Off-Label Use of Biologics and Devices in Orthopaedics

Stuart B. Goodman, MD, PhD; Shep J. Friedman, MD; Ivan Cheng, MD; A. Seth Greenwald, DPhil (Oxon); and Barbara D. Buch, MD

Many innovations in orthopaedic surgery and other medical subspecialties have evolved from off-label use of approved devices, biologics, and pharmaceutical products. Examples include the use of antibiotic-loaded bone cement, early use of cementless total joint replacement, cardiovascular stents (which evolved from biliary stents), numerous adult medications or devices used in children, and the perioperative use of beta-adrenergic blocking agents, among others.

According to a study published in 2010, approximately 85 percent of bone morphogenetic protein (BMP)-2 use in spine surgery has been off-label. An earlier study (2008) noted that only about 30 percent of off-label medication prescriptions have been supported by adequate scientific evidence. Thus, it’s important that orthopaedic surgeons know the regulations surrounding off-label use of medical products so they can deliver safe and effective care to their patients and comply with federal regulations.

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