News
10/02/1991

<TITLE>Vitek Jaw Implant</TITLE>
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Vitek Jaw Implant

91-25                                      Food and Drug Administration
IMMEDIATE RELEASE                       Sharon Snider - (301) 443-3285
    The Food and Drug Administration today advised patients with certain jaw
implants manufacturered by Vitek Inc. of Houston to obtain an immediate
    The Food and Drug Administration today advised patients with certain jaw
examination to determine whether the implants are breaking down or causing
bone degeneration.
    FDA said it is taking responsibility for alerting patients with the
implants because Vitek Inc., which was ordered to re-notify doctors and
notify patients, is bankrupt.  The devices were manufacturered by Vitek from
1973 through 1988.
    The implants were used to treat temporomandibular joint syndrome, or
TMJ, a painful condition of the joint that connects the jaw and the skull.
At least 26,000 implants were distributed to doctors and hospitals, but the
agency does not have data on how many patients have them.  The implants,
made with a composite coating called Proplast, are reported to break apart,
fragment and function improperly, which may cause the bone to deteriorate.
    Symptoms of implant breakdown include pain radiating from around the
ear, joint noise, limited lower jaw movement, a change in bite, difficulty
chewing and, in some patients, headaches.  In some cases, no symptoms occur
while the implant is breaking down, thus increasing the importance of
regular medical examinations.
    "Although FDA announced a recall of unused implants in January, the
agency wants to make sure all patients who have the implants are aware of
the risks and have a doctor monitor their implants," said FDA Commissioner
David A. Kessler, M.D.  "It is especially important that these people be
examined because bone degeneration can sometimes occur without symptoms," he
said.
    The examination often includes a computed axial tomography (CAT) scan or
magnetic resonance imaging (MRI) procedure.  Even if the examination finds
that the implant has not failed, a patient should be examined once a year as
long as the implant remains in the jaw, FDA said.  If the implant has failed
and the patient is experiencing bone deterioration, the implant may have to
be removed.
    FDA is establishing a notification program for these patients, which
will be operated by Medic Alert, a non-profit foundation.  Doctors who have
implanted the devices or patients who have them are urged to call
1-800-554-5297.
    The notification program is directed at patients who received the Vitek
Interpositional Implant (a TMJ disk replacement) and those who received
Vitek's total joint replacement called the Vitek Kent (VK) and the Vitek
Kent I (VK-I).  Oral Surgery Marketing Inc. (OSMI) of Houston, a successor
corporation of Vitek, also manufacturers a VK-II TMJ implant that may
present similar risks.
    Callers will receive information on the risks of these implants and
instructions on how to enroll in Medic Alert's International Implant
Registry.  This will enable them to receive new information about the
implants as it becomes available.
    FDA said it is taking responsibility for alerting patients with the
implants because Vitek Inc. which was ordered to re-notify doctors and
notify patients, is bankrupt and cannot follow up appropriately.  The
devices were manufacturered by Vitek from 1973 through 1988.
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