUGS and ACOG Joint Committee Opinion on Vaginal Placement of Synthetic Mesh for POP (11/21/2011)

Committee Opinion #513 “Vaginal Placement of Synthetic Mesh for Pelvic Organ Placement” is published in the December 2011 issue of Obstetrics & Gynecology. (12/2011)