The FDA is investigating the AGGA dental device following a patient harm investigation by KHN-CBS News

In the wake of a joint investigation by KHN and CBS News In a dental device that multiple lawsuits allege caused serious harm to patients, the FDA has begun investigating 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 company that previously trained dentists to use the AGGA, is now training dentists to use a different device, which it has described as “almost exactly the same device.” This is called the Anterior Remodeling Appliance or ARA.

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 study the product, which court records say has been fitted to more than 10,000 dental patients.

Tenenbaum said that after her report was released by KHN and CBS News, she was contacted by “very concerned” FDA officials who said they had begun “investigating” the AGGA but have yet to determine how much legal authority the authority to regulate them.

“The FDA is looking at what authorities they may have regarding this device — what they may be able to do,” Tenenbaum said. “Whether this device is FDA-regulated or not, of course it still has to be safe.”

KHN and CBS News reviewed online news confirming that an FDA official communicated with Tenenbaum about the AGGA. The FDA declined to comment on AGGA or confirm if it is evaluating the device.

The AGGA’s KHN-CBS News investigation included interviews with 11 patients who said they were injured by the device — plus attorneys who said they represent or have represented at least 23 others — and dentists who said they examined patients to have affected severe complications with the AGGA. The investigation also found no record of AGGA’s registration with the FDA, despite the agency’s role in regulating medical and dental devices.

The inventor of the AGGA, the dentist Dr. Tennessee’s Steve Galella, in a court affidavit, said the device was never submitted to the FDA, which he says has no jurisdiction. Tenenbaum said the lack of registration is “incredibly problematic” because it’s a way the FDA collects reports of a device’s adverse effects.

She encouraged anyone who witnessed AGGA complications to help the FDA by submitting a report through her MedWatch portal.

“Whether that’s a dentist, an orthodontist, a surgeon, a patient, a family member, or a caregiver,” Tenenbaum said, “anyone can and should file these reports so the FDA can better understand what’s happening.”

Victor Krauthamer, a former FDA official who worked in a medical device regulation division at the agency for three decades, said it’s normal for an FDA investigation of a device to begin by examining the limits of the agency’s powers , to ensure that all future actions have a solid legal basis.

Krauthamer said he expects the FDA to take regulatory action against the AGGA, including sending a warning letter to the manufacturer and possible custody of the devices.

“At this point, I’d be surprised if there wasn’t some sort of compliance action like a seizure,” Krauthamer said, later adding, “I think that’s probably where the FDA is — trying to do a case.” to do, the stock has in court and will not be thrown out.”

Jeffrey Oberlies, an attorney for AGGA maker Johns Dental Laboratories, said in an email that the company “looks forward to resolving the allegations made against it,” and declined to pose any concern to AGGA or the FDA to express the device.

Galella said in his statement that he has personally used the AGGA on more than 600 patients and has trained other dentists in the use of the device for years. In video footage of a workout session produced in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “reshape” forward, making them more attractive and reducing common ailments like sleep “heals”. Apnea and temporomandibular joint disorder or temporomandibular joint.

“It’s okay to make a lot of money,” Galella told the dentists in the video. “You’re not ripping anyone off. you heal them you help them You make her life so beautiful forever and ever.”

Dentists across the country have referred to Galella’s teachings on their websites, often saying that the AGGA can “grow,” “reshape,” or “enlarge” an adult’s jaw without surgery. Since the release of the KHN-CBS News investigation on Jan.

“I think that’s good to hear,” said Boja Kragulj, a former professional clarinetist who alleges in a court case that the AGGA caused catastrophic damage to her teeth. “I think if you take away that information from patients who are looking for the device and you see those claims, that’s generally a good thing.”

Kragulj is one of at least 20 AGGA patients who have filed lawsuits over the past three years against Galella and other defendants who claim the AGGA didn’t work — and can’t. The plaintiffs allege that instead of expanding their jawbones, the AGGA left them with damaged gums, loose teeth and eroded bone.

Some claim in court cases 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 literally wiggle 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 company consulted with each of their dentists about their AGGA treatment.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, said in a written statement that the AGGA “is safe and can produce beneficial outcomes.”

All AGGA lawsuits are pending. Attorneys for Galella and his company, the Facial Beauty Institute, have denied liability in court filings. Johns Dental Laboratories has settled one lawsuit for an undisclosed amount but is continuing to fight the allegations in the other cases. The Las Vegas Institute, which previously held AGGA classes for dentists and promoted the device on Facebook, has declined liability in court and has a pending motion to terminate claims in a court case, naming it as a defendant.

In an affidavit filed in that lawsuit, Las Vegas Institute CEO Dr. Bill Dickerson that in 2020 he began to question the claims of what the AGGA could accomplish and then severed all ties with Galella.

However, according to Facebook posts by Dickerson, the Las Vegas Institute switched to the Anterior Remodeling Appliance, or ARA, that same year. Dickerson has said that AGGA and ARA are very similar in several Facebook posts over the past three years, including a June 2021 post that described ARA as “almost exactly the same device.” He also said most dentists associated with the Las Vegas Institute have switched to the 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. The institute’s attorney, William Schuller, has previously declined to speak about the ARA.

Dentists who warned about the AGGA said they were also alerted by the ARA.

dr Kasey Li, a California maxillofacial surgeon, and Dr. George Mandelaris, a Chicago-area periodontist, who both said they have examined several patients harmed by AGGA, said after looking at a photo of the ARA on the manufacturer’s website, it appears to be very similar to the AGGA .

“It’s very similar to the AGGA,” Mandelaris said in an email. “Almost equal.”

KHN (Kaiser Health News) is a national newsroom producing in-depth journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the three major operational programs at KFF (Kaiser Family Foundation). KFF is a donated non-profit organization that provides information on health issues to the nation.