MP30-05 TRENDS IN INNOVATION IN THE SURGICAL MANAGEMENT OF STRESS INCONTINENCE AND PELVIC ORGAN PROLAPSE: A “DEEP DIVE” INTO THE FDA 510(K) AND PREMARKET APPROVAL DATABASES

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (MP30)1 Apr 2020MP30-05 TRENDS IN INNOVATION IN THE SURGICAL MANAGEMENT OF STRESS INCONTINENCE AND PELVIC ORGAN PROLAPSE: A “DEEP DIVE” INTO THE FDA 510(K) AND PREMARKET APPROVAL DATABASES Cristina Fox* and MD Debra FromerMD Cristina Fox*Cristina Fox* More articles by this author and Debra FromerDebra Fromer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000869.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In 2008, the FDA issued a landmark Public Health Notification (PHN) regarding adverse events of transvaginal mesh (TVM) for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2011, the FDA update stated that serious adverse events of TVM for POP repair are not rare. This same year, an FDA Executive Advisory Panel considered reclassification of TVM for POP repair from Class II (low to moderate risk) to Class III (high risk), which mandated a more extensive and costly Premarket Approval (PMA). The FDA followed with 109 orders for device manufacturers to initiate post-market 522 studies of existing TVM for POP repair and single-incision slings by 2013. In early 2016, up-classification of TVM for POP repair to Class III was announced along with a deadline of mid-2018 for PMAs and 522s. In April 2019 all TVM for POP repair were withdrawn from the market as the FDA revoked their clearance based on 1-year data. This series of events brings to question: how are the FDA regulatory clearance processes affecting trends in surgical innovation in the management of SUI and POP? METHODS: Utilizing the FDA 510(k) and PMA databases on the FDA website, we analyzed the trends of devices granted clearance for POP and SUI between 1999 and 2018. This included both modifications to existing devices and novel devices. Quantification of the number of novel device submissions during this study period was correlated to the FDA issued communications to estimate trends in device innovation. RESULTS: From 1999 to 2018, there were 127 total Cleared 510(k) Premarket Notifications, 48 for POP and 79 for SUI. Of the total submissions, there were 29 novel devices for POP and 40 for SUI. Figure 1 demonstrates a temporal analysis of submissions, correlating to a peak from 2004 to 2008, and accounting for 56% of all submissions. Conversely, post-2008, there is a precipitous drop in novel submissions, resulting in a literal flatline. CONCLUSIONS: The declining trend in device manufacturer innovation correlates with increasing demands from the FDA involving intensive premarket approval processes. Such a trend limits surgical options for women with POP and SUI and threatens the quality, evidence-based care that our patients deserve. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e439-e440 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Cristina Fox* More articles by this author Debra Fromer More articles by this author Expand All Advertisement PDF downloadLoading ...