FDA says it never inspected lab that made controversial device intended to fix patients’ jaws

Documents show a dental lab that made a device that was supposed to help patients with TMJ jaw disorder was never inspected by the FDA before a CBS News and KFF Health News investigation. Numerous patients have said the “anterior growth guidance appliance,” or AGGA, damaged their mouths. The device’s inventor, dentist Dr. Steve Galella, claimed it could cure TMJ jaw disorder and sleep apnea. The device and its inventor are under criminal investigation. They have denied wrongdoing. Anna Werner reports.