In the wake of a CBS News-KHN investigation, the FDA said it is 'evaluating safety concerns' over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients.
The FDA said it is"aware of reports of serious complications with use of these devices" and asked that patients and health care providers report any complications experienced with them to the agency.
The CBS News-KHN investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device - plus attorneys who said they represent or have represented at least 23 other patients - and dental specialists who said they'd examined patients who had experienced severe complications using the AGGA. The investigation found no record of the AGGA being registered with the FDA, despite the agency's role in regulating medical and dental devices.
Additionally, CBS News and KHN reported that the Las Vegas Institute, a company that previously taught dentists to use the AGGA, now trains dentists to use another device its CEO has described as"almost exactly the same appliance." That one is called the Anterior Remodeling Appliance, or ARA. All the AGGA lawsuits are ongoing. Galella and the other defendants have denied liability in court filings. Cara Tenenbaum, a former senior policy adviser in the FDA's device center, said reports of complications from these devices are of critical importance and can be submitted through FDA's MedWatch portal.
"It's OK to make a crapload of money," Galella told dentists in the video."You're not ripping anybody off. You're curing them. You're helping them. You're making their life totally beautiful forever and ever." Reached Thursday, Kragulj said:"While it's too late for me and many others, there is some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the injuries and lost years that many of us have now suffered."
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