Federal prosecutors have launched a criminal investigation after at least 20 lawsuits were filed by patients who were harmed by the Anterior Growth Guidance Appliance (AGGA) dental device.
The criminal investigation was revealed in a court motion that was filed by the U.S. Attorney’s Office for the Western District of Tennessee and the U.S. Department of Justice.
The investigation will likely result in criminal charges and the presentation of evidence to a grand jury.
The defendants include John’s Dental Laboratory Inc., OrthoMatrix Corp., Steve Galella DDS., and LVI Global LLC.
The AGGA device (also called the Osseo-Restoration Appliance) is a retainer-like device that uses metal wires to put pressure on the front teeth and upper palate. It is being advertised by some dentists to cure common ailments like sleep apnea, and “remodel” a person’s jawline.
Unfortunately, many patients have reported tooth loss and facial disfigurement when the device pushed their front teeth out of position.
On March 30, the FDA announced that it was evaluating safety concerns with AGGA devices and other non-removable palate expanders.
The agency was specifically concerned that these products were being marketed for adults to remodel the jaw or treat other conditions, when they were originally designed for children.
In children, AGGA devices can gradually remodel the jaw and/or palate as the bones naturally grow — but in adults, where bone growth has stopped, the devices can push teeth out of their sockets and cause other complications, including chronic pain, disfigurement, flared teeth, gum damage, and more.