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New Report on Temporomandibular Disorders: Priorities for Research and Care

Over a year and half ago, the National Academy of Medicine (NAM) began the most comprehensive study ever undertaken on Temporomandibular Disorders (TMD). The study assessed the current state of TMD research, education and training, the safety and efficacy of clinical treatments, and associated burden and costs.

Statement by NIDCR Acting Director on the National Academies of Sciences, Engineering, and Medicine Report on Temporomandibular Joint Disorders

I am pleased to announce the release of the National Academies of Sciences, Engineering, and Medicine (NASEM) report, Temporomandibular Disorders: Priorities for Research and Care. As underscored by the comprehensive report, temporomandibular joint disorders (TMJDs) are a diverse and still poorly understood set of complex, painful conditions affecting the jaw muscles and tissues, temporomandibular joints, and associated nerves. Clearly, there is much more to be understood, and these conditions continue to confound medical and dental health care providers and researchers.

Have you seen the film Dark Waters?

The Film. Dark Waters is about attorney Robert Billott's real-life 20 year legal battle against DuPont chemical for releasing toxic waste - perfluorooctanoic acid, or PFOA - into Parkersburg, West Virginia's water supply, with devastating health effects on the townspeople and livestock. PFOA, also known as C8, is a man-made chemical. It is used in the process of making Teflon and similar chemicals known as fluorotelomers.

Online TMD Diet Diary Research Project

Online TMD Diet Diary Research Project The TMJ Association received the following request from Professor Justin Durham and his research team at Newcastle University. We encourage TMJ patients to participate in this project as it is an under researched

Drug Induced Bruxism

The authors of this article state that orofacial movement disorders (bruxism) are treated typically by dental professionals and not by those specialists (neurologists) researching and treating the other movement disorders (Parkinson's disease, Huntington's disease, tremors, etc.). Again, this is more evidence of the complexity of TMD and the need for multidisciplinary research and treatment in TMD.

TMJ Implant Devices - 510(k) Process

  • Dec 21, 2017

The Institute of Medicine (IOM) of the National Academy of Sciences was commissioned by the Food and Drug Administration (FDA) to evaluate the 510(k) clearance process for medical devices and to make recommendations directed toward improving regulation of these devices. The IOM is a widely respected organization that assembles experts to study a range of health-related issues, often at the request of government agencies.

The 510(k) process allows manufacturers to market new devices without clinical testing for safety and efficacy if they were shown to be "substantially equivalent" to devices marketed before passage of the 1976 Medical Devices Amendment Act. As a result, many TMJ patients had devices made of synthetic materials, for example, silicone and Proplast-Teflon, which broke down and caused serious complications.

In 2011 The TMJ Association (TMJA) submitted a written statement to Congress concerning TMJ implant devices and the FDA’s 510k approval process. Additionally, Terrie Cowley, President of The TMJA, attended the April 13, 2011, Senate Congressional Hearing entitled, "A Delicate Balance: The FDA and the Reform of the Medical Device Approval Process." We encourage you to read the TMJA’s written statement and summary and recommendations submitted and included in the Congressional Hearing.

The IOM’s report on medical devices was released, on July 29, 2011. In the report the IOM committee concluded that the 510(k) process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one."

The FDA released a statement in response to the IOM's recommendation to scrap the 510(k) process. “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. FDA is now seeking public comments through a Federal Register notice. The TMJA submitted comments on the 510(k) process concerning TMJ implants and encourages patients to do so as well.

TMJ Disorders

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In Treating TMJ

To view or order a free booklet about TMJ Disorders, visit the National Institutes of Health website.

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National Institutes of Health
National Institute of Dental and Craniofacial Research
Office of Research on Women's Health