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U.S. Department of Health and Human Services

Medical Devices

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Serious Problems With Proplast-Coated TMJ Implant

This is an archived document and is no longer current information.

 

December 28, 1990 

 

To Oral and Maxillofical Surgeons:  

This is to urge you to re-examine all of your patients who have received temporomandibular joint (TMJ) interpositional implants which were manufactured or marketed by either Vitek Inc. or Oral Surgery Marketing, Inc. (both of Houston, Texas). These implants were distributed between February 1983 and June 1988 and were the subject of Vitek’s March 23, 1990 safety alert. The patent for this medical device is currently held by Hadaco, Ltd. (British Virgin Islands). 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
Attention: Mr. Ben Floyd  

 

Problem

These implants, all of which are made of ProplastR (TeflonR -carbon or TeflonR – aluminum oxide fiber composite), have been associated with implant perforation, fragmentation and/or a foreign body response which may result in progressive bone degeneration of the mandibular condyle and/or the glenoid fossa1-3. If bone degeneration continues unchecked, patients may experience intense pain and severely limited joint function. One study found that all patients will ProplastR coated TMJ interpositional implants who experienced complications demonstrated progressive bone degeneration in as little as one to two years1. In a second study, implant failure and bone degeneration occurred in both symptomatic and asymptomatic patients2.

 

Recommendations

Because asymptomatic patients may experience bone degeneration, FDA recommends that all patients with these implants who have not had a radiograph taken in the past six months undergo immediate and appropriate radiographic examination. The examination will assist in determining if loss of implant integrity has occurred or if progressive bone degeneration is occurring. 

  • If loss of implant integrity or progressive bone degeneration is not occurring, regular radiographic examinations of the implant should be performed every six months for as long as it remains in the jaw.
  • If either loss of implant integrity or progressive bone degeneration is found, explantation may be appropriate. If explantation is chosen, patients should be evaluated to determine what alternative procedures might be appropriate, e.g., a non-ProplastR coated implant, an autologous bone graft, or no replacement (symptomatic management). 

I would appreciate your sharing the information in this Safety Alert with other practitioners who might find it useful. If you have questions concerning the Alert, please contact: Gregory Singleton, D.D.S., Center for Devices and Radiological Health, Food and Drug Administration, 1390 Piccard Drive, HFZ-250, Rockville, MD 20850.

 

Sincerely yours,

Walter E. Gundaker
Acting Director
Center for Devices and Radiological Health
Food and Drug Administration

   

References:
1. Primely, Donald, Jr., “Histological and Radiographic Evaluation of the Proplast- Teflon Interpositional Implant in Temporomandibular Joint Reconstruction Following Meniscectomy”, Thesis, Masters Degree in Oral Maxillofical Surgery, May 1987. University of Iowa.
2. Westlund, Kurt J., “An Evaluation Using Computerized Tomography of Clinically Asymptomatic Patients Following Meniscectomy and Temporomandibular Joint Reconstruction Using the Proplast- Teflon Interpositional Implant”, Thesis, Masters Degree in Oral and Maxillofical Surgery, May 1989. University of Iowa.
3. Wagner, J.D., and Mosby, E.L., “Assessment of Proplast- Teflon Disc Replacements”, J. Oral Max. Surg. 48:1140-1144(1990).

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100