The TMJ Association - changing the face of TMJ

Who We Are - Member Presentations

Biomaterials and Medical Devices: An Industry in Transition The Impact of Healthcare Reform, Product Liability, Regulatory Issues, and Raw Materials Shortages

Perhaps the historical perspective of the temporomandibular joint (TMJ) implant disaster is most effectively given by examining the state of the art of research and treatment of TMJ disorders over the past several decades. This could well prove to be a case study of how every professional organization and governmental agency fell down on the job of protecting the TMJ patients of this country.

In the thirties, temporomandibular joint disorders were turned over to the dental "turf" by James Costen, an ENT specialist, who believed that TMJ disorders stemmed from occlusal factors. From that time, research and treatment of these disorders remained in the dental realm.

In the late seventies, "TMJ" became the buzz word and catch-all for many complaints that didn't fall into any specific disease. Dentists took to TMJ disorders like fleas on a dog. Treatment modalities proliferated in number until today 49 can be listed. Dental specialists touted the benefits of their particular treatments and expertise. As a dentist once told me, "At my dental school, you received TMJ treatment depending upon where the elevator stopped -- sixth floor, oral surgery; fourth, prosthodontics; third, orthodontics, etc." Even now, we don't have one standard of care; we have many standards of care.

The American Dental Association (ADA) has never made TMJ disorders a specialty. Thus, dental or continuing education criteria are nonexistent. As Dr. Harold Perry, orthodontist and professor at Northwestern University, states, many self-professed TMJ specialists received their education at "sporadic, single-concept 'Hilton University' weekend seminars."2 Treatment of this joint has been largely based on anecdotal information and trial and error. Because there was no scientific evidence to repudiate the proclaimed advantages of these treatments, dental professionals dogmatically defended them -- even in the face of failure.

The lack of hard science and the financial rewards of multi-modality treatment practices have no doubt contributed to what Dr. Perry sees as a greater proportion of iatrogenic problems resulting from misdiagnosis and mistreatment."3 In the early eighties, TMJ received a new nickname -- "The Money Joint." Advertisements acknowledged that taking on TMJ was one way to "increase, revitalize, and inflation-proof" dental practices.4 What evolved was a cottage industry profession whose members lacked not only the skills and knowledge necessary to understand and do scientific research, but scientific curiosity as well. As Dr. Enid Neidle, former director of scientific affairs for the ADA, so succinctly put it: "Where dental schools have done an exceedingly poor job, and continue to do so, is to incorporate those things into the curriculum that will create in their graduates an inquiring mind, a respect for science, a comprehension of what research means, and a deep understanding of how fundamental to the practice of dentistry scientifically generated knowledge is."5 These are the people who took on the treatment of the most complex joint in the body.

At the National Institute of Dental Research (NIDR), TMJ disorders were placed in the Craniofacial Anomalies, Pain Control, and Behavioral Research Branch. Through the years, this disorder has been a low priority where funding is concerned. Even in the nineties, approximately 2 percent of the NIDR budget is directed toward TMJ disorders which, conservatively speaking, affect approximately 30 million people, the majority of whom are women. There has been no serious attempt to fund basic research into these disorders. Most of the funding has been directed toward the "psychosocial" components of this problem. As with many disorders, until etiology is scientifically established, the patient is perceived to cause or propagate the problem. However, with TMJ disorders, the psychological cause is usually pulled out of the hat of tricks after all the patient's money has been spent on those other 49 treatment modalities and/or the disorder is iatrogenically induced. To this date, not one grant has been funded to support studies of TMJ implants.

The lack of basic research in the TMJ area has permitted what one researcher calls "the Great American Medical Disaster" -- TMJ implants.

Since the mid-sixties, professionals have been using various materials to replace all or part of the temporomandibular joint. Sometimes, surgeons replace the disc with what is frequently called an interpositional implant (IPI). In other instances, the condyle (the head of the mandible, or lower jaw), fossa (the skull, or socket, of the jaw joint), or both, are replaced with prosthetic devices. The total number of implant recipients is unknown; however, a conservative estimate would be that 150,000 Americans have received biomaterial jaw joint parts.

Most biomaterials for jaw joint reconstruction were introduced on the market before the 1976 Medical Devices Amendment Act was passed requiring manufacturers to provide evidence that their devices were safe and effective. The TMJ implants that were first marketed after 1976 were allowed on the market without testing, because of a legal loophole which required manufacturers to prove only that their devices were substantially equivalent" to a pre-Amendment device.

Two products that have been widely used as disc replacements for torn and/or displaced natural discs are Dow Corning's Silastic and Vitek's Proplast-Teflon.

Silastic

Silastic implants appeared in several forms. The first, introduced in the mid-sixties, was a block of Silastic, or silicone rubber, carved to shape. Another was Silastic HP Sheeting, which was reinforced with dacron. This was followed by the Wilkes design, marketed in 1985. Designed for temporary use only, this implant was made with "tabs" to allow for easy removal after several months.

Short-term studies in the early seventies looked good. Reports after one to five years, however, showed substantial problems, including ankylosis, arthritis, and lymph node swelling. One 1982 study warned doctors that particle migration meant they should be alerted to possible systemic reactions and foreign body synovitis, speeding failure.6 A 1986 article reported "fragmentation, perforation, and deterioration of the (Silastic) material."7 And another stated, "silicone may not be a totally inert material and that its biomechanical properties are not ideal for use in the TMJ."8 By the end of the 198Os, enough failures had occurred for some researchers to call for strict limits on the use of Silastic.9

Dr. Mark Lappe, professor of Health Policy and Ethics at the University of Illinois, stated in testimony before Congress that, from Dow Corning's public documents and a review of the literature, it is clear that Dow Corning knew decades earlier what doctors found in 1985-that Silastic is intrinsically flawed as a biomaterial for long-term implantation into the human body." 10 As early as the sixties, they saw foreign body giant cell reaction and knew it induced fibrosis and calcification. But even in the late seventies and early eighties, with the knowledge of the adverse effects of the wear particles, Dow Corning issued no adequate warning in the package insert and continued marketing the implants." Dr. Lappe further stated that Dow Corning "knowingly allowed their silicone sheeting to be used for repairing the damaged TMJ even though it was highly likely that the sheeting, even when reinforced, could not stand up to the stresses typical of a major, pressure-bearing, inflammation-damaged joint."12

As late as 1989, there was not one long-term study of the use of Silastic in animals or humans. As a matter of fact, a single study in 1965 "served as the principal impetus to encourage the marketing of Silastic sheeting for this new, and untested purpose."13 In 1991, when sheep studies were conducted, severe bony destruction and foreign body giant cell reaction were found. Finally, after 20 years of use, it was decided that Silastic isn't appropriate for long-term use and that even short-term use is highly experimental.14

Dr. Lappe describes the development of Silastic and other implant materials for the TMJ as "marked by a pattern of haphazard development, entrepreneuralism, unverified assertions in the absence of animal testing, and a silent FDA. In 1992," he states, "we are left with no truly suitable implant material, in part because the most commonly used one -- Silastic brand reinforced sheeting -- was only belatedly subjected to testing. And then, it was found to be deficient for just the properties which were known to its manufacturer fully twenty years earlier."15

Proplast-Teflon

In the seventies, Vitek developed and sold Proplast Sheeting (Teflon FEP film laminated to a porous composite material made from polytetrafluoroethylene (PTFE) and carbon). The implant was modified in the early eighties, and Teflon film was then laminated to PTFE and aluminum oxide. These implants, usually no larger than a thumbnail, were manufactured individually or custom cut from sheets in the operating room by the surgeon, and then sutured to the fossa or condyle.

As with the Silastic implants, early reports claimed success, and in 1983, the FDA allowed Vitek to market a pre-cut disc. Under the law, the company's president, Charles Homsy, merely had to convince the Food and Drug Administration (FDA) that the device was "substantially equivalent" to Dow Corning's Silastic disc, marketed years earlier.

At the 1986 meeting of the American Association of Oral and Maxillofacial Surgeons (AAOMS), several surgeons reported catastrophic biomechanical failure of the IPI that caused a giant cell reaction, leading to bone resorption and pain. A summary of the literature from 1986 to 1991 reported a failure rate of 10 to 25 percent. By 1992, a success rate of less than 20 percent was being reported.16

Only after reports of failure began appearing in 1984, were animal studies conducted on dogs. The results were "essentially catastrophic," according to a 1990 deposition that Dr. Jack Kent, a Vitek consultant who owned 21,000 shares in the company, gave in an Arizona court case against Vitek. After just a few months, the Teflon layer was "completely worn," and Teflon particles had triggered bone erosion in the dogs.17 Dr. Kent wrote a letter to Dr. Homsy in early 1984 expressing his concern that, based on his experience with one of his patients, Vitek might have a "calamity of unbelievable proportions on our hands."18 This did not, however, deter Dr. Kent from continuing to write articles praising the Vitek implants, and it certainly did not stop him from collecting his royalties.

In March 1990, due to an increasing number of reports of implant failure, the FDA recalled Vitek's IPIs. Several months later, Vitek declared bankruptcy as a result of rising litigation costs. However, Vitek continued to market their TMJ implants, and surgeons still used them, until eventually the FDA seized all products from Vitek as well as its subsidiaries.

Over the last year, on a typical day, many people throughout the country picked up Woman's Day or the Wall Street Journal, or watched "20/20." They saw themselves in print or on the screen. They found out they had the dreaded Vitek implant everyone was talking about, or the Dow Corning implant nobody was talking about. At that moment, the reason for all those years of frightening symptoms, diminished quality of life and health their doctors had no answers for and belittled them for, were being answered in the media. And at that time, they knew they had a good reason to worry about their health and prognosis. Perhaps even more frightening, they would soon learn that nobody knows what is wrong. And worse, they don't know what medical problems they will face in the future.

Equally distressing -- if not more so-- are the psychosocial effects resulting from failed implants. The TMJ Association hears daily from patients, their spouses, mothers, fathers, and friends, even their children. Their lives have been destroyed -- marriages broken, careers lost, families torn apart. These patients can't function on a daily basis. They can no longer do all the things normal people take for granted. Tragically, many implant patients have lost every last penny of their life's savings, their homes, their cars-- everything. They are literally bankrupt.

Most TMJ implant recipients we talk to are in there twenties or thirties. The National Center for Health Statistics reports that "compared with the general population, persons with implants are more likely to be limited in their ability to perform their major and other activities and to be assessed in fair or poor health." When compared by age, the relative overall health of implant recipients under the age of 65 "appears to be poorer (when compared with all persons of similar age)…" and they are "almost four times as likely to report an activity limitation."19 Can you imagine the status of the women who have had 15, 25, 35 TMJ surgeries, multiple devices and materials? They are still living, and the only logical question to ask is HOW?

Every implant patient experiences pain, from discomfort to unrelenting and intractable. Another problem associated with implant failure is bone resorption due to foreign body Giant cell reaction and abrasion during function -- sometimes to the extent of skull Perforation. Given The TMJ Association's limited database, in one week we heard from three implant recipients who underwent brain surgery because of dura perforation. Some of the other symptoms and diagnoses we hear from implant recipients are the following: non-malignant tumors, bite changes, fibromyalgia, and chronic fatigue syndrome, flu-like symptoms, dizziness, vertigo, nausea, vomiting, tinnitus, diminished hearing or hearing loss, hyperacusis, visual disturbances, memory loss, confusion, seizures, swollen lymph nodes, parotid gland abnormalities, rashes, Sjogren's Syndrome, allergies and/or chemical sensitivities, intolerance to heat or cold, asthma, pneumonia, chronic or episodic hoarseness, fibrocystic breast disease, radiographic abnormalities without a definitive diagnosis, mitral valve prolapse, atypical MS, sarcoidosis, and abnormal laboratory test results.

It is possible that these symptoms are totally unrelated to TMJ implants, or a component part of the complex TMJ disorder, or a manifestation of an entirely different disease . . . we simply don't know. What we do know is that what we are hearing is sufficiently alarming to motivate appropriate agencies and professionals to take IMMEDIATE action.

The professional organizations that represent the people treating the patients are the American Dental Association and the American Association of Oral and Maxillofacial Surgeons.

American Dental Association

The parent organization, the ADA, published the FDA information concerning TMJ implants only once in the ADA News. When patients request information, they are sent the FDA's "TMJ Implants: Consumer Information Update." The ADA has yet to make a statement regarding the implant issue and assumes no responsibility.

American Association of Oral and Maxillofacial Surgeons

The AOMMS Code of Professional Conduct states: "Oral and maxillofacial surgeons should observe the laws of our land and by their conduct they should uphold the honor of their profession. They should safeguard their patients, their profession, and the public by ensuring that care is rendered only by persons who are professionally competent and of good moral character."20 And their 75th anniversary seal motto is: "Dedicated to education, research, and the public welfare for 75 years."

We are prompted to ask how oral surgeons have upheld the honor of their profession. How have they safeguarded their patients? And are patients being given care by competent doctors of "good moral character." These questions can be answered by looking at how AAOMS has responded to the TMJ implant disaster.

After all these years, they have yet to carry out one prospective longitudinal studies of implant patients. They have yet to take an official advisory position on the safety and efficacy of TMJ implants and the treatment of patients with failed implants. Although they held a workshop on the use of TMJ implants and the management of implant patients in November 1992, "the recommendations presented represent a consensus of the workshop participants and are not an official statement of the AAOMS."21

The American Association of Oral and Maxillofacial Surgeons has failed to ensure that their membership complies fully with the FDA's instructions concerning patients with TMJ implants. No, as a matter of fact, we have been informed that Vitek prosthetic devices are -still being used in this country. And, although DOW Corning discontinued sales of their Silastic implants almost two years ago, doctors are implanting Silastic into the temporomandibular joint as of the writing of this talk. Doctors say the FDA hasn't said anything about Silastic, and "I've never had any problems, so I'm using it."

AAOMS has not conducted any type of serious media campaign to notify implant recipients about the dangers of the implants. They have not intervened to convince insurance companies of the necessity of coverage for implant removal and subsequent revision or reconstruction surgeries. They have not recommended a sliding fee payment schedule or waiver of fees to remove failed implants and provide follow-up treatment. TMJ implant patients who call AAOMS asking for information are sent literature on dental implants or the names of members in their states who, in many cases, will not take on another surgeon's failure.

AAOMS and its members say they were taken advantage of by overzealous manufacturers -- that they would never have implanted these materials they had not been approved by the FDA. Yet, as early as 1963, John Charnley reported in the orthopedic literature on the failure of Teflon used in hip prostheses, resulting in fragmentation, giant cell reaction, and bony changes.22 Certainly, "the orthopedic experience could have predicted the long-term results described in the oral and maxillofacial surgery literature."23

What the American Association of Oral and Maxillofacial Surgeons is busy doing is practicing damage control. A year ago, with the "20/2O" segment on TMJ implants imminent, they hired one of the country's top public relations firms to run interference for them. Insult was added to patient injury when, in an urgent and confidential memo, AAOMS discussed how fortunate they were that the "20/20" broadcast would be opposed by game 3 of the American League Championship Series! 24

The TMJ Association has made attempts to encourage AAOMS to issue a formal advisory statement regarding TMJ implants. We have written to them, asking for answers to questions all TMJ implant patients deserve, answers to. To date, we have received no response. This organization's philosophy comes across most clearly in a statement made by Daniel Laskin, DDS, and Editor-in-Chief of the Journal of Oral and Maxillofacial Surgery, when he said, "Why should we do anything to help the patients? If we did, that would only imply we did something wrong."25

Oral Surgeons

The vast majority of TMJ implants were implanted by oral surgeons. These surgeons were the ones who saw the craniofacial and systemic damage firsthand -- the ones the patients called asking for help. However, many doctors deny that the implants can cause the craniofacial and systemic problems experienced by implant recipients. They often blame the patients and recommend psychological help. Patients have been lied to and abandoned, left with no medical care at all, and, in many cases, unable to find another doctor who will treat them. An increasing number of people tell us they go to their doctors, play dumb, and then get their information from other patients or The TMJ Association, because if they ask questions and act like they know anything, their doctors suggest that perhaps they should find another doctor. Not only have patients lost confidence in their doctors, there is a tremendous amount of distrust as well. For example, many tell us that, once they've alienated their surgeons and the relationship has begun to deteriorate, they are afraid to allow these doctors to operate on them.

Even after oral surgeons were instructed to notify their patients of the Vitek recall and risks, many have failed to do so. In fact, almost all the people we talk to were never informed of the recall by their implanting surgeons. All members of AAOMS received a copy of the FDA "Safety Alert" concerning these implants. Later, in the "Public Health Advisory," doctors were asked to notify their patients, discuss the risks of device failure, and to continue to monitor them. In addition, they were told to encourage their patients to enroll in Medic Alert's International Implant Registry, and were given 30 days to complete Patient Notification Confirmation forms regarding the action they had taken. A year later, only 312 patients had been registered with Medic Alert, and less than 200 notification forms had been received from surgeons. In August 1992, in their own "TMJ Implant Advisory," members of AAOMS were reminded that, "It is vitally important that you make concerted efforts to reach your TMJ implant patients."26 We would like to see the evidence that these instructions have been carried out by every oral surgeon in this country who has ever put any type of implant into the temporomandibular joint.

Since the congressional hearing of June 4, 1992, "Are FDA and NIH Ignoring the Dangers of TMJ (Jaw) Implants?" it has become increasingly difficult for the dental community to dismiss the complaints of implants recipients as psychological and non-related to the implants and/or surgical procedures. However, the fact that there are no explanations for the systemic problems and certainly no solutions for rectifying the craniofacial damage, leaves the patients in limbo. Physically, their conditions are worsening. The more they are diagnosed, the less they know, and their future becomes more uncertain and the present more unbearable.

There is no standard of care for the implant recipients. The medical/dental communities have no scientific basis for treatment of these patients. There are very few centers where oral surgeons have shared the implant cases with medical professionals and made efforts toward collaboration to solve the problems of people with TMJ implants. This has left the patients seeking help by intuition and/or senseless referrals, with no practitioner assuming responsibility for their care.

Because of the implants, we are suffering from a new disease, and nobody knows how to treat us. We don't fit into anybody's specialty. Our doctors tell us: "It's all in your head," "You're the only one with a problem, " "I don't know why you're having pain -- everything's fine." Or, often, "You're just going to have to learn to live with-it." "It is horrifying that, in this day of sophisticated science, professionals can see the pathology of an arthritic joint, the resorption of cranial and condylar bone, giant cell reaction, evidence of debris migrating through the brain, and imply that if only these people had a better attitude their pain would go away. This is dangerous medicine due to the absence of research. And the continued absence of research prohibits effective treatment solutions for all TMD patients."27

Food and Drug Administration

The first reports of TMJ implant failures began at least 10 years ago. The FDA was being told of adverse-problems at least by 1986. 28 However, because of a mix-up with their Medical Device Report (MDR) program, these reports were dismissed. By 1988, they "had received information from experts that the Vitek implants were failing and needed to be explanted, and that patients with explanted devices were worse off than they had been before treatment. Problems included excruciating pain and the degeneration of parts of the skull."29

Public Citizen, in a letter to the FDA earlier this year, stated: "The implants ate away at bone and tissue; in some cases making a cavity which went through the skull to the brain. Yet despite literature reports of such tragedies, the Federal Register reproposed rule (59 FR 6935) indicates that the TMJ prostheses were inadvertently omitted from the dental devices considered for reclassification by the agency back in 1987.... Curiously, at an April 1989 meeting of the FDA Dental Products Panel, again the Panel did not make a recommendation regarding the classification of the glenoid fossa or the mandibular condyle implants.... At the very least, it would have been prudent for FDA to call for safety and effectiveness data from all TMJ implant manufacturers when problems first surfaced with the Vitek devices and at least by 1987.... At a February 1993 meeting, the FDA Dental Products Panel finally recommended that the devices be classified into class III." However, manufacturers of the mandibular condyle and glenoid fossa prostheses are not required to submit premarket safety and effectiveness data to the FDA for at least another 2-l/2 years. In the meantime, they can continue marketing their devices. "Considering the disfigurement and agony (not to mention financial ruin) experienced thus far by many recipients of various brands of these devices, it is inconceivable that…the situation has not begun to be remedied until now."30

We think Public Citizen sums it up pretty well. It is clear that the FDA, who is responsible for "protecting the public health against unapproved and defective medical devices,"31 have fallen down on the job. Who are they talking about protecting? Everybody but people with breast implants? Or TMJ implants? We realize this is the first experience the FDA has had in recalling a device manufactured by a company that has declared bankruptcy. Usually when a product is recalled, the company is solvent and assumes responsibility, at least for patient notification. However, the FDA has yet to conduct an extensive media campaign to find and notify patients about the possible risks associated with their implants.

To date, the FDA has no adequate complaint reporting system. In June 1993, they introduced MedWatch, a Medical Products Reporting Program. This program is specifically intended for VOLUNTARY PROFESSIONAL reporting of adverse events and product defects. The TMJ Association is receiving reports from implant patients that their doctors won't fill out the MedWatch forms, or don't believe their complaints and therefore won't report them to the FDA. Patients have no way have knowing whether their doctors actually file the complaints or not.

Since the congressional hearing, we have told every implant patient who has called or written to The TMJ Association to contact the FDA to report problems they are experiencing. We are concerned there is a possibility these complaints may not have been documented. Many people tell us they have called and left messages on an answering machine, yet never received any information. Many say they have to ask for the MedWatch Reporting Form three or four times before they receive it. Several recipients of prosthetic devices were told by the FDA that "no one had ever reported any problem" with their devices. However, these patients know of others who have filed formal complaints on the same devices.

The TMJ International Implant Registry, established by Medic Alert at the FDA's request three years ago, has closed. We now question who will have access to the names in their database. Will those who registered get new information on their implants, and from whom?

The TMJ Association is hearing from patients who have had the grandfathered devices implanted, many of whom are experiencing device failure as well as implant rejection. Some say they are unwilling to complain to the FDA because they are being emotionally blackmailed by the threat of having the device taken off the market. The absurdity of this is that these people are in a no-win, damned-if-they-do, damned-if-they-don't situation.

We know of at least three oral surgeons who have developed and are implanting their own "custom devices." In light of the disastrous results of other TMJ devices, our questions are: Who is monitoring the patient? Who is monitoring the device? Where are the records of device performance and safety? The FDA says there are none. If this is so, how is the patient being protected in all this chaos? Are we facing another Vitek disaster?

Device Manufacturers

Dr. Charles Homsy, founder of Vitek, declared bankruptcy in 1990. At this time, two subsidiaries, Oral Surgery Marketing, Inc. (OSMI) and Novamed, took over the marketing of these devices until the FDA eventually shut them down. Since early 1992, Dr. Homsy has been in "professional" exile in Switzerland. He blames everyone for the implant disaster --except himself. He blames surgeons for putting his product in the wrong patients or for botching the procedure. He blames patients for not following post-operative instructions against opening their mouths, chewing, talking, etc. Unbelievably, he still claims his product is perfectly safe.

Not only did Dr. Homsy fail to conduct adequate testing on the Vitek implants, he discounted reports of adverse effects. He claimed the problems with the implants are exaggerated, and that Vitek was targeted by the FDA to prove to Congress and healthcare advocates that it was beefing up regulation of the medical devices industry.

In January 1993, nine months after the congressional hearing, Dow Corning voluntarily discontinued selling their Silastic implants.

Over the years, numerous prosthetic devices made of a combination of various types of metal, acrylic, and plastic, have been developed. Among those that are no longer available, at least for now, are the ones manufactured by Vitek and TiMesh. The devices manufactured by Techmedical and Osteomed have been removed from the market. They were presented as "custom devices," and the FDA disagreed. The two remaining on the market are the Christensen device (TMJ Implants, Inc.) and the Morgan implant (The Temporomandibular Research Foundation). Both of these devices were grand fathered by the FDA. According to the FDA, "At present the safety and effectiveness of these devices has not been determined."32

National Institutes of Health

Fortunately, in the last year, the National Institute of Dental Research has taken several steps toward solving the TMJ dilemma. To begin with, in April, they co-sponsored the first international scientific workshop on TMJ. This was followed in September with a satellite workshop on TMJ implants, In a few months, a meeting will be held to assess the craniofacial destruction resulting from implants, the state of the art of biomaterials and bioengineering in TMJ prosthetic devices, and the state of the art of the biomechanics of the jaw joint.

The TMJ Association's recommendations have been taken seriously by the NIH for what we feel is the most timely and financially expedient manner in which to address the many facets of this disorder. And that is to do so in a collaborative manner, calling upon the existing scientific protocols and intellectual expertise at other institutes, governmental agencies, and the private sector. Over the last year and a half, we have developed an effective working relationship with the National Institutes of Health.

The Office of Research on Women's Health has recently expressed a commitment to become involved in relevant aspects of TMJ disorders. Considering that the large majority of sufferers are women, it certainly makes sense that they now see how they can help.

Early on, the Musculoskeletal Branch of the Arthritis Institute saw the importance of a collaborative effort. They contributed funds for the workshop and will be providing funds for a future meeting. Thanks to the Arthritis Institute, we are bringing in credible scientists from other disciplines who are being asked to direct their skills and talents toward solving the many problems faced by people with TMJ implants.

Because of The TMJ Association's unrelenting efforts and ongoing communication with the Senate Appropriations Committee, for the second year, report language has been included in the Senate Appropriations bill for the 1995 NIDR budget urging this agency to increase funding for TMJ research. This year, the Committee felt it imperative to direct the NIDR to collaborate with the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases, and other appropriate institutes of the NIH.

Third-Party Payers

Ironically, the insurance companies who refused to cover conservative therapies yet paid for implant surgery, have refused to have failed implants explanted, claiming it's "experimental." It is apparent that the implant recipients will require a number of surgical and medical procedures in the future, which the insurance companies clearly are not anxious to pay for. Because of the foreign body destruction to the craniofacial structures, revision procedures, such as total joint replacements, are necessary. The average condyle/fossa price leaving the manufacturer is $2,000. Typically, the hospital doubles the cost -- $4,000 to the patient, or $8,000 bilaterally. This has recently doubled due to the additional cost of device tracking and the amount to be escrowed for legal costs. This puts these devices at $20,000 bilaterally per procedure. We are talking about procedures that are second only to open heart surgery in cost. In precedent-setting actions, many insurance companies are not covering any TMJ implantation devices or procedures. Whose moral, ethical responsibility is it to remove these implants and pay for subsequent surgical procedures and treatment?

As co-founder and president of The TMJ Association, Ltd., I have had hundreds of conversations with the FDA, the NIH, the Agency for Health Care Policy and Research, manufacturers, medical and dental professionals -- and countless other organizations that have the capability of improving the quality of healthcare and life for the TMJ patients of this country. I have become increasingly astounded by the lack of communication among these groups, and even more astounded by their unwillingness to talk or work with us.

After years of knocking down doors and running up against bureaucrats, I contacted the House Subcommittee on Human Resources and Intergovernmental Relations and begged them to look into the disastrous results of TMJ implants and the overall shabby state of the art of research of this disorder. The result was the congressional hearing of June 4, 1992. Only after the hearing did I begin to see a change. Only because of congressional intervention has any action been taken -- action that should have been taken at least a decade ago.

The purpose of this meeting is to discuss the impact of healthcare reform, product liability, regulatory issues, and raw materials shortages on the biomaterials and medical devices industry. We hope that you can now begin to comprehend the impact that inadequate testing, regulation, and device tracking, and competitiveness, progress, and greed has had on the lives of thousands of TMJ patients. Our question to you is this: How can we survive in this era of "entrepreneurial spirit" and "market growth?" Can we have our lives back? How do we face what lies ahead?

Several months ago, we received a copy of Dr. Homsy's talk. We were tempted to dismiss any opportunity for rebuttal; however, we feel it is important to take issue with some of his positions because they seem to be universal to this audience. And it is imperative that you hear the patient's side in all this.

Dr. Homsy has described what he sees as "obstacles" to medical device innovation and supply. Among these are product liability and the media. Let's talk about product liability. In a letter to the editor of the New York Times, Kristen Rand, Counsel to the Washington, DC, office of the Consumers Union, stated that "product liability actions are almost the consumer's only protection from dangerous, defective medical devices"33…And in congressional testimony, she pointed out that "... liability provides an irreplaceable incentive in making medical devices safer and in ensuring that consumers who are injured by defective devices are compensated."34 According to Dr. Sidney Wolfe, Public Citizen, "litigation is an inevitable result of misguided federal laws and policies that have allowed most medical implants to reach the public without extensive testing and specific approval from the FDA."35 As Ms. Rand says, "Virtually without exception, lawsuits the industry describes as frivolous turn out to be valid, and products alleged to be safe prove dangerous."36

Dr. Homsy cites Senator Lieberman's concern that "a shortage of implant materials has resulted as suppliers have pulled their products from the markets because they have become entangled in implant lawsuits."37 A recent article in Forbes ASAP discusses the fact that only five cents worth of Teflon was used per Vitek implant, and the legal costs of the company were running into millions of dollars.38 We do not know of a single implant recipient who went to an oral surgeon and asked for an implant that would cause so much destruction, just so she could sue the manufacturer 10 years later. If our implants hadn't failed, we wouldn't be suing. They don't print enough money to make this worthwhile.

I suggested to the Forbes writer that he now do another article on the financial status of each implant recipient -- an analysis of how a middle-class family went bankrupt within six months of the first surgery, how couples divorced so the implant recipient could get Medicaid coverage, how even extended family members have mortgaged their homes for that next surgery to get the mandible out of the trachea, how people only get their meals from a church food brigade.... I further recommended that he analyze the financial benefits to the oral surgeons as a result of an increasing number of revision surgical procedures becoming necessary because of the failed implants. How dare it be implied that we, the victims, are now also the culprits.

The economic impact on the implant patient who has undergone 5, 20, 30, or more surgical procedures and is facing perhaps a dozen more (unless they die first), is begging to be calculated. If Senator Lieberman has a problem suing manufacturers, okay -- set up a victims' compensation fund. We will simply have the government pay for all of our continuing medical expenses -- those $50,000 procedures three times a year, plus, of course, the cost of the device, the surgeon's fee, and hospital charges. When Senator Lieberman looks at the year-end statement, he may be singing a different tune. He may even ask the surgeons to contribute their services as they do in underdeveloped nations. Regardless, the bottom line I so frequently hear is still: "Terrie, I don't want money - just my life back, just to look at my kids and enjoy them for who they are right now, not with tears in my eyes feeling I won't be with them much longer."

I think it must be very hard for you to fathom that we have people all across this country, taking articles in bags to their doctors, begging them to read them, just so their doctors will believe they have reason to be concerned, and make some effort to help them. We are in the scientific infancy of implant disease, or whatever you want to call this. We can't care about those manufacturer-financed studies that say not to worry. Live with us one week and see if we don't have reason to worry. To quote the Wall Street Journal, doctors who have treated women with implants stress that such epidemiological or statistical studies are intriguing and perhaps significant but must be placed in context. "I've been treating these women since 1981, before the lawyers showed up," says UCLA's Dr. Weiner. "All the epidemiology in the world doesn't make the patients go away."39

Dr. Homsy, in talking about death from failure of a heart valve, states that, "USA society as a whole cannot be well served by large monetary settlements . . . on patients who claim pain and suffering from worry that their implant may fail." I do not expect anybody who has never experienced this to understand what it is like. Simply try to imagine waking out of a sound sleep at 2 a.m., going to the bathroom, and your mind immediately going to the question, How much longer can I live with the failed implants before they eat through my skull? The alternative is another surgery, increasing pain, increasing paralysis, increasing adhesions, more surgery, more deterioration,... If I leave the implants in, there is equal destruction -- but I know I can still handle this. But if I don't die before surgery, I'll have that surgery and live with the varying degrees of pain and telling myself it isn't bad, because another surgery could incapacitate me. Or asking my husband why he has that stricken look on his face when he wakes and tells me he had the nightmare again. He only talked about it once -- he came home to find I took my own implants out and was dead. I don't blame anyone for not understanding that underlying every moment of an implant patient's day is a low-grade to raging terror of more pain, more ravaging surgery, more disfigurement, more disappointment. You people have no comprehension of the way we have been forced to live.

What about the media? Well, it should be insulting to us that we don't even qualify for "Oprah," "Donahue," or "Geraldo." However, we have suffered our indignity by the establishment. We have been told by some media personnel that this is too controversial, too ugly to cover, the people are too deformed to put on the screen -- they would turn the viewers away. Dr. Homsy says that "checkbook journalism" is out of the closet. Apparently, we didn't qualify for that either. I asked the patients on "20/20" and "American Journal" if they got paid. They didn't. I did not question the doctors or manufacturer. We thank the media for taking on the government's and oral surgeons' responsibility to alert the patients to the risks of the implants.

If all the energy expended by everyone on damage control, denial, and excuses went into a concerted effort to help the patients, we would all be better off. To this date, not one person has come forth from these ranks to advocate for these people. Today, I am honored and deeply humbled to speak for the TMJ implant patients. In a letter to the NIH, Amy Marks stated, "We are greatly indebted to Terrie Cowley, for carrying the weight of this effort for me and the other TMJ patients who are too ill to fight for themselves. The truth is that every one of us is fighting for ourselves and each other...."40

I have just told you about TMJ implants. Are they typical of all implants? We presume not. Are we the aberration? We would like to think so. However, in a presentation to the Planning Conference on Management Requirements for a National Implant Data System in April of this year, Professor David Williams stated, "For whatever reason, and without making any value judgments on any of the issues, the very fact that our breasts are, metaphorically, exposed so sordidly and exploited so unashamedly in the world's media, and that TMJ is now a household acronym where only a few years ago even some oral surgeons did not know where it was, tell us that our best has not been good enough. And if all of our efforts to evaluate and test, control and assure, experiment and optimize, cannot ensure acceptable levels of performance, we need to do something more."41 Implant failure/success comes in all degrees -- many shades of gray between the white and black. And patient experiences encompass this shading.

Dr. Williams further states that "... inherently in our system, we have the good patient, the less-good patient, the good manufacturer, the less-good manufacturer, the good clinician, the less than average clinician, the good academic, the appalling academic."42 Hopefully, it is apparent that the patients, along with you all, are risk takers; along with you all, are stakeholders in the implant venture. If you choose to do devices -- believe this we are all in this together. I do not minimize the worst that can happen to you . . . a lost venture. The worst that can happen to the patient is a lost life.

If our experiences and feelings are dismissed as the ranting of a few disgruntled women, if you do not take our concerns and the information we share with you seriously, this time (not to mention our money) will have been wasted. We are thankful that you asked for our input at this meeting, for that must indicate that you are at least curious about our plight. Let's make this beginning an opportunity for the exchange of mutual concerns, opportunities, needs, ideas, and potential. For, as I said earlier, we need each other. Without you, we have no hope for a better future; without us, you have no job. In the name of all the TMJ patients, we are asking for your cooperation and assistance to help get this disorder out of the gutter where it has fallen. We look to you -- the biomaterials specialists, bioengineers, manufacturers, academics, bureaucrats, and politicians, to work with us on the development of the best temporomandibular joint prosthetic device possible. We aren't going to go away. We are involved, and we will be watching the technological developments that affect us.

I will give you an example of how far we have come from our first surgery when our concerns were, who will watch the children while I'm, in the hospital? Do I have a respectable nightgown. I overheard a conversation between two patients, in which one said, "Before you have the next surgery, you WILL know how many millimeters the condyle has resorbed, you WILL know what materials the device is made of, you WILL know how many screws are in the device, you WILL know what materials they are made of, you WILL know the model number and lot number, you WILL know the manufacturer and where it is made. You WILL know the complications… the expected life span of the device." You may have not yet learned lessons from the TMJ implant disaster, but I assure you, we have.

1. That the FDA develop a system whereby scientific expertise is solicited from academia voluntary societies, industry, and federal agencies. Among such agencies are the National Institutes of Health, the National Science Foundation, NASA, NIST, and ad hoc members with expertise in an area pertinent to relating to the device under review. Rationale: The FDA, in 1982, could have conducted a simple Medline search on PTFE that would have raised a red flag of caution and further inquiry. That this was not done is still a mystery to the implant Victims. Hopefully, a peer review system as proposed would become a checks and balance system that would prevent approval of unsafe devices.

2. That the FDA develop a user-friendly complaint registry that is multi-tract so there can be cross-analysis of complaints registered by the patient, the professional, and the manufacturer. There must be 800 number access for the patient. Rationale: "The complaint system is the ONLY early warning signal that something is wrong with a medical device. Manufacturers have been required to report device problems since 1985. But scores of them haven't done it."43 The TMJ patients do not trust the manufacturers or the professional providers to file complaints on their devices. A system should be instituted, wherein information is provided pre-implantation, with directions to the implant recipients that they must report any device-related problems, including systemic side effects, to the FDA.

3. That an implant database and implant retrieval system be established independent of the FDA. It is obvious that in order for this database to be effective, it must be compulsory. It should also be internationally compatible, with involvement of the World Health Organization. It should be able to detect device problems in such time so as to minimize the number of people who could be damaged by the device. It also needs to be a retrieval system for successful implants that should be explanted during autopsy and sent to the implant retrieval center for evaluation. The monitoring system should have a complaint system such as recommended to the FDA so that the implant recipient's self-assessment is incorporated into the device evaluation. Rationale: An independent implant database and implant retrieval system is a most important means by which device problems can be detected at an early stage and warning given to unsuspecting recipients. It is equally important as a means of assessing the success rates of implants and gleaning information on the ranges of the success/failure scale of the devices. A retrieval system will be an effective research tool for enabling the assessment of the condition of explanted successful devices and surrounding tissues and perhaps extrapolating the mechanism for that success to other devices.

4. That device development becomes a more integrated process. While maintaining "specialist" roles, all entities are part of a unified product and directly or indirectly responsible and accountable for a final product. Rationale: It appears that a device has the utmost chance of success if all involved parties are held accountable and responsible for the final product. For example, the involvement of the design engineer and materials specialist throughout the project allows for reformulation and/or fine tuning, leading to clinical trials.

5. That there be developed a TMJ device team, headed by the National Institutes of Health, composed of state of the art scientists who will create a science base to develop the safest and most effective TMJ total joint prosthetic device possible. Rationale; Given the general difficulties in this area; the lack of an optimal alloplastic implant that does not induce immune response, rejection, or failure; the relatively small market for TMJ devices; the wake of the TMJ implant disaster; and, above all, the limited knowledge of the biomechanics of the jaw joint, it is imperative that this country takes on TMJ, making this joint the focus for basic and advanced research into 18the biomechanics of the TMJ, as well as biomaterials and bioengineering. The results of this collaborative effort could be utilized as a model for other devices.

6. That with controversial devices and those "less good" manufacturers and professionals, there is an additional component to the independent compulsory database. This entity will serve as a broker or clearinghouse, wherein the implant can be received from the manufacturer; necessary information logged; the model, lot, and serial number sent to the patient; and the device sent to the hospital of the implant recipient. Rationale: We have heard from, and received substantiated evidence that, patients were told they were getting a certain device, yet learned post-surgically that they had received another. Patients have heard from hospital administrators who claim the devices were never bought by the hospital. I know our recommendation for a "broker" cannot ensure a certain device will be implanted, but we must make an effort to eliminate the potential for fraud or deception.

7. That there be established an international body composed of representatives of professional organizations and regulatory agencies with the mission to address the ethical issues that arise from device/material problems. Rationale: Because of Charnley's research results, the orthopedic community abandoned the use of PTFE in the early sixties. I have been told by biomaterials scientists that they had "knock-down, drag-out" arguments with Dr. Homsy in the seventies about the danger of using the material in the jaw joint. Thousands of lives destroyed later, we now see that PTFE is resurging in the Bitek hip being manufactured by Dr. Homsy's company in joint venture with Kobe Steel. He states that over 500 patients in the Netherlands were involved in clinical trials. What are the ethical issues in this scenario, and how are patient's rights and lives being protected? I am certain that this is just one of many issues begging analysis and action from a bioethics and international law perspective. The GATT treaty, if passed, could open the door for world standardization that could affect the importation of unsafe devices from other countries.

1James Berry, "Questionable Care: What Can Be Done About Dental Quackery?" Journal of the American Dental Association 115 (November 1987): 685.

2Harold Perry, "Above All Else, Do No Harm," Journal of Craniomandibular Disorders: Facial and Oral Pain 5, no. 2 (1991): 8.

5Enid Neidle, PhD, "On the Brink: Will Dental Education Be Ready for the Future?" Journal of Dental Education 54, no. 9 (1990): 565.

6M. Gordon and P.G. Bullough, "Synovial and Osseous Inflammation in Failed Silicone-Rubber Prostheses," Journal of Bone and Joint Surgery 64 (1982):574-80.

7L. Eriksson and P.-L. Westesson, "Deterioration of Temporary Silicone Implant in the Temporomandibular Joint: A Clinical and Arthroscopic FoIIow-Up Study," Oral Surgery, Oral Medicine and Oral Pathology 62, no. 1 (July 1986): 2. v8M.F. Dolwick and T.B. Aufdemorte, "Silicone-Induced Foreign Body Reaction and Lymphadenopathy After Temporomandibular Joint Arthroplasty," Oral Surgery, Oral Medicine and Oral Pathology 59, no. 5 (May 1985): 452.

9Congress, House, Committee on Government Operations, Are FDA and NIH Ignoring the Dancers of TMJ (Jaw) Implants?: Hearing before the Committee on Government Operations, 102d Cong., 2d sess., 4 June 1992, 58.

14A.G. Bosanquet, J. Ishimaru, and A.N. Goss, "The Effect of Silastic Replacement Following Discectomy in Sheep Temporomandibular Joint," Journal of Oral and Maxillofacial Surgery 49, no. 11 (1991), 1204-9.

16Jennifer Hutchinson, Cynthia Still, and Bill Still, The Truth About TMJ: How to Help Yourself (Winchester, VA: Reinhardt & Still Publishers, 1994), 62.

17Bruce Ingersoll and Rose Gutfeld, "Medical Mess: Implants in Jaw Joint Fail, Leaving Patients in Pain and Disfigured," Wall Street Journal, 31 August 1993, sec. A, p. 4(E).

19National Center for Health Statistics, "Use of Selected Medical Device Implants in the United States, 1988," Advance Data 191 (26 February 1991), 6-7.

20American Association of Oral and Maxillofacial Surgeons (AAOMS), Code of Professional Conduct. Judicial Procedures. and Official Advisory Opinions. and Guidelines for Filing a Complaint, "Section Two, Professional Obligations" (Rosemont, IL: AAOMS, May 1991), 7.

21"Recommendations for Management of Patients with Temporomandibular Joint Implants," Journal of Oral and Maxillofacial Surgery 51 (October 1993): 1166.

22John Charnley "Tissue Reactions to Polytetrafluoroethylene," Lancet 2 (1963): 1379.

24AAOMS, Memorandum re "Vitek TMJ Implant Publicity" (Rosemont, IL: AAOMS, 5 October 1993).

25Daniel Laskin, DDS, Interview by Terrie Cowley, 25 September 1992, Chicago, IL.

27Terrie Cowley, "Testimony to the Blue Ribbon Panel on Envisioning the Future of the NIDR Intramural Research Program," 27 January 1993, National Institutes of Health, Bethesda, MD.

30Public Citizen, to Dockets Management Branch, Food and Drug Administration, 15 April 1994, 2-4.

31Food and Drug Administration (FDA), Compliance Guidance Series: Medical Device Reporting Questions and Answers, Publication 884226 (Rockville, MD: FDA, February 1988, Reprinted August 1990).

32FDA, TMJ Implants: A Consumer Information Update (Rockville, MD: FDA, August 1993), 11.

34Congress, Senate, Committee on Governmental Affairs, Availability of Medical Devices: Hearing before the Committee on Governmental Affairs, 20 May 1994.

35Barnaby Feder, "Implant Industry Is Facing Cutback by Top Suppliers," New York Times, 25 April 1994, sec. C, p. 3.

39Thomas Burton, "Doctors See Hazards in Breast Implants Despite What Recent Studies May Say," Wall Street Journal, 24 August 1994, sec. B, p. 2.

40Amy Marks, to Participants at "TMJ Alloplastic Implants and Local/Systemic Response: Observations and Research Needs Workshop," 12-13 September 1994.

41David Williams, "International Perspectives on Implant Data," Presentation given to Planning Conference on Management Requirements for a National Implant Data System, Hyannis, MA, April 1994, 3.

Biomaterials and Medical Devices: An Industry in Transition The Impact of Healthcare Reform, Product Liability, Regulatory Issues, and Raw Materials Shortages

TMJ Implants -- Historical Perspective

Silastic

Proplast-Teflon

Experiences of TMJ Implant Recipients

Response by Professional and Governmental Agencies to TMJ Implant Patients

American Dental Association

American Association of Oral and Maxillofacial Surgeons

Oral Surgeons

Food and Drug Administration

Device Manufacturers

National Institutes of Health

Third-Party Payers

The Turning Point

The Bottom Line -- Who Represents the Patient?

Recommendations

Endnotes