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.
Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the AGGA, now trains dentists to use another device it has described as “almost exactly the same appliance.” That one is called the Anterior Remodeling Appliance, or ARA.
The FDA’s interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.
Tenenbaum said that after KHN and CBS News published their report, she was contacted by “very concerned” FDA officials who said they have begun “looking into” the AGGA but have yet to determine how much legal authority the agency has to regulate it.
“The FDA is looking at what authorities they may have around this device — what they may be able to do,” Tenenbaum said. “Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”
Cara Tenenbaum is a former senior policy adviser in the FDA’s device center. Tenenbaum says the FDA has begun looking into the Anterior Growth Guidance Appliance, or …