![]() ![]() Plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.Īdditionally, CBS News and KHN reported that the Las Vegas Institute, a company that previously taught dentists to use the AGGA, now trains dentists to use another device its CEO has described as "almost exactly the same appliance." That one is called the Anterior Remodeling Appliance, or ARA.ĬBS News and KHN reached out Thursday to attorneys for Galella, the Las Vegas Institute, and the manufacturers of the AGGA and the ARA but received no immediate response. Steve Galella, has said in a sworn court deposition that the AGGA was never submitted to the FDA and that he believes the agency wouldn't have jurisdiction over it.Īt least 20 AGGA patients have in the past three years filed lawsuits against Galella and other defendants claiming the AGGA did not - and cannot - work. The AGGA's inventor, Tennessee dentist Dr. The FDA confirmed Thursday that the devices "are not cleared or approved by the FDA." The investigation found no record of the AGGA being registered with the FDA, despite the agency's role in regulating medical and dental devices. The CBS News-KHN investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device - plus attorneys who said they represent or have represented at least 23 other patients - and dental specialists who said they'd examined patients who had experienced severe complications using the AGGA. ![]()
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