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)
(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)
(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.
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.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Sources:
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
FDA=Food and Drug Administration public releases
FOI =Food and Drug
Administration Documents obtained under
Freedom of Information Act
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
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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