A Tennessee dentist, Steve Galella, has invented and trained dentists to use a dental device called the Anterior Growth Guidance Appliance (AGGA) for TMJ and sleep apnea conditions. However, he has been sued by multiple patients claiming harm and tooth loss due to the device. Galella has settled almost all the lawsuits and rebranded the AGGA as the Osseo-Restoration Appliance, despite the device being investigated by the FDA and DOJ. Galella denied claims of representing the device as a cure for TMJ but video footage contradicts his statement. The invention of AGGA has raised concerns among dental specialists due to insufficient evidence of its safety and effectiveness. Subpoena, criminal charges, and ongoing investigations into AGGA safety, patient harm, and lack of FDA approval have raised further doubts. Galella’s lawyers are confident in the usage of AGGA, but interviews and research papers with dental specialists reveal an increasing number of patients being harmed by the device due to the lack of bone support for their teeth. Finally, the Department of Justice investigates the AGGA for its safety concerns, patient harm, and the marketing practices used by Galella and the manufacturer, Johns Dental.
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