Teflon-Proplast Implants

by Keith Webster


One of our many correspondents wrote about problems after a Teflon TMJ Implant:

" I had a Teflon implant removed from my TMJ joints in 1987 which had been implanted in 1984. At the time there seemed to be no negative reaction although the surgical report stated foreign body reaction had been observed. Unfortunately I was involved in a car accident complications from which affected the TMJ requiring grafting of rib material to reconstruct the jaw.

My question is: Are there any tests to see if the teflon residue can be detected in either the tissue removed in the later surgery or even now post surgically (there seem to be some complications in the right joint)."

A TMJ implant, which was made out of a Teflon-Proplast material and used as a meniscus replacement. With hindsight severe degenerative changes occurred in about 90% of cases.

The implant disintegrated under load, producing a foreign body giant cell reaction , subsequent bone erosion and lymphadenopathy.

Vitek withdrew the implant and went into liquidation. The U.S. Food and Drug administration subsequently produced a consensus statement advising the removal of all symptomatic implants and 6 monthly radiographic follow up of asymptomatic patients. Once the source of the inflammatory response is removed then the migration of this tissue to the lymph nodes ceases.

A foreign body reaction is seen after any implantation of any alloplastic material and is a chronic inflammatory response. However if the response is low grade and produces no symptoms then no action is necessary. There are analogies here with the similar response to reactions to implantible silicone breast implants.

Unfortunately the search for a biocompatible TMJ implant has not produced any serious contenders and in the UK most TMJ reconstructions are performed with autografts of cartilage capped rib (costochondral grafts) or new menisci are formed by using interpositional muscle or dermal grafts. The main prosthetic TMJ under consideration in the UK is the Christensen prosthesis composed of a cobalt-chrome articular fossa and a methyl methacrylate condyle replacement attached to a cobalt chrome ascending ramus. However there appear to be no long term solutions to the multiply operated patient and only about 5% of all patients treated for TMJ disorders undergo open TMJ surgery.


References:

US Food and Drug Administration: FDA Safety Alert. Rockville, MD, US Food and Drug Administration Dec. 28 1990

Kaplan PA, Tu HK, Williams SM. Erosive arthritis of the temporomandibular joint caused by Teflon-Proplast implants: Plain film features. Am J Roentgenol 1988; 151: 337-340

Dolwick MF, Dimitroulis G. Is there a role for temporomandibular joint surgery? Br J Oral Maxillofac Surg 1994; 32: 307-313.


"To answer the question whether tests could detect traces of Teflon, yes, a biopsy of the joint area might show microscopic bits of Teflon. However, it is not clear what the results could mean. It would be quite difficult to remove all particles of Teflon when removing an implant. Many patients who have had Teflon implants removed are not showing signs of foreign body reaction, yet traces of Teflon surely remain. Teflon implants are used successfully in other parts of the body - in places not subjected to heavy stress - indicating that Teflon itself may not be harmful.

In general, patients who undergo TMJ surgery are rarely painfree and seldom experience a complete resolution of TMJ symptoms They usually have some continued complications. Armed with this knowledge, patients with mild or minimal TMJ symptoms can avoid wasting time and money seeking a medical 'cure' which probably does not exist. Instead, concentrate on changing behavior patterns or bad habits like bruxing, clenching, chewing gum, etc.

Teflon-coated TMJ implants were manufactured exclusively by the Vitek Corporation beginning in 1973 until the company folded about 1993. The U.S. Public Health Service sent warning letters to 20,000 people who received Vitek implants. Symptoms of TMJ implant breakdown include;

Concerned patients in the US may call Medic Alert, a non-profit foundation, telephone 800-554-5297, for further information about where to find TMJ support groups. The U.S. Food & Drug Administration has information about TMJ implants, telephone 301-443-4190 or 301-443-3170."

Submitted by Robert B. Stevenson, DDS, MS
Columbus, Ohio
gold2ooth@aol.com

Further contributions on this subject are invited.