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  • Jun 8, 2017

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 Background

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):  

  1. Develop outcome assessment and reporting tools based on patient input.
  2. Explore the multidisciplinary intersection of patient biology, anatomy, genetics, and physiology with TMJ medical devices and clinical patient-centered outcomes in order to better target therapies toward the patients most likely to benefit from them.
  3. Develop evidence to incorporate patient-centered data into clinical care.

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.

Patient-Centeredness

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:   

  • TMD Treatments
    • No comprehensive medical care or service lines to address the many related medical needs of TMJ patients
    • Treatments for TMJ and treatments for routine dental work can cause or exacerbate the condition
    • Dentists look specifically at the treatment/surgical procedure to the neglect of the entire patient, including pre-existing conditions and previous surgical failures
    • TMJ treatment plans will differ with each provider seen
    • No protocols exists for pre, during, and post-surgical/implant procedures
    • Compared to infection protocols for other joint devices, those for TMJ are non-existent and patients are treated haphazardly
    • No protocols exist for diagnosis and treatment for device-related infections
    • No protocols exist for diagnosis and treatment of sensitivity to device materials
    • Patients and their psychological state are frequently blamed for their TMJ problems
    • There is a reluctance to address complications of either conservative or surgical treatments
    • There is no formal venue to record the medical conditions patients develop over time following TMJ implantation
    • Patient abandonment is not uncommon
    • Professional organizations have shirked their fiduciary responsibility to put the patient’s interests before that of their paying members
  • Quality of Life
    • We grieve the loss of our old selves, who we used to be, and what we used to do -- our dreams, our careers, family plans, and our hopes for the future
    • Our face changes dramatically from one surgery to another and even with a shifting bite. We no longer recognize ourselves in the mirror. Our teeth break. We have facial paralysis. Our self-esteem is diminished; we feel shame and revulsion.
    • Our body image becomes distorted from weight gain from medications or only eating high-fat foods that are easiest to swallow and require no chewing. Or we lose weight because we can’t eat or have lost our appetite. Many patients exist on liquids or blended foods for years. As a result, we suffer from different digestive problems. Nutrition is a challenge for us.
    • We are self-conscious about eating and drinking in front of others and deliberately avoid eating out because the food falls out of our mouths. We have trouble chewing, swallowing, experience choking and drooling - all embarrassing.
    • We have difficulty speaking, pronouncing words, we lisp. We don’t talk on the phone because holding the phone to our face is painful.
    • Our family life is turned upside down. Elderly parents become our caretakers once again. Children “parent” us when they themselves need nurturing. Our loved ones live with the fear that we will die. And there are times we wish we would.
    • TMJ treatment is a money pit. TMJ is excluded or limited from insurance plans and controversy continues whether this is medical, dental or neither and treatment outcomes are lacking upon which to base coverage. This results in savings, children’s college funds, and pension funds being depleted. Bankruptcy is not uncommon.
    • There is stress on the marriage and family. This can lead to divorce or changing dynamics in the relationship.
    • Our unpredictability is predictable. If we make plans they often have to be cancelled with short notice as the condition waxes and wanes.
    • Travel is difficult. Flying causes excruciating ear and face pain and headaches that take days from which to recover. TMJ devices have been known to break in flight. Car rides are as difficult.
    • Changes in weather cause increased pain and flu-like symptoms. If you have a total joint device and live in a cold climate you develop frost bite on your face in the imprint of the device.
    • Our personal hygiene suffers – brushing your teeth is torturous, and having shower water touch your face or head is excruciatingly painful.
    • Libido is diminished; being kissed, having our face stroked, and actions involved in intimacy are painful.  Even receiving and expressing affection from and to friends and loved ones is prohibitive.
    • We live in constant fear of and are desperate for treatment options.
  • Pain Management
    • Pain was the primary symptom leading to TMJ treatments, yet the dental/surgical treatments to alleviate the pain only increased the pain.
    • Pain relief is seldom achieved.
    • Many pain clinics refuse to treat TMJ pain.
  • Device Oversight
    • FDA’s approval of TMJ devices is largely based on “the patients need something,” not on scientific evidence. FDA should not approve a device without the animal, bioengineering, biocompatibility, and clinical data that validates the safety and effectiveness of a device; should inspect facilities to determine that manufacturers are tracking TMJ implant patients; should rigorously monitor the MedWatch Database.
    • Because information on biomaterial TMJ joints is not evidence based; the adverse events, side-effects, systemic effects, are not documented in any credible manner, heretofore information on adverse events, even deaths, have either not been submitted to the manufacturer by the surgeon or the manufacturer to the FDA, it is impossible to have a credible assessment of a device’s performance and its impact on the health of the recipient.
    • FDA’s voluntary MedWatch system is dismal. Every problem is not reported and MedWatch reports are not analyzed on a regular basis to detect device problems.
  • Awareness & Education
    • The chasm between dentistry and medicine is detrimental to the health of TMJ patients.
    • No formal TMD education programs exist for dental professionals.
    • Surgeons are educated through “Hilton University” weekend TMD education seminars and have limited or infrequent experience with the procedures they perform, which lead to medical disasters.
    • No formal education programs on TMD exist for medical professionals.
    • There is no obvious awareness within medicine, dentistry, and the public of the severity of TMD.
    • Scientific evidence is lacking for diagnostics and treatments for initial consultations and ongoing TMD care.

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.

To view the June 16th agenda, click here.

TMJ Disorders

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