Federal prosecutors have launched a criminal investigation into the Anterior Growth Guidance Appliance, or “AGGA” dental device, following a recent KFF Health News-CBS News investigation, according to a motion filed in federal court.
Multiple lawsuits allege the device has caused grievous harm to at least 20 patients and the FDA is now investigating its safety, KFF Health News and CBS News have reported.
The AGGA is a retainer-like device promoted by some 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 criminal investigation of the use of the AGGA was revealed in a court motion that seeks to delay the largest of the lawsuits "pending the outcome of any criminal proceedings." The motion was filed this month by attorneys for AGGA inventor Dr. Steve Galella, his company, the Facial Beauty Institute, and AGGA manufacturer Johns Dental Laboratories, who said the investigation is being conducted "for the purpose of potentially bringing criminal charges" against their clients.
The attorneys said in their court filing that there is "no doubt" the investigation arose at least in part by the KFF Health News-CBS News coverage of the AGGA.
"The U.S. Attorney's Office for the Western District of Tennessee and the U.S. Department of Justice is currently conducting a criminal investigation which, it is anticipated, will ultimately result in the presentation of evidence to a grand jury relating to the facts in this case," the attorneys state in the court filing in support of the motion.
None of the court records suggests what criminal charges could result from the investigation.
The U.S. Attorney’s Office in Memphis, which generally does not discuss ongoing investigations, declined to comment. Scott Charnas, an attorney representing many AGGA patients, also declined to comment. Attorneys for Galella, the Facial Beauty Institute, and Johns Dental did not respond to requests for comment on Tuesday.
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. Galella has said pressure from the device causes an adult's jaw to "remodel" forward, which he described, in training footage produced in discovery in an AGGA lawsuit, as the key to possibly "curing" patients and making them more beautiful.
"You can sell good health. You can help people and at the same time you're going to make a wheelbarrow full of money," Galella tells dentists in the video footage. "And it's all OK, and it's all fair. We're not cheating anybody and we're not being greedy, but that just comes with the territory."
The KFF Health News-CBS 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. Galella has said in a sworn court deposition that the device was never submitted to the FDA, which he believes wouldn't have jurisdiction over it.
The FDA announced late last month that it is "evaluating safety concerns" about the AGGA and other similar devices.
Galella has declined to be interviewed by KFF Health News and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA, "when properly used, is safe and can achieve beneficial results."
All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings.
The plaintiffs do not allege in their lawsuits that Galella treated them but allege he or his company consulted with each of their dentists about their AGGA treatment.
CBS News producer Nicole Keller contributed to this article.
This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.