Following an investigation by KHN-CBS News, the Food and Drug Administration (FDA) on Thursday said it was “evaluating safety concerns” for the use of a dental appliance that multiple lawsuits allege caused grievous harm. patients.
The federal agency told the public in a “safety announcement” posted on his website that he is reviewing not only this product, the Anterior Tooth Growth Control Device, or AGGA, but other similar dental devices, including the Anterior Tooth Remodeling Device, or ARA, mentioned 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 associated with them to the agency.
The agency stated that it is aware that these devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder, also known as TMJ or TMJ, but noted that “the safety and efficacy of these devices intended for these uses, have not been established.”
According to court records, the AGGA device alone has been installed by more than 10,000 dental patients.
The AGGA investigation by KHN-CBS News included interviews with 11 patients who said they were harmed by the device, attorneys who said they represented or represented at least 23 other patients, and dental professionals who said they were examining patients who had experienced serious complications while using AGGA. The investigation found no records of AGGA registration with the FDA, despite the agency’s role in the regulation of medical and dental devices. On Thursday, the FDA confirmed that the devices are “not approved or approved by the FDA.”
Inventor of AGGA, Tennessee dentist Dr. Steve Galella said at sworn testimony that AGGA has never presented itself to the FDA, which it believes has no jurisdiction over it.
At least 20 AGGA patients have filed lawsuits against Galella and other defendants over the past three years, alleging that AGGA does not and cannot work. The plaintiffs allege that instead of expanding their jawbones, AGGA left them with damaged gums, loose teeth and shattered bone.
Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously trained dentists in the use of the AGGA, is now training dentists in the use of a different device, which its CEO described as “almost exactly the same device.” This is called Anterior Remodeling Appliance, or ARA.
KHN and CBS News contacted attorneys for Galella, the Las Vegas Institute, and makers AGGA and ARA on Thursday, but received no immediate response.
Galella declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuzo, previously said in a written statement that AGGA is “safe and can produce positive results.”
All AGGA lawsuits are ongoing. Galella and other defendants denied responsibility in court documents. Kara Tenenbaum, a former senior policy adviser at the FDA’s device center, said reports of complications related to these devices are critical and could be submitted through the FDA 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 has a better understanding of what’s going on.”
In court, Galella said he had personally used AGGA on over 600 patients and had taught other dentists how to use it for years. In videos of one workout during the AGGA trial, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “realign” forward, making them more attractive and “curing” common ailments such as sleep apnea and TMJ.
“It’s okay to make a ton of money,” Galella told the dentists in the video. You don’t rob anyone, you heal them. You help them. You make your life beautiful forever and ever.”
In a statement Thursday, the FDA said it is aware the devices have been used “for jaw reconstruction in adults” but indicated that devices such as “fixed (non-removable) palatal expanders” are commonly used in children and adolescents. “In which the bones of the upper jaw have not yet fused.” In contrast, the FDA stated that “the adult maxillary bones are fused and when the fixed palate expansion device applies force, the palate resists expansion. If improper force is applied to the teeth, serious complications can occur, including chronic pain, misaligned teeth, swollen teeth, misaligned bites, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”
Patients interviewed by KHN and CBS News said they experience many of these problems. One patient who filed a lawsuit, former professional clarinetist Boya Kragul, said that specialists later had to remove four of her front teeth. Now she wears false teeth.
Kragulj said Thursday: “While it is too late for me and many others, there is some consolation that the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the trauma and wasted years that so many of us are now experiencing.”
The Food and Drug Administration said it plans to “investigate possible violations” in connection with the use of the devices, and that it “is identifying and contacting those responsible to inform [its] concern.”
The American Dental Association, which has a membership of 159,000 dentists, said it “will keep dentists informed about the FDA evaluation and will continue to monitor FDA updates regarding these devices and concerns.”
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