FDA looks into dental device after KHN-CBS News investigation of patient harm

Anterior Growth Guidance Appliance, or AGGA, has been fitted on more than 10,000 dental patients.

Multiple lawsuits allege the appliance caused grievous harm to patients.

A former FDA official says the FDA has begun looking into the product.

The FDA declined to comment on the AGGA or confirm whether it was evaluating the device.

At least 20 AGGA patients have filed lawsuits in the past three years claiming the device did not work.

Plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Attorneys for Galella and his company, Facial Beauty Institute, have denied liability in court.