Transvaginal synthetic mesh: Use in pelvic organ prolapse (POP)
- Emanuel C Trabuco, MD, MS
Emanuel C Trabuco, MD, MS
- Associate Professor
- Department of Obstetrics and Gynecology
- Division of Urogynecology
- Mayo Clinic
- John B Gebhart, MD, MS
John B Gebhart, MD, MS
- Department of Obstetrics and Gynecology
- Division of Urogynecology
- Mayo Clinic
Synthetic mesh has become widely used in procedures aimed at treating pelvic organ prolapse (POP) and urinary incontinence. While transvaginal synthetic mesh slings have become the standard of care for surgical treatment of stress urinary incontinence, concerns have been raised about the safety of synthetic mesh in treating POP. When treating POP, the durability of surgical repair with synthetic mesh must be balanced against the risk of mesh-related complications.
This topic will discuss issues related to transvaginal mesh for surgical treatment of POP. Related discussions on synthetic mesh for the treatment of urinary incontinence, complications of synthetic vaginal mesh, and management of mesh exposure and pain are presented separately:
GRAFT MATERIAL FOR POP TREATMENT
Reconstructive materials used in the surgical repair of POP include synthetic mesh, trocar-guided synthetic mesh inserts or kits (figure 1), and biologic materials (ie, autograft, allograft, and xenograft).To continue reading this article, you must log in with your personal, hospital, or group practice subscription. For more information on subscription options, click below on the option that best describes you:
- US Food and Drug Administration. 2016 Information for health care providers for stress urinary incontinence. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345221.htm (Accessed on January 12, 2016).
- Chapple CR, Cruz F, Deffieux X, et al. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol 2017.
- Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013; :CD004014.
- Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev 2016; 11:CD004014.
- Elmér C, Altman D, Engh ME, et al. Trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol 2009; 113:117.
- Simon M, Debodinance P. Vaginal prolapse repair using the Prolift kit: a registry of 100 successive cases. Eur J Obstet Gynecol Reprod Biol 2011; 158:104.
- Lo TS. One-year outcome of concurrent anterior and posterior transvaginal mesh surgery for treatment of advanced urogenital prolapse: case series. J Minim Invasive Gynecol 2010; 17:473.
- Pacquée S, Palit G, Jacquemyn Y. Complications and patient satisfaction after transobturator anterior and/or posterior tension-free vaginal polypropylene mesh for pelvic organ prolapse. Acta Obstet Gynecol Scand 2008; 87:972.
- Khandwala S, Jayachandran C. Transvaginal mesh surgery for pelvic organ prolapse--Prolift+M: a prospective clinical trial. Int Urogynecol J 2011; 22:1405.
- FitzGerald MP, Mollenhauer J, Bitterman P, Brubaker L. Functional failure of fascia lata allografts. Am J Obstet Gynecol 1999; 181:1339.
- Schimpf MO, Abed H, Sanses T, et al. Graft and Mesh Use in Transvaginal Prolapse Repair: A Systematic Review. Obstet Gynecol 2016; 128:81.
- Tate SB, Blackwell L, Lorenz DJ, et al. Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up. Int Urogynecol J 2011; 22:137.
- Chughtai B, Barber MD, Mao J, et al. Association Between the Amount of Vaginal Mesh Used With Mesh Erosions and Repeated Surgery After Repairing Pelvic Organ Prolapse and Stress Urinary Incontinence. JAMA Surg 2017; 152:257.
- Glazener CM, Breeman S, Elders A, et al. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet 2017; 389:381.
- Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2016; 2:CD012079.
- Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 2013; 309:2016.
- Nüssler E, Eskildsen JK, Nüssler EK, et al. Impact of surgeon experience on routine prolapse operations. Int Urogynecol J 2017.
- Morgan DM, Pulliam S, Adam RA, et al. Analysis of High-, Intermediate-, and Low-Volume Surgeons When Performing Hysterectomy for Uterovaginal Prolapse. Female Pelvic Med Reconstr Surg 2016; 22:43.
- Kelly EC, Winick-Ng J, Welk B. Surgeon Experience and Complications of Transvaginal Prolapse Mesh. Obstet Gynecol 2016; 128:65.
- European Commission Scientific Committee on Emerging and Newly Identified Health Risks. Opinion on the safety of surgical meshes used in urogynecological surgery. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf (Accessed on January 12, 2016).
- US Food and Drug Administration. Reclassification for surgical mesh to repair pelvic organ prolapse. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery (Accessed on January 05, 2016).
- Health Canada Advisory. Complications associated with transvaginal implantation of surgical mesh for the treatment of pelvic organ prolapse and stress urinary incontinence. http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/39475a-eng.php (Accessed on January 13, 2016).
- Scottish Independent Review of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence and pelvic organ prolapse in women. Final Report. March 2017. http://www.gov.scot/Resource/0051/00515856.pdf (Accessed on November 30, 2017).
- National Institute for Health and Care Excellence. Interventional procedure consultation document: Surgical repair of vaginal wall prolapse using mesh. Draft recommendations. May 2017. www.nice.org.uk/guidance/gid-ipg10036/documents/interventional-procedure-consultation-document-2 (Accessed on November 30, 2017).
- The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Polypropylene vaginal mesh implants for vaginal prolapse. Renewed November 2016. www.ranzcog.edu.au/getattachment/Statements-Guidelines/Gynaecology/Polypropylene-Vaginal-Mesh-Implants-for-Vaginal-Pr/Polypropylene-vaginal-mesh-implants-for-vaginal-prolapse-(C-Gyn-20)-Review-November-2016.pdf?lang=en-AU&ext=.pdf (Accessed on November 30, 2017).
- Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. US Food and Drug Administration, 2011.
- US Food and Drug Administration. Obstetrical and gynecological devices: Reclassification of surgical instrumentation for use with urogynecologic surgical mesh, January 2017. https://www.federalregister.gov/documents/2017/01/06/2016-31862/obstetrical-and-gynecological-devices-reclassification-of-surgical-instrumentation-for-use-with (Accessed on October 23, 2017).
- US Food and Drug Administration. 522 Postmarket Surveillance Studies Program. November 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm (Accessed on November 30, 2017).
- US Food and Drug Administration. Information for health care providers for pelvic organ prolapse. Updated January 2017. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345204.htm (Accessed on November 30, 2017).
- American Urogynecologic Society’s Guidelines Development Committee. Guidelines for providing privileges and credentials to physicians for transvaginal placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2012; 18:194.
- Murphy M, Society of Gynecologic Surgeons Systematic Review Group. Clinical practice guidelines on vaginal graft use from the society of gynecologic surgeons. Obstet Gynecol 2008; 112:1123.
- Committee on Practice Bulletins—Gynecology and the American Urogynecologic Society. Practice Bulletin No. 176: Pelvic Organ Prolapse. Obstet Gynecol 2017; 129:e56.
- Barber MD, Brubaker L, Nygaard I, et al. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol 2009; 114:600.
- Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 2014; 311:1023.
- Karram M, Maher C. Surgery for posterior vaginal wall prolapse. Int Urogynecol J 2013; 24:1835.
- Committee on Gynecologic Practice. Committee Opinion no. 513: Vaginal placement of synthetic mesh for pelvic organ prolapse. Obstet Gynecol 2011; 118:1459.
- Davila GW. Optimizing safety and appropriateness of graft use in pelvic reconstructive surgery: introduction to the 2nd IUGA Grafts Roundtable. Int Urogynecol J 2012; 23 Suppl 1:S3.
- Davila GW, Baessler K, Cosson M, Cardozo L. Selection of patients in whom vaginal graft use may be appropriate. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 2012; 23 Suppl 1:S7.
- Slack M, Ostergard D, Cervigni M, Deprest J. A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 2012; 23 Suppl 1:S15.
- Winters JC, Jacquetin B, Castro R. Credentialing for transvaginal mesh placement--a case for "added qualification" in competency. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 2012; 23 Suppl 1:S27.
- Miller D, Milani AL, Sutherland SE, et al. Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 2012; 23 Suppl 1:S33.
- ACOG Committee on Practice Bulletins--Gynecology. ACOG practice bulletin No. 104: Antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol 2009; 113:1180. Reaffirmed 2016.
- American Urologic Association. Urologic surgery antimicrobial prophylaxis. http://www.auanet.org/content/media/antimicroprop08.pdf (Accessed on August 16, 2011).
- Sanabria A, Domínguez LC, Valdivieso E, Gómez G. Prophylactic antibiotics for mesh inguinal hernioplasty: A meta-analysis. Ann Surg 2007; 245:392.
- GRAFT MATERIAL FOR POP TREATMENT
- Synthetic mesh
- Transvaginal mesh kits
- Biologic materials
- OUR APPROACH
- ISSUES SURROUNDING SYNTHETIC MESH FOR POP
- Advisory statements
- Recommendations to health care providers
- Professional society guidelines
- Resources for patients and clinicians
- PREOPERATIVE PREPARATION
- Informed consent
- Antibiotic prophylaxis
- SUMMARY AND RECOMMENDATIONS