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South Med J. 2013 Dec;106(12):684-8. doi: 10.1097/SMJ.0000000000000031.

Estimating the early impact of the FDA safety communication on the use of surgical mesh.

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1
From the Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill.

Abstract

OBJECTIVES:

To estimate the early impact of the July 2011 Food and Drug Administration Safety Communication on the practice patterns of gynecologic surgeons using surgical mesh to manage pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

METHODS:

A cross-sectional study was performed by administering a mesh usage questionnaire to physician attendees at the opening session of the American Association of Gynecologic Laparoscopists Global Congress of Minimally Invasive Gynecology in November 2011.

RESULTS:

Of the 827 physicians attending the opening session of the conference, 281 (34%) completed the questionnaire, 202 (72%) of whom reported performing surgery for POP and/or SUI. The respondents were attending physicians (83.4%) with at least 10 years of experience (65.7%), 136 (71.1%) identifying themselves as General Gynecology, 29 (17.3%) as Urogynecology, 13 (7.1%) as Minimally Invasive Gynecologic Surgery, and 3 (1.8%) as Urology. When compared with generalists, specialists were more likely to use mesh for abdominal (86% vs 56.3%, P < 0.001) and vaginal (65.9% vs 37.2%, P = 0.001) POP repair. Specialists reported using mesh for the anterior compartment (50% vs 28.3%, P = 0.01) and the posterior compartment (36.4% vs 12.5%, P = 0.001), and total vaginal mesh kits (13.6% vs 1.7%, P = 0.005). Respondents reported an increase in mesh use for primary abdominal POP repair (82 vs 92, P = 0.013) and a decrease in mesh use for recurrent vaginal POP repair (99 vs 75, P < 0.001), with more surgeons opting against mesh for recurrent POP (49 vs 74, P < 0.001). For patient counseling, 53.7% reported changing their methods.

CONCLUSIONS:

In a self-selected sample of pelvic surgeons, we noted that the 2011 FDA Safety Communication had an impact, with changes in mesh usage and counseling patterns.

PMID:
24305528
DOI:
10.1097/SMJ.0000000000000031
[Indexed for MEDLINE]
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