February 2001 AAOS Report

FDA tells concerns about use of PMMA bone cement in spine

The U.S. Food and Drug Administration (FDA) has expressed concern about potentially serious patient care issues involved with the use of polymethlymethacrylate (PMMA) bone cement in the spine. A physician might insert the PMMA bone cement into vertebrae by various procedures, including vertebroplasty and kyphoplasty. Orthopaedic surgeons should be alert to possible complications. PMMA bone cement is considered a device for FDA purposes. In October 1999, the FDA reclassified PMMA bone cement as a Class II device for its intended use "in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone." The use of a device for other than its FDA-cleared indication is an off-label use. Physicians may use a device off-label if they believe, in their best medical judgment, that its use is appropriate for a particular patient (e.g., tumors). The use of PMMA bone cement in the spine is described in Academy educational courses, videotapes and publications for educational purposes only. As is the Academy's policy regarding all of its educational offerings, the fact that the use of PMMA bone cement in the spine is discussed does not constitute an Academy endorsement of this use.

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