The U.S. Attorney's Office for the Western District of Tennessee and the U.S. Department of Justice have launched a criminal investigation into the Anterior Growth Guidance Appliance, a retainer-like device that claims it can expand the jaw without surgery, CBS and Kaiser Health News reported April 12.
The investigation comes on the heels of the FDA's March announcement that it is now evaluating safety concerns of fixed nonremovable palatal expanders such as the AGGA after the device was targeted in multiple lawsuits for allegedly causing severe damage to patients' teeth.
A court motion that seeks to delay the largest of the lawsuits until after the investigation was filed in April by the attorneys of the device's inventor Steve Galella, DDS; his company, the Facial Beauty Institute in Collierville, Tenn.; and AGGA manufacturer Johns Dental Laboratories, according to CBS and KHN. The parties said the investigation is being conducted "for the purpose of potentially bringing criminal charges" against their clients.
The court records do not state what criminal charges could come from the investigation, according to CBS and KHN.
CBS and KHN have extensively covered the lawsuits surrounding the device, which was recently rebranded to the Osseo-Restoration Appliance.