Literature DB >> 23797515

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.

Jeffrey L Clemons1, Milena Weinstein, Marsha K Guess, Marianna Alperin, Pamela Moalli, William Thomas Gregory, Emily S Lukacz, Vivian W Sung, Bertha H Chen, Catherine S Bradley.   

Abstract

OBJECTIVE: To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members.
METHODS: An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test.
RESULTS: Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures.
CONCLUSIONS: Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Entities:  

Mesh:

Year:  2013        PMID: 23797515     DOI: 10.1097/SPV.0b013e31829099c1

Source DB:  PubMed          Journal:  Female Pelvic Med Reconstr Surg        ISSN: 2151-8378            Impact factor:   2.091


  18 in total

1.  Vaginal native tissue repair versus transvaginal mesh repair for apical prolapse: how utilizing different methods of analysis affects the estimated trade-off between reoperation for mesh exposure/erosion and reoperation for recurrent prolapse.

Authors:  Alexis A Dieter; Marcella G Willis-Gray; Alison C Weidner; Anthony G Visco; Evan R Myers
Journal:  Int Urogynecol J       Date:  2015-02-03       Impact factor: 2.894

2.  The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial).

Authors:  Charles W Nager; Halina Zyczynski; Rebecca G Rogers; Matthew D Barber; Holly E Richter; Anthony G Visco; Charles R Rardin; Heidi Harvie; Dennis Wallace; Susan F Meikle
Journal:  Female Pelvic Med Reconstr Surg       Date:  2016 Jul-Aug       Impact factor: 2.091

Review 3.  Making surgery safer through adequate communication with the stakeholders: vaginal slings.

Authors:  Sandra Elmer; Janelle Brennan; Rebecca Mathieson; Briony Norris; Marcus Carey; Caroline Dowling
Journal:  World J Urol       Date:  2019-07-04       Impact factor: 4.226

4.  An Internet-based survey to evaluate the comfort and need for further pubovaginal sling training.

Authors:  Neha T Sudol; Sonia Dutta; Felicia Lane
Journal:  Int Urogynecol J       Date:  2018-07-03       Impact factor: 2.894

5.  Pelvic organ prolapse surgical management in Portugal and FDA safety communication have an impact on vaginal mesh.

Authors:  Teresa Mascarenhas; Miguel Mascarenhas-Saraiva; Amélia Ricon-Ferraz; Paula Nogueira; Fernando Lopes; Alberto Freitas
Journal:  Int Urogynecol J       Date:  2014-08-16       Impact factor: 2.894

Review 6.  Transvaginal mesh: a historical review and update of the current state of affairs in the United States.

Authors:  Shilpa Iyer; Sylvia M Botros
Journal:  Int Urogynecol J       Date:  2016-08-22       Impact factor: 2.894

Review 7.  Prolapse Repair Using Non-synthetic Material: What is the Current Standard?

Authors:  Ricardo Palmerola; Nirit Rosenblum
Journal:  Curr Urol Rep       Date:  2019-10-14       Impact factor: 3.092

8.  Update in native tissue vaginal vault prolapse repair.

Authors:  Andrea Braga; Maurizio Serati; Stefano Salvatore; Marco Torella; Roberto Pasqualetti; Andrea Papadia; Giorgio Caccia
Journal:  Int Urogynecol J       Date:  2020-06-18       Impact factor: 2.894

9.  The impact of the 2011 US Food and Drug Administration transvaginal mesh communication on utilization of synthetic mid-urethral sling procedures.

Authors:  Alexander A Berger; Jasmine Tan-Kim; Shawn A Menefee
Journal:  Int Urogynecol J       Date:  2020-11-18       Impact factor: 2.894

Review 10.  Post-Sling Urinary Retention in Women.

Authors:  Dominique R Malacarne; Victor W Nitti
Journal:  Curr Urol Rep       Date:  2016-11       Impact factor: 3.092

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