In June 2012, the Current Urology Reports Journal published a review article which assesses the risks and benefits of using synthetic mesh for Pelvic Organ Prolapse (POP) repair, giving particular emphasis to repairs of the posterior vaginal wall compartment. The present article summarizes the main points presented in the Current Urology Reports review.
POP is common in women that underwent menopause. According to trial data presented in this review, in 30% of cases, women that had surgery to repair POP have to undergo surgery again due to recurrence of prolapse. To reduce recurrence, the methodology of using grafts to expand native tissue was developed, in the past decade the use of synthetic meshes has been more common. Several Transvaginal mesh (TVM) kits have been approved by the FDA (U.S. Food and Drug Administration), these kits were designed to repair anterior and posterior compartments, vaginal vault and a combination of those. There is not sufficient post-market data from manufacturers to evaluate their results; therefore the authors reviewed publicly available outcome data.
Traditionally, the posterior compartment is repaired with midline plication (“folding”) of the connective tissue (fascial layer) or with site-specific repairs (restorations to normal anatomy). Outcomes are acceptable and present low complication and reoperation rates. Initially, anatomic cure was defined as pelvic prolapse quantification (POPQ) stage I or less, according to data presented in this article, most women present prolapse stages 0 to I, but 35% have stage II. Of those patients presenting stage II prolapse, many are asymptomatic, symptoms are more likely to appear if prolapse is beyond the hymenal remnant. When failure is defined as prolapse at or beyond the hymen remnant, success rates of these procedures are lowered. Failure was therefore redefined using a composite approach, which defines failure as prolapse beyond the hymen, presence of symptoms, or need or retreatment. Using this definition, posterior POP cure rates are 90% or better and reoperation rates after treating with traditional methods are only 3%, while mesh repairs have complication rates of 16.9% and recurrence of 4.1-16.9%. Although available data from randomized control studies for mesh repair of the posterior compartment is scarce and not very clear.
Patients with POP frequently need the repair of multiple compartments and would have either a total vagina mesh or a combination of anterior-posterior mesh placed. Correspondingly, in the studies discussed in this review, most complications were related to anterior compartment or total vagina repair using meshes. Complications can be perioperative (during the surgical procedure, from ward admission to recovery unit), intraoperative (operating room to recovery unit) or postoperative. There is a wide range of complications, from visceral puncture to bleeding or infections during or immediately after surgery; to delayed complications like mesh extrusion, retraction, pain or sexual side effects.
The FDA released a safety communication in 2008 with regard to complications related to TVM. Subsequently, additional information was collected using the FDA’s MAUDE (Manufacturer and User Facility Device Experience). This database consists of voluntary reports of adverse events involving medical devices, although that data is not intended to be used either to evaluate rates of adverse events or to compare rates across devices. Based on that database, in 2011 the FDA released an update to the 2008 communication. The updated communication was based on the analysis of close to 3,000 mesh complication reports that were submitted during that three year period and reported that complications from using TVM to repair POP are not rare. Consequently, the FDA re-classified the TVM kits and asked for manufacturers to present post-market studies. Authors report an article published in Bloomberg News which states that lawsuits against mesh manufactures have sharply increased as a result of the updated FDA communication, reaching 650 cases at the news article’s publication time.
The authors expect that with the post-market studies requested by the FDA, more safety and efficacy data will be available to adequately assess the use of mesh on posterior POP repairs. Nevertheless, based on present treatment data of patients with posterior compartment prolapse, traditional methods that involve native tissue repair have similar outcomes to synthetic mesh repair, but do not present the risks associated with the use of TVM. Therefore, until new data is available, the gold standard method to treat posterior compartment is native tissue repair, which presents good outcome and relatively low complications.
References
What is the Gold Standard for Posterior Vaginal Wall Prolapse Repair: Mesh or Native Tissue? Brian K. Marks and Howard B. Goldman. Current Urology Reports. 2012. 13:216-221
MAUDE: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm