The FDA is evaluating safety concerns of fixed nonremovable palatal expanders such as the Anterior Growth Guidance Appliance after the device was targeted in multiple lawsuits for allegedly causing severe damage to patients' teeth.
The Anterior Growth Guidance Appliance is a retainer-like device that claims it can expand the jaw without surgery as well as cure sleep apnea and temporomandibular joint dysfunction. There are no peer-reviewed studies to back these claims and the product has not been evaluated by the FDA.
CBS and Kaiser Health News have extensively covered the lawsuits surrounding the device.
The FDA is evaluating the Anterior Growth Guidance Appliance and Fixed Anterior Growth Guidance Appliance, the Anterior Remodeling Appliance and Fixed Anterior Remodeling Appliance, the Osseo-Restoration Appliance and Fixed Osseo-Restoration Appliance and other similar devices, according to a March 30 news release from the administration.