Home Men's Health ‘AGGA’ inventor testifies his dental machine was not meant for TMJ or sleep apnea

‘AGGA’ inventor testifies his dental machine was not meant for TMJ or sleep apnea

‘AGGA’ inventor testifies his dental machine was not meant for TMJ or sleep apnea


A Tennessee dentist who has been sued by a number of TMJ and sleep apnea sufferers over an unproven dental machine he invented has stated underneath oath that he by no means taught dentists to make use of the machine for these illnesses — contradicting video footage of him telling dentists use it.

Steve Galella, the inventor of the Anterior Progress Steerage Equipment, or “AGGA,” has stated in courtroom depositions that his machine had been used on about 10,000 sufferers, and that he educated many dentists to make use of the AGGA in courses across the U.S. and abroad.

Not less than 23 sufferers, a few of whom described being determined for aid from sleep apnea or temporomandibular joint dysfunction (TMJ), have sued Galella in recent times claiming that the AGGA broken their mouths and, in some circumstances, induced tooth loss. Galella denied wrongdoing in these lawsuits and has settled virtually all of them throughout the previous few months.

Galella was deposed earlier than he settled the most important of these lawsuits. In keeping with a deposition transcript lately obtained by KFF Well being Information and CBS Information, Galella stated underneath oath that he had not represented that the AGGA may deal with or remedy TMJ or sleep apnea.

Video footage tells a distinct story.

Galella repeatedly references treating TMJ and sleep apnea sufferers with the AGGA, generally along with different units, in footage from a coaching session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.

At one level within the footage, Galella could be seen displaying two variations of the AGGA to the dentists, pointing to at least one he says is most well-liked by “TMJ and sleep sufferers” — after which saying, “And I give it to them.”

“Are you able to remedy TMJ? Sure,” Galella instructed dentists as his 2017 coaching started, in accordance with the footage. “Are you able to remedy delicate to reasonable sleep apnea? Sure.”

A dental machine was offered to repair jaws however some sufferers declare it wrecked their enamel

The AGGA, which Galella lately rebranded because the Osseo-Restoration Equipment, resembles a retainer and makes use of springs to use stress to the entrance enamel and higher palate, in accordance with a patent software filed in 2021. This 12 months, after a joint investigation by KFF Well being Information and CBS Information reported allegations of sufferers harmed by the AGGA, the FDA and the Division of Justice opened investigations into the machine.

Dentists throughout the nation have promoted the AGGA on their web sites, usually claiming it may “develop,” “transform,” or “broaden” an grownup’s jaw with out surgical procedure, generally saying it has the potential to make sufferers extra enticing and to deal with frequent illnesses like TMJ and sleep apnea, which afflict hundreds of thousands of Individuals. Galella has stated in depositions and video footage that the AGGA causes the bones in an grownup’s jaw to “transform” ahead, reshaping their face.

The 2017 video footage comprises different examples of Galella educating dentists to deal with TMJ and sleep apnea sufferers with the AGGA, which he generally calls a “progress equipment.” In a single section, he describes utilizing a progress equipment on “9 out of 10” of his TMJ sufferers. In one other occasion, Galella presents pictures of what he says is a TMJ affected person, then proceeds to explain how he handled them with an AGGA whereas displaying pictures of the affected person’s machine and saying: “It is easy with this equipment.” The footage additionally reveals Galella calling a progress equipment “the remedy” for sleep apnea, and he later says in reference to sleep apnea that “with a progress equipment, yeah, you possibly can repair it.”

When Galella was confronted with this video footage throughout his current deposition, he stated his statements had been taken “out of context,” in accordance with the deposition transcript.

The AGGA plaintiffs alleged of their lawsuits not that Galella handled them immediately however as an alternative that he or his firm consulted with their dentists and ready AGGA “remedy plans” for every affected person.

Galella stated throughout his deposition he had reviewed greater than 12,000 remedy plans however stated he’d by no means seen one which used the AGGA to deal with TMJ or sleep apnea, in accordance with the transcript. Within the AGGA lawsuits, a couple of dozen remedy plans are filed as reveals, and a few of these plans checklist the affected person’s “chief grievance” as TMJ or sleep apnea.

Galella’s attorneys didn’t reply to a number of current requests for remark, and Galella declined to be interviewed when approached in individual in February. One in every of Galella’s attorneys, Alan Fumuso, stated in a written assertion in February that the AGGA “is protected and might obtain helpful outcomes” when used correctly.

The KFF Well being Information-CBS Information investigation of the AGGA was based mostly on interviews with 11 individuals who stated they had been damage by the machine and dental specialists who stated they’d witnessed extreme issues in AGGA sufferers. The investigation discovered no report of the AGGA being registered with the FDA and no peer-reviewed proof displaying the machine “expands” or “remodels” the jaw as Galella and different dentists have claimed.

“The whole idea of this machine, of this remedy, makes zero sense,” stated Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has printed analysis on AGGA sufferers. “It would not develop the jaw. It would not widen the jaw. It simply pushes the enamel out of their authentic place.”

Within the wake of the KFF Well being Information-CBS Information investigation, the FDA introduced it was “evaluating security considerations” in regards to the AGGA and the same machine, the Anterior Transforming Equipment. The company stated the units had been used to deal with TMJ and sleep apnea despite the fact that they weren’t cleared by the FDA and their security and effectiveness had not been established.

Weeks later, the legal investigation into the AGGA was disclosed in courtroom filings by Galella and machine producer Johns Dental Laboratories, who stated the U.S. legal professional’s workplace in Memphis, Tennessee, was “probably bringing legal expenses” in opposition to them. In one other courtroom submitting, Johns Dental supplied a duplicate of a grand jury subpoena looking for all kinds of AGGA paperwork, together with “any complaints acquired from any supply in any way concerning the AGGA.”

Since then, Galella has resolved lawsuits from at the very least 19 AGGA plaintiffs by way of out-of-court settlements with none public admission of fault. Extra AGGA lawsuits had been filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they had been harmed whereas being handled for TMJ or sleep apnea.

Alice Runion, a 30-year-old IT guide residing outdoors Indianapolis, alleged in a kind of lawsuits that carrying an AGGA as a part of her TMJ remedy resulted in “everlasting impairment and disfigurement” and “induced extreme injury to the roots of [her] enamel.”

In an interview, Runion added that the AGGA induced lingering migraines which have left her unable to work on a pc for lengthy stretches, forcing her out of her job. Runion stated that even after corrective jaw surgical procedure that value tens of hundreds of {dollars}, a few of her enamel should be in danger.

“My surgeon and my well being care suppliers have instructed me that it’s potential that I may lose enamel sooner or later nonetheless due to the remedy I acquired,” Runion stated.

The AGGA can be being studied by orthodontists Neal Kravitz and Jeffrey Miller, who stated they intend to publish a analysis paper subsequent 12 months on how the machine hurts sufferers. Miller, who has been a paid guide for some AGGA plaintiffs, stated he has examined dental scans from at the very least 30 sufferers who had been “broken” by the AGGA.

“It isn’t tough to see the sample,” Miller stated. “The sufferers lose bone that helps the housing of their enamel.”

Miller and Kravitz stated that they purchased an AGGA in Might for his or her analysis and that the Division of Justice despatched an official to {photograph} the unboxing of the machine for the legal investigation.

Miller and Kravitz added that Johns Dental was keen to promote them the AGGA provided that they didn’t discuss with the machine by title whereas buying it. They supplied KFF Well being Information and CBS Information with a duplicate of an e-mail by which a Johns Dental worker writes: “To order the expansion home equipment from right here on out, you’ll must keep away from utilizing the names of these home equipment or Dr. Galella’s title.”

A Johns Dental facility was inspected by the FDA in July, in accordance with on-line inspection data. These data present the corporate was issued seven citations pertaining to medical units, however don’t particularly point out the AGGA or any particular machine. One quotation was for an unspecified machine whose “design historical past file doesn’t display that the design was developed following the necessities” of federal legislation. Johns Dental declined to remark by way of its legal professional, Jeffrey Oberlies.

Ten days after that FDA inspection, Johns Dental proprietor Jerry Neuenschwander was deposed in an AGGA lawsuit, courtroom data present. He pleaded the Fifth in response to each query, in accordance with a deposition transcript obtained by KFF Well being Information and CBS Information.

Spokespeople for the Justice Division and the FDA declined to touch upon the AGGA. Attorneys for Neuenschwander didn’t reply to requests for remark.

CBS Information producer Nicole Keller contributed to this report.

Kaiser Health NewsThis text was reprinted from khn.org, a nationwide newsroom that produces in-depth journalism about well being points and is likely one of the core working packages at KFF – the unbiased supply for well being coverage analysis, polling, and journalism.



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