Chronology of an Implant Disaster

Orthopedic Network News, Vol. 6, No. 2, April 1995

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 (Wall Street Journal)
Dupont sends Homsy warning about complications caused by implanted Teflon.
1968/ WSJ (Wall Street Journal)
Proplast developed by Homsy at DuPont.
1970’s/ ONN (Orthopedic Network News)
Homsy starts Vitek.
1974/ WSJ (Wall Street Journal)
Kent started collaboration with Homsy.
1976, 5/28 FDA
Medical Device Amendments: Premarket notification is not required for devices developed prior to 5/28/76.
1978, 3/1 TMJ (TMJ Association)
Earliest known recipient of Vitek Proplast/Teflon implant.
1982, 3/30 FOI (documents obtained under the Freedom of Information Act)
Kent writes Homsy that procedures to rise to 10,000 per year for TMJ implants.
1982, Oct JOMS (Journal of Oral & Maxillofacial Surgery)
Wolford compares Silastic to Proplast in twelve patients. Follow-up ranged from one to four years. No differences in comfort, mobility. Proplast had better long-term stability than Silastic.
1982, 11/23 FOI (documents obtained under the Freedom of Information Act)
Vitek files intent to market Interpositional Implant (IPI) with FDA.

Distribution Begins
1983, 3/23 FOI (documents obtained under the Freedom of Information Act)
FDA notifies Homsy that IPI is equivalent to device marketed prior to May 28, 1976.
1983 Commercial distribution of IPI implants begins.
1983, 12/9 FOI (documents obtained under the Freedom of Information Act)
510(k) approval for Dow Corning Silastic TMJ implant H.P. based on substantial equivalence to Silastic sheeting marketed prior to 5/28/76.
1984, 2/14 FOI (FDA documents obtained under the Freedom of Information Act)
Kent concerned about safety of Vitek implants warns Homsy of “calamity of unbelievable proportions.”
1984 WSJ (Wall Street Journal)
First animal dog studies done on IPI.
1984, July JBJS (Journal of Bone & Joint Surgery)
Tullos, et. al. report thirty-six percent of forty-seven hips coated with Proplast failed after an average of thirty-seven months. Concluded that coating had insufficient strength to withstand normal weight-bearing loads.

Growing Concerns
1985, May TMJI (TMJ Institute Newsletter, medical College of Wisconsin)
First problems with Proplast reported by Ryan. (“degeneration of condyles”)
1986, Apr CONG
(Proceedings of Congressional Hearings on TMJ implants, June 4, 1992)
First Vitek Proplast Medical Device Report.
1986, Apr DCNA (Dental Clinics of North America)
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 (Journal of Oral & Maxillofacial Surgery)
Timmis et. al. report giant cell reactions by rabbits to Proplast/Teflon and silicone implants. “Indicate a need for further evaluation of these materials as disc replacements in humans.”
1986, Oct AAOMS (American Association of Oral & Maxillofacial Surgery)
 El Deeb reports 6 monkeys showed Proplast fragmentation with giant cell reactions after 3-12 months.
1986, Oct WSJ (Wall Street Journal)
Vitek’s survey of oral surgeons 91.5% of 5,070 satisfactory results. Vitek says prognosis for IPI’s success beyond 3 years was unknown in package insert.
1987, 2/20 FOI (documents obtained under the Freedom of Information Act)
U.S. Air Force reports problems with Proplast to Vitek, FDA (“severe painful and nonpainful foreign body reaction with resorption of condyle and glenoid fossa”).
1987, Spring HC (Huston Chronicle)
First lawsuit against Vitek.
1987, DC (Dow Corning)
Wilkes design TMJ implant marketed by Dow Corning.

Shutdown-The Bureaucracy Swings into Action
1988, June WSJ (Wall Street Journal)
Distribution of IPI suspended by Vitek.
1988, July WSJ (Wall Street Journal)
FDA conducts first inspection of Vitek’s plant.
1989, Mar HC (Houston Chronicle)
FDA cites Vitek for not reporting patient complaints
through Medical Device Reports (MDRs)
1989, May JOMS (Journal of Oral & Maxillofacial Surgery)
El Deeb publishes 1986 findings on monkeys.
1990, 3/ 23 FOI (documents obtained under the Freedom of Information Act)
Vitek issues letter advising docs that IPIs could fragment.
1989, Jul JOMS (Journal of Oral & Maxillofacial Surgery)
Valentine et. al. Nine patients (14 joints) showed deteriorations, foreign-body giant cell reaction in all joints.
1989, Dec OMSC
Yih/Merrill report “both silicone rubber and Teflon-Proplast are not biologically acceptable implant materials in the functional TMJ.”
1990, 6/7 HC (Houston Chronicle)
Vitek files for Chapter 7 bankruptcy.
1990, June
Oral Surgery Marketing, Inc (OSMI) takes over Vitek products.
1990, 8/30 FDA
FDA rescinds 510(k) for Vitek’s IPI implant.
1990, Sept OSOMOP (Journal of Oral Surgery, Oral Medicine, Oral Pathology)
Estabrooks reports 88.7% surgical success with Proplast/Teflon implants with average follow-up of 33 months. Only 10% resulted in removal.
1990, Oct HC (Houston Chronicle)
FDA seized all implants manufactured by Vitek, NovaMed Inc. and OSMI. (NovaMed, a sister company of Vitek, manufactured hip implants.)
1990, 12/28 FDA
FDA safety alert to oral and maxillofacial surgeons warning of complications associated with Proplast-Teflon.
1991, 1/7 FDA
FDA recalls Vitek IPI (Class I recall).
1991, 10/2 FDA
FDA issues medical alert to patients with Vitek implant.
1991, Fall ONN (Orthopedic Network News)
Bankruptcy court appoints JAMS to referee Vitek lawsuits.
1992, Feb JOMS (Journal of Oral & Maxillofacial Surgery)
Fontenot reports that laboratory tests of IPIs show thatthey have a service life of about three years. Intermediate and long-term survival of implant is uncertain.
1992, Mar HC (Houston Chronicle)
Homsy moves to Switzerland!
1992, Jun HC (Houston Chronicle)
Implant inventory of NovaMed and OSMI crushed
with a bulldozer, buried in Houston dump.

The Aftermath
1992, CONG
(Proceedings of Congressional Hearings on TMJ implants, June 4, 1992)
Congressional hearings on TMJ implants.
1992, Oct OSOMOP (Journal of Oral Surgery, Oral Medicine, Oral Pathology)
 Spagnoli/Kent report that of 465 patients with IPI, 86% of implants were still in place after an average of 32 months. 92.4% were asymptomatic, however 249 showed some degree of condyle resorption. Project that 54% may fail.
1992, Nov AAOMS (American Association of Oral & Maxillofacial Surgeons)
AAOMS workshop on TMJ implants. “Recommend removal of Teflon/Proplast implant and affected soft tissues.”
1993, 1/26 ONN (Orthopedic Network News)
Dow Corning exits the TMJ business.
1993, April JOMS (Journal of Oral & Maxillofacial Surgery)
Wolford reports revision surgery after Proplast-Teflon failure. 88% of 163 joints showed significant osseous changes after two to 126 months.
1993, 4/26 ONN (Orthopedic Network News)
Class action lawsuit filed against Dow Corning and Dupont on behalf of both Vitek and Dow Corning Silastic TMJ recipients.
1993, 8/31 WSJ (Wall Street Journal)
Article about TMJ patients.
1993, Sept-Oct/ 20/20, American Journal,
Current Affair segments aired on ABC TV.
1994, 12/20FR (Federal Register)
FDA reclassifies TMJ implants as Class III.
1995, 4/1 ONN (Orthopedic Network News)
Claims against Vitek exceed 2,200, excluding about 500 patients who received $1,000 total reimbursement.
AAOMS=Annual meeting of American Association of Oral and Maxillofacial Surgeons
CONG=Proceedings of Congressional Hearings on TMJ implants, June 4, 1992
DC=Dow Corning
DCNA=Dental Clinics of North America
FDA=Food and Drug Administration public releases
FOI =Food and Drug Administration Documents obtained under
Freedom of Information Act
FR=Federal Register, December 20, 1994
HC=Houston Chronicle articles of September 10, 1990, April 1, 1991, June 23, 1992
JBJS=Journal of Bone and Joint Surgery (American)
JOMS=Journal of Oral and Maxillofacial Surgery
ONN=Orthopedic Network News 
OSOMOP=Oral Surgery Oral Medicine Oral Pathology
TMJ=TMJ Association, Ltd., Milwaukee, Wisconsin
TMJI=TMJ Institute Newsletter, Medical College of Wisconsin
WSJ=Wall Street Journal article of August 31

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