The FDA is evaluating safety concerns with unapproved dental devices after receiving "reports of serious complications," the agency said March 30.
The devices are fixed palatal expanders marketed to remodel the jaw, and treat sleep apnea and a jaw joint disorder, the FDA said. The "devices of concern" are:
- Anterior Growth Guidance Appliance
- Fixed Anterior Growth Guidance Appliance
- Anterior Remodeling Appliance
- Fixed Anterior Remodeling Appliance
- Osseo-Restoration Appliance
- Fixed Osseo-Restoration Appliance
Issues from the products include chronic pain, tooth dislocation, difficulty eating, tooth loss, damaged guns, bone erosion, flared teeth, uneven bite and exposed roots.
Thousands of people have used these devices, according to an investigation by Kaiser Health News and CBS News. Numerous lawsuits have been filed concerning these devices, which have been fitted on more than 10,000 dental patients, CBS News reported March 31.
The FDA asked patients and providers to report complications with any of these devices so it can "identify and better understand the risks."