News
01/07/1991

<TITLE>Recall of Jaw Implant </TITLE>
<PRE>
Recall of Jaw Implant 

P91-3                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285 

    The Food and Drug Administration today announced that Vitek Inc. is 
voluntarily recalling certain jaw implants used to treat temporomandibular
joint (TMJ) syndrome, a painful condition of the joint which connects the 
jaw bone and the skull.  The agency said the implants may cause bone
degeneration. 
    People who think they may have one of these implants should contact the 
dentist who performed the surgery for further information.
    FDA urged these dental surgeons to reexamine the patients to see if the 
implants should be replaced.
    The devices known as interpositional implants, were manufactured by 
Vitek, Inc. of Houston, Texas.  They were marketed between l983 and l988. 
The implants are made with a Teflon composite coating that can break down 
under pressure, producing particles that cause the body to reject them as 
foreign substances. 
    Several studies have demonstrated that this can result in bone
degeneration around the implant in as little as 1-2 years, sometimes with 
intense pain and severely limited jaw movement, and sometimes without any 
symptoms. 
    FDA urged dental surgeon's to x-ray patients with these implants to 
determine whether they are experiencing complications.  This procedure is 
                                   


                                            Page 2, Jaw Implants, P91-3 
particularly important because even patients without symptoms can experience
bone degeneration.
    FDA in a safety alert letter has recommended that if the x-ray shows
that the implant has not failed and no bone degeneration has taken place, 
the patient should be re-examined every six months for as long as the 
implant remains in the jaw.  If the implant has failed or if bone 
degeneration is found, the implant may have to be removed.  It can sometimes
be replaced with an implant made of different materials, or the TMJ symptoms
can be treated in other ways. 
    About 26,000 of the Vitek interpositional implants were distributed.  It
is not known how many were implanted in patients.  FDA advises oral surgeons
that any remaining implants should not be used and should be returned to: 
Bonham, Carrington, and Fox, Bankruptcy Trustee for Vitek, Inc., 400 One
Shell Plaza, Houston, Texas 77002.

</PRE>