May 16, 2003
Document Control Office (7407 M)
Office of Pollution Prevention and Toxics (OPPT)
Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington DC 20460-0001
Dear Environmental Protection Agency:
The TMJ Association is a non-profit advocacy organization for those who suffer
from temporomandibular diseases and disorders, commonly referred to as TMJ.
These are complex and poorly understood condition manifested by jaw area pain
and/or dysfunction and complications affecting other body organs and systems.
We are aware that the Environmental Protection Agency has taken seriously a
complaint from The Environmental Working Group regarding Teflon toxicity and
human health concerns. We trust you will find the following information
important as you proceed with your investigation of Teflon and any relationships
to the health of the American public.
A treatment commonly performed on TMJ patients throughout the 1980’s was the
insertion of a thin piece of material into the jaw joint – between the glenoid fossa
(the bony depression in the skull) and the head of the condyle (the rounded end of
the mandible, or jaw bone). One material used was composed of
polytetrafluoroethylene – Proplast-Teflon and either carbon or aluminum oxide.
The Vitek Company of Houston, Texas manufactured this implant. Du Pont
employed the President of Vitek, Dr. Charles Homsy, in 1959 and in 1966 he left
to pursue the development of what ultimately became Proplast, a composite
consisting mainly of polytetrafluoroethylene (PTFE), a form of Du Pont’s plastic
product line known as Teflon.
In 1990, the FDA issued a Class I recall on the Vitek Proplast-Teflon implant
because of reports of a range of serious symptoms and problems. These were
annotated in the 1999 TMJ Implants - A Consumer Information Update booklet
http://www.fda.gov/cdrh/consumer/tmjupdate.html by the Food and Drug
Severe pain around the ear and in the jaw area;
Radiographic evidence of severe bone loss to the condyle and glenoid
Limited lower jaw movement;
Bone degeneration/soft tissue deterioration;
Joint noise in the jaw;
Nausea, dizziness or ringing in the ear;
Fragmentation and/or displacement of the implant;
Vision and hearing problems.
Patients in whom large amounts of wear debris occurs because of the breakdown
of the implant material, exhibit immune reactions in the form of foreign body
giant cell formation and bone resorption. The giant cell response may extend into
the bone, muscle, adipose tissue and lymph nodes as a result of the spread of
implant particles not only in adjacent tissue, but at distant body sites. Other
reactions include severe reactive synovitis resulting in destructive arthritis,
lymphadenopathy, avascular necrosis of the mandibular condyle and condylar
neck with resultant severe changes in occlusion. Residual implant particulate
material has persisted in these patients and is a factor in the failure of subsequent
biologic grafts. The material in many instances has eroded through the skull into
the brain. Patients have died. Considering these patients are primarily women in
their childbearing years, death can certainly be thought to be premature.
In 1992, at our instigation, Congress held a hearing entitled, Are FDA and NIH
Ignoring the Dangers of TMJ Implants? From that time we have been a resource
for receiving and disseminating information on TMJ diseases and disorders.
What we have learned from the thousands of implant patients who have contacted
us is that not only are they suffering craniofacial-related problems but also,
systemic problem. These include but are not limited to persistent fevers,
infections, visual disturbances, memory loss, confusion, seizures, dementia,
abnormal thyroid function, allergies, sensitivities to chemicals and medications,
rashes, chronic hoarseness, intolerance to heat or cold, atypical multiple sclerosis.
Because there is no viable registry of Proplast-Teflon patients, complete with
systemic health status data, we can only relate what we have heard from implant
patients over the past 11 years. To date, the Food and Drug Administration, the
Centers for Disease Control and Prevention, the Agency for Healthcare Research
and Quality and the National Institutes of Health have not taken the medical
problems these patients manifest sufficiently seriously to investigate the link
between implanted materials and subsequent health status of the recipients.
The EPA and the Environmental Working Group have stated that no one has
found that the chemicals have a toxic effect on humans, though animal research
does indicate potential toxicity. Without scientific study but information from
thousands of implant patients, we can definitively say that most we have heard
from developed a worsening health condition following implantation.
Because TMJ implant patients have over the years manifested symptoms and
developed medical problems, which have eluded clear-cut disease diagnoses and
because the EPA is sufficiently concerned with Teflon toxicity to conduct an
investigation, we recommend the following:
that the EPA compares the chemical properties and molecular structure of
the Vitek implant material with the polymer under investigation.
that the EPA collaborate with the Center for Disease Control and
Prevention in collecting, analyzing and reviewing clinical information
from Vitek implant patients for the purpose of comparison with those who
have had high exposure to PFOA as well as the general population.
We appreciate your review of the material we are submitting with our comment
and will cooperate with you in any way possible to facilitate our
The TMJ Association
P.O. Box 26770
Milwaukee, WI 53226