Over the last 20 years, there has been a great deal of innovation in the field of FPMRS, not only involving surgical implants, but also new methods of treating a range of common conditions, including stress incontinence and overactive bladder. There are many forces that drive innovation, including the desire to improve patient outcomes and address unmet clinical needs. Both physicians and industry play an important role in the development of new devices and techniques to treat pelvic floor disorders, but the future of innovation is being challenged by a number of external forces, including FDA decisions and mass tort litigation. As surgeons, we find ourselves at a crossroads, and which way we go depends not only on these external factors, but on our own actions. In this lecture, we will explore the history of innovation in FPMRS, and how we can have an impact on the future of our field.
Describe the changing regulatory process for new medical devices in the field of FPMRS
Review the history of litigation involving transvaginal mesh for prolapse and stress incontinence
Identify factors that medical device companies consider when evaluating potentially innovative solutions
Director of Urogynecology and Reconstructive Pelvic Surgery, Assitant Professor of Ob/Gyn, Harvard Medical School,
Mount Auburn Hospital
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