Regulator ‘never’ inspected dental lab that made controversial AGGA device
The U.S. Food and Drug Administration (FDA) never inspected Johns Dental Laboratories, in Terre Haute, Indiana, during more than a decade in which it made the Anterior Growth Guidance Appliance, or "AGGA" dental device. Multiple lawsuits allege the device has caused grievous harm to at least 20 patients, and it is now the subject of a criminal investigation. According to FDA documents obtained through the Freedom of Information Act, the agency "became aware" of the AGGA following a joint investigation by Kaiser Health News and CBS News into the product, involving interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented at least 23 others — and dental specialists who said they'd examined patients who had experienced severe complications using the AGGA. The regulator then responded with its first-ever inspection of Johns Dental months later. Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA's radar — for so long because of the lack of inspections and investigations at Johns Dental. When the FDA was asked to explain the lack of inspection, the regulator said that, based on what it knew at the time, it was not mandated to inspect the company until 2018 when it registered as a "contract manufacturer" of other medical devices. Former FDA analyst M. Jason Brooke said the regulator uses an internal risk-based algorithm to determine when to inspect manufacturers. When a company "doesn't follow the law," Brooke observed, "the FDA is in the dark," adding "If there aren't complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there's just a dearth of information for the FDA to consume to trigger an inspection." The AGGA has been fitted on more than 10,000 dental patients, according to court records.
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