It’s taken persistence and too much time, but on June 16th of this year your TMJ Association, working with the Food and Drug Administration (FDA), led the first-ever RoundTable bringing together all those concerned with TMJ implants: patients, providers, manufacturers, regulators, researchers, and policymakers. The meeting was held under the auspices of MDEpiNet − a Public Private partnership working to improve patient-centered outcomes for medical devices, wherever they are used in the world, through better data gathering and analysis, the use of appropriate methodologies, and by conducting research studies. The meeting was hosted by the FDA’s Center for Devices and Radiological Health at FDA headquarters in Maryland.
The need for the RoundTable grew out of conflicting reports on TMJ implants. Device manufacturers and surgeons have claimed that patients get better after receiving implants. But comments from FDA’s MedWatch system, as well as what has been circulating on social media and what we hear at The TMJ Association tell a different story. Many patients say their pain and jaw dysfunction has gotten worse; some developed infections and sensitivity to metals or other materials. Often patients have required additional surgeries or other treatments. There have also been reports of systemic problems that have developed, such as autoimmune disorders. In more than a few cases, patients have been rendered totally disabled.
Unfortunately, at this stage of TMJ science there are no telltale tests or specific kinds of patient data to indicate who will benefit from an implant and who will not. Further, when patients do experience adverse events following implant placement, the news is seldom reported in the published professional literature. (See background)
After Terrie Cowley, TMJA President and a member of MDEpiNet, brought this background information to MDEpiNet colleagues, plans for a TMJ Patient RoundTable were born. And, interestingly, this time the response from all stakeholders was dramatic: “We were overwhelmed by the numbers and stature of professionals who expressed enthusiasm about participating,” Cowley said.
The Meeting Itself
At the outset of the June 16th meeting three long-term goals were announced (click here to view detailed goals):
As co-chair of the RoundTable, Cowley welcomed participants explaining how the idea for the RoundTable had developed, but has now expanded. Not only would the project examine issues with regard to jaw implants, the RoundTable would also explore the evidence underlying other TMD treatments and decisions that lead to implant surgery. These studies will necessarily encompass research to understand the role of genetics, physiology, sex, biology and behavior in the development of TMD in pre- and post-implant patients. It will even include the state of TMD professional education, protocols, and standards-of-care among the health professions.
Following Cowley’s introduction, co-chair Dr. Benjamin Eloff, Senior Scientific Program Manager in the Division of Epidemiology in the Center for Devices and Radiological Health at FDA, discussed the format and structure of the meeting. He remarked that since everyone in the room could lay claim to being a TMJ expert; all titles were to be left at the door.
Dr. Suzanne Schwartz, Associate Director for Science and Strategic Partnerships in the Center for Devices and Radiological Health at FDA, was the first of several speakers who focused on patient-centeredness. She stated that a patient’s life experiences must be integral to the regulatory decision-making process. Incorporating real-world experience is critical to that effort and the FDA is committed to that level of patient engagement. Dr. Danica Marinac-Dabic, Director of the Division of Epidemiology in the Center for Devices and Radiological Health at FDA, echoed Dr. Schwartz’s message on the importance of developing outcome assessment and reporting tools based on patient input. In turn, Hugo Campos, Stanford Medicine X ePatient Advisor, White House Champion of Change for Precision Medicine, stressed the need to empower patients to engage with clinicians. “Patients are very interested in receiving information about their devices,” he said. “Transparency is expected and is driving patient engagement.”
Views from Industry and Providers
Dr. Brian Hatcher, Director of Research at Zimmer/Biomet, said that they typically do not work with patients but with oral surgeons. However, their presence at the RoundTable was an indication that they wanted to listen and learn. He expressed the company’s excitement about this opportunity and said they were looking forward to discovering how they can do things better.
Dr. Peter Quinn, a representative of the American Society of Temporomandibular Surgeons, provided the oral surgeon’s perspective, noting that the TM joint is the most complex joint in the body. He focused on the physiological complexity of TMD patients, the many patients who experience comorbid pain conditions and other medical problems. He said that it is difficult to get clinicians to adopt protocols, and reviewed the problematic history of TMJ implants over the decades. He concluded that “we are in a better place and have better science today.”
The Patients Speak
Eight TMD patients presented their cases in the next session. Seven patients described symptoms and how that led to a variety of dental treatments culminating in TMJ implants. One of the participants, the mother of a young TMJ patient who is faced with the prospect of having TMJ implant procedures for the first time, decried the lack of credible information and conflicting professional opinions, leading to her concerns and fears about making a decision. All expressed concerns about the current TMD treatment system and the need for change. One patient succinctly summarized the issues facing implant patients.
Some of the concerns voiced by the patients were:
The above lists of adverse events and other issues important to TMJ patients is not all inclusive.
The afternoon session opened with comments from Dr. Pamela Scott, Deputy Director and Director of Research and Development in the Office of Women’s Health at FDA, who announced that TMD was now within the FDA Women’s Health Issues. She was grateful for the opportunity to participate in the meeting and learn about TMD.
Dr. Martha Somerman, Director of the National Institute of Dental and Craniofacial Research (NIDCR), highlighted how the institute has invested in research on TMD, especially in relation to the goals of the RoundTable to explore patient biology, anatomy, genetics and physiology and use systems biology to define the contribution of these various physical systems to these conditions. She underscored the disconnect between dentistry and medicine and lamented that developing TMJ science is “taking too long.”
The speakers in the remainder of the afternoon session focused on current findings with regard to the state of TMD science, chronic pain, surgery/device failure mechanisms, and resources/capabilities using big data. Dr. John Kusiak, Acting Deputy Director at NIDCR, summed up the session proposing research directions including advancing phenotyping and diagnostics of the disorders, behavioral research, micribiota studies (oral microbiomes, infections, biofilms, etc.), overlapping chronic pain conditions, immune system–inflammation, infection, neuro-immune interactions, sex differences, big data and data science, tissue engineering, and toxicity and implant failure.
In the last session Dr. Elise Berliner, Director of the Technology Assessment Program at the Center for Outcomes and Evidence in the Agency for Healthcare Research and Quality (AHRQ), encouraged patients to keep sharing their stories because they can usefully direct scientists and practitioners. She pointed out that the one stakeholder who was not in the room was the one who pays for care. Payers needed to be included as they also will benefit from this project. There is a need for really robust data collection, she emphasized, and suggested resources to contact for collaboration. She offered AHRQ’s resources in developing a registry and patient outcome data.
Dr. Gregory Ness, representing the American Association of Oral and Maxillofacial Surgeons, discussed incorporating patient-centered outcomes into TMJ device studies. While acknowledging the value of precision medicine, he said we first need to ensure evidence-based medicine. Regarding the past history of devices, Dr. Susan Runner, Branch Chief Dental Devices in the Center for Devices and Radiological Health at FDA stated, “If there was to be another TMD device study today, the outcomes would be very different, as the FDA is now committed to working with the patient population in developing patient-centered outcomes.” Danica Marniac-Dabic concluded the session with recommendations for the development of a registry in partnership with AHRQ and other stakeholders.
In concluding the meeting, Ben Eloff and Terrie Cowley thanked participants and indicated an immediate next step: to develop working groups to address the issues raised at the meeting.