Estimating the early impact of the fda safety communication on the use of surgical mesh

Erinn Myers, Elizabeth Geller, Andrea Crane, Barbara Robinson, Catherine Matthews

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)684-688
Number of pages5
JournalSouthern medical journal
Volume106
Issue number12
DOIs
StatePublished - Dec 1 2013

Fingerprint

Surgical Mesh
Pelvic Organ Prolapse
Communication
Safety
Stress Urinary Incontinence
Physicians
Gynecology
Counseling
Uterine Prolapse
Gynecologic Surgical Procedures
Minimally Invasive Surgical Procedures
Urology
United States Food and Drug Administration
Cross-Sectional Studies
Surveys and Questionnaires

Keywords

  • Food and Drug Administration
  • mesh
  • mesh warning
  • midurethral sling
  • vaginal mesh

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Estimating the early impact of the fda safety communication on the use of surgical mesh. / Myers, Erinn; Geller, Elizabeth; Crane, Andrea; Robinson, Barbara; Matthews, Catherine.

In: Southern medical journal, Vol. 106, No. 12, 01.12.2013, p. 684-688.

Research output: Contribution to journalArticle

Myers, Erinn ; Geller, Elizabeth ; Crane, Andrea ; Robinson, Barbara ; Matthews, Catherine. / Estimating the early impact of the fda safety communication on the use of surgical mesh. In: Southern medical journal. 2013 ; Vol. 106, No. 12. pp. 684-688.
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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.",
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N2 - 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.

AB - 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.

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