Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm.
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or 'AGGA,' a dental device that has allegedly harmed patients and is now the subject of a criminal investigation.
Last year, the KFF Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they'd lost teeth.
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