The following article was published in Orthopedic Network News (ONN), Trauma Update, Volume 6, Number 2, April 1995. To sign up for all ONN editions in print and online, plus all archives, click here: ONN Subscription
Temporomandibular joint disorders (TMD) are conditions that affect as many as 10 million people in the U.S. Women outnumber men sufferers by as much as five or six to one, and most sufferers are less than 40 years old. People with pain in their temporomandibular joints can suffer excruciating headaches and dizziness which limit their work, social activities and enjoyment of day-to-day living. A bad hip, knee, or elbow may result restricted mobility; a bad jaw or painful temporomandibular joints may result in years of excruciating pain, soft diet, altered physical appearance as well as swallowing or even talking difficulties. Patients with long-term debilitating TMJ pain endure bouts of depression, despair, and hopelessness as do many terminally-ill patients.
TMJ disorders can be caused by trauma, but for many patients, there is no known cause. Because so little is known about what causes this disease, there are many providers who offer treatments for TMJ pain. These providers include oral and maxillofacial surgeons, plastic, ENT, and craniofacial surgeons, neurologists, dentists, psychologists, physical therapists, massage therapists, and chiropractors. Patients, desperate with pain, are referred to many of these specialties all with limited success and often end up worse off than when they sought treatment in the first place. According to the Academy of General Dentistry, there are 49 different treatment modalities for TMJ pain. At one extreme is rest and hot and cold packs, and at the other is surgical intervention including total joint implants.
There are two types of surgical procedures involving implants: replacement of the disc, which rides above the mandibular condyle, and replacement of the condyle and/or glenoid fossa. Disc replacements were supplied in the 1980s by Vitek of Houston, Texas, and Dow Corning of Midland, Michigan. Currently only TMJ Implants, Inc. of Golden, Colorado, and the TMJ Research Foundation of La Crescenta, California manufacture joint implants, although Vitek, Osteomed, Techmedica, and others have in the past. Other surgical procedures involve the transplantation of ear cartilage, rib graft, muscle, or fascia into the joint. Surgical repair of the temporomandibular joint reached its peak in the United States in the mid-1980s, according to data supplied by HCIA, a Baltimore-based healthcare information company. In 1985, over 17,000 temporomandibular joint arthroplasty procedures were performed; between 1973 and 1993, over 170,000 procedures were performed. What is not known is how many of which type of procedure were performed during those years. Estimates are that about 26,000 patients received Vitek’s implants, and about 20,000 received Dow Corning sheeting or implants between 1983 and 1993. Vitek’s disc replacements, known as interpositional implants (IPIs), were made of Teflon® FEP film laminated to Proplast®. Proplast, developed by Dr. Charles Homsy at DuPont, consisted of Teflon PTFE and vitreous carbon. Subsequently, the carbon was replaced with aluminum oxide, and the resulting structure was known as Proplast® II. These implants were sold by Vitek, a company started by Dr. Homsy, between 1983 until 1988 when they were taken off the market. Other Vitek TMJ implants included the VK-I, and VK-II, which included a condyle and a glenoid fossa component, designed by Dr. John Kent of the Louisiana State University Medical Center. Dow Corning provided Silastic® sheeting and a Silastic TMJ implant based on a design by Dr. Clyde Wilkes, of Minnesota. They were taken off the market in 1993.
What amazes patients and many orthopedic surgeons is that problems with PTFE (i.e. Teflon) implants were reported as far back as 1963 by Sir John Charnley, the acknowledged father of hip implant surgery. “Teflon [PTFE] proved unsuitable not so much because of its low resistance to wear as by the adverse tissue reactions caused by the wear debris. It may seem strange that it took us some 300 operations and between three and four years to arrive at this conclusion [that PTFE was unsuitable]… the results up to three years were so spectacular, that we could not bring ourselves to face the suspicion that the x-rays were showing incipient harmful evidence.”
“…resorption of the glenoid fossa [caused by the implant] would expose the brain.”
In 1983, Vitek was given approval by the Food and Drug Administration (FDA) to sell their interpositional implant (IPI) to surgeons to treat TMJ disorders. Even while the FDA was approving the IPI for distribution, the main medical advisor to Dr. Homsy, Dr. John Kent from Louisiana State University, was beginning to discover problems with the Teflon-coated device. In a February 14, 1984 letter to Homsy, Kent warned of a “calamity of unbelievable proportions” based on the excessive wear of one of the components in one of his patients. By 1985, the first problems with Proplast were disseminated to a wider professional audience. In a May 1985 newsletter from the Medical College of Wisconsin, Doran Ryan reported that “our experience [over the last five years] of Proplast/Teflon implants has not been favorable. We have encountered degeneration of the condyles.” In April 1986, the FDA received their first Medical Device Report concerning Vitek’s TMJ devices.
Animal studies, using the implants, which had not been performed prior to FDA approval were now being conducted. The first studies involving dogs were performed in 1984; El Deeb at the University of Minnesota examined the results of Proplast implants in monkeys and reported his findings at the annual American Association of Oral and Maxillofacial Surgeons meeting in October 1986. His conclusion was that the monkeys were experiencing “progressive fragmentation with giant cell reactions.” In July 1986, Timmis reported giant cell reactions in rabbits to both Proplast/Teflon as well as silicone.
February 20, 1987, the Air Force surgeons who had been using the IPIs reported problems with patient reactions to both the FDA and Vitek and suspended their use. They reported “severe painful and nonpainful foreign body reaction with resorption of condyle and glenoid fossa.” Continued resorption of the glenoid fossa would expose the brain. By May 1, 1987, Vitek had its first patient lawsuit and in June 1988, Vitek had removed the IPI from the market. Under pressure from the FDA, Vitek began to issue advisories to physicians on the potential fragmentation of the implant. Under growing litigation, Vitek filed for Chapter 7 bankruptcy protection on June 7, 1990. Aimed at Vitek, the FDA began a series of actions including a patient notification program warning patients of adverse reactions to the Vitek implants, alerting oral and maxillofacial surgeons, and rescinding Vitek’s approval to sell the IPI. In June 1992, all of the implant inventory of Novamed and Oral Surgery Marketing, Inc. (sister companies of Vitek) were seized by the FDA, crushed by a bulldozer, and buried in a Houston, Texas dump.
It has been four years since the Vitek implants were pulled from the market, and two years since the intensive media scrutiny. There has been fallout on all parties involved—the manufacturers, physicians, regulators, insurers, and of course, the patients.
The manufacturers: Currently, there are over 2,200 claims against Vitek from patients who are trying to obtain funds to have their implants removed, a course suggested by the FDA. Given the limited funds available from the Vitek bankruptcy court, patients with the Vitek implant have filed a class action lawsuit against DuPont, and those with the Silastic implant have filed against Dow Corning. DuPont provided about five cents’ worth of Teflon for the Vitek implant but is being sued for the medical expenses of the tens of thousands of patients with the implants. Dow Corning and other raw materials manufacturers have begun to disassociate themselves from the development of products because of the liability associated with them.
The FDA reclassified TMJ implants as Class III devices, which means new TMJ devices must submit several years of data on patient outcomes before they can be marketed. Scientific data on safety and efficacy may need to be submitted for devices manufactured by TMJ Research Institute and TMJ Implants, even though they have been manufactured prior to the 1976 Medical Device Amendments. The reclassification of these devices has also led both Synthes and Howmedica to withdraw their Ramus joint prostheses from the market. Ramus prostheses are predominately used for patients with cancer.
The physicians: The American Association of Oral and Maxillofacial Surgeons (AAOMS) represents about 4,700 active members in the United States, and many were involved in placing implants in patients in the mid-1980s. While the literature in the mid-1980s discussed options and surgery to deal with TMJ pain, many of these professionals must now deal with the multiply-operated patient and those who suffer the aftereffects of failed TMJ implants. Dr. Daniel Laskin, editor of the Journal of Oral and Maxillofacial Surgery, says that “their members were led to believe that the implants were safe because the FDA had approved them. Most oral surgeons don’t have the time to investigate the devices and review the literature.” These events have also opened the oral surgeon community to unexpected scrutiny in their practices and profession. Congressional hearings in June 1992 led to a November 1992 AAOMS workshop on management of patients with TMJ implants in which the majority of participants “recommend removal of [Proplast/Teflon] implant and affected soft tissues.” In a rare display of self-assessment, one oral surgeon has called for a reduction in the number of residents graduating from oral and maxillofacial surgery programs. “The scope of services provided by our specialty has greatly increased in the past 10 years, especially in the area of cosmetic surgery. Interspecialty rivalries are at an all-time high. Some services are being provided for patients with little justification of their benefit. One could argue that surgical experimentation is being performed on humans…[the] problems we face can be directly related in one way or another to an excess of manpower.”
The surgical success of oral surgery is now being compared to other medical specialties. While orthopedic implants are looking at longer time frames for success—decades instead of years—TMJ procedures are considered successful if 75% of patients have pain reduction at five years. Although some patients with TMJ implants have been tracked for over thirty years, many with the Vitek and silicone implants have unknown prognoses as they approach their forties, fifties, and beyond. It is a valid question to determine how many patients in this age group will allow themselves to have a surgery on their jaw every three or four years.
The regulators: In 1992, under pressure from patient constituents, Congressional hearings were held on TMJ implants and whether the FDA and National Institutes of Health (NIH) had been ignoring their dangers. One upshot is that funding of basic research into TMJ disorders will almost double over the next three years.
This episode has also highlighted the separate dental and medical research communities who often independently research similar issues, but seldom share information. Dental researchers have investigated materials used in orthopedics such as hydroxyapatite, titanium, and bone cements; similarly orthopedics and other medical specialties have had experience with PTFE (Teflon), silicones, and other materials which the dental specialties could learn from. This lack of commmunication, at least in the case of the TMJ implants, has harmed patients.
Insurers/payers: The history of TMJ coverage has been intermittent and haphazard since the 1970s. With the advent of TMJ implants in the early 1980s, many insurers offered coverage to patients. When implants were found to be unsuccessful, they began to deny coverage, even for surgery to repair the problems of the first surgery or for the removal of implants which had begun to deteriorate. Insurers in some states cover the surgical management of TMJ disorders, but not the non-surgical care of these patients. Minnesota started providing coverage for nonsurgical management of TMJ disorders and found that the number of patients treated increased, the surgical rate decreased, and the overall costs decreased.
The patients: By 1986, Terrie Cowley had had a Silastic implant in her jaw for four years. After her surgeon told her, “I don’t know why you are having pain,” she embarked on a mission to see if other people had had as bad a reaction as she had. She now heads a not-for-profit organization whose mission is to help those with TMJ disorders or TMJ implants, and to provide advocacy to those who need it. The Association has been instrumental in obtaining Congressional hearings on TMJ implants, and having research money allocated to basic TMJ research within the National Institutes of Health.
Of the 5,000 members in the TMJ Association, 257 are known to have a Vitek implant, and 189 are known to have a Silastic implant. Of the Vitek implant patients, the average age in which they received their surgery was 34 years old, and the average number of surgeries they have received is 6.0. There were two patients who had more than 30 surgeries on their jaw, and five who had 20 or more surgeries. Several indicated that their medical expenses exceeded hundreds of thousands of dollars. For example, one patient’s bill obtained by ONN for the surgeon fees for the removal of a Vitek implant and the implantation of another was $37,500. This did not include the cost of the hospitalization, implant, or anesthesiologist.
“One patient’s bill for surgeon fees for the removal of a Vitek implant and the implantation of another was $37,500. This did not include the cost of the hospitalization, implant, or anesthesiologist”
For those with implants who are suffering in pain, the future can be a devastating prospect both physically and financially. Multiple surgeries as well as devastation of careers, marriages, and finances are not uncommon. For the many implant patients who have had relief from their TMJ pain, the studies on Proplast and Silastic can raise many doubts in their minds. Should they live with their pain and their degenerating condition or should they risk getting worse by having their implants removed? The worst part of this problem is that even after the implants are removed, the deterioration of the bones in the skull will continue.
Insurance relief for medical expenses, even the removal of the implant, is generally not available even though this has been recommended by the FDA. The insurers for Vitek have made a pool of $22 million available for these patients. Patients receive between $1,000 and $8,000 depending on their degree of disability, number of surgeries, age, and other factors. Thus far, approximately 2,700 patients have been paid from this fund.
One of the most hopeful signs for patients is the recognition by many of the providers that their pain is not all caused by stress. Much of the research in the past has examined the “TMJ personality,” and sources of stress which can lead to their pain. Patients have argued for years that their underlying pain can lead to the stresses which the researchers were examining. What they hope for is more research into the root causes of TMJ disorders.