AAGL Response to FDA Patient Safety Statement on the Use of Surgical Mesh for Pelvic Organ Prolapse

AAGL has a 40 year history of significantly contributing to advances in minimally-invasive approaches to gynecologic conditions and disorders.  The association has played a leadership role in helping to guide the safe and effective adoption of new technologies in clinical practice.  On July 13, the FDA released a Safety Communication titled “Urogynecologic Surgical Mesh:  Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse”.  The full statement can be viewed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.   The following comments are offered by AAGL to assist members, and the patients they care for, in the interpretation of the recent FDA Safety Communication.

The impetus for the update was the increase in reports of surgical mesh complications to the MAUDE database from January 1, 2008 to December 31, 2010.  During that time, the FDA received 2,874 reports of complications with surgical mesh devices, 1,503 of which were related to the use of transvaginal mesh for the treatment of pelvic organ prolapse.   The FDA also conducted a systematic review of the literature from 1996 to 2011 to evaluate the safety and effectiveness of surgical mesh for treatment of POP and SUI and provided the results of this review in the Safety Communication.

The FDA concluded that the most common complication related to transvaginal placement of mesh is erosion/exposure/extrusion/protrusion of mesh through the vagina.  The FDA also reported mesh contraction/shrinkage as a previously unidentified risk of transvaginal prolapse repair mesh.   The FDA’s conclusion is that “surgical mesh for transvaginal repair of POP is an area of serious concern” and that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

It should be noted that much of the July 13, 2011 FDA Safety Communication is supported by AAGL and is consistent with the October 20, 2008 FDA Public Health Notification concerning mesh, including the following recommendations to health care providers:

- Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.

- Be vigilant for potential adverse events from the mesh, especially erosion and infection.

- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations

- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.

- Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.

- Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives

- Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.

AAGL has recognized some concerns with the current FDA Safety Communication as outlined below:

It is noted that the current report and recommendations from the FDA pertain to transvaginal placement of mesh for prolapse repairs and the conclusions and recommendations do not apply to the use of mesh for treatment of stress incontinence (i.e. synthetic mid-urethral slings) or the use of abdominally placed mesh (i.e. open, laparoscopic and robotic sacrocolpopexy).  However, it must also be recognized that all surgical procedures for POP have potential risks, some of which are unique to each particular procedure.  It is likely many complications associated with non-mesh repairs and mesh placed abdominally are not reported through the MAUDE database.  Caution must be exercised in drawing conclusions concerning the complication rates of procedures for POP based on reports made to the MAUDE database.

AAGL recognizes the difficulty faced by the FDA in performing a systematic review concerning surgical treatment of POP.   Because the vast majority of literature concerning surgical treatment of POP consists of studies which do not meet criteria for inclusion in systematic reviews, utilizing this methodology may limit the ability to provide comprehensive conclusions.  When attempting to answer questions related to surgical practice, additional data from other types of studies may be needed to provide meaningful answers to clinical questions.  For example, many advanced laparoscopic procedures which are now considered standard of care in gynecologic practice were developed, studied and supported during their initial stages of implementation based on large case series provided by surgeons with sufficient skill and experience to provide the necessary clinical data to determine the best use of these techniques.  A similar situation exists today in the rapidly evolving field of urogynecology where some questions related to best surgical care may not be answered without similar use of large series of cases provided by skilled surgeons.    

The final point of concern is that neither the MAUDE database nor the systematic review performed by the FDA provides a mechanism to account for what could be argued as the most critical factor related to surgical outcomes and potential complications with the use of mesh---the skill, experience and expertise of the surgeon performing the procedure.  As has been AAGL’s experience with other MIS techniques, comparing outcomes of procedures performed by inexperienced surgeons to outcomes of expert surgeons, whether in the context of large case series or well-designed RCTs, has the potential to result in significantly different conclusions.  It is important to realize that the design of many RCTs does not control for the most significant confounding variable in evaluating new surgical procedures, surgeon experience and expertise. The current report by the FDA does not allow surgeon factors to be included in the analysis of complications.

As has been stated by AAGL concerning hysterectomy, if an individual surgeon does not have the requisite skill and experience to safely perform appropriate MIS techniques, he/she should consider enlisting the assistance of a colleague who can provide the necessary level of expertise to provide best outcomes for patients who require such surgical intervention.  AAGL strongly recommends that this same consideration be followed for transvaginal mesh procedures.  To help guide the development and implementation of evidence-based best treatments for POP, AAGL encourages development of processes which support continued scientific study of evolving surgical techniques employed as material construct and implant delivery systems also evolve.  AAGL also encourages both physicians and hospitals to work together to establish clear credentialing processes for transvaginal mesh privileges and effective tracking of individual surgeon’s clinical outcomes.

Pelvic organ prolapse is a prevalent condition and the development of safe, effective MIS techniques for treating POP is clearly necessary and consistent with AAGL’s mission to advance minimally invasive gynecology worldwide.   AAGL applauds the contribution made by the FDA in its efforts to assure safe, effective treatment for women suffering from pelvic organ prolapse.  AAGL likewise recognizes its own responsibility through its members to join in such efforts through ongoing contributions to the scientific study of pelvic floor disorders and continued efforts to improve training in and monitoring of surgical skills necessary to achieve best outcomes for patients undergoing surgical treatment. 

Adopted by the AAGL Board of Trustees on August 10, 2011