Clinical Review

Transvaginal mesh for prolapse: Where are we in 2016?

OBG Manag. 2016 March;28(3)

References

Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Washington DC: US Food and Drug Administration, Centers for Devices and Radiological Health; July 2011.
Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–1115.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Updated January 6, 2016. Accessed February 12, 2016.
Premarket notification 510(k). US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Updated September, 16, 2016. Accessed February 11, 2016.
Gartner Hype Cycle. Gartner website. http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp. Accessed February 12, 2016.
Barber MD. Thirty-third American Urogynecologic Society Annual Meeting Presidential Address: the end of the beginning. Female Pelvic Med Reconstr Surg. 2013;19(1):2−7.
FDA public health notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Updated August 6, 2015. Accessed February 12, 2016.
Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Updated October 6, 2014. Accessed February 12, 2016.
Hughes C. FDA issues 522 orders for postmarket surveillance studies: urogynecologic surgical mesh implants. American Urogynecologic Society website. . Published January 5, 2012. Accessed February 12, 2016.
Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2 pt 1):325–330.
Ozkan N, Kayaoglu HA, Ersoy OF, Celik A, Kurt GS, Arabaci E. Effects of two different meshes used in hernia repair on nerve transport. J Am Coll Surg. 2008;207(5):670–675.
Clemons JL, Weinstein M, Guess MK, et al; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–198.
Maher C, Feiner B, Baessler K, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cocrane Database Syst Rev. 2016;2;CD012079.
Information for Health Care Providers for POP. US Food and Drug Administration website. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345204.htm. Updated January 4, 2016. Accessed February 13, 2016.
Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The Pelvic Floor Disorders Registry: purpose and development [published online ahead of print January 30, 2016]. Female Pelvic Med Reconstr Surg.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncementsFeiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management.

The PFDR has 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. I encourage specialists who are board-certified in Female Pelvic Medicine and Reconstructive Surgery to be involved in the quality improvement research. For this, physicians basically can track their own success and complication rates, including nonsurgical outcomes. This information could be helpful to achieving our ongoing goal of getting better at what we do surgically. If you are doing well, it will be very validating. Your patients will be happy, you will have good outcomes, and that probably will not be bad for marketing your practice.

There may be some opportunities to reach the health-related quality indicators that we need to meet right now as part of government-mandated initiatives. For many reasons, it is important for surgeons who are performing a high volume of POP surgeries per year to get involved in the PFDR. In fact, even if you are not performing surgery, you still can get involved with the nonsurgical pessary side. This also is important information for us to move forward with as a specialty as we seek to understand the natural history of POP.

The PFDR will serve many different purposes—one of the best of which is that we are going to be able to safely promote mesh technology for the most appropriate cases and not stifle innovation. The comparison groups, already built in to the registry, will allow for native tissue arms to be compared head to head with the currently available meshes. In addition, we will be able to see signals sooner if certain products or patient profiles, and even individual surgeon outcomes, are concerning.

Cheryl B. Iglesia, MD, was the Keynote Speaker at the Pelvic Anatomy and Gynecologic Surgery (PAGS) Symposium held in Las Vegas, Nevada, December 10–12, 2015. This article was developed from Dr. Iglesia's presentation titled "The How, Why and Where of Synthetic and Biologic Mesh: Lessons Learned."

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

References

Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. Washington DC: US Food and Drug Administration, Centers for Devices and Radiological Health; July 2011.
Rogo-Gupta L, Rodriguez LV, Litwin MS, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–1115.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Updated January 6, 2016. Accessed February 12, 2016.
Premarket notification 510(k). US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Updated September, 16, 2016. Accessed February 11, 2016.
Gartner Hype Cycle. Gartner website. http://www.gartner.com/technology/research/methodologies/hype-cycle.jsp. Accessed February 12, 2016.
Barber MD. Thirty-third American Urogynecologic Society Annual Meeting Presidential Address: the end of the beginning. Female Pelvic Med Reconstr Surg. 2013;19(1):2−7.
FDA public health notification: Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm. Updated August 6, 2015. Accessed February 12, 2016.
Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA safety communication. US Food and Drug Administration website. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Updated October 6, 2014. Accessed February 12, 2016.
Hughes C. FDA issues 522 orders for postmarket surveillance studies: urogynecologic surgical mesh implants. American Urogynecologic Society website. . Published January 5, 2012. Accessed February 12, 2016.
Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2 pt 1):325–330.
Ozkan N, Kayaoglu HA, Ersoy OF, Celik A, Kurt GS, Arabaci E. Effects of two different meshes used in hernia repair on nerve transport. J Am Coll Surg. 2008;207(5):670–675.
Clemons JL, Weinstein M, Guess MK, et al; AUGS Research Committee. Impact of the 2011 FDA transvaginal mesh safety update on AUGS members’ use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2013;19(4):191–198.
Maher C, Feiner B, Baessler K, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cocrane Database Syst Rev. 2016;2;CD012079.
Information for Health Care Providers for POP. US Food and Drug Administration website. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/ucm345204.htm. Updated January 4, 2016. Accessed February 13, 2016.
Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The Pelvic Floor Disorders Registry: purpose and development [published online ahead of print January 30, 2016]. Female Pelvic Med Reconstr Surg.
FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncementsFeiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management.

Transvaginal mesh for prolapse: Where are we in 2016?

References

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