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
http://www.medscape.com/viewarticle/514629 © 2005
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