Graduated introduction of orthopaedic implants: encouraging innovation and minimizing harm.

Abstract

There is continued pressure for the development of innovative orthopaedic surgical devices and techniques to meet the demands of increasingly younger and more active patients. However, as demonstrated by several recent orthopaedic implant withdrawals and recalls, clinically important unknown modes of failure for newly introduced devices may not become apparent for several years after widespread adoption, affecting a large number of patients. Different reasons have been implicated for this problem, including weaknesses in the United States medical device approval process, as well as deficiencies in mechanisms for post approval implant performance monitoring. Several remedies have been proposed over the past decades. We aim to stimulate discussion concerning the adoption of orthopaedic technology by describing the concept of a graduated implant approval process for orthopaedic devices that builds on recommendations previously made by other authors; by explaining how this will benefit patients, surgeons, and device manufacturers; and by clarifying why the time has come for the orthopaedic community to reconsider the adoption of such a process.