Issue: Discussion of Devices for Use in the Diagnosis and/or Treatment of Temporomandibular Joint Dysfunction and Oral Facial Pain

I'm Terrie Cowley, a TMJ patient, co-founder and the President of the TMJ Association, a non profit patient advocacy organization for people suffering from what the dental professionals tell us we have ? TMJ. It is also the term most familiar to the patients and the public, thus we use that term.

I am not here to evaluate the scientific merits of the devices being assessed today, for that is your charge. However, as a TMJ patient and patient representative, I am personally affected by every decision made by professional organizations and governmental agencies on TMJ disease and disorder issues. For that reason, I feel compelled to address certain topics which were directly discussed or incidentally referred to in the November 1997 FDA Dental Products Panel meeting.

It is first appropriate to address the issue of what exactly is this medical/dental/mental malady we refer to as TMJ/TMD/and a myriad of other letter combinations. The November `97 meeting took almost a day of discussions for the panel to come to a working agreement on the meaning of "temporomandibular disorders and associated pain and/or dysfunction." This tells you that there is no exaggeration to the fact that, try as we might, we come up short pinpointing what may be the multiple and complex reasons for the different types of pain an/or breakdown of the joint that forces millions of patients into dental offices and medical facilities all over this country seeking help. As the Washington Post concluded in their article covering the NIH Technology Assessment Conference, `you don't know what you are calling TMD and you don't know what pain in the jaw signifies. "

The second issue I will touch on is treatments. In 1988, the Director of Scientific Affairs for the American Dental Association, Dr. Enid Neidle, described TMJ as "dentistry's hottest area of?out and?out quackery. " in 1991, in an editorial entitled "Above All Else, Do No Harm," Dr. Harold Perry stated, "our current weekly referral service routinely will see a good 50% of the patients presenting with an iatrogenic disturbance because of inappropriate surgery, unnecessary coronoplasty, unwarranted restorations, orthodontics, and most frequently, incorrect splint therapy. " The 1996 Technology Assessment Conference did not find marked improvement in the TMJ research and treatment status since Drs. Neidle and Perry's statements were made, for it concluded, "the efficacy of most treatment approaches for TMD is unknown, because most have not been adequately evaluated in long?term studies, and virtually none in randomized controlled trials. "

It is said that most patients get better with or without treatment. We do not doubt that. The question that we don't have scientific answers to is, how many patients are unaffected, improved or harmed by one or many of the treatments they received. We know some patients get better on treatment, But lacking the science, how ethical is it to put a patient's life at risk without knowing what those risk factors are, that a patient may turn out like the thirty thousand plus that we have received letters from and personally talked to. One dentist said "patient selection criteria are little to none with the exception of ability to pay. The type of treatment the patient received depended upon the floor they exited in the dental school or office building. The TMJ public has clearly been denied the scientific proof and regulatory protection which would assure them of the safety and efficacy of the 49 plus treatments they are receiving. To again paraphrase the Washington Post, `you don't know what works and what doesn't, because you haven't done randomized clinical trials... "

The third matter, frequently referred to in the last meeting, is the politics of TMJ. I would like you to know how we, the TMJ patients, view the political and economical dynamics of TMJ over the years. Until recently, TMJ has been referred to in sardonic jest as The Money Joint. Dental journals touted the treatment of TMJ as a sure way to inflation?proof one's practice and ensure a financially healthy retirement. Although the dental community has largely been the care providers to TMJ patients, the American Dental Association has judiciously neglected to adopt TMJ as a specialty, for it lacks any substantial body of scientific knowledge necessary to confer specialty status. This has in effect been a policy of malicious neglect, since left to their own devices, their members developed numerous methods of treating TMJ. The dental gurus of TMJ passed these methods on to their devotees through what Dr. Perry describes as "sporadic, single concept, Hilton University weekend TMD education. " The past half century witnessed the formation of numerous professional organizations, based upon their treatment beliefs, some paradoxical to each other, as the equilibration society and the non?equilibration society, denigrating the others beliefs to the patient, vying with each other in turf battles and which only unite when they are threatened by actions of the FDA and recently the NIH Technology Assessment Conference. Treatment of this joint continues to be largely based on anecdotal information and professional treaters preferences. The many different treatment preferences yields a field rife with chaos and controversy and this is certainly obvious to most patients if they have seen more than one treating professional.

Which brings me to the fourth issue, the harm that has befallen TMJ patients. I could share with you for days the information in our data base which is filled with information on the patient with 39 splints in two years, the patient whose dentist treated her TMJ by banging her teeth into her gums with a wooden mallet, the few who had their episiotomy scars injected to cure their TMJ, the paralysis, deformity, feeding tubes, morphine pumps, suicides and deaths???but you know all those stories.

Which leads me to the issue of psychogenic etiology, psychological overlay. In the course of TMJ, patients are forced to abandon such dreams as promising careers, marriage, children, committing to anything planned or predictable, eating in a restaurant, having one's faced touched by a child and intimate acts. However, there are additional problems. The media, fed information by the treating professionals, present TMJ as some little problem afflicting crazy, stressed?out women that can be fixed by a little tweaking of the teeth, magic plastic, a new spouse, a jaw exerciser, new job, some wine or similar remedy. It is little wonder most TMJ patients are closet bound and refuse to admit they have TMJ, for nobody believes it can be as bad as we know it to be.

If the patient's condition worsens as treatment progresses, the patient is usually blamed ?? we hear "your body didn't like the material," or "why don't you want to get well?" And your family and friends are told "everything is fine, there is no reason she is having pain." The husband of one woman who had twelve surgeries and four different devices told us when they returned from an appointment with the oral surgeon, he said, "the doctor is the expert, who should I believe, him or you?" Upon which she went into the bedroom and shot herself. The psychological community would say she was depressed. She may have been depressed, but we would say she was desperate... desperate to have everybody stop lying to her and validate the damage done to her, desperate for someone to understand that she was indeed in pain and needed help. We would say she felt betrayed ?? betrayed by doctors who took an oath to do no harm., betrayed by the FDA whose mission was to protect her, and betrayed by the NIH who funded a negligible amount of research over the years.

The TMJ implant disaster is a case study which demonstrates how every entity responsible for protecting the health and safety of the TMJ patients failed in their responsibility. In 1963, John Charnley published an editorial stating that Proplast/Teflon failed miserably in the hip ? a load bearing joint. Subsequently, the orthopedic community abandoned the use of PTFE in load bearing joints. Twenty years later, the FDA approved the Vitek proplast/teflon implant saying it was substantially equivalent to Dow Corning Silastic. Dow Corning never conducted studies on Silastic for trismus of the jaw joint but labeled their product accordingly. We now know the problems with that material. The oral surgeons implanted these devices with vigor.

When the FDA issued a Class I recall on the Vitek because of the damage that was being documented by lawyers, suddenly failure became an orphan. Dr. Homsy, President of Vitek, declared bankruptcy while taking his assets and fleeing the country for Switzerland. The FDA said they were not to blame, they just 510k'd the product. Materials scientists and other device manufacturers who strenuously argued with Homsy regarding the utility and safety of his product at meetings years before, did nothing to warn the unsuspecting public. The oral surgeons said the FDA approved it so it must be safe and besides we don't have time to read the literature. However, if they did read the dental literature they would only have read and continue to read good news and nothing much about implant damage. The National Institutes of Dental Health said they never funded research on implants because they did not approve of them. Insurance companies who paid to have the implants put in refused to pay for explantation, citing that procedure is experimental. Animal experiments were only conducted four years after being implanted in humans and to confirm the pathology they were seeing in humans. Since there was no TMJ implant registry, there was no way of knowing how many patients had implants and how to find them. In this scenario, no one has accepted responsibility for any of these actions and not one of these groups has yet stepped forward to assume responsibility for the TMJ implant patients. To paraphrase the Washington Post, "and a lot of people have been harmed. "

The Vitek situation is a case study, reflective of the whole of TMJ, which demonstrates a system in which each entity functions independently and irresponsibly, lacking any integration of the individual parts, each moving in uncoordinated directions. When all was said and done it became a "who us ? no, it was them" blame game. And who was left holding the bag? The patients.

Today you will be evaluating devices which will have a direct impact on the TMJ patients of this country. If we believe the Tech conference statement as reported by the Washington Post ? "You don't know what you're calling TMD," then we shouldn't even be here, for the devices are labeled for something ? we know not what.

But we are here. Perhaps you will decide that a device does what it is labeled to do and it then goes to the practice of dentistry and they are confused about what they're treating, and they don't file MDR. reports, or they do and the manufacturer doesn't send them to the FDA, or they do send them to the FDA, but what good is it if they do if the FDA has a backlog of 60,000 MedWatch reports and it takes years to detect the damage I think you see where I'm going here.

The FDA will make decisions these two days, the manufacturers devices will be decided upon. If we are to change the face of TMJ, every entity, including the TMJ patients, must put the safety of the TMJ patients as their priority in every action taken within their realm of responsibility. And today, the manufacturers and this panel must put the safety of the TMJ patients of this country first and foremost in their deliberations. The FDA and the manufacturers must then excel in their responsibilities as partners in this integrated system of checks and balances so that harmful treatments are detected and delete from the standard practice of the TMJ diseases and disorders before thousands or millions of people are harmed.

Perhaps the most encouraging and insightful statement made at the November `97 meeting was made by Dr. Barry Cooper. He said, "maybe what we really have to do is respect the fact that there is a bigger illness or bigger possible implication... while acknowledging that the field is still open to discussion and knowledge, and that there will be other things that will be proven to be involved in it. "

Ask any TMJ patient where they have pain other than the jaw are and most will tell you they have generalized musculoskeletal pain. Ask if they have mitral valve prolapse and hyper mobile joints and over 50% will say yes. In the bits and pieces of scientific information drifting out of laboratories recently, we are learning that the joint may not be just like other joints in the body, that hormonal influences on pain may be gender differentiated and what are we to make of nerve growth hormone injected into the arm producing pain in the jaw join?. At this time we do not know where TMJ will shake down. But clearly we are in the infancy of what promises to be a most exciting scientific future for TMJ which will yield improved health care and quality of life for the millions of US, TMJ patients. In this, what we hope is not the too distant future, we will have unlocked for us those secrets??? what is TMJ ...why mostly women, what works, and what big picture is this a part of.

In response to Dr. Jenkleson's remark on the Vitek patients ...It is impossible to know how many Vitek patients were put on the instrumentation devices at one time or another. Wouldn't it have been nice to have had clinical trials with long term follow up on either the instrumentation devices or the implants or both? I do know one thing. I haven't heard one of the mutilated patients tell me they were put on instrumentation devices to aid in the reconstruction of their joints or teeth. They are barely able to find a dentist who will even extract their broken teeth.

Yesterday Dr. Cooper talked about his treatment plans for patients citing the function of the devices being discussed as "treatment aids." Dr. Cooper said that the diagnosis was made before the use of instrumentation devices. However, he goes on to explain, that these devices are used to assess the progress the patient is making in the road to the perfect alignment goal, kind of like a guidance system.

As Dr. Cooper went down the treatment plan, it was clear that he had everything down pat, the mandibular repositioning splint, adjustments, metal partial dentures, reconstruction of the teeth, crowns, bridges, orthodontists. And in the event there is a joint problem, the patient is referred to the oral surgeon. The fact t there is a sort of triage to the system??some get better, some may be unaffected and some get worse We don't really know many were lost to follow up. Was the patient selection criteria inappropriate, or do we do the same thing to every patient even though there are multiple diseases/disorders under this thing we call TMJ.

In 1991 we invited an instrumentation device devotee to speak to our monthly support group. After the talk, as I was speaking to the dentist, a young woman interrupted and told him that the previous month her dentist told her she needed this testing. She went on to explain that her insurance plan would not pay for these tests and she could not afford the $3,000 they cost. He took her firmly by the arm, told her to go to the bank the next morning and borrow that money for that would be the best investment she would ever make.

If these devices are strictly inert so to speak, and the diagnosis and treatment are operator dependent, then perhaps Dr. Cooper's techniques, using the devices is perfect and there is no one else with his "art" of dentistry. But, how do the patients know this?

And today we just heard Dr. Tilley uses a different approach. And Dr. Jankelson said, forget the philosophy of TMD but that's all we have to talk about because we don't have the science of TMD to talk about.

So, maybe we're back to uncertainty of treatment results unless we get the machines and Dr. Cooper and now Dr. Tilley and maybe these are the only two people who know what TMD really is.

The treatment plan outlined above is costly at minimum of $3 thousand for tests and evaluation, in New York $2,000 for a splint, in Milwaukee, $125 for each splint adjustment. The efficacy factor here should perhaps involve a cost benefit ratio analysis for the patient. The money joint requires quite a layout from the over 10 million American seeking help. It still boggles my mind that in our files we have a copy of a bill for a total joint replacement procedure of $101,000. Perhaps those getting all this money could unite and start a foundation to support scientific research on TMJ diseases and disorders. An all too familiar story to us is when the problem gets too big, bail out. It goes like Connie in Ohio wrote on July 26th.

It started 6 years ago, anyhow, I tried to get good care. Everyone thought I needed a bridge, I was young and I didn't know. So a bridge is what I got, then it just seemed like it was so big, bigger than my other teeth. So the dentist filled the teeth on each outer side top and bottom. Cut my molars off and told me to, well, have a good day. After the fusion in my neck, I couldn't close my mouth all the way. So I was talked into splint therapy and manipulation. Pain the whole way. Then the dentist said I've run out of ideas and sent me somewhere else. The next dentist made 2 lower splints. I kept telling him the splints felt very uncomfortable. In 10 weeks he yelled saying he could no longer help me.

Off to the jaw surgeon, praying for help. He told me it was neuromuscular and neurological and couldn't help me. Yet, in the report, he said skeletal facial deformity and class III open bite. So, I returned to the nightmare here. The massage therapist I'd been seeing tried to line up my sinus bones and pressed extremely hard above my right ear in my skull. After that, no one would fill my teeth, the right jaw locked open and seemed to go left. Then my skull started to become numb over my ear ....she goes on but ends the letter by saying... Dreaming I could have my life back, simple as it was. I am in so much pain and will go anywhere and do anything if I thought I'd stand half a chance. I just hope someone can still help me. Could it be you?

Is it too much to ask that we, the patients, no longer be bound to a system where no one professional takes responsibility for the patient ??a system of unbelievable referrals with unscientific, unproven treatments (and hope) sold to the patient by each referring physician. In many cases, patients end up worse and more and more destitute, yet they grasp for hope with each referral. Is it too much to ask that we get the protection we deserve under the Hippocratic oath to do no harm and the laws of the United States?