MP05-10 ACCURACY OF MEDIA COVERAGE ABOUT THE 2019 US FOOD AND DRUG ADMINISTRATION BAN ON TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (MP05)1 Apr 2020MP05-10 ACCURACY OF MEDIA COVERAGE ABOUT THE 2019 US FOOD AND DRUG ADMINISTRATION BAN ON TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE Shagnik Ray*, Marisa Clifton, and Kevin Koo Shagnik Ray*Shagnik Ray* More articles by this author , Marisa CliftonMarisa Clifton More articles by this author , and Kevin KooKevin Koo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000819.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: On 4/16/2019, the US Food and Drug Administration (FDA) banned the sale of surgical mesh for transvaginal (TV) repair of pelvic organ prolapse (POP). Given the clinical prevalence of POP and urinary incontinence (not included in the ban), we analyzed media coverage of the ban and its potential impact on patient perceptions of mesh surgery. METHODS: We queried the NexisUni database(>15000 news sources indexed), for English-language articles about TV mesh or the FDA, published between 1 week before the ban (4/8/19) and 7/1/19. We excluded news ticker results and articles about mesh without mentioning FDA. Content analysis was based on discussion of the ban, mesh use indications, quoted sources, and mesh complications. The extent of media coverage of TV mesh was tracked using Google Trends. RESULTS: Of 290 news articles retrieved, 57 articles met inclusion criteria. The volume of news reports about TV mesh increased ∼ 400% the week of the FDA announcement, equal to twice the coverage anytime during the preceding year. Most articles focused on the regulatory effect of the ban (51 articles, 89%) and the implications on manufacturers (25 articles, 44%). Relatively few articles discussed the FDA’s prior actions on TV mesh for POP; only 18 (31%) and 13 (22%) articles cited the 2011 FDA Public Health Notification and 2016 Update, respectively. Regarding the indications for mesh surgery, the majority of articles either did not mention an indication for mesh surgery (17 articles, 30%) or discussed both POP and incontinence (16 articles, 28%). However, 45 (79%) articles did not specify that the ban applied only to POP and not incontinence, while 1 (2%) article stated this distinction incorrectly. A plurality of articles (26 articles, 46%) cited mesh-related complications (most commonly pain, bleeding, “permanent injury”), but only 6 (11%) articles quoted surgeons who use TV mesh, compared to 16 (28%) articles quoting lawyers. Despite evidence-based statements on mesh by 3 professional organizations including the AUA, only 1 (2%) article cited 1 statement (American Urogynecologic Society). CONCLUSIONS: The 2019 FDA ban on transvaginal mesh for POP received extensive media coverage, but 80% of articles did not accurately distinguish between the banned use of mesh for POP versus urinary incontinence. Given the prevalence of both conditions, the findings raise concern about patients’ perceptions of and future access to mesh surgery regardless of indication. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e44-e45 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shagnik Ray* More articles by this author Marisa Clifton More articles by this author Kevin Koo More articles by this author Expand All Advertisement PDF downloadLoading ...