I am writing to comment on the clinical opinion presented in the August 2010 issue “Use of vaginal mesh in the face of the recent FDA warnings and litigation.”
I commend the authors for discussing a topic that is a catalyst to much controversy in the field of pelvic reconstructive surgery. I appreciate the description of the legal components and agree. I do have some concerns with the conclusion “… the use of transvaginal mesh in repair of POP and SUI continues to be an excellent option … .” I believe that this is a narrow way of looking at a larger topic and may lead the less experienced down the wrong path.
The Society of Gynecologic Surgeons systematic review group published a detailed and extensive look at the literature dealing with vaginal mesh. This guideline evaluated the literature available looking at the use of mesh. Though the quality of the studies looking at nonabsorbable synthetic graft is low, recommendations were able to be made. In their conclusion, nonabsorbable synthetic graft use may improve anatomic outcomes of anterior vaginal wall repair, but with trade-offs in regard to additional risks. The group suggested that this must be raised in the preoperative period with the patient during the consent process. The same advantage was not seen in the posterior compartment. This is an important point that needs to be understood when making a global conclusion as was stated in this opinion.
Another component of whether you decide to use vaginal mesh is not only what the FDA is saying but also what our own governing organizations say. The American College of Obstetrics and Gynecology in Practice Bulletin 85 states “Given the limited data and frequent changes in the marketed products for vaginal surgery for prolapse repair (particularly with regard to type of mesh material itself, which is associated with several of the postoperative risks, especially mesh erosion), patients should consent to surgery with an understanding of the postoperative risks and complications and lack of long-term outcomes data.” This potentially contradicts the clinical opinion in stating that the use of mesh in vaginal surgery is an “excellent option.”
In regard to law suits, the authors allege that patients sue doctors who have had mesh placed in their pelvis because they have little recourse. Unfortunately, this is not the only reason for litigation. Patients also sue physicians for a variety of reasons, including serious compromise of their daily quality of life whether it pertains to urinary, sexual, or colorectal health.
It is in my opinion that making the decision to use vaginal mesh is one that cannot be made lightly. The authors bring up excellent points concerning the consenting process but ultimately, the physician also has to truly understand the risks and the data as they pertain to the procedure they are planning on performing. The ultimate question that must be posed to patients: are the benefits greater than the potential consequences of the procedure in the individual situation?