In an investigation by KHN-CBS news, the FDA said Thursday that it is “evaluating safety concerns” in the use of dental equipment that has several causes of serious harm to patients.
The federal government announced the move to the public in a “safety communication.” his website look not only at that product, the Augment Guided Anterior Appliance, or AGGA, but also similar dental devices, including the Anterior Remodeling Appliance, or ARA, which was featured in a recent KHN and CBS News article.
The FDA said it was “aware of reports of serious complications with the use of these devices” and asked patients and healthcare providers to report any complications they experienced while working with them.
The agency said it is aware of devices that treat conditions including sleep apnea and temporomandibular disorder of the jaw joint, known as TMD or TMJ, but notes that “the safety and efficacy of these devices for these uses have not been established.”
The AGGA machine alone has fitted more than 10,000 dental patients, according to royal records.
A KHN-CBS News investigation into AGGA interviewed 11 patients who said they were harmed by the machine — plus attorneys who said they represent or have represented at least 23 other patients — and dental technicians who said they have examined patients. expert on serious complications using AGGA. Research found no evidence of AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. The FDA confirmed Thursday that the devices “have not been cleared or approved by the FDA.”
Inventor AGGA, Tennessee dentist Dr. Steve Galella said in a sworn to the court of deposition AGGA has never submitted to the FDA, which it believes does not have jurisdiction over it.
At least 20 AGGA patients in the past three years have lawsuits against Galella and other defendants who claim AGGA cannot work. AGGAE’s gums, teeth and bone eroded, the actors left them for looseness of the jaws.
Additionally, KHN and CBS News reported that the Las Vegas Institute of the company, which had previously taught dentists to use AGGA, now trains dentists to use another device, its CEO described as “pretty much the same tool.” That’s called Front End Appliance remodeling, or ARA.
KHN and CBS News reached out Thursday to representatives for Galella, the Las Vegas Institute, the AGGA and ARA manufacturers, but received no immediate response.
Galella declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a letter to AGGA that he “is safe and can achieve beneficial results.”
All AGGA lawsuits are ongoing. Galella and the other defendants pleaded not guilty at trial. Cara Tenenbaum, a former senior adviser at the FDA’s device center, said reports of complications from these devices are and can be critical. summary via the FDA’s MedWatch portal.
“Whether it’s a dentist, orthodontist, surgeon, patient, family member, or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so the FDA can better understand what’s going on.”
In a court deposition, Galella said he personally used AGGA for more than 600 patients and over the years trained other dentists to use it. In video footage of one of the training sessions, which was produced as part of the AGGA case finding, Galella said the machine presses on the patient’s palate and causes the adult’s jaw to “unfold” and make it more gentle and common remedies, such as sleep apnea and TMJ.
“It’s good to make a crapload of money,” Gallella told the dentists in the video. “You’re not tearing anyone down. You care. You’re helping them. Making their lives totally beautiful forever and ever.”
In its Thursday announcement, the FDA said it knows the devices are used “to open the jaws in adults,” but pointed out that devices like these, called “palatal examiners” (non-removable), are mostly used by children and adolescents; “Whose upper jaw bones have not yet fused.” In contrast, the FDA said, “The upper jaw bones of an adult are fused, and when the fixed expansion of the palate uses force, the palate resists the expansion. If the wrong set of teeth are used, serious complications can also include chronic pain, tooth dislocation, teeth firing, uneven bite, difficulty eating, damaged gums, exposed roots, eroded mouth, tooth loss.
Patients interviewed by KHN and CBS News are experiencing many of those problems. One patient who got it, former clarinetist Boja Kragulj, later told the artists that they pulled her four front teeth. She now wears false teeth.
Reached Thursday, Kragulj said: “While it is too late for me and many others, there is some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its rights. I hope to spare other patients the injuries and many years that have already been lost.
The FDA said it plans to “investigate potential violations” in connection with the use of the devices, and to “identify and contact those responsible.” [its] care “.
The American Dental Association, which has 159,000 dentist members, said it will “notify dentists of the FDA evaluation, and will continue to monitor the FDA on these devices and issues.”
KHN (Kaiser Health News) is a national newspaper that produces in-depth journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the three major operating programs KFF (Kaiser Family Foundation). KFF is a non-profit organization dedicated to educating the nation on health issues.
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