The investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA.
Lawsuits allege grievous harm to patients' teeth. The FDA's interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.
In the wake of a joint investigation by KHN and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the FDA has begun looking into the product, the Anterior Growth Guidance Appliance, or AGGA, according to a former agency official.
Boja Kragulj, an accomplished clarinetist who once performed with orchestras in New York, Philadelphia and Jacksonville, Florida, has already lost four teeth. And she expects to lose at least a dozen more.