KFF’s Kaiser Health
News and CBS News Team Up to Investigate a Dental Device That Allegedly
Has Left a Trail of Mangled Mouths and Devastated Patients
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.
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 device -- 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
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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
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home to the nation’s #1 news program 60 MINUTES, the CBS News Streaming
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service that is available free to everyone with access to the internet.
The CBS News Streaming Network is the destination for breaking news, live
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and Stations’ top anchors and correspondents working locally, nationally,
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platforms and apps, as well as CBSNews.com and Paramount+. The service is
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