Following a joint investigation by KHN and CBS News into a dental device that multiple lawsuits say caused serious harm to patients, the FDA began investigating the product, the anterior growth guidance device, or AGGA, according to a former FDA official. the agency. .
Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists how to use the AGGA, now trains them to use another device that it has described as “almost the exact same device.” That is called the Anterior Remodeling Appliance, or ARA.
The FDA’s interest in AGGA was revealed by Cara Tenenbaum, a former senior policy adviser at the agency’s device center, who said the FDA should investigate the product, which has been placed in more than 10,000 dental patients, according to court records.
Tenenbaum said that after KHN and CBS News published her report, she was contacted by “very concerned” FDA officials who said they had begun “investigating” AGGA but had yet to determine how much legal authority the agency has to regulate it
“The FDA is looking at what authorities they can have around this device, what they can do,” Tenenbaum said. “Now, of course, whether or not this device is regulated by the FDA, it still needs to be safe.”
KHN and CBS News reviewed online posts verifying that an FDA official contacted Tenenbaum about AGGA. The FDA declined to comment on AGGA or confirm whether it was evaluating the device.
The KHN-CBS News investigation into the AGGA included interviews with 11 patients who said the device injured them, as well as attorneys who said they represent or have represented at least 23 others, and dental specialists who said they have examined patients who had experienced serious complications with AGGA. The investigation also found no FDA-registered AGGA registration, despite the agency’s role in regulating dental and medical devices.
AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the device was never submitted to the FDA, which he believes has no jurisdiction over it. Tenenbaum has called the lack of registration “incredibly problematic” because that is one method by which the FDA collects reports of a device’s negative effects.
He encouraged anyone who has witnessed AGGA complications to help the FDA by submit a report through your MedWatch portal.
“Whether it’s a dentist, an orthodontist, a surgeon, a patient, a family member or a caregiver,” Tenenbaum said, “anyone can and should submit these reports so the FDA better understands what’s going on.”
Victor Krauthamer, a former FDA official who worked in a division that regulates medical devices at the agency for three decades, said it was normal for an FDA investigation into a device to start by looking at the limits of the agency’s authority. ensuring that any future action has a solid legal basis.
Krauthamer said he expects the FDA to take regulatory action against AGGA, including sending a warning letter to the manufacturer and potentially taking custody of the devices.
“At this point, I’d be surprised if there wasn’t some kind of enforcement action, like a seizure,” Krauthamer said, later adding, “I think that’s probably where the FDA is at: trying to make a case that stands up.” . in court and you won’t be expelled.”
Jeffrey Oberlies, attorney for the manufacturer AGGA John’s Dental LaboratoriesIt said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on AGGA or FDA interest in the device.
Galella said in his statement that he personally used the AGGA on more than 600 patients and has trained other dentists on how to use the appliance for years. In video footage of a training session, produced in the discovery of an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “reshape” forward, making it more attractive and “curing” common ailments like sleep apnea. and temporomandibular joint disorder, or TMJ.
“It’s okay to make a lot of money,” Galella told the dentists in the video. “You are not scamming anyone, you are curing them. You are helping them. You’re making your life totally beautiful forever and ever.”
Dentists across the country have relied on Galella’s teachings on their websites, often saying that AGGA can “grow,” “reshape,” or “expand” an adult jaw without surgery. At least 11 of those dentists’ websites appear to have removed any mention of AGGA since the KHN-CBS News investigation was published on March 1.
“I think it’s good to hear that,” said Boja Kragulj, a former professional clarinetist who has alleged in a lawsuit that the AGGA did catastrophic damage to his teeth. “I think when you take this information away from patients who are looking for the device and see these claims, it’s usually a good thing.”
Kragulj is one of at least 20 AGGA patients who in the past three years filed lawsuits against Galella and other defendants alleging that AGGA did not and cannot work. The plaintiffs allege that instead of expanding their jaws, the AGGA left them with damaged gums, loose teeth and eroded bones.
Some allege in lawsuits that they will lose teeth because of the device, adding in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.
“Now I can take my finger and literally move my front teeth,” said Melanie Pappalardi, 28, who said she wore an AGGA for a year and filed a lawsuit in Indiana. “I can’t bite at all.”
The plaintiffs do not allege in their lawsuits that Galella treated them, but rather that he or his company consulted with each of their dentists about their AGGA treatment.
Galella has declined to be interviewed by KHN and CBS News. His lawyer, Alan Fumuso, has said in a written statement that AGGA “is safe and can achieve beneficial results.”
All AGGA lawsuits are ongoing. Lawyers of Galella and his company, the facial beauty institute, have denied their responsibility in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount, but continued to fight the allegations in the other cases. he las vegas institutewho previously taught AGGA classes for dentists and promoted the device on Facebookdenied liability in court and has a pending motion to put an end to the claims in a trial in which you are named as a defendant.
In an affidavit filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson said that in 2020 he began to question claims about what AGGA could achieve and later cut all ties to Galella.
However, that same year, the Las Vegas Institute transitioned to the previous Remodeling Apparatus, or ARA, according to facebook posts by Dickerson. Dickerson has said in various Facebook posts over the past three years that AGGA and ARA are very similar, including in a June 2021 post that he described ARA as “almost the exact same device.” He also said that most of the dentists associated with the Las Vegas Institute have switched to ARA, which is made by a different dental lab than AGGA’s maker.
“Different lab. Same thing,” Dickerson said in another facebook post.
The Las Vegas Institute did not respond to requests for comment on the ARA. Institute attorney William Schuller has previously refused to discuss the ARA.
Dental specialists who have raised the alarm about the AGGA said they are also alarmed about the ARA.
dr. Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, each of whom has said they have examined several patients injured by AGGA, said that after looking at a photo of the ARA of the manufacturer’s website, it appears to be very similar to the AGGA.
“It’s very similar to AGGA,” Mandelaris said in an email. “Almost identical.”
KHN (Kaiser Health News) is a national newsroom that produces detailed journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the top three operating programs in KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.
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