FDA Approvals:"Total TMJ Replacement System for Diseased/Damaged Jaw Joints"by Yael Waknine, reviewed by Gary D. Vogin, M.D. On Sept. 21, 2005, the FDA approved a prosthetic device (Total Temporomandibular Joint [TMJ] Replacement System, made by Walter Lorenz Surgical, Inc.) for the functional reconstruction of diseased and/or damaged jaw joints. Its two components (mandibular condyle and glenoid fossa) are available in multiple sizes as right- and left-side specific designs and are attached to bone by screws. Approved indications for the TMJ prosthesis include arthritic conditions such as osteoarthritis, traumatic arthritis, or rheumatoid arthritis; ankylosis including but not limited to recurrent ankylosis with excessive heterotopic bone formation; and revision procedures in which other treatments have failed (eg, alloplastic reconstruction, autogenous grafts). The prosthesis may also be used for avascular necrosis, multiply operated joints, fracture, functional deformity, benign neoplasms, malignancy (eg, posttumor excision), degenerated or resorbed joints with severe anatomic discrepancies, and developmental abnormalities. The approval was based on data from a prospective six-year clinical study in 224 patients (329 joints), showing that patients receiving the implant demonstrated decreased pain, increased function, an increase in maximal incisal opening, and satisfaction with outcome. The device is not intended for partial TMJ reconstruction or for use in patients susceptible to infection or having active/chronic infection, insufficient bone to support the device, an immature skeleton, or hyperfunctional habits such as clenching/grinding of teeth. Reprinted with permission from "Medscape Medical News" 2005 |