Feds launch legal investigation into ‘AGGA’ dental system and its inventor

Federal prosecutors have launched a legal investigation into the Anterior Progress Steering Equipment, or “AGGA” dental system, following a latest KFF Well being Information-CBS Information investigation, in keeping with a movement filed in federal court docket.

A number of lawsuits allege the system has prompted grievous hurt to at the least 20 sufferers and the FDA is now investigating its security, KFF Well being Information and CBS Information have reported.

The AGGA is a retainer-like system promoted by some dentists as an possibility for increasing grownup sufferers’ jawbones, beautifying their faces, and curing widespread illnesses like sleep apnea. The lawsuits have alleged sufferers suffered broken gums, eroded bone, and, in some instances, misplaced enamel.

The legal investigation of the usage of the AGGA was revealed in a court docket movement that seeks to delay the most important of the lawsuits “pending the end result of any legal proceedings.” The movement was filed this month by attorneys for AGGA inventor Dr. Steve Galella, his firm, the Facial Magnificence Institute, and AGGA producer Johns Dental Laboratories, who stated the investigation is being carried out “for the aim of doubtless bringing legal fees” towards their shoppers.

The attorneys stated of their court docket submitting that there’s “little doubt” the investigation arose at the least partly by the KFF Well being Information-CBS Information protection of the AGGA.

“The U.S. Lawyer’s Workplace for the Western District of Tennessee and the U.S. Division of Justice is at the moment conducting a legal investigation which, it’s anticipated, will in the end consequence within the presentation of proof to a grand jury regarding the details on this case,” the attorneys state within the court docket submitting in help of the movement.

Not one of the court docket information suggests what legal fees might consequence from the investigation.

The U.S. Lawyer’s Workplace in Memphis, which typically doesn’t focus on ongoing investigations, declined to remark. Scott Charnas, an legal professional representing many AGGA sufferers, additionally declined to remark. Attorneys for Galella, the Facial Magnificence Institute, and Johns Dental didn’t reply to requests for touch upon Tuesday.

The AGGA, which was lately rebranded because the Osseo-Restoration Equipment, makes use of springs to use strain to the entrance enamel and higher palate, in keeping with a patent utility filed in 2021. Galella has stated strain from the system causes an grownup’s jaw to “transform” ahead, which he described, in coaching footage produced in discovery in an AGGA lawsuit, as the important thing to probably “curing” sufferers and making them extra stunning.

“You possibly can promote good well being. You possibly can assist folks and on the identical time you are going to make a wheelbarrow full of cash,” Galella tells dentists within the video footage. “And it is all OK, and it is all truthful. We’re not dishonest anyone and we’re not being grasping, however that simply comes with the territory.”

The KFF Well being Information-CBS Information investigation of the AGGA concerned interviews with 11 sufferers who stated they have been harm by the system — plus attorneys who stated they signify or have represented at the least 23 others — and dental specialists who stated they’d examined sufferers who had skilled extreme problems utilizing the AGGA. The investigation additionally discovered no report of the AGGA being registered with the FDA, regardless of the company’s position in regulating medical and dental gadgets. Galella has stated in a sworn court docket deposition that the system was by no means submitted to the FDA, which he believes would not have jurisdiction over it.

The FDA introduced late final month that it’s “evaluating security issues” concerning the AGGA and different comparable gadgets.

Galella has declined to be interviewed by KFF Well being Information and CBS Information. His legal professional, Alan Fumuso, beforehand stated in a written assertion that the AGGA, “when correctly used, is secure and may obtain helpful outcomes.”

All of the AGGA lawsuits are ongoing. Galella and the opposite defendants have denied legal responsibility in court docket filings.

The plaintiffs don’t allege of their lawsuits that Galella handled them however allege he or his firm consulted with every of their dentists about their AGGA remedy.

CBS Information producer Nicole Keller contributed to this text.