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/
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.