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Dental Device Investigation
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.
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.
The FDA’s interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.
Brett Kelman
Anna Werner, CBS News
David Hicks
Lydia Zuraw
Eric Harkleroad
Oona Tempest
John Hillkirk
Kelly Johnson
Terry Byrne
Gabe Brison-Trezise