CBS News and Kaiser Health News recently investigated one of the many temporomandibular disorder (TMD) treatments that are on the market and sold to patients without evidence of safety and efficacy. Professionals and the public routinely get misinformation about TMD treatments, and this investigation portrays the reality of what goes on in this area and the effect of these devices on the lives of TMD patients.
Dental patients complain of harm from an unproven dental device – Patients report irreparable harm by an unregulated dental device. An investigation by CBS News and Kaiser Health News found the device that allegedly left a trail of mangled mouths has not been reviewed by the FDA.
You can also read the Kaiser Health News article which is available at: https://khn.org/news/article/dental-device-lawsuits-displaced-teeth-agga-steve-galella/
The CBS Morning YouTube videos can also be viewed directly on CBS’s website at: https://www.cbsnews.com/news/criminal-investigation-agga-dental-device-and-its-inventor/
Report TMJ Splint-related Issues to the Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The devices of concern include:
- Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA),
- Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA),
- Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA), and
- Any other similar device types.
The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD) and remodeling the jaw in adults. However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.
The FDA is also aware of reports of serious complications with use of these devices. The FDA is asking patients, caregivers, and health care providers to report any complications with these devices to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The FDA is working to evaluate information from all available sources to provide additional information on this issue.
How to Report a Device Problem
Should you be experiencing ANY type of TMD device problem, including splints, it is important that you report these issues to the FDA through their MedWatch system.
Splints are known by a wide variety of names such as: intraoral appliance, stabilization appliance, occlusal appliance, interocclusal appliance, repositioning splint, bruxism splint, night guard, mouth guard, and others, with names denoting commercial vendors promoting particular designs.