PHOTO: Dr. Kasey Li, a California maxillofacial surgeon, who has examined about 10 patients fitted with the AGGA and reviewed dental scans of five more, describes it as a “medieval” device. Li says his experience with the AGGA patients he has examined is that “it does nothing but basically make them lose their teeth.” Courtesy Anna Werner / CBS News.
In a months-long project, KFF’s Kaiser Health News correspondent Brett Kelman joined forces with CBS News National Consumer Investigative Correspondent Anna Werner to investigate an unregulated dental device that is at the heart of numerous accounts of pain and disfigurement. The story originally appeared on KHN on March 1, 2023.
At least 10,000 dental patients have been fitted with the fixed Anterior Growth Guidance Appliance (“AGGA”), which costs about $7,000. The device resembles a retainer, is typically worn for several months, and uses springs to apply pressure to the front teeth and upper palate, according to the patent application filed by the inventor of the device.
In videos of the inventor training dentists, he says the pressure can expand a patient’s jaw, which he cites as the key to making people more beautiful and curing common ailments like sleep apnea and TMJ.
But dental specialists interviewed by KHN and CBS News said that based on their experiences with former AGGA patients the device pushed teeth out of position and sometimes left them loose and weak.
At least 20 patients have filed lawsuits in the past three years claiming the device — which has not been reviewed by the Food and Drug Administration — left them with flared teeth, damaged gums, exposed roots, or erosion of the bone that holds teeth in place. The inventor and other defendants have denied liability in all the lawsuits.
The joint KHN-CBS News investigation aired on “CBS Mornings” in two installments, on March 1 and March 2. A digital version of the story, which includes embedded video of the TV segments, appears on khn.org and cbsnews.com. This is the first investigative project stemming from a broader editorial partnership between CBS News and KFF.
“A hallmark of KHN’s investigative journalism is that we illuminate systemic flaws in American health care,” said KHN Publisher David Rousseau, the executive director of journalism and technology at KFF. “This investigation shows no one was watching.”
“This is a great example of reporters teaming up to expose a problem that can impact the health and finances of everyday Americans,” said Shawna Thomas, Executive Producer of CBS Mornings. “By partnering with Kaiser Health News, we’re able to expand the depth of our health care and consumer coverage.”
The editorial partnership also features regular appearances by Dr. Céline Gounder, KHN’s senior fellow and editor-at-large for public health, on all of CBS News’ platforms, as well as stories, segments, and specials drawing upon reporting from across KHN’s newsroom and bureaus. It includes the popular “Bill of the Month” series, in which KHN Editor-in-Chief Elisabeth Rosenthal appears regularly on “CBS Mornings” to discuss surprising medical bills and what they tell us about the health care system. (“Bill of the Month” is a collaborative investigative project of KHN and NPR.) And it now includes the KHN Health Minute, a weekly feature for CBS News Radio stations that will help millions of listeners understand how developments in health care delivery and policy affect them.
For the dental device story, KHN and CBS News journalists interviewed 11 dental patients who said they were harmed by the AGGA — eight of whom have active lawsuits concerning the device — plus attorneys who represent or have represented at least 23 others.
In every case, the patients said they mistakenly assumed the device would not be for sale unless it was proven safe and effective. Dental experts said, based on their experience with former AGGA patients, that patients can suffer tens of thousands of dollars in damage to their mouths.
According to a KHN and CBS News review of the FDA’s device database, the AGGA does not appear to be on the radar of the agency, which is responsible for regulating medical and dental devices in the United States. A manufacturer is supposed to register devices with the FDA, and those 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. The manufacturer of the AGGA said in a court document it has no record of communicating with the FDA about the device before beginning to make or sell it, and claimed that the device is exempt from premarket review under an exemption for dental labs.
About KFF and KHN
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis, Polling and Survey Research and Social Impact Media, KHN is one of the four major operating programs at KFF. KFF is an endowed nonprofit organization providing information on health issues to the nation.
About CBS News and Stations
CBS News and Stations brings together the power of CBS News, 28 owned television stations in 17 major U.S. markets, the CBS News Streaming Network, CBS News Streaming local platforms, local websites and cbsnews.com, under one umbrella.
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