MP11-18 THE MEDICOLEGAL AND ECONOMIC IMPLICATIONS REGARDING THE USE OF TRANSVAGINAL MESH

Abstract

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Practice Patterns, Cost Effectiveness II1 Apr 2014MP11-18 THE MEDICOLEGAL AND ECONOMIC IMPLICATIONS REGARDING THE USE OF TRANSVAGINAL MESH Marc Colaco, Austin Hester, Jason Sandberg, Jayadev Mettu, and Gopal Badlani Marc ColacoMarc Colaco More articles by this author , Austin HesterAustin Hester More articles by this author , Jason SandbergJason Sandberg More articles by this author , Jayadev MettuJayadev Mettu More articles by this author , and Gopal BadlaniGopal Badlani More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.433AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Although the use of transvaginal mesh placement has long been considered an option for the treatment of pelvic organ prolapse (POP), recent developments have brought this practice under controversy. Several studies have questioned the efficacy and safety of mesh usage, and the FDA has made multiple communications regarding the potential complications of mesh usage. While the implications for clinical practice are still hotly debated, these developments also have medicolegal and economic implications. Thus, the purpose of this study is to analyze the product liability litigation rate for two large mesh manufactures and to correlate these findings to FDA communications as well as other possibly related factors. METHODS Retrospective analysis was performed using legal case listings from the New Jersey judiciary Multicounty Litigation Center regarding mass tort for all pelvic mesh related cases filed prior to August 2013. This database was chosen as both Bard, Inc. and Ethicon Endo-Surgery, Inc. are based in New Jersey and thus New Jersey is the jurisdiction for these mass torts. Data was then compared to FDA communication releases and any landmark legal findings to determine correlation. Statistics were analyzed via parametric methods using Statsplus® software. RESULTS A total of 4385 Ethicon cases and 811 Bard cases were identified in this review. Rates of case filing did not significantly correlate to either FDA communication. Significant increases in filing were seen, however, in correlation with major verdicts decided in plaintiffs’ favors: mean number of cases filed within 3 months of either landmark court case was significantly higher than at all other times during this period (273 versus 67, p<0.01). CONCLUSIONS Device related lawsuits are an unfortunate reality of modern medicine, and awareness of liability is vital to the medical practice. Our results show that in regards to pelvic mesh related lawsuits case filings are more related to court decisions than to FDA communications. These findings may reflect the impact of financial incentives within the medicolegal arena, and demonstrate the need for physicians to keep abreast of current and ongoing legal precedence. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e102-e103 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Marc Colaco More articles by this author Austin Hester More articles by this author Jason Sandberg More articles by this author Jayadev Mettu More articles by this author Gopal Badlani More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...