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01-01-2012 | Debate: Transvaginal Mesh for POP -- The Recent FDA Update

Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

Authors: Bernard T. Haylen, Peter K. Sand, Steven E. Swift, Christopher Maher, Paul A. Moran, Robert M. Freeman

Published in: International Urogynecology Journal | Issue 1/2012

Excerpt

Recently (July 13, 2011), the United States Food and Drug Administration (FDA) issued a document entitled “FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” [1]. This was stated as an update of a previous document issued on October 20, 2008, entitled “A Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat pelvic organ prolapse (POP) and SUI (stress urinary incontinence)”. Accompanying the recent FDA concerns was a 15-page document entitled “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse” which has a literature review identifying 27 key references [2]. …

FDA (2011) FDA Safety Communications: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. http://www.fda.gov/MedicalDevices/Safety/AlertandNotices/ucm262435.htm. Accessed 13 July 2011

Urogynecologic surgical mesh: Update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse (2011) http://www.fda.gov/MedicalDevices/Safety/AlertandNotices/ucm262760.pdf

Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J, Dwyer PL, Fatton B, Kocjancic E, Lee J, Maher C, Petri E, Rizk DE, Sand PK, Schaer GN, Webb RJ (2011) An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery. Int Urogynecol J 22:3–15PubMedCrossRef

Roovers J-PWR (2007) Registries: what level of evidence do they provide? Int Urogynecol J 18:1119–1120CrossRef

Inglesia C, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S (2010) Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 116(2):293–303CrossRef

Cassidenti AP (2011) A reproducible technique to perform full thickness vaginal wall dissection for POP mesh placement that minimizes mesh exposure rates. IUGA Lisbon abstracts. http://www.abstractsonline.com/plan/AuthorIndex.aspx?letters=CA. Accessed June 2011

Milani AL, Lucente V, Urquhart C, Hinoul P, Cosson M (2011) Two-year clinical outcomes of a trocar-guided transvaginal mesh repair utilizing a new light-weight synthetic mesh. Int Urogynecol J 22(Suppl 1):S26

Jia X, Glazener C, Mowat G, MacLennan G, Bain C, Fraser C, Burt J (2008) Efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse: systematic review and meta-analysis. Br J Obstet Gynaecol 115(11):1350–1361CrossRef

Maher C et al (2010) Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 4:CD004014PubMed

10.

Summers A, Winkel LA, Hussain HK, DeLancey JOL (2006) The relationship between anterior and apical compartment support. Am J Obstet Gynecol 194:1438–1443PubMedCrossRef

Title: Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible
Authors: Bernard T. Haylen
Peter K. Sand
Steven E. Swift
Christopher Maher
Paul A. Moran
Robert M. Freeman
Publication date: 01-01-2012
Publisher: Springer-Verlag
Published in: International Urogynecology Journal / Issue 1/2012
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-011-1580-3

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Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible

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