Dental Nightmares

Johns Dental Laboratories stopped making the Anterior Growth Guidance 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.

The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.

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.

A KHN and CBS News investigation found that a dental appliance called the AGGA has been used by more than 10,000 patients, and multiple lawsuits allege it has caused grievous harm to patients.

A dental device called AGGA has been used on about 10,000 patients without FDA approval or proof that it works. In lawsuits, patients report irreparable harm. The AGGA’s inventor and manufacturer have denied all liability in court.