The Food and Drug Administration (FDA) has issued a safety communication regarding the use of fixed palate expanders on adults to remodel the jaw or to treat conditions.
These dental devices, which include the Anterior Growth Guidance Appliance, the Fixed Anterior Growth Guidance Appliance, the Anterior Remodeling Appliance, the Fixed Anterior Remodeling Appliance, the Osseo-Restoration Appliance and the Fixed Osseo-Restoration Appliance, have not been established as safe or effective, nor have they been cleared or approved by the FDA, to treat conditions such as obstructive sleep apnea or temporomandibular joint disorder of the jaw, or to remodel the jaw in adults.
Use of fixed palatal expansion devices in adults has been reported to lead to serious complications, including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. As such, the FDA will be investigating these safety concerns and will provide additional information as it becomes available.
The Agency is currently unaware of any safety concerns related to the use of palate expanders in children. These devices are used during orthodontic treatment in pediatric patients whose upper jaw bones are not yet fused.
Any device problems should be reported to the FDA’s MedWatch program.
Evaluation of safety concerns with certain dental devices used on adults – FDA Safety Communication. US Food and Drug Administration. Accessed March 30, 2023. https://www.fda.gov/medical-devices/safety-communications/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication