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.
According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.
That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.
The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.
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. Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a …
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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.
According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.
That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.
The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.
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. Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a …nnDiscussion:nn” ai_name=”RocketNews AI: ” start_sentence=”Can I tell you more about this article?” text_input_placeholder=”Type ‘Yes'”]