Article by Sophia Stone, TMJA contributing author
It is still all too fresh in the minds of many patients. Fifty years ago, between the 1970s and 1980s, some 10,000 TMJ patients received Vitek jaw implant devices. Over time, these would shatter into microscopic Teflon particles, "cannibalizing" through the skull and even implanting in brain tissue. The result was a major inflammatory response and years of unrelenting pain. What's worse is that Vitek implants were approved by the Food and Drug Administration (FDA) in the absence of any human clinical trials demonstrating their safety.
In total, Vitek, Inc. sold about 28,000 TMJ implant devices, of which about 10,000 were implanted into patients. When patients returned complaining of debilitating pain, Vitek initially issued safety warnings, and two years later withdrew its device from the market. After yet another two years, the FDA recalled the device and issued its own safety alert. Meanwhile, Vitek filed for bankruptcy and its founder, Charles Homsy, fled to Switzerland to seek legal immunity from a tidal wave of lawsuits. But a $22 million settlement fund won't reverse the skull degeneration, facial deformity, and devastating pain surviving patients continue to suffer. The Vitek device is one example of implant devices TMJ patients have received over the years.
By contrast, consider the situation today: the average medical device racks up a bill of over $30 million before FDA approval. How is it even conceivable that, despite presumably millions of dollars and years of development, a device like the Vitek implant would get through this pipeline, a device that would be implanted at a critical joint in a sensitive region of the face, mere millimeters of bone separating it from the skull?
So who's to take the heat for the Vitek implant disaster? The inventors at Vitek? The FDA staff that pushed for its approval? The oral surgeons who implanted the device in thousands of patients? One might well imagine considerable friction, if not downright animosity, between the device industry, dental and medical practitioners and TMJ implant patients.
A RoundTable of Former Adversaries
But, incredibly, this has not been enough to keep them from coming together, united in the fight to improve the plight of TMJ patients. On May 11, 2018, this diverse group of interested parties met for the second TMJ Patient RoundTable at FDA headquarters.
Their initial meeting took place on June 16, 2016, at which time they established three objectives:
Two years later, this cohort of FDA administrators, National Institute of Health directors, scientists, healthcare professionals, clinicians, device manufacturers, and, most importantly, TMJ patients met to review progress on these aims.
As a TMJ patient with a science background, I found the most striking takeaway from this meeting was the gap between the emerging science on temporomandibular disorders (TMD) and the critical needs of actual, living patients today-patients sitting, quite literally, elbow-to-elbow with the scientists who've spent their careers studying the problem. From a purely scientific perspective, the dizzyingly technical discussions about genome-wide association studies, bioinformatics, the human microbiome, artificial intelligence, and stem cell models were fascinating. It inspired hope to think that top scientists in leading fields are deploying our biggest and baddest technologies against a condition that, according to some estimates, affects the lives of millions of Americans. But from a patient's perspective, it's impossible to disentangle scientific inquiries into TMD from the very real, everyday experiences of patients. They are mutually interdependent.
Yet this separation was very much my experience working in a research lab years ago. There it was impossibly easy to disassociate what we were doing from the painful reality of the disease we were studying. That's actually okay-science demands cool objectivity in the lab, and I wouldn't wish the psychological burden of TMD to fall upon any clinician or researcher. But one of the patient advocates at the RoundTable, Tricia Kalinowski reminded the group that she had undergone 12 jaw surgeries over 35 years. She said she's "watched the dentists and others who got to move on with their lives and mine got stuck, and in fact has gotten much worse. I lost my career and so much more."
More Basic Science...
As RoundTable participants noted, temporomandibular joint disorders represent a complex family of conditions, and research should match that complexity. The RoundTable discussion focused to a significant extent on the extensive needs of TMD science, including:
That is, we need more-and more rigorous-science on the TMJ itself, as well as on medical devices like TMJ implants before they go to market, and frankly, into patients' skulls. Others at the meeting remarked upon the challenge of balancing such regulation with innovation so that we can get new, cutting-edge therapies to the patients who need them, but safely. It's a commandment of Medical Ethics 101 to only offer patients evidence-backed treatments that have been proven safe. But for that to happen, significant scientific groundwork must be laid-from exhaustive genetic and molecular models to animal studies to all stages of human clinical trials. In short, we need the basic knowledge just to understand the disorder, let alone develop effective treatments. The kind of patience this requires can be frustrating, as perhaps is best expressed by a patient advocate at the meeting. She reacted to someone's "comment that 'we needed to temper patients' expectations' regarding jaw replacement surgery by questioning why were we even there."
...And Clinical Studies Too
RoundTable participants emphasized clinical needs, stressing patient-centeredness:
Limited Practice Guidelines and a Failure to Educate
One of the Working Groups was tasked with evaluating the TMD practice guidelines of professional dental/medical organizations. They found there are scientific statements and parameters of care, but no formal guidelines for TMD treatment formulated by professional groups for the management of TMD. Of 24 organizations, only 5 had published directives on TMD care. Almost no mentions of patient-centeredness were found. The American Dental Association (ADA) does not publish any standards of care.
This is unfortunately consistent with the Working Group's report on the lack of educational standards for dentists. That's not an exaggeration: the Council on Dental Accreditation (CODA) does not require that TMD or orofacial pain be taught in dental schools. Dental graduates who want to develop expertise in this area can choose between only 12 CODA-approved orofacial pain training programs. Tracy Jones, a patient advocate at the meeting, has seen over 20 dentists during her 25 years with TMD. She recalled that when "one dentist examined me, he told me that he 'knew just enough about jaws to be dangerous' and suggested I go to the dental school." Turns out the punch line is on the patient.
RoundTable participants who had personal experience with TMD were particularly enthusiastic about a registry to track patient outcomes. According to Kalinowski, "Vitek [implant] patients were promised a registry. We got one for a year and then the funding ran out. We were also told they would do research on the effects the Vitek truly had on patients and that we should be followed medically...That didn't happen. There isn't any test that exists that shows them where in my body the Teflon might be or what conditions to follow me for." Clearly such uncertainty would be unnerving.
From My Perspective
It's understandable that the collaborative spirit of the RoundTable was not necessarily felt by all. Some participants felt that the dental community has failed to "step up to the plate" and take sufficient responsibility for TMD care. "It takes everything I've got to sit in these meetings and not scream," Kalinowski explained. "The anger I recently experience over what happened to me because of the failure of [the FDA] to do its job caught me by surprise. I tried to tell myself that nobody here would have done that and pretended like it never happened."
The TMJ Patient RoundTable was fundamentally organized to explore ways to improve TMJ implant treatment outcomes and bring all stakeholders to the table with a patient-led focus. I cannot and do not claim to speak on behalf of the dozen or so other patient advocates who traveled hundreds or thousands of miles to be present at the RoundTable. The physical distance traveled fails to speak to the days of recovery that would be followed for many just to be present for a few hours at this meeting. And the money spent by patients who are treatment poor. But we're not just TMJ patients. We're programmers and teachers and medical device testers. We laughed and gossiped and swapped stories over our soups and smoothies during the lunch break.
The outrage felt in the TMJ community-at negligent practices, at a failure of regulatory systems, or at the genetic lottery-is very real, and it would be a waste of our shared human experience not to use this raw emotion for good. We need to protect the next generation of patients from these preventable tragedies. Trust needs to be rebuilt from within the medical and dental communities, starting with a patient-centered approach to treatment. Kalinowski, who left the RoundTable early because she was feeling very sick, questioned how well her needs were heard. The science is essential and necessary, but so too should the patient's needs be held at the forefront.
While a TMD cure may not reveal itself overnight, consider what the committed patient advocates at The TMJ Association has (almost) single-handedly accomplished over the last 30 years, and continues to accomplish. If anyone's going to crack this puzzle, it is going to be a collaborative unit that doggedly persists in the goal of giving TMJ patients what they need. Hope.