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.
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.
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 thewhich has been fitted on more than 10,000 dental patients, according to court records. "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."
Photos of a 21-year-old man who has been affixed with an AGGA device and was examined by Dr. Kasey Li, a California maxillofacial surgeon. Li says images A and C show the patient at the start of his AGGA treatment and images B and D show the end, after the AGGA created gaps behind his canines.
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