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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.

FDA Orders Postmarket Surveillance of TMJ Implant Devices

  • Dec 21, 2017

This morning The TMJ Association received a call from Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health, of the Food and Drug Administration (FDA) advising us of the FDA's action on TMJ implant devices. Terrie Cowley, President of The TMJ Association, met with Dr. Shuren in July of 2010 and discussed device issues that TMJ implant patients brought to our attention.

Dr. Shuren also sent the following FDA News Release.

FDA NEWS RELEASE

  • For Immediate Release: Feb. 7, 2011
  • Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
  • Consumer Inquiries: 888-INFO-FDA

FDA orders postmarket surveillance of certain TMJ implants

Agency wants data on length of time before removal, replacement

Today the U.S. Food and Drug Administration ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons. The TMJ connects the lower jaw (mandible) to the temporal bone in the skull. A person may have an implant to replace the socket in the temporal bone or the rounded edge of the lower jaw that glides in the temporal bone socket because of an injury, arthritis, physical abnormality, or lost mobility.

The three manufacturers, TMJ Solutions, TMJ Medical, and Biomet Microfixation, make all of the currently approved TMJ devices marketed in the United States. The companies will have 30 days to submit a study plan which will need to be approved by the agency before any postmarket studies can begin.

TMJ implants also can be used to treat temporomandibular disorder (TMD) that has not responded to more conservative treatments such as limiting jaw movement, soft diet, jaw splint or adjustments, medicine to reduce pain, or physical therapy. The FDA analyzed TMJ implant-related adverse event reports submitted between April 30, 2004 and Aug. 17, 2010. The analysis described a substantial number of patients who had implants replaced within three years or less after implantation because of extreme pain. This is considerably shorter than the expected minimum five-year life span of the device, based on premarket mechanical testing.

The FDA is not recommending any changes on use of the implants. The agency may revise its recommendations or issue other recommendations after reviewing additional clinical data from the studies. Patients who have or are considering a TMJ implant should consult with their health care professional.

TMJ implant manufacturers were required to collect postmarket data on their implants as part of the approval process. However, the data collected did not adequately address the timing or reasons for replacement, and the studies lost contact over the years with many of the enrolled patients.

  • The TMJ implant postmarket surveillance studies must address the following: Time between initial implant and removal/replacement
  • Association between patient diagnosis and the timeframe between implant and removal/replacement
  • For replacement implants, the time between implant and subsequent removal/replacement
  • Reasons for removal/replacement of the implant
  • Associations between patient demographic and clinical data and the need or removal/replacement

Assessment of devices that have been removed from patients As part of its review, the FDA will consider whether labeling changes, additional preclinical and clinical testing requirements, or other regulatory actions are necessary for these devices. For more information:

522 Postmarket Surveillance Studies

522 Postmarket Surveillance Studies – Frequently Asked Questions


The TMJ Association has been approached by media outlets and our comment is as follows: The TMJ Association is pleased that FDA took this action. As a GAO report and research conducted by an investigative reporter of the Milwaukee Journal Sentinel revealed, those who receive TMJ implants do not have the benefit of scientifically based information regarding their implants. This FDA action is long overdue. In fact, this information should have been obtained before approving these devices. We can only hope that calling for this post-market surveillance data will finally reveal whether these devices are safe and effective and ultimately who, indeed, these devices actually help.

Patient safety should be the ultimate goal of device manufacturers, surgeons and especially the FDA and we applaud this action which we can only hope leads to more credible information on TMJ devices and the health of the patient.

TMJ Disorders

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