Lawsuits Claim Dental Device Used on Patients Without FDA Approval Has Ruined Teeth


A dental device claiming to fix patients’ jaws and breathing is amidst many patient lawsuits as it was not evaluated by the FDA and resulted in many wrecked teeth, according to a joint investigation by KHN and CBS News.

“More than 10,000 dental patients have been fitted with an Anterior Growth Guidance Appliance, or ‘AGGA,’ according to court records,” reported KHN. Patients believed this appliance would not be available if it had not been approved by the FDA; however, investigations show the device was never submitted.

One patient, Boja Kragulj, an accomplished clarinetist, has already needed to have four teeth removed and is expected to need many more surgeries going forward. Kraguli claims she can no longer play clarinet, losing her source of livelihood.

Read more about this case from KHN.