FDA never inspected lab that made controversial dental device: Report

FDA documents obtained by KFF News and CBS News reportedly show that the federal agency did not inspect a dental lab manufacturing a dental device that has become the subject of several lawsuits, according to a May 13 report

The Anterior Growth Guidance Appliance is a retainer-like device invented by Steve Galella, DDS, that claims to expand the jaw without surgery. It has been the source of several lawsuits after patients alleged it caused severe damage to their teeth.

The FDA began evaluating safety concerns related to the fixed nonremovable palatal expanders after the lawsuits, with the U.S. Attorney's Office for the Western District of Tennessee and the U.S. Department of Justice launching criminal investigations into the AGGA device shortly after.

Nine things to know: 

1. The documents obtained by KFF and CBS reportedly show the FDA launched its first-ever inspection of Terre Haute, Ind.-based Johns Dental Laboratories after the two news organizations published a joint investigation into the device in March 2023.

2. The FDA requires companies manufacturing medical devices to investigate complaints and forward them to the agency. 

3. The FDA's inspection of Johns Dental in July 2023 found that the lab did not require all customer complaints to be investigated. The company also did not investigate some complaints about people being hurt by products, including the AGGA device, according to the documents.

4. Johns Dental, which has made the AGGA since 2012, has settled lawsuits from 20 patients who alleged that the dental device caused them harm, but has not admitted liability.

5. Two former FDA officials told KFF and CBS that the device was likely able to stay on the market for so long because of the lack of investigations by Johns Dental. 

6. The FDA said it does not regularly inspect dental labs, but it can if it has concerns or receives complaints. It added that it was not required to inspect Johns Dental until 2018 after the lab registered as a "contract manufacturer" of other medical devices. 

7. The documents show Johns Dental stopped making the AGGA after the KFF Health News-CBS News original report in 2023. 

8. The lab was also issued seven citations after the FDA's inspection.

9. After the FDA's inspection, the lab reportedly also revised its complaint policies to require more investigations and hired a consultant and auditor to address other FDA concerns.

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