FDA Evaluating Safety Concerns About Unapproved Devices Used for Sleep Apnea, TMJ

The Food and Drug Administration (FDA) issued an alert indicating that the agency was investigating the unapproved use of certain dental devices for obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMJ) in adults. The specific devices under investigation are fixed palatal extenders, which are used to remodel the jaw in adults, including the following:

• 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)
• Any other similar device type

As part of this investigation, the FDA is following up on reports of serious complications from the use of these devices, such as mouth pain, dislocated teeth, flared teeth, uneven bite, difficulty with eating, gum damage, bone erosion, and tooth loss. Problems have not been reported for the use of these devices in children and adolescents.

The statement issued by the FDA indicated that these devices have not been cleared for use to treat OSA and TMJ and that the safety and efficacy of the devices have not been established.

Individuals and healthcare providers are asked to report any issues with these devices by contacting the FDA: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

The agency will continue to provide updates about their ongoing investigation.