BERKELEY, CA (UroToday.com) - Since the original 2008 Food and Drug Administration (FDA) advisory about complications associated with transvaginal mesh prolapse repairs, these procedures have drawn significant public and media attention. Multiple different mesh kits have since been withdrawn from the market. However, studies have shown that synthetic transvaginal mesh can provide additional support during vaginal pelvic floor repair procedures, with traditional anterior colporrhaphy resulting in more anterior compartment recurrence, compared to anterior polypropylene mesh repair.
In response to concerns regarding transvaginal mesh, FDA 522 Postmarket surveillance studies have been initiated in the last few years. Products still available on the market and undergoing this rigorous evaluation include trocarless Polyform™ devices, such as Uphold, by Boston Scientific, Natick, MA, USA. Our study retrospectively compared older generation trocar-guided Gynemesh PS™ transvaginal mesh procedures to newer trocarless Polyform™ procedures. We were able to demonstrate a reduced risk of mesh exposure and need for surgical re-intervention after these trocarless procedures.
At a time when surgeons are looking for improved vaginal surgical techniques for the repair pelvic organ prolapse, this information confirms the value of newer synthetic mesh kits. With an enhanced understanding of complication risks associated with these procedures, physicians still need to exercise caution and clinical judgment in selecting appropriate candidates. Our findings motivated us to continue offering trocarless Polyform™ transvaginal mesh procedures to women with risk factors for recurrence in our practice. Extensive preoperative counseling is imperative in this setting. This counseling includes informing patients of the risk of mesh exposures, pelvic pain, and possible need for re-intervention after such procedures. Results from our study have also impacted our practice by allowing us to better counsel patients about these risks.
- Maher C, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013;4:CD004014 doi: 10.1002/14651858.CD004014.
- FDA. 522 Postmarket Surveillance Studies. Accessed at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pss.cfm on October 25, 2014.
Jens-Erik Walter, MD, FRCSC as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
Department of Obstetrics and Gynecology, McGill University Health Centre, 687 Pine Avenue West, Room F8.59, Montreal, QC, Canada, H3A 1A1