Time Plus News

Breaking News, Latest News, World News, Headlines and Videos

KHN-CBS News FDA looks into dental device after investigating patient harm

On the eve of Joint investigation by KHN and CBS News In a dental appliance that multiple lawsuits allege caused serious harm to patients, the FDA has opened an investigation into the product, the anterior growth guidance appliance, or AGGA, according to a former agency official.

Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training organization that previously taught dentists to use the AGGA, now trains dentists to use another device described as “almost the exact same device.” This is called an anterior reconstruction tool or ARA.

The FDA’s interest in AGGA was sparked by Kara Tenenbaum, a former senior policy adviser at the agency’s Device Center, who said the FDA should investigate the product, which has been implanted in more than 10,000 dental patients, according to court records.

Tenenbaum said that after KHN and CBS News published their reports, he was contacted by “very concerned” FDA officials who said they have begun “looking into” AGGA but have yet to determine how much legal authority the agency has to regulate it. could not

“The FDA is looking at what authority they might have around this device — what they might be able to do,” Tenenbaum said. “Now, of course, whether this device is FDA regulated or not, it still needs to be safe.”

KHN and CBS News reviewed online messages that verify that an FDA official contacted Tenenbaum about AGGA. The FDA declined to comment on AGGA or confirm whether it is evaluating the device.

Kara Tenenbaum

Cara Tenenbaum, a former senior policy advisor at the FDA’s Device Center.

CBS News

A KHN-CBS News investigation of AGGA interviewed 11 patients who said they were injured by the device — plus attorneys who said they represented or at least 23 others — and dental experts who said they examined experienced patients. Serious complications using AGGA. The investigation found no record of AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices.

AGGA’s inventor, Tennessee dentist Dr. Steve Galala, said in a sworn court deposition that the device was never submitted to the FDA, which he believes does not have jurisdiction over it. Tenenbaum said the lack of registration is “incredibly problematic” because it is the method by which the FDA collects reports of negative effects of a device.

He encouraged anyone who has seen complications from AGGA to help the FDA by submitting a report through its 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 can better understand what’s going on.”

Before and after photos of dental patient's teeth

Photo of a 21-year-old man fitted with an AGGA device and examined by California maxillofacial surgeon Dr. Casey Lee. Lee says that photos A and C show the patient at the beginning of her AGGA treatment, and photos B and D show the end, after the AGGA created a gap in her dog’s back.

Kase Lee

Victor Krauthammer, a former FDA official who worked at the agency for three decades in a division that regulates medical devices, said it is natural to begin researching the boundaries of the agency’s authority to investigate an FDA device, to ensure any future action. Strong legal basis.

Krauthammer said he expects the FDA to take regulatory action against AGGA, including sending a warning letter to the manufacturer and potentially impounding the devices.

“At this point, I’d be surprised if there wasn’t some kind of compliance action, like a seizure,” Krauthammer said, later adding, “I think that’s probably where the FDA is — trying to make a case that will hold up in court and out. will not be given.”

Jeffrey Oberlis, an attorney for AGGA manufacturer Johns Dental Laboratories, said in an email that the company “looks forward to resolving the allegations against it” and declined to comment on AGGA or the FDA’s interest in the device.

Dr. Steve Galella

Dr. Steve Galala, inventor of the AGGA device, declined to speak to KHN and CBS News reporters outside his clinic in suburban Memphis on Feb. 9, 2023.

Brett Kelman/KHN

Galella said in his deposition that he has personally used the AGGA on more than 600 patients and has trained other dentists on how to use the device over the years. In video footage of a training session produced in discovery of an AGGA case, Galella says the device applies pressure to the patient’s palate and “recreates” an adult’s jaw, making them more attractive and “cures” common ailments such as sleep. Apnea and temporomandibular joint disorder or TMJ.

“It’s OK to spend a lot of money,” Galella tells the dentists in the video. “You’re not tearing someone down. You’re healing them. You’re helping them. You’re making their lives completely beautiful forever.”

Dentists across the country draw from Galela’s teachings on their websites, often saying AGGA can “grow,” “remodel” or “expand” an adult’s jaw without surgery. At least 11 dental websites appear to have removed any mention of AGGA since the March 1 KHN-CBS News investigation was published.

A dental device was sold to fix the jaw but some patients claimed it damaged their teeth


“I think that’s good to hear,” said Boja Kragulz, a former professional clarinetist who alleges in a lawsuit that AGGA caused catastrophic damage to his teeth. “I think when you take this information from patients who are searching for equipment and seeing these claims, it’s generally a good thing.”

Kragulj is one of at least 20 AGGA patients who have sued Galella and other defendants over the past three years, claiming AGGA didn’t — and couldn’t — work. The plaintiffs allege that instead of expanding their jawbones, AGGA left them with damaged gums, loose teeth and decayed bones.


Boja Kragulz, an accomplished clarinetist, alleges in an ongoing lawsuit that the AGGA (Anterior Growth Guidance Appliance) dental device caused catastrophic damage to his teeth. AGGA inventor Dr. Steve Galala and his company disclaim all liability.

Makris Music Society; Boza Kragulz

Some allege in the lawsuit 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.

“I can now take my finger and I can 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 into anything at all.”

The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his firm consulted each of their dentists about their AGGA treatment.

Galella declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, said in a written statement that AGGA “could achieve safe and beneficial results.”

All AGGA cases are ongoing. Attorneys for Galella and his company, Facial Beauty Institute, denied liability in court filings. John’s Dental Laboratories settled a lawsuit for an undisclosed amount but continues to fight the allegations in other cases. The Las Vegas institute, which previously hosted AGGA classes for dentists and promoted the device on Facebook, denied liability in court and has a pending motion to end the claim in a lawsuit that names it as a defendant.

Dental patients complain of damage from an unproven dental device


In a sworn deposition filed in that lawsuit, Dr. Bill Dickerson, CEO of the Las Vegas Institute, said that in 2020 he began questioning claims about what AGGA could achieve, then cut all ties with Galella.

However, that same year the Las Vegas Institute moved on to the Interior Remodeling Appliance, or ARA, according to Dickerson’s Facebook post. Dickerson has said in multiple Facebook posts over the past three years that AGGA and ARA are very similar, including a June 2021 post describing ARA as “almost the exact same instrument.” He also said that most of the dentists affiliated with the Las Vegas institute switched to ARA, which is made by a different dental laboratory than AGGA’s manufacturer.

“Different lab. Same thing,” Dickerson said in another Facebook post.

The Las Vegas Institute did not respond to requests for comment about the ARA. Institute attorney William Shuler previously declined to discuss the ARA.

Dental experts who have warned about AGGA say they are also alarmed by ARA.

California maxillofacial surgeon Dr. Casey Lee and Chicago-area periodontist Dr. George Mandelaris, who each said they have examined multiple patients affected by AGGA, said after viewing a photo of ARA on the manufacturer’s website, it appears similar to AGGA.

“It’s the same as AGGA,” Mandelaris said in an email. “Almost identical.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Along with policy analysis and polling, KHN is one of the three main operating programs of the KFF (Kaiser Family Foundation). KFF is a non-profit organization that provides health information to the nation.

Trending news

Source link