January 4, 2012
American Urogynecologic Society (AUGS) Response: FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse (July 2011)
In response to the recent announcement from the FDA on the safety and effectiveness of transvaginal placement of surgical mesh for pelvic organ prolapse, AUGS and its leadership remain committed to advancing training, education, science and research in the diagnosis and treatment of women with pelvic floor disorders. Pelvic organ prolapse effects a considerable proportion of women and approximately 300,000 U.S. women undergo surgery each year for this condition. In an effort to find improved surgical techniques in the treatment of pelvic floor disorders (PFDs) for women, innovation has led to the use of vaginal mesh in the hopes of improving the effectiveness and durability of pelvic organ prolapse surgery. The currently available synthetic mesh and mesh delivery systems were cleared by FDA through the 510K approval process. AUGS is encouraged that the FDA is reconsidering the appropriateness of this approach. AUGS supports an improved approval process for these devices - one that includes better and longer term randomized trials of new surgical devices and materials before going to market. AUGS also supports an improved post market surveillance process through registries and national databases. AUGS continues to support future research on this topic in order to clarify the appropriate role of synthetic mesh in the treatment of pelvic organ prolapse and other PFDs. A few things regarding the FDA report are worth emphasizing:
The report pertains to the transvaginal placement of synthetic mesh for treatment of pelvic organ prolapse. The conclusions and recommendations of the report do not apply to the use of synthetic mesh for treatment of stress urinary incontinence or abdominal or laparoscopic repair of pelvic organ prolapse (i.e. sacrocolpopexy) where the benefits of mesh are more clearly delineated and the risks are less.
AUGS strongly supports the FDA recommendations that surgeons thoroughly inform patients seeking treatment for pelvic organ prolapse about the benefits and risks of all potential treatment options including non-surgical options, non-mesh surgery (i.e. native tissue vaginal repairs), abdominal or laparoscopic mesh procedures and transvaginal mesh placement. No one approach has proven to be superior in all cases. There may be particular circumstances when the placement of transvaginal mesh is appropriate.
Surgeons placing vaginal mesh should undergo training specific to each procedure, have experience with pelvic reconstructive surgery and a thorough understanding of the relevant pelvic anatomy.
In patients who have had vaginal mesh surgery for pelvic organ prolapse and are satisfied with their surgery and are not having complications or symptoms, there is no need to take any action other than routine check-ups and follow-up care. Patients with complications or symptoms after surgery should notify their health care provider.
AUGS remains committed to educating both members and non-member clinicians who take care of women with PFDs with the most up-to-date clinical information and surgical techniques supported by high-quality research.
Improved patient care is accomplished through teaching pelvic anatomy, patient selection for these procedures, appropriate surgical techniques, and the prevention and management of intra-operative and post- operative complications. Through improved approval processes, surveillance, continued education and research, AUGS and its membership will continue to fulfill its mission of providing the best care for women with pelvic floor disorders.
We encourage our members to review the document which is located at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.