Dental device at center of lawsuits was used on patients without FDA review

USA: Thousands of dental patients have claimed harm from an unproven and unregulated dental device known as the Anterior Growth Guidance Appliance (AGGA).

According to court records, over 10,000 dental patients have been fitted with the device, which is at the center of patient lawsuits. However, the AGGA has not been evaluated by the Food and Drug Administration (FDA), as revealed by a joint investigation conducted by KHN and CBS News.

Sold to patients without undergoing required government review

The AGGA is designed to expand the jaws or improve breathing, but patients who were interviewed by CBS News claimed they assumed the device would not be for sale unless it was proven safe and effective. Manufacturers of medical and dental devices are required to register new products with the FDA, and devices that pose even a moderate risk to patients may need to go through a pre-market review to ensure their safety and efficacy. However, the AGGA was never submitted for review and was sold to patients without undergoing the required government review.

“Incredibly problematic”

Former senior policy adviser in the FDA’s device center, Cara Tenenbaum, expressed concern over the AGGA not being registered, saying it was “incredibly problematic” since that is how the FDA collects reports of negative effects.

The FDA confirmed it had no record of the AGGA being registered in its device database, but did not comment on whether the device should have been registered or if it would be investigated. The agency also would not say whether it was aware of the AGGA before being contacted by KHN and CBS News.

All the AGGA lawsuits are ongoing, and attorneys for the inventor, Dr Steve Galella, and the company he leads, the Facial Beauty Institute, have denied liability and argued that plaintiffs were appropriately warned of potential complications from the device, including “teeth dying” or “removal of teeth.”

The FDA is responsible for regulating medical and dental devices in the United States, and Tenenbaum questioned who was protecting the consumer if a device was put out without anyone looking at it and potentially harming people.