This article first appeared in Kaiser Health News, republished with permission.

An unproven and unregulated dental device at the center of patient lawsuits has not been evaluated by the FDA, according to a months-long joint investigation by KHN and CBS News. 

More than 10,000 dental patients have been fitted with an Anterior Growth Guidance Appliance, or AGGA, according to court records. 

CBS News national correspondent Anna Werner talks to patients who said in interviews and lawsuits that they were convinced the device would expand their jaws or improve their breathing and that they mistakenly assumed the AGGA would not be for sale unless it was proven safe and effective.

The AGGA appears to be off the radar of the FDA, which is responsible for regulating medical and dental devices in the United States. Device manufacturers are supposed to register new products with the agency, and any devices that pose even a moderate risk to a patient can be required to go through a pre-market review to check if they are safe and effective.

But KHN and CBS News reporting shows the AGGA was never submitted and it has been sold to patients without that government review.

Werner interviewed Cara Tenenbaum, a former senior policy adviser in the FDA’s device center, who said she believes the AGGA falls within the FDA’s jurisdiction and it was “incredibly problematic” that it was not registered, at least in part because that’s how the FDA collects reports of negative effects.

“​​Who’s protecting the consumer if somebody puts a device out there and nobody looks at it and people are potentially harmed by it?” Tenenbaum said. “That’s the FDA’s job.”

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

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

To read the full story, click here.KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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