Federal prosecutors launched a criminal investigation into a device some patients say damaged their teeth.
Multiple lawsuits allege the device has caused grievous harm to at least 20 patients andThe AGGA is a retainer-like device promoted by dentists as an option for expanding adult patients' jawbones, beautifying their faces, and curing common ailments like sleep apnea. The lawsuits have alleged patients suffered damaged gums, eroded bone, and, in some cases, lost teeth.
The attorneys said in their court filing that there is"no doubt" the investigation arose from the investigations by CBS News and KFF Health News. Dr. Steve Galella, the inventor of the AGGA device, near his clinic in the Memphis suburbs on Feb. 9, 2023. The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021.
The CBS News-KFF Health News 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 others — and dental specialists who said they'd examined patients who had experienced severe complications using the AGGA. The investigation also found no record of the AGGA being registered with the FDA, despite the agency's role in regulating medical and dental devices.
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