FDA reviews ‘Safety Concerns’ for dental devices highlighted in KHN-CBS investigation
In the wake of a KHN-CBS News investigatesThe FDA on Thursday said it was “evaluating safety concerns” over the use of dental equipment that many lawsuits allege caused serious harm to patients.
The federal agency spoke to the public in a “secure communication” posted on its website that it considers not only that product, the Anterior Growth Guiding Device, or AGGA, but also other similar dental devices, including the Anterior Remodeling Device, or ARA, as identified in a recent articles by KHN and CBS News.
The FDA says it is “aware of reports of serious complications with the use of these devices” and asks patients and healthcare providers to report any complications that occur to them. for the agency.
The agency said it was aware of these devices already being used to treat conditions including sleep apnea and temporomandibular joint disorder, also known as TMD or TMJ, but noted that “the The safety and effectiveness of these devices for these uses have not been established. establish.”
The AGGA device alone has been fitted to more than 10,000 dental patients, according to court records.
KHN-CBS News’ investigation into AGGA involved interviews with 11 patients who said they were injured by the device — plus attorneys who said they represented or have represented at least 23 patients other individuals — and dental professionals say they have seen patients who have experienced serious complications from 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. The FDA confirmed on Thursday that the devices were “not authorized or approved by the FDA.”
The inventor of AGGA, the Tennessee dentist, Dr. Steve Galella, said in a sworn in court that the AGGA was never filed with the FDA, which he believed would have no jurisdiction over it.
At least 20 AGGA patients over the past three years have filed lawsuits against Galella and other defendants alleging that AGGA does not — and cannot — work. The plaintiffs allege that instead of expanding their jawbone, the AGGA left them with damaged gums, loose teeth, and eroded bone.
Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously taught dentists to use AGGAs, is now training dentists to use another device that its CEO described described as “almost exactly the same device”. That’s called a Front Remodeling Device, or ARA.
KHN and CBS News reached out on Thursday with attorneys for Galella, the Las Vegas Institute and the producers of AGGA and ARA but did not receive an immediate response.
Galella declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a written statement that AGGA is “safe and can achieve beneficial outcomes.”
All AGGA lawsuits are ongoing. Galella and the other defendants disclaimed liability in court filings. Cara Tenenbaum, former senior policy adviser at the FDA’s device center, said reports of complications from these devices are of particular importance and can sent through the FDA’s MedWatch portal.
“Whether it is a dentist, orthodontist, surgeon, patient, family member or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so that the FDA can better understand what is happening.”
In a court affidavit, Galella said he personally used AGGA on more than 600 patients and trained other dentists in its use for many years. In a video of a training session, produced to be explored in an AGGA lawsuit, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” to front, making them more attractive and “curing” common ailments, such as sleep apnea and TMJ.
Galella tells the dentists in the video: “It’s okay to make a lot of money. “You don’t rip anyone off. You are healing them. You are helping them. You are making their life absolutely beautiful forever.”
In Thursday’s announcement, the FDA said it knew these devices had been used “for jaw correction in adults” but pointed out that devices like these are known as “permanent palate expanders”. fixed (non-removable)” is commonly used for children and adolescents. “have an unfused upper jaw.” In contrast, the FDA says, “the maxillary bone of an adult is fused, and when a fixed palatal expander applies force, the palate resists expansion. If pressure is not applied properly, serious complications can occur including chronic pain, misaligned teeth, protruding teeth, irregular bite, difficulty eating, damaged gums, exposed roots, wear bone and tooth loss.”
Patients interviewed by KHN and CBS News described experiencing many of these problems. One patient sued, Boja Kragulj, a former professional clarinetist, said specialists then had to remove four of her front teeth. Now she wears dentures.
By Thursday, Kragulj said: “Although it is too late for me and many others, I take comfort in knowing that the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope the other patients don’t suffer and lose the many years that many of us are suffering now.”
The FDA said it plans to “investigate potential violations” related to the use of the devices and that it is “identifying and contacting the responsible parties to contact [its] concerns.
The American Dental Association, which has 159,000 dentist members, said it “will notify dentists of the FDA’s review and will continue to monitor FDA updates regarding these devices and issues.” .
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with Policy Analysis and Exploration, KHN is one of the three main activities in Vietnam KFF (Kaiser Family Foundation). KFF is a funded non-profit organization that provides information on health issues to the nation.
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