The device was invented by Tennessee dentist Steve Galella, DDS, leader of Facial Beauty Institute Research in Collierville, Tenn.
In addition to nonsurgical jaw expansion, Dr. Galella claimed AGGA could cure sleep apnea and temporomandibular joint dysfunction; however, a joint CBS and KHN investigation found no peer-reviewed study to back these claims.
Though court records say more than 10,000 patients have been fitted with AGGA, the investigation found that the product has not been evaluated by the FDA.
The investigation found that at least 20 people have sued Dr. Galella and others over the damage caused by the AGGA treatment. In their lawsuits, the plaintiffs do not allege that Dr. Galella treated them but that he or his company consulted with their dentists about their AGGA treatment, according to the report.
Dr. Galella’s attorney told CBS that the device, “when properly used, is safe and can achieve beneficial results for the patient.”
