In the wake of a KHN-CBS News investigation, the FDA on Thursday said it is “evaluating safety concerns” over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients.
The federal agency told the public in a “safety communication” posted on its website that it is looking not only at that product, the Anterior Growth Guidance Appliance, or AGGA, but other similar dental devices as well, including the Anterior Remodeling Appliance, or ARA, identified in a recent KHN and CBS News article.
The FDA said it is “aware of reports of serious complications with use of these devices” and asked that patients and health care providers report any complications experienced with them to the agency.
