A Tennessee dentist who has been sued by multiple TMJ and sleep apnea patients over an unproven dental device he invented has said under oath that he never taught dentists to use the device for those ailments — contradicting video footage of him telling dentists how to use it.
Steve Galella, the inventor of the Anterior Growth Guidance Appliance, or “AGGA,” has said in court depositions that his device had been used on about 10,000 patients, and that he trained many dentists to use the AGGA in classes around the U.S. and overseas.
At least 23 patients, some of whom described being desperate for relief from sleep apnea or temporomandibular joint disorder (TMJ), have sued Galella in recent years claiming that the AGGA damaged their mouths and, in some cases, caused tooth loss. Galella denied wrongdoing in those lawsuits and has settled almost all of them within the past few months.
Galella was deposed before he settled the largest of those lawsuits. According to a deposition transcript recently obtained by KFF Health News and CBS News, Galella said under oath that he had not represented that the AGGA could treat or cure TMJ or sleep apnea.
Video footage tells a different story.
Galella repeatedly references treating TMJ and sleep apnea patients with the AGGA, sometimes in conjunction with other devices, in footage from a training session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.
At one point in the footage, Galella can be seen displaying two versions of the AGGA to the dentists, pointing to one he says is preferred by “TMJ and sleep patients” — and then saying, “And I give it to them.”
“Can you cure TMJ? Yes,” Galella told dentists as his 2017 training began, according to the footage. “Can you cure mild to moderate sleep apnea? Yes.”
The AGGA, which Galella recently rebranded as the Osseo-Restoration Appliance, resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. This year, after a joint investigation by KFF Health News and CBS News reported allegations of patients harmed by the AGGA, the FDA and the Department of Justice opened investigations into the device.
Dentists across the country have promoted the AGGA on their websites, often claiming it can “grow,” “remodel,” or “expand” an adult’s jaw without surgery, sometimes saying it has the potential to make patients more attractive and to treat common ailments like TMJ and sleep apnea, which afflict millions of Americans. Galella has said in depositions and video footage that the AGGA causes the bones in an adult’s jaw to “remodel” forward, reshaping their face.
The 2017 video footage contains other examples of Galella teaching dentists to treat TMJ and sleep apnea patients with the AGGA, which he sometimes calls a “growth appliance.” In one segment,
