The Innovation and Evolution of Medical Devices

This text provides a central resource for the epidemiology, basic science, ultrasound imaging, clinical management, medicolegal and business implications of vaginal mesh kits. Since ultrasound techniques are minimally invasive and easily available for pelvic floor imaging, special emphasis is given for preoperative and intraoperative ultrasound imaging of mesh.Dramatic presentation of vaginal mesh complications gave way to innovative approaches in dealing with this previously unseen entity. The chapters on management of complications will help the reader to understand and plan for the complexity of these complications.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.In recognition of the pelvic floor disorders and of its squeal on the quality of life of women, the authors have compiled the practical evidence-based book that will aid as a resource for practitioners with an interest in the imaging, diagnosis and treatment of vaginal mesh complications. The book is meant to be concise, evidence-based, and practical for the first time users in order to confer technical capability to the reader. Concise textual information from acknowledged experts is complemented by high-quality diagrams and images to provide a thorough update of this rapidly evolving field. Introductory chapters fully elucidate the anatomical basis underlying disorders of the pelvic floor, followed by 3D ultrasound imaging, surgical management, medicolegal and business implications.With a luxurious number of well-marked pictures, readers will gain a clear understanding of the fundamental principles and techniques of vaginal mesh kit complications. The book provides a rich practical resource written in a simple a step-by- step approach for a novice in their approach to new devices and technologies.

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 Dr