A Tennessee dentist who has been sued by a number of TMJ and sleep apnea sufferers over an unproven dental gadget he invented has stated beneath oath that he by no means taught dentists to make use of the gadget for these illnesses — contradicting video footage of him telling dentists the best way to use it.
Steve Galella, the inventor of the Anterior Growth Guidance Appliance, or “AGGA,” has stated in court docket depositions that his gadget had been used on about 10,000 sufferers, and that he skilled many dentists to make use of the AGGA in lessons across the U.S. and abroad.
At least 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, prompted tooth loss. Galella denied wrongdoing in these lawsuits and has settled nearly all of them throughout the previous few months.
Galella was deposed earlier than he settled the most important of these lawsuits. According to a deposition transcript just lately obtained by KFF Health News and CBS News, Galella stated beneath 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, typically together 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 may be seen displaying two variations of the AGGA to the dentists, pointing to 1 he says is most well-liked by “TMJ and sleep patients” — after which saying, “And I give it to them.”
“Can you cure TMJ? Yes,” Galella informed dentists as his 2017 coaching started, based on the footage. “Can you cure mild to moderate sleep apnea? Yes.”
The AGGA, which Galella just lately rebranded because the Osseo-Restoration Appliance, resembles a retainer and makes use of springs to use stress to the entrance enamel and higher palate, based on a patent software filed in 2021. In 2023, after a joint investigation by KFF Health News and CBS News reported allegations of sufferers harmed by the AGGA, the FDA and the Department of Justice opened investigations into the gadget.
Dentists throughout the nation have promoted the AGGA on their web sites, usually claiming it will possibly “grow,” “remodel,” or “expand” an grownup’s jaw with out surgical procedure, typically saying it has the potential to make sufferers extra enticing and to deal with widespread illnesses like TMJ and sleep apnea, which afflict thousands and thousands of Americans. Galella has stated in depositions and video footage that the AGGA causes the bones in an grownup’s jaw to “remodel” ahead, reshaping their face.
The 2017 video footage accommodates different examples of Galella educating dentists to deal with TMJ and sleep apnea sufferers with the AGGA, which he typically calls a “growth appliance.” In one section, he describes utilizing a progress equipment on “nine 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 gadget and saying: “It’s easy with this appliance.” The footage additionally reveals Galella calling a progress equipment “the cure” for sleep apnea, and he later says in reference to sleep apnea that “with a growth appliance, yeah, you can fix it.”
When Galella was confronted with this video footage throughout his current deposition, he stated his statements had been taken “out of context,” based on the deposition transcript.
The AGGA plaintiffs alleged of their lawsuits not that Galella handled them straight however as an alternative that he or his firm consulted with their dentists and ready AGGA “treatment plans” for every affected person.
Galella stated throughout his deposition he had reviewed greater than 12,000 therapy plans however stated he’d by no means seen one which used the AGGA to deal with TMJ or sleep apnea, based on the transcript. In the AGGA lawsuits, a couple of dozen therapy plans are filed as displays, and a few of these plans listing the affected person’s “chief complaint” 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 of Galella’s attorneys, Alan Fumuso, stated in a written assertion in February that the AGGA “is safe and can achieve beneficial results” when used correctly.
The KFF Health News-CBS News investigation of the AGGA was primarily based on interviews with 11 individuals who stated they have been harm by the gadget and dental specialists who stated they’d witnessed extreme issues in AGGA sufferers. The investigation discovered no file of the AGGA being registered with the FDA and no peer-reviewed proof displaying the gadget “expands” or “remodels” the jaw as Galella and different dentists have claimed.
“The entire concept of this device, of this treatment, makes zero sense,” stated Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has revealed analysis on AGGA sufferers. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”
In the wake of the KFF Health News-CBS News investigation, the FDA introduced it was “evaluating safety concerns” in regards to the AGGA and an analogous gadget, the Anterior Remodeling Appliance. The company stated the units had been used to deal with TMJ and sleep apnea although they weren’t cleared by the FDA and their security and effectiveness had not been established.
Weeks later, the felony investigation into the AGGA was disclosed in court docket filings by Galella and gadget producer Johns Dental Laboratories, who stated the U.S. lawyer’s workplace in Memphis, Tennessee, was “potentially bringing criminal charges” towards them. In one other court docket submitting, Johns Dental supplied a duplicate of a grand jury subpoena searching for all kinds of AGGA paperwork, together with “any complaints received from any source whatsoever regarding the AGGA.”
Since then, Galella has resolved lawsuits from not less than 19 AGGA plaintiffs by way of out-of-court settlements with none public admission of fault. Additional AGGA lawsuits have been filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they have been harmed whereas being handled for TMJ or sleep apnea.
Alice Runion, a 30-year-old IT advisor dwelling exterior Indianapolis, alleged in a type of lawsuits that carrying an AGGA as a part of her TMJ therapy resulted in “permanent impairment and disfigurement” and “caused severe damage to the roots of [her] teeth.”
In an interview, Runion added that the AGGA prompted 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 still be in danger.
“My surgeon and my health care providers have told me that it is possible that I could lose teeth in the future still because of the treatment I received,” Runion stated.
The AGGA can also 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 gadget hurts sufferers. Miller, who has been a paid advisor for some AGGA plaintiffs, stated he has examined dental scans from not less than 30 sufferers who have been “damaged” by the AGGA.
“It’s not difficult to see the pattern,” Miller stated. “The patients lose bone that supports the housing of their teeth.”
Miller and Kravitz stated that they purchased an AGGA in May for his or her analysis and that the Department of Justice despatched an official to {photograph} the unboxing of the gadget for the felony investigation.
Miller and Kravitz added that Johns Dental was keen to promote them the AGGA provided that they didn’t discuss with the gadget by title whereas buying it. They supplied KFF Health News and CBS News with a duplicate of an electronic mail wherein a Johns Dental worker writes: “To order the growth appliances from here on out, you’ll need to avoid using the names of those appliances or Dr. Galella’s name.”
A Johns Dental facility was inspected by the FDA in July, based on on-line inspection data. Those data present the corporate was issued seven citations pertaining to medical units, however don’t particularly point out the AGGA or any particular gadget. One quotation was for an unspecified gadget whose “design history file does not demonstrate that the design was developed following the requirements” of federal regulation. Johns Dental declined to remark by way of its lawyer, Jeffrey Oberlies.
Ten days after that FDA inspection, Johns Dental proprietor Jerry Neuenschwander was deposed in an AGGA lawsuit, court docket data present. He pleaded the Fifth in response to each query, based on a deposition transcript obtained by KFF Health News and CBS News.
Spokespeople for the Justice Department and the FDA declined to touch upon the AGGA. Attorneys for Neuenschwander didn’t reply to requests for remark.
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CBS News producer Nicole Keller contributed to this report.
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(KFF Health News, previously generally known as Kaiser Health News (KHN), is a nationwide newsroom that produces in-depth journalism about well being points and is among the core working applications of KFF — the impartial supply for well being coverage analysis, polling and journalism.)
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Source: www.bostonherald.com”