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TMJ Bioengineering Conference_ Bolder Colorado - The TMJ - DOC

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					                       TMJ Bioengineering Conference - Boulder Colorado
                                          May 25-27, 2006
              Presentation by Terrie Cowley, President of The TMJ Association


Let me congratulate Michael Detamore, Kerry Athanasiou and Jeremy Mao for organizing a
scientific meeting on temporomandibular diseases and disorders. Speaking for TMJ patients, we
are grateful that well-respected scientists are turning their attention to a joint which has long
deserved scientific scrutiny, but which it has long lacked. Bringing new players to the field is so
important and we commend the organizers for inviting researchers who may be naïve to the
complexities of the temporomandibular joint and its problems. The organizers of this meeting
have asked me to do three things. Provide background information and history, identify the
problems and provide directives.


Let me begin with background. As you no doubt know, the temporomandibular joints are the two
joints which enable the jaw to move up and down, side to side and forward and backward under
the control of a complex set of muscles. The combination of hinge and sliding motions allowing
3-dimensional movements, and the fact that these joints are co-dependent make the TM joints
among the most complex in the body. The joints, located at the base of the skull, are situated
amidst the most sensitive and vulnerable areas of the head, at the convergence of the body‘s
major cardiovascular, neurological, auditory and ocular systems.


In 1996, the National Institutes of Health defined temporomandibular disorders as a collection of
medical and dental conditions affecting the temporomandibular joint and/or the muscles of
mastication, as well as contiguous tissue components. While conditions such as degenerative
arthritis and trauma underlie some joint problems, for the most part TMJ diseases and disorders
comprise a heterogeneous group with no common etiology. What the conditions have in common
are pain and dysfunction of the jaw, but these, too, vary widely in extent and severity. Pain may
be limited to the face or jaw joint area, but may include headaches and earaches, dizziness,
masticatory musculature hypertrophy, limited mouth opening, inability to open or close the
mouth, joint sounds and other complaints. The severity of pain can range from mild to
intractable, and jaw dysfunction may range from a bite that feels ―off,‖ to the need for a feeding
tube for sustenance.


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Interestingly, as information has accumulated in the past few years, it appears that many patients
with temporomandibular disorders also exhibit co-morbidities associated with other body
systems. Examples include chronic fatigue syndrome, fibromyalgia, irritable bowel syndrome,
multiple chemical sensitivity/allergies, tension and migraine headaches, and a variety of
cardiovascular symptoms including mitral valve prolapse and arrhythmias, and sleep
disturbances.
With the recognition of these co-morbidities, the TMJ problem is now being viewed as just one
component of a multi-systems illness. As a result, TM diseases and disorders, once considered
dental problems, are being recognized as a complex disease influenced by gender, genes,
environmental and behavioral triggers.


The epidemiological data for TMJ problems are all over the place—we really don‘t have good
incidence and prevalence figures of who is affected by TMJ problems. The lowest prevalence
puts the number at over ten million people. One thing we do know is that overwhelmingly—an
estimated 90 percent of those seeking treatment -- are women in their childbearing years:
teenagers through menopause.


For the past 70 years there have been dozens of theories, philosophies and treatment programs
for TMDs, essentially proposed by dentists. These theories mainly revolved around the
occlusion, the position of the condyle, and ways to ―recapture the disc.‖ In addition, there were
many ―it‘s all in your head‖ practitioners who attributed joint problems to psychological causes.
The various theories and treatment regimens were, and I add, continue to be zealously promoted
by what one editorial writer described as ―Hilton University TMJD seminars.‖


He went on to write that in the early days most dentists believed TMJ to be related to medicine
and most physicians believed it to be primarily a dental problem. ―It was a ‗no man‘s land‘ of
diagnosis and treatment,‖ a classic case of a condition that ―fell through the cracks,‖ where it still
lies.


In 1989, Enid Neidle, then the scientific advisor to the American Dental Association, wrote,
―TMJ is the hottest area of unorthodoxy and out-and-out quackery.‖ Seven years later not much
had changed. Conclusions from the 1996 NIH-sponsored Technology Assessment Conference
on Management of Temporomandibular Disorders were summarized by a Washington Post

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reporter who wrote, and I‘ll paraphrase, ―the professionals don‘t know what pain in the jaw
signifies, don‘t know what to call it, don‘t know who should treat it, don‘t know what works, and
a lot of people‘s lives are being destroyed.‖


In 2001, the Health Technology Assessment Information Service of ECRI (a non-profit health
service research agency) and the Agency for Healthcare Research and Quality published reports
on several TMJ treatments. These two studies confirmed the findings of the 1996 technology
assessment conference and reinforced other reviews of the literature that decried the lack of large
randomized clinical trials or other types of rigorous studies that could demonstrate the safety and
efficacy of treatments for TMJ diseases and disorders. As well, there was no consensus regarding
the etiology, course of disease, and even diagnostics of TMJDs. Today as many as 25 different
types of practitioners, including general dentists, orthodontists, prosthodontists, oral surgeons,
nutritionists, chiropractors, osteopaths, physical therapists, those who treat pain and
psychologists treat TMJDs. It is said that the floor where you exit the elevator in a building
determines the treatment you‘ll get.


And what are these treatments? In 1994 there were 49 treatments being recommended to TMJ
patients and hardly a month goes by when we don‘t hear of yet another new ―cure‖ or gimmick.
You will have gathered by this time that these treatments are mainly based on faith and
anecdotes. You should also understand that many patients get better without treatment. What we
don‘t know is how many patients are unaffected, improved or harmed by one or many of the
treatments they receive or if in fact the placebo effect is responsible for the success of some
treatments. What we do know is that TMJ patients are being treated in a system where no one
professional takes responsibility for the patient – a system in which an unbelievable number of
referrals, with unscientific, unproven treatments, and hope, is sold to the patient by each referrer.


One of the 50+ treatments is TMJ implants of varying kinds. A frequent problem with jaw joints
is that the disc that serves as a cushion between the skull and the condyle tears or dislocates. One
procedure to solve this problem has involved removal of the disc and replacing it with one
composed of reinforced Silastic sheeting by Dow Corning, or Proplast-Teflon by the Vitek
Company. These implants, no larger than a thumbnail, are manufactured individually or custom
cut from sheets or blocks in the operating room by the surgeons and then sutured to the skull or
condyle. Basically, Silicone products had been grandfathered into use in the jaw by the FDA

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because they were on the market before the Safe Medical Devices Act was passed. The FDA also
approved the Vitek Proplast-Teflon implant in 1983, saying it was substantially equivalent to the
Silicone products. These devices lacked fundamental bioengineering and biocompatibility
testing.


Reports of failure of the Vitek implant began surfacing in 1984 and, amazingly, the scientific
advisor to the company, following the removal of one of the implants, wrote to the manufacturer
that they may have ―a calamity of unbelievable proportions on our hands.‖ Nevertheless, he and
the manufacturer continued to aggressively market the material and surgeons continued to
implant it.


In 1990, the FDA recalled the product because ―the implants ate away at bone and tissue; in
some cases making a cavity which perforated the skull into the brain.‖ The FDA called this,
―open communication to the brain.‖ They also said that the device would fail 100% of the time.
Several months after the recall the FDA seized all implants at Vitek. The founder and president
moved the patents offshore, declared bankruptcy and fled the country leaving FDA to handle a
class I recall for the first time in its history. When I asked an FDA official how this could happen
he simply said, ―TMJ implants fell through the cracks here.‖ When I asked what they were going
to do about the Silastic implant, which we knew was also causing problems, he replied, ―There
haven‘t been any studies on those, so we can‘t do anything.‖ Silastic is still being used in TM
joints off label.


Implantation of autogenous and cadaver materials, such as ear or femur cartilage, temporalis
muscle flap, rib grafts, fat grafts, etc. are common procedures but are relatively unsuccessful.


Total joint devices made of various materials and whose components are screwed to the skull
and mandible began to be aggressively marketed as the remedy to the joint destruction that had
been caused by Silastic and Proplast-Teflon.


Over one thousand people with these devices reported the various following problems to us:
severe pain, facial deformity, infections, metalosis, extreme facial swelling, allergic reactions to
the materials, the components cracking and/or breaking, a component breaking through the


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middle ear, the skull, exiting the side of the face, screws coming loose, paralysis and numbness
causing inability to swallow, make facial expressions and close one‘s eyes.


Total joint devices, too, have had a catastrophic history at FDA. These devices remained
unclassified until 1999 when PMA‘s were called for. Some devices were approved with woefully
inadequate testing and clinical data. The Safety and Summary Statement Inclusion Criteria for
one basically says that we don‘t know who this device will help but we are sure it will help
someone. Another device went to the Dental Products Panel, received approval and three weeks
later the FDA inspected the offices of one of the two implanting surgeons taking part in the
study. They found violations which included failure to obtain signed consent documents, to
conduct the study in accordance with the investigation plan, to maintain accurate and complete
subject records and to use the IRB approved consent form for subjects. At least half of the
subjects had to be dropped from the panel approved study.


TMJ implants provide the perfect segue for me to explain my passion about this problem and
why there is a TMJ Association. In 1980, a dentist determined that I had hypermobile jaw and he
refused to even clean my teeth until my jaw was stabilized. Two years, four dentists, three
splints, and two equilibration sessions later, surgery was recommended and I opted for it,
thinking if it was done at an academic institution, it had to be OK. And if this was the only way I
could get my teeth cleaned I had no choice. Before the operation the surgeon told me, ―You will
never know you had a problem. You will be at work the day after surgery and the material we
use is from Dow Corning, and they make the best cookware around.‖


Two months later, enduring excruciating pain, and still unable to drive or work, I asked the
surgeon if I was going to die, asked him what had gone wrong. He simply said, ―I don‘t know
what‘s wrong with you, your joints are fine,‖ when in fact the implants had already broken.


I have never had a day since the surgery that I do not know I have a jaw problem. I am never
without some degree of pain and, like the thousands of other implant patients we‘ve heard from,
I continue to endure life-altering consequences of these implants.


Four years after my surgery I met another TMJ patient and we instantly knew we had to do
something about this. We formed a support group in Milwaukee which became The TMJ

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Association. We interviewed everyone in town we knew who was treating the condition, read the
literature and over the next four years with enlisted scientific expertise determined that there
wasn‘t credible science behind what practitioners were doing. We also met many patients who
were in far worse straits than we were. By 1990, we knew we had to change the quality and
direction of TMJ research and demand that treatments be based in sound science.


In 1991, I was so outraged over the Vitek disaster that I began to look to Congress for help. After
visits to about 25 representatives and senators, in 1992, New York Congressman Ted Weiss held
a hearing titled, “Are FDA and NIH Ignoring the Dangers of FDA implants?” The investigation
revealed sordid details of the roles of manufacturers, oral surgeons, clinical scientists working
with manufacturers, and the impotence of the FDA and NIH in what the Wall Street Journal, in
their longest article to date, dubbed ―a medical mess.‖ What ensued was a ―who‘s on first‖
blame game with the FDA blaming the manufacturers, the manufacturers blaming the surgeons
and patients and the surgeons blaming all of the above. No one was accountable, no one
responsible.


Following the congressional hearing, phone calls, letters and e-mails began pouring in from
across the country to the TMJA office located in a spare bedroom in our house. I networked with
other TMJ patients, who were board members, across the country by phone and fax. Most
implant patients told us that their skulls and condyles were degenerating. Many experienced
repeated bouts of heterotopic bone growth, limiting their ability to open their mouths to the point
that they had to shove pieces of food through a 5 mm opening, or were forced to subsist on a
liquid diet or have repeated surgical procedures to chop away the bone. Jaw positions changed.
Many developed an open bite which means their mouths were never able to close completely.
Most patients experienced increased pain, while others were asymptomatic while major
degeneration took place. What we heard over and over was that people had numerous surgeries –
4-12-16- 28-40 and some had as many as 6 sets of implants. The record holder in our database
was a woman in Pittsburgh who died at the age of 41 after her 62nd jaw surgery. And may I
remind you, the ages of these implant victims were in their teens through 50s.


What we hear from these patients is that the systemic problems are as troubling as the
craniofacial problems they face.


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Some of the symptoms or diagnoses reported to us are fibromyalgia, neurological problems
(atypical MS, dizziness, balance problems, seizures), fatigue and malaise – repeated bouts of
fever, night sweats, vomiting, weakness, visual problems, hearing problems and ear pain,
immunological diseases, cardiovascular problems, neurological problems, sleep apnea. Many
patients experienced a gradual ―systems breakdown‖ which resulted in the deaths of many
patients that I‘ve known.


Unquestionably treatment failures have had devastating effects on the lives of many of the
patients who have contacted us and their loved ones. In response to a survey we conducted, one
patient wrote, ―You should have asked a question relating to personality changes. I, myself, can
mark the day that everything changed for me and I became a different person. I miss the person I
used to be and so does my husband of 30 years.‖ Another said, ―I went into the OR one woman
and came out someone different.‖ Promising careers fade, jobs are lost, and hopes of having
children are abandoned. Parents once again become caretakers of their adult children or children
take care of parents. Friends are lost because of the overwhelming presence of TMJ in the
patient‘s life and the unpredictability of knowing how you will feel from hour to hour. Dining
out, contemporary society‘s way of interacting in a social manner is embarrassingly difficult
because of the oral disability.


In the 80s, groups treating TMJ advertised their seminars in dental journals and enticed
practitioners by referring to this as TMJ, ―The Money Joint.‖ Ironically, in other languages, TMJ
is ATM. Most TMJ patients who have experienced multiple treatments are not wealthy if they
once were. Because of the lack of scientific evidence to justify treatments, TMJ joins cosmetic
surgery as routine exclusions to insurance policies; the patient must pay and in most cases sign
contracts in order to receive diagnostic testing, splints, etc. We‘ve heard costs as high as $7,000.
When it comes to total joint devices -- explantation of failed ones and implantation of new ones
you‘re looking at costs in excess of $125,000 – implants costing $25,000 – 35,000, surgery fees
$25,000 and the rest in hospital costs. And you better have a certified check on the surgeon‘s
desk one week in advance of the surgery.


Spouses of TMJ patients are forced to assume household and childrearing responsibilities and
often take on second jobs because of the loss of the spouse‘s income. Many marriages don‘t
survive TMJ. Many couples do not share their bed. I‘ve heard from so many patients who sleep

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in lounge chairs because if they lie down the unsupported mandible falls back and impinges on
their trachea and they can‘t breathe. Others have nightmares and flashbacks of their multiple
surgeries or are kept awake by pain. Needless to say, once pleasurable sensations like being
touched, hugged, kissed, having one‘s face stroked, things that are an integral part of lovemaking
and affection sharing, are for many excruciatingly painful.


To add insult to injury those treating TMJ have very often blamed the patient for treatment
failure or imply they are hypochondriacs. This usually happens after the patient has exhausted
financial resources or the provider has run out of options. One patient wrote, “All these years he
told me my pain was psychosomatic…so I continued with his treatments – counseling,
biofeedback, TENS, hypnosis, 13 surgeries. I cannot believe I’ve been deceived all these years.
The only way I learned about my condition was out of a magazine.” Ten years ago a man from
New Jersey called and was sobbing. He would not identify himself, just told me about his wife
and then begged me to keep doing what I was doing for patients. His wife had 11 surgeries and
three different implants. She was suffering greatly. He accompanied her on a visit to the oral
surgeon. They sat in his office and the surgeon reared back in his chair and told the husband,
“There’s nothing wrong with your wife that a good shrink can’t cure.” When they got home they
argued, the husband asked his wife, “He’s the expert, who should I believe you or him? Upon
which she went into the bedroom and shot herself.


We recognize that there are clear indications for jaw surgeries and joint replacements. We also
recognize that there are people who have had surgical procedures and implants that have
improved their lives. However, there are so many unsolved problems, complexities and
contradictions in this field compared to most others that we cannot make rational and informed
decisions based on what is currently known. A treatment may work for one person and harm
another. Implant failure occurs in all shades of gray. It is exactly these observations that tell us
what we don‘t know and what we need to know to advance this field.
The risk-benefit ratios of our treatments have not been determined in any scientific manner and
there are no scientifically acceptable outcome studies that go beyond the patient‘s ability to chew
and the pain index. To not have made progress in all this time indicates that we do not have the
right science with the right people! Our challenge to you is to improve our odds substantially
through new avenues of research – with the right science and the right scientists – and now!


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Based on 20 years of experience and interactions with such patients and the recommendations
that have resulted from the three scientific meetings of The TMJ Association, co-sponsored by
multiple agencies of the National Institutes of Health, we urge the following:
Generate in vitro, in vivo, transgenic and computer models of the jaw and its component parts,
making use of data from human and animal studies of jaw motion and load-bearing
characteristics. Data from failed and explanted jaw devices will also be valuable in constructing
dynamic models—robotic jaws, if you like.


As far as materials are concerned you are well aware of the range of tests needed to assure
against deformation, wear, and incompatibility with human tissues. You also know the potential
for combining inert materials with living cells and resorbable scaffolding to construct a working
joint. Today‘s ever-improving imaging techniques are essential aids in your research, enabling a
fine tuning of the anatomy and physiology of the joint, including its blood supply, its complex
network of muscles and nerves and their central control. Conducting this research demands a
team approach with bioengineers working side by side with mathematicians, cell physiologists,
neuroscientists, geneticists, endocrine specialists and others who can talk the language of
bioinformatics and gene arrays, who study how the jaw responds to stress or injury, how
endocrine factors affect jaw function, and how chronic pain may contribute to progressive joint
deterioration.


But let‘s not restrict this research technique to the joint and let‘s not restrict it to the dental
community! Until now, TMJ research has revolved around the cultural, intellectual and scientific
resources available to this community, thereby drastically limiting progress in the field. It has
also reinforced the disconnect with what the patients are experiencing health-wise and what
those treating us think we‘re experiencing. Over the years, the most frustrating cry we hear from
the patients is -- ―This is not a dental condition, it’s medical!” We now know that TMJ is a
complex disease with associated medical co-morbidities and that alone dictates that the
healthcare needs of many patients will not be met in dentistry. It is also a joint with affiliated
tissue components, like all the other joints in the body – joints that enjoy the benefit of the
expertise of orthopedists and rheumatologists . The pain component is consistent with many
other medically treated pain conditions, for example, fibromyalgia, treated in rheumatology.
Therefore, it is imperative that the TMJ research teams need the inclusion of the medical


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sciences if we are ever to make progress in this disease. It is way past due that we reconnect the
head to the body and study the patient within the entire biological system.


As we have described the team that we need to work on the TM joint, we need to expand that
team to investigate the TMJ diseases and disorders in a comprehensive manner. In this post-
genomic age, the biological sciences have become overwhelmingly dominated by an enormity of
qualitative and descriptive facts with too little understanding of how they quantitatively relate to
each other. In other words, it is not enough to know that there are genes and proteins, hormones,
and so forth, but that we know how they operate together and integrally within the individual.
The concept of a ―systems biology‖ research approach that is emerging within the scientific
community and is being encouraged by the NIH Roadmap directive is clearly necessary to study
complex diseases like TMJDs.


In order to initiate this approach we must develop cross-cutting teams of scientists in
computational biology, bone, cartilage, skeletal muscle, vasculature, the neurosciences,
endocrinology, molecular genetics, genomics, proteomics, bioinformatics, inflammation and free
radical chemistry, immunology, tissue engineering and the sub-specialties that bring their
expertise to bear upon these complex diseases, like TMJ. These teams must develop novel
computational and experimental approaches leading to the convergence of genetic sequence,
proteome data, cell, tissue and organ data into quantitative mathematical models capable of
predicting the physiology and pathophysiology of the patient. Similar teams must develop novel
non-invasive diagnostic approaches and safe therapies for TMJ patients. Though bioengineering
is only one component of these integrated cross-cutting teams, it is you, the engineers and
computational biologists that are best trained to think about how the various elements of a
complex system work together to provide the whole that is greater than the sum of its parts.


I recognize that this would be a remarkable achievement in any field of biology, but TMJ
patients would ask why not start with us?


In fact, Dr. Tabak, Director of the National Institute of Dental and Craniofacial Research, asked
the same question at the close of our last scientific meeting -- “Can we create a team that is truly
multi-disciplinary to take what the next step needs to be in order to solve this thing?” I think we
can and we can begin right here at this meeting! The topics being discussed are state-of-the-art in

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their respective areas and I must say exciting to this TMJ patient advocate! Though the
culmination of such a team project may be years off -- you, the attendees at this meeting have the
opportunity to form the collaborations and team building that I described and endorsed by the
NIH and requested by Dr. Tabak. Such team science will yield the information that will improve
the quality of healthcare and life for the millions of TMJ patients. The hope of the patients is in
science and I hope you will join us in changing the face of TMJ.”


Let me close by giving you a few specific directives from some of the patients I surveyed in
anticipation of this meeting.
Betsy in Minneapolis asked me to, “Tell them to design a joint that will let me chew, talk, cry,
swallow and smile without pain, one that will restore my mandibular function and my facial
structure….one that will not make me worse than I already am or eventually kill me. Oh, and be
ready to prove to me that it does all those things.” That sentiment was echoed by all the patients
with whom I talked. Other requests are, “Please find out why we keep growing heterotopic
bone.” “Study TMJ in connection with other connective tissue diseases.” For example, are there
inheritable differences in the makeup of the collagens in the TMJ disc and other regions such as
the mitral valves that predispose them to dysfunction? Importantly, why are women more likely
to get TMJ disorders and does being a woman predispose them to greater implant failure? Could
we get away from hardware joints, please? For those of us in the cold climates the metal
conducts the cold and causes me to get migraine headaches. Sometimes the imprint of the device
stays on my skin for a day. Lastly, patients ask why they aren‘t consulted by device teams. I
encourage you to talk to the patients, form focus groups and just let them talk about the
experience of having implants. You‘ll be surprised what you will learn. In the recent past
patients and patient advocates have become partners with those involved in the science that
affects their lives. I encourage you to contact me if you think that those involved with this
organization or I may be helpful to you in anyway.


I‘m honored to represent the TMJ patients at this most important and impressive meeting and I
thank you for the opportunity.




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