THE NIGHTMARE’S BEGIN…….
The following are some of the relevant publications, filings, and correspondences in this episode.
THE BACKGROUND RESEARCH
April 6, 1938 – Teflon is Discovered
1963 12/28Lancet 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 ther 1970″s) DOW CORNING HAD CONCERNS OF IMPLANTATION IN LOADED JOINTS.
1970 Christensen and Morgan Implants
1970″s ONN HOMSY starts VITEK.
1974 WSJ 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…
Continued…. Part Two…..The Aftermath