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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