AGGA

Johns Dental Laboratories stopped making the appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.

KFF Health News and CBS News recently reported that multiple lawsuits allege the device has led to grievous injuries to patients’ mouths, resulting in loss of teeth.

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.

The Anterior Growth Guidance Appliance has been used on about 10,000 patients without FDA approval or proof that it works. However, patients report irreparable harm. The inventor and manufacturer have denied all liability in court.