This text provides a central resource for physicians, entrepreneurs, and the MBA students about how innovation occurs in medical device industry. The book uses the rise and fall of vaginal mesh kits to highlight the evolution of responses by the physicians, patients and the regulatory bodies. There are specific chapters reviewing the US regulatory issues and business practices that were consequential to withdrawal of most vaginal mesh kits from the US market. The book is meant to be concise, evidence-based, and practical for the first time readers to understand the innovation forces. Concise textual information from acknowledged experts is complemented by high-quality diagrams and images to provide a thorough update of this rapidly evolving medical device industry. The case study chapters fully elucidate the anatomical basis that led to conceptualization of vaginal mesh kits, their introduction into the market, medicolegal and business implications followed with innovation that occurred by the surgeons to utilize ultrasound for and innovative surgeries to overcome device complications. With a luxurious number of well-marked pictures, readers will gain a clear understanding of the medical device innovation and evolution.
Innovation and Evolution of Medical Devices: The vaginal Mesh Kits provides a rich practical resource written in a simple a step-by- step approach for all readers in their approach to new medical devices and technologies.
Table of Content
Introduction: Why a Case Study of Vaginal Mesh Kits?.- Innovation of Medical Devices.- Business Aspects of Vaginal Mesh Kits: Lessons Learned.- Medical-Legal Aspects of Transvaginal Mesh Kit Complications: A Historical Perspective and the U.S. Food and Drug Administration Review Process.- Medical Device Marketing and the Ethics of Vaginal Mesh Kit Marketing.- Medical Devide Innovation and Errors: The Patient Perspective.- Pelvic Floor Anatomy as it Relates to the Design and Development of Vaginal Mesh Kits.- Basic Science of Vaginal Mesh.- Vaginal Mesh for Prolapse: An Epidemiologic and Historical Perspective.- Innovations Breed Innovations: How Pelvic Floor Ultrasound Filled the Diagnostic Gap for Vaginal Mesh Kid Complications.- Surgical Considerations for Vaginal Mesh Complications.- Complications of Transobturator Synthetic Slings.- Vaginal Mesh and Pain Complications.- Outcomes of Vaginal Mesh Surgeries.
About the author
S. Abbās Shobeiri, MD, FACS, FACOG
Professor of Obstetrics and Gynecology,
Virginia Commonwealth University School of Medicine Inova Fairfax Campus
Professor, Cell Biology & Anatomy, Graduate College, OUHSC
Vice Chair, Gynecologic Subspecialties,
Falls Church, VA
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