Adverse Event Reports Associated with Vaginal Mesh: An Interrupted Time Series Analysis |
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| Institution: | 1. Department of Sociology, Simmons College, Boston, Massachusetts;2. Master of Public Policy Program, Simmons College, Boston, Massachusetts;1. Department of Obstetrics and Gynecology, Rambam Medical Center, Haifa, Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel;2. Neurourology Division, Department of Urology, Rambam Medical Center, Haifa, Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel;1. Genetic Pathology Laboratory, Department of Pathology, Princess Margaret Hospital, Hong Kong Special Administrative Region;2. Department of Paediatrics, United Christian Hospital, Hong Kong Special Administrative Region;3. Department of Diagnostic Radiology and Organ Imaging, United Christian Hospital, Hong Kong Special Administrative Region;4. Department of Pathology, United Christian Hospital, Hong Kong Special Administrative Region;5. Department of Pathology, Queen Mary Hospital, Hong Kong Special Administrative Region;6. Department of Pathology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region;1. Department of Mathematics and Statistics, The Open University, Milton Keynes, MK7 6AA, United Kingdom;2. Non Communicable Disease Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom;1. Department of Chemistry, William Jewell College, 500 College Hill, Liberty, MO 64068, United States;2. Department of Chemistry, University of Iowa, E331 Chemistry Building, Iowa City, IA 52242-1294, United States;1. Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, Minnesota;2. Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;3. Department of Public Health Sciences and Department of Obstetrics and Gynecology, College of Medicine, Penn State University, Hershey, Pennsylvania |
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| Abstract: | BackgroundSurgery with vaginal mesh is often used to treat female urinary incontinence. Questions have emerged over the past decade about the safety and efficacy of vaginal mesh devices.ObjectiveThis study examines trends in adverse event reports associated with vaginal mesh devices, testing the hypothesis that Food and Drug Administration (FDA) announcements will result in increased adverse event reports to the FDA.MethodsUsing interrupted time series regression models, we analyzed adverse event report data collected from the FDA's Manufacturer and User Facility Device Experience reporting system in 1998 through 2015.ResultsFDA announcements had limited effects on the number of adverse event reports, whereas an announcement from a mesh manufacturer that it was withdrawing devices from the market resulted in a large spike in reports.ConclusionsThese findings raise concerns about the dispersion of risk communications, the FDA's reliance on adverse event reports for postmarket surveillance, and the FDA's clearance of vaginal mesh without safety or efficacy testing. |
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