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Feds Launch Criminal Investigation into ‘AGGA’ Dental Device and Its Inventor

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Feds Launch Criminal Investigation into ‘AGGA’ Dental Device and Its Inventor

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(Oona Tempest/KFF Health News Illustration; Device Photo by Karan Gill

According to a federal court motion, federal prosecutors have opened a criminal investigation into the Anterior growth Guidance Appliance (or “AGGA”) dental device. This was in response to a recent KFF Health News/CBS News investigation.

Multiple lawsuits claim that the device caused grievous harm for at least 20 patients. CBS News and KFF Health News reported that the FDA is currently investigating the safety of the device.

The AGGA is a retainer-like device that dentists promote as a way to expand adult patients’ jawbones and beautify their faces. It also helps with common conditions like sleep apnea. Patients were alleged to have suffered from damaged gums and eroded bone. In some cases, they even lost their teeth.

A court motion seeking to delay the largest lawsuits concerning the AGGA was filed by the attorneys for Dr. Steve Galella, the Facial Beauty Institute and Johns Dental Laboratories. They stated that the investigation was being done “for the purpose potentially bringing criminal charges against their clients.”

In a court filing, the attorneys stated that there is no doubt that the investigation stemmed from the KFF News-CBS News coverage on the AGGA.

“The U.S. Attorney’s Office in the Western District of Tennessee is currently conducting a crime investigation that, it is expected, will ultimately lead to the presentation of evidence before a grand jury relating the facts in this matter,” the attorneys stated in a court filing supporting the motion.

None of the court records indicate what criminal charges might result from the investigation.

The Memphis U.S. Attorney’s Office, which does not normally discuss ongoing investigations, declined comment. Scott Charnas (an attorney representing many AGGA clients) also declined to comment. On Tuesday, Galella, Johns Dental, and the Facial Beauty Institute declined to comment.

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According to a 2021 patent application, the AGGA was rebranded as Osseo-Restoration Device. The device uses springs to apply pressure on the upper palate and front teeth. Galella claims that the device causes an adult’s jaw “remodel” forward when pressure is applied to it. This Galella described in training footage obtained in discovery in an AGGA lawsuit as the key to possibly “curing” patients and making them more beautiful.

“You can sell good healthcare. Galella tells dentists that you can help people while making a lot of money. It’s all okay, it’s fair. We aren’t cheating anyone and we aren’t being greedy, but that’s just part of the territory.”

Interviews with 11 patients who claimed they were injured by the AGGA were conducted by KFF Health News-CBS News. Also, attorneys said they represented or had represented at least 23 other people. And dental specialists said they’d seen patients who had suffered severe complications from the AGGA. The investigation also revealed that there was no record of the AGGA having been registered with the FDA despite its role in regulating dental and medical devices. Galella stated in a sworn court testimony that the device was not submitted to FDA. He believes that FDA wouldn’t have jurisdiction.

Late last month, the FDA announced that it was “evaluating safety concerns” regarding the AGGA and similar devices.

Galella declined to be interviewed for CBS News or KFF Health News. In a written statement, Alan Fumuso, Galella’s attorney, stated that the AGGA is safe and can produce beneficial results “when properly utilized.”

All AGGA lawsuits remain pending. Galella and other defendants denied liability in court filings.

Galella is not mentioned by the plaintiffs in their lawsuits, but they claim that he or his company discussed their AGGA treatment with each of their dentists.

Nicole Keller, a producer at CBS News, contributed to this article.

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