THE NIGHTMARE’S BEGIN…….
The following are some of the relevant publications, filings, and correspondences in this nightmare.
THE BACKGROUND RESEARCH
April 6, 1938 – Teflon is Discovered
1963 12/28 Lancet CHARNLEY WARNS against the use of TEFLON in JOINTS because of INTENSE FOREIGN-BODY REACTIONS. Describes UNFAVORABLE RESULTS of INJECTING TEFLON into HIS OWN THIGH.
1967 WSJ DUPONT sends HOMSY WARNING about COMPLICATIONS caused by IMPLANTED TEFLON.
1968 WSJ PROPLAST developed by HOMSY at DUPONT.
1969 .First report 1969 silastic used in TMJ joint (popular in their 1970″s) DOW CORNING HAD CONCERNS OF IMPLANTATION IN LOADED JOINTS.
1970 Christensen and Morgan Implants
1970″s Charles HOMSY starts VITEK.
1974 WSJ Dr KENT started collaboration with HOMSY.
1976 Silastic Sheeting (Dow Corning, Midland, MI)
1976 5/28 FDA MEDICAL DEVICE AMENDMENTS: PREMARKET NOTIFICATION is NOT Required for devices developed prior 5/28/76.
May 28, 1976 -The Medical Device Amendments were enacted giving FDA authority to REGULATE medical devices, such as TMJ implants, which were already on the market.
1976-1983 Medical Device Amendment
1978 3/1/TMJ EARLIEST KNOWN RECIPIENT of VITEK PROPLAST/TEFLON IMPLANT. 1822 3/30 FOI KENT writes HOMSY that procedures TO RISE to 10,000 PER YEAR for TMJ IMPLANTS.
1982, OCT JOMS WOLFORD compares SILASTIC to PROPLAST in 12 patients. Follow-up ranged from one to four years. No differences in comfort, mobility.
PROPLAST HAD BETTER LONG-TERM STABILITY THAN SILASTIC. *****SILASTIC WAS FAILING****
1982, 11/23 FOI VITEK files intent to market INTERPOSITIONAL IMPLANT (IPI) with FDA.
1983 Proplast I (Vitek, Houston, TX)
1983, 3/23 FOI FDA notifies HOMSY that IPI is equivalent to device marketed prior to May 28, 1976.
March 1983 – Vitek, Inc. notified FDA that it was planning to market the Interpositional Implant (IPI) to treat TMJ problems. The firm claimed that it was SUBSTANTIALY equivalent to anEXISTING product, SILICONE SHEETING which was ALSO USED as a TMJ implant. FDA agreed with the manufacturer’s claim of EQUIVALENCE and the IPI device was allowed to be marketed.*
1983-1990 Proplast II (Polytetrafluoroethylene) pre-cut discs
1983 COMMERCIAL DISTRIBUTION of IPI IMPLANTS BEGINS.
1983, 12/9 FOI 510(K) approval for DOW CORNING SILASTIC TMJ IMPLANT H.P. based on SUBSTANTIAL EQUIVALENCE to SILASTIC SHEETING marketed prior toMay 26, 1976.
1984, 2/14 FOI KENT concerned about SAFETY of Vitek implants, WARNS HOMSY of “CALAMITY OF UNBELIEVABLE PROPORTIONS”
1984 WSJ FIRST ANIMAL dog studies, done on IPI.
1984, July JBJS TULLOS, et. Al. Report 36% of 47 hips coated with PROPLAST FAILED after an average of 37 months. CONCLUDED that coating had INSUFFICIENT STRENGTH to WITHSTAND NORMAL WEIGHT-BEARING LOADS. Dow Corning KNEW this back in the 1970′s and EVEN BEFORE THIS
1985 Proplast IPI inserted in approximately 25,000 to 30,000 patients
1985, TMJI FIRST PROBLEMS with PROPLAST reported by “RYAN”. (“DEGENERATION OF CONDYLES”)
1986, Apr CONG FIRST Vitek Proplast Medical Device Report!
1986, Apr DCNA MORICONI et. al. “The TMJ IPI’S should be SINGLED OUT as having provided a NEW and MORE PREDICTABLE mode of TMJ RECONSTRUCTION.”
1986, Jul JOMS TIMMIS et. al. REPORT GIANT CELL REACTIONS by rabbits Proplast/Teflon And SILACONE IMPLANTS. “Indicate a NEED FOR FUTHER EVALUATION of theseMATERIALS as DISC REPLACEMENTS IN HUMANS!”
1986 Oct, AAOMSm El DEEB reports 6 monkeys showed PROPLAST FRAGMENTATION with GIANT CELL REACTIONS AFTER 3-12 MONTHS
1986, Oct, WSJ Vitek’s survey of oral surgeons 91.5% of 5,070 satisfactory results. Vitek says prognosis for IPI”S success beyond 3 years UNKNOWN in package insert
1987, 2/20 FOI U.S. Air Force REPORTS PROBLEMS with PROPLAST to VITEK, FDA (“SEVERE
PAINFUL AND NONPAINFUL FOREIGN BODY REACTION WITH RESORPTIONOF CONDYLE AND GLENOID FOSSA”)
1987, Spring HC FIRST Lawsuit against VITEK
1987 DC WILKES design TMJ IMPLANT marketed by DOW CORNING
SHUTDOWN-THE BUREAUCRACY SWINGS INTO ACTION
1988 FDA FDA became aware of COMPLAINTS about the IPI IMPLANTS and explants showing BONE RESORBTION, IMPLANT FRAGMENTATION, and DELAMINATION.
1988, June WSJ Distribution of IPI SUSPENDED by Vitek
1988, July WSJ FDA conducts FIRST INSPECTION OF VITEK’S PLANT
1989, Mar HC FDA cites Vitek for NOT REPORTING PATIENT COMPLAINTS through Medical Device Reports (MDRs)
1989, May JOMS El DEEB publishes 1986 FINDINGS ON MONKEYS.
1989, Jul, JOMS VALENTINE et. al. 9 PATIENTS (14 JOINTS) showed DETERIORATIONS,
FORIEGN-BODY GIANT CELL REACTION IN ALL JOINTS
1989, Oct, FDA FDA issued a letter to Vitek, Inc., a REGULATORY LETTER for Medical Device reporting (MDR) and Good Manufacturing Practices (GMP) VIOLATIONS!
Dec 1989 OMSC Yih/Merrill report”both silicon rubber and Teflon-Proplast ar not biologically acceptable implant materialsIn the functional TMJ”
1990 Vitek issues safety and cessation of manufacturing
January 26, 1990 – FDA issued a letter to Vitek, Inc. Advising them to WARN all oral surgeons of record against implanting further devices and MONITORING their PATIENTS until further clinical data was evaluated demonstrating long term safety and effectiveness.
Mar 1990 Reports started to surface of problems with Proplast and Silicone
1990, 3/23 FOI Vitek issues letter advising Docs that IPIs could fragment.
March 23, 1990 – Vitek, Inc., issued a “Dear Doctor” letter informing doctors of the hazards associated with the IPI product and advising them to closely monitor all patients by clinical and radiographic examination. FDA classified this action as a voluntary safety alert.
1990, June Oral Surgery Marketing, Inc (OSMI) takes over Vitek products
June 1990 – Vitek, Inc., filed for bankruptcy. Oral Surgery Marketing, Inc. (OSMI) and Novamed, Inc., were created.
July 27, 1990 – FDA issued Vitek, Inc., a letter informing it that its VOLUNTARY SAFETY ALERT WAS INEFFECTIVE. An audit check of the safety alert disclosed that some consignees were never notified. what about the patients)
1992 Congressional Hearings…
Part Two ~ More information
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. [disease of the lymph nodes]
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.
A foreign body reaction is seen after any implantation of any alloplastic material and is a chronic inflammatory response. (Also called Giant Cell 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 implantable silicone breast implants.
Unfortunately the search for a biocompatible TMJ implant has not produced any serious contenders and in the UK and USA. Most TMJ reconstructions are performed with auto-grafts 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 and USA 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.
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 now showing signs of foreign body reaction, and 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 pain -free 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;
- pain radiating from around the ear
- limited lower jaw movement
- joint noise
- change in occlusion (bite)
- difficulty chewing
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
Further contributions on this subject are invited.
And Baroness Says:
If you are reading this because you have been diagnosed (d/x) with TMJ disease and received TM Jaw Implants please feel free to contact me with any questions or comments.
Let me tell you this now; If I had to do it over again and I had the hindsight of the information I carry today; I WOULD NOT HAVE SURGERY with man-made foreign material implants.
IF, and I say if you have bone on bone in the joint(s) then possibly a surgical reconstruction of the disintegrated cartilage might be considered to repair so to alleviate pain, improve range of motion, and to maybe hamper bone erosion. But the only way I would go in to it today would be armed with the knowledge I have now that only an auto-graft from ones own body is the way to go.
What I HAVE NOW. Harvested from somewhere else on your body (mine is cartilage from the backs of my ears & hips in my second surgery).
If you do not have any degeneration of the joint and a doctor is recommending surgery I would run as fast I could to the closest exit. It a doctor is diagnosing you with such, I highly recommend that you demand the films, take them with you for a second opinion. Even maybe a third.
Today after over 30 years of research and study concerning TMJ disease and talking with other people afflicted the popular treatment modality today is to wait it out. There are many things that can be mastered to help cope and alleviate the pain and spasms.
Please just don’t be ready to jump when surgery is offered. I know how tempting the promise of no pain can be. But it is never NO More Pain. It can make things much worse even though today the implants that have caused so much destruction are no longer marketed in the USA there is still a risk with any surgery.
There are still medical implants being used every day. They are also being recalled by the FDA every day. Not much has changed.in 30 yrs.
Again, Thank you so much for your time, and your attention.