Registries as Tools for Clinical Excellence and the Development of the Pelvic Floor Disorders Registry

Abstract

Surgical device innovation has been less regulated than drug development, allowing integration of unproven techniques and materials into standard practice. Successful device registries gather information on patient outcomes and can provide postmarket surveillance of new technologies and allow comparison with currently established treatments or devices. The Pelvic Floor Disorders Registry was developed in collaboration with the Food and Drug Administration, device manufacturers, and other stakeholders to serve as a platform for industry-sponsored postmarket device surveillance, investigator-initiated research, and quality and effectiveness benchmarking, all designed to improve the care of women with pelvic floor disorders.

Keywords: Pelvic floor disorders; Pelvic reconstructive surgery; Postmarket device surveillance; Registry; Surgical device innovation; Urogynecology.