Boja Kragulj, an accomplished clarinetist who once performed with orchestras in New York, Philadelphia, and Jacksonville, Florida, has already lost four teeth. And she expects to lose at least a dozen more.<\/p>\n

Five years ago, seeking to correct her bite and improve her breathing, Kragulj tried a dental device that she was told would put pressure on her upper palate, lengthening her jawbone to fix her issues without surgery, according to an ongoing lawsuit she has filed in federal court<\/a>. Kragulj said she discovered the device through Facebook, and it sounded \u201cmiraculous.\u201d<\/p>\n

What she said happened next was ghastly. Kragulj alleged in her lawsuit that instead of changing her jaw, the device pushed her teeth forward through the bone that anchors their roots in place, which put her front teeth in jeopardy. Dozens of photos provided by her attorney show that over time her teeth bulged out of her mouth, warping her smile into a twisted mess. In the three years since filing her suit, Kragulj has had four unsalvageable teeth removed and two others ground to nubs, she said.<\/p>\n

Now Kragulj\u2019s only option is to undergo far more extensive surgeries than she faced before, according to her lawsuit. She described pain when eating anything that must be chewed and sometimes struggles to speak clearly through false teeth. And her livelihood is lost: Despite decades of training, Kragulj recently said she can no longer play clarinet well enough to perform or teach.<\/p>\n

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\u201cSo now something I had only seen in very old studies that were published in black and white, on animals, I saw in my patients with 3D X-rays.\u201d<\/p>\n
Dr. Marianna Evans, orthodontist and periodontist<\/cite><\/p><\/blockquote>\n
More than 10,000 dental patients have been fitted with an Anterior Growth Guidance Appliance, or \u201cAGGA,\u201d according to court records. But the unproven and unregulated dental device, often costing patients about $7,000, has not been evaluated by the FDA, according to a months-long joint investigation by KHN and CBS News. The FDA relies on device companies to submit new products for evaluation, and because the AGGA was never submitted, it has been sold to patients without that government review.<\/p>\n
Photos of a 21-year-old man who has been affixed with an AGGA device and was examined by Dr. Kasey Li, a California maxillofacial surgeon. Li says images A and C show the patient at the start of his AGGA treatment and images B and D show the end, after the AGGA created gaps behind his canines.(Kasey Li)<\/span><\/figcaption><\/figure>\n
\u201cThey\u2019re still selling it. And still teaching classes. And still putting it in people\u2019s mouths,\u201d Kragulj, 42, said in an interview.<\/p>\n
Dentists across the country promote the AGGA on their websites, often claiming it can \u201cgrow,\u201d \u201cremodel,\u201d or \u201cexpand\u201d an adult\u2019s jaw without surgery, sometimes saying it has the potential to make patients more attractive and treat common ailments like sleep apnea and TMJ. However, after reviewing dental scans that the AGGA inventor submitted in court to prove the device works, eight experts told KHN and CBS News the scans show signs of the AGGA displacing teeth instead of expanding the jaw. Some experts said, based on their experience with former AGGA patients, the device caused tens of thousands of dollars in damage to the patient\u2019s mouths.<\/p>\n
Dr. Marianna Evans, a Philadelphia orthodontist and periodontist who has examined multiple AGGA patients experiencing pain or complications, said she was reminded of gruesome, decades-old experiments that intentionally displaced the teeth of monkeys and dogs to test the limits of orthodontia.<\/p>\n
\u201cThese studies could not be done on humans because it was ethically wrong,\u201d Evans said. \u201cSo now something I had only seen in very old studies that were published in black and white, on animals, I saw in my patients with 3D X-rays.\u201d<\/p>\n
At least 20 AGGA patients, including Kragulj, have in the past three years filed lawsuits detailing their complaints about the device, claiming it left them with flared teeth, damaged gums, exposed roots, or erosion of the bone that holds teeth in place. Some plaintiffs said in lawsuits they would lose teeth and added in interviews that they no longer have enough healthy bone to replace their teeth with dental implants.<\/p>\n
Most of their lawsuits do not name the dentists who installed the device as defendants, but are filed against the AGGA\u2019s inventor, its manufacturer, and companies that train dentists to use it, alleging they profit from false claims about a device that does not \u2014 and cannot \u2014 work.<\/p>\n
All the AGGA lawsuits are ongoing. Attorneys for the inventor, Dr. Steve Galella<\/a>, and the company he leads, the Facial Beauty Institute<\/a>, have in court filings denied liability and argued that plaintiffs were appropriately warned of potential complications from the device<\/a>, including \u201cteeth dying\u201d or \u201cremoval of teeth.\u201d The Las Vegas Institute<\/a>, which previously held AGGA classes for dentists and promoted the device on Facebook<\/a>, denied liability in court and has a pending motion<\/a> to end claims in one lawsuit in which it is named as a defendant. And the AGGA\u2019s manufacturer, Johns Dental Laboratories<\/a>, has settled one lawsuit for an undisclosed amount but continues to fight allegations in the rest of the cases.<\/p>\n
Galella, 70, a Tennessee dentist who invented the AGGA in the 1990s, declined to be interviewed after being contacted by phone, email, and in person. His attorney, Alan Fumuso, said in a written statement that Galella \u201chad not been made aware of any complaints\u201d about the device prior to the recent lawsuits.<\/p>\n
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Dr. Steve Galella, the inventor of the AGGA device, declines to speak with KHN and CBS News journalists near his clinic in the Memphis suburbs on Feb. 9.(Brett Kelman \/ KHN)<\/span><\/figcaption><\/figure>\n
\u201cThe [AGGA], when properly used, is safe and can achieve beneficial results for the patient,\u201d Fumuso said. \u201cThis is not only the personal observation and experience of Dr. Galella, but also the experience of other dentists as well.\u201d<\/p>\n
The plaintiffs do not allege in their lawsuits that Galella treated them but that he or his company consulted with each of their dentists about their AGGA treatment.<\/p>\n
For this article, KHN and CBS News journalists interviewed 11 dental patients who said they were harmed by the AGGA \u2014 eight of whom have active lawsuits concerning the device \u2014 plus attorneys who said they represent or have represented at least 23 others. In every case, the patients said in lawsuits or interviews that they were convinced the device would expand their jaws or improve their breathing and mistakenly assumed the AGGA would not be for sale unless it was proven safe and effective.<\/p>\n
None of their jawbones expanded, the patients alleged in lawsuits and interviews.<\/p>\n
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\u201cThe entire concept of this device, of this treatment, makes zero sense. \u2026 It doesn\u2019t grow the jaw. It doesn\u2019t widen the jaw. It just pushes the teeth out of their original position.\u201d<\/p>\n
Dr. Kasey Li, maxillofacial surgeon and sleep apnea specialist<\/cite><\/p><\/blockquote>\n
Leigh Peterson, 47, of Ohio, spent $7,000 on AGGA treatment in hopes of alleviating her TMJ, or temporomandibular joint disorder, which had caused her pain since she was a teen.<\/p>\n
Within months of AGGA use, Peterson said, her teeth were so loose she could feel them move when rubbing moisturizer on her cheeks. Kissing her boyfriend became uncomfortable.<\/p>\n
Peterson, who does not have an active lawsuit, said that according to a dental specialist she will need at least one round of bone grafts to stabilize her teeth.<\/p>\n
\u201cI feel like all I have to look forward to now is treatment and pain and fear and debt,\u201d Peterson said. \u201cAnd I just regret it. I wish I\u2019d never done any of this.\u201d<\/p>\n
The AGGA, which was recently rebranded as the Osseo-Restoration Appliance, resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. The version of AGGA intended for adults is affixed to a patient\u2019s molars, typically worn for several months, and must be removed by a medical professional. Galella said pressure from the device causes an adult\u2019s jaw to \u201cremodel\u201d forward \u201cto where the body really wants it to be,\u201d according to video footage from one of his dentist trainings produced in discovery in an AGGA lawsuit. In the video, Galella describes this transformation as the key to \u201ccuring\u201d patients and making them more beautiful.<\/p>\n
\u201cWe fix the facial biology,\u201d Galella said in the video.<\/p>\n
However, in a series of interviews with orthodontists, periodontists, and maxillofacial surgeons \u2014 all of whom have more training than the average dentist \u2014 these experts said that while it is possible to expand the jaws of children without surgery, jawbones stop growing forward as people mature into adulthood. Experts who have examined patients fitted with an AGGA said the device aggressively moved teeth, sometimes creating an illusion of jaw growth by tilting some teeth forward and forcing gaps between others. In the worst cases, those experts have seen teeth shoved so far out of position that their roots are pushed free of the bone and into the gums.<\/p>\n
$\"A$
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 \u201cmedieval\u201d device. Li says his experience with the AGGA patients he has examined is that \u201cit does nothing but basically make them lose their teeth.\u201d(Anna Werner \/ CBS News)<\/span><\/figcaption><\/figure>\n
Dr. Kasey Li, a California maxillofacial surgeon and sleep apnea specialist, last year published a study \u2014 the abstract of which appeared on a National Institutes of Health website<\/a> \u2014 describing loose teeth and bone loss among AGGA patients he has examined.<\/p>\n
In an interview, Li described the AGGA device as \u201cmedieval\u201d and said using it to try to expand a jaw is not unlike trying to make your house bigger by simply pushing on the wooden framing in the walls.<\/p>\n
\u201cThe entire concept of this device, of this treatment, makes zero sense,\u201d Li said. \u201cIt doesn\u2019t grow the jaw. It doesn\u2019t widen the jaw. It just pushes the teeth out of their original position.\u201d<\/p>\n
Rolling Out the AGGA<\/strong><\/p>\n
The AGGA device has been used on patients for about 15 years. Its biggest promoter is Galella, who operates out of a small, unremarkable clinic in a strip mall in the Memphis suburbs.<\/p>\n
Galella said in a 2021 sworn deposition in one of the lawsuits that he has applied the AGGA to about 600 patients and prepared treatment plans for patients getting an AGGA from another dentist on about 9,800 occasions, collecting a \u201croyalty\u201d of $50 to $65 each time the device is made.<\/p>\n
The Facial Beauty Institute has also taught an undisclosed number of dentists to use the device during three-day courses costing about $5,000, according to the company\u2019s website. The Las Vegas Institute, also known as LVI Global, offered similar AGGA classes for years and lists on its website about 75 dentists across the U.S. and Canada who have taken that class.<\/p>\n
Dave Hornblower, 36, of Ontario, who was fitted with an AGGA in 2019 by a dentist who trained at the Las Vegas Institute, now expects to lose multiple teeth<\/a>, according to his lawsuit against the company, the inventor, and other defendants.<\/p>\n
Hornblower said in an interview the AGGA did not improve his breathing and he now feels pain whenever he makes a \u201cTH\u201d sound, brushing his tongue against the back of his front teeth.<\/p>\n
\u201cMy dentist said he\u2019d went to courses, seen the evidence, and he seemed very sure of himself, so I was sure of him,\u201d Hornblower said. \u201cHe told me it would do all that magical stuff, and I believed him.\u201d<\/p>\n
William Schuller, an attorney for the Las Vegas Institute, said in a phone interview that the Institute disputes claims the AGGA is \u201cinherently dangerous\u201d or \u201chas no utility to adults.\u201d Schuller said AGGA training is no longer offered at the institute and disputed that the institute ever taught dentists to use the device.<\/p>\n
\u201cI wouldn\u2019t go so far as to say that LVI directly taught dentists to use the AGGA device ever,\u201d he said. \u201cLVI is a campus that provides the ability to teach courses in a variety of procedures and techniques. The doctors who taught the courses were associated with Dr. Galella. It was his course and his course materials that he prepared.\u201d<\/p>\n
However, according to a sworn deposition filed in one of the AGGA lawsuits<\/a>, the AGGA training at the Las Vegas Institute was for years taught by the company\u2019s \u201cco-orthodontic directors,\u201d Dr. David Buck and Dr. Timothy Gross. Buck said in that deposition he created lectures and wrote materials for the course, which were approved by Galella and the leadership of the institute, which kept 70% of the tuition paid for the trainings. A slideshow presentation from one of these training sessions, filed as an exhibit in another AGGA lawsuit, identifies Buck and Gross as \u201cclinical instructor[s]\u201d at the institute.<\/p>\n
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\u201cWe are not aware of any peer-reviewed articles regarding AGGA working and we\u2019re not aware of any peer-reviewed articles regarding AGGA not working.\u201d<\/p>\n
William Schuller, attorney <\/cite><\/p><\/blockquote>\n
When pressed during his deposition, Galella said he was not aware of any peer-reviewed studies<\/a> or clinical trials demonstrating that the AGGA works as claimed on patients whose jaws have finished growing. Galella said his confidence in the device comes from years of using it on patients and dental scans he had not published.<\/p>\n
\u201cIt proved it to me,\u201d Galella said. \u201cBut for the rest of the world, I hadn\u2019t posted anything. Sorry.\u201d<\/p>\n
Galella\u2019s company has posted a non-peer-reviewed \u201cwhite paper\u201d<\/a> that summarizes the theory behind the AGGA and contains one image from a dental scan of an unidentified, presumably adult patient that describes 1 to 3 millimeters of \u201coutward relocation\u201d of the upper jawbone after wearing an AGGA for four months. The paper says research on the AGGA \u201ctakes some time\u201d and \u201cwe have begun this research in earnest.\u201d<\/p>\n
Schuller acknowledged the lack of peer-reviewed evidence behind the AGGA.<\/p>\n
\u201cWe are not aware of any peer-reviewed articles regarding AGGA working,\u201d he said in an interview, \u201cand we\u2019re not aware of any peer-reviewed articles regarding AGGA not working. So my understanding is that there is no literature to speak to it one way or the other.\u201d<\/p>\n
Faced with the lack of professional studies, a federal judge last year ordered Galella to turn over a sample of his dental scans. Galella was required to provide the plaintiffs with before-and-after scans from five patients over age 30 that demonstrate the AGGA is effective.<\/p>\n
Those scans offer no proof, according to an expert witness enlisted by the plaintiffs. In a sworn affidavit filed with the court, Dr. Ricky Harrell<\/a>, who leads the residency program at the Georgia School of Orthodontics, said Galella\u2019s dental scans \u201c demonstrate no appreciable growth<\/a>\u201d of the adult jawbones.<\/p>\n
KHN and CBS News had those scans reviewed by eight independent experts, including orthodontists, periodontists, maxillofacial surgeons, and faculty from dental colleges at Columbia, Harvard, and the University of Florida. None of these experts was involved in any of the AGGA lawsuits at the time of their interviews.<\/p>\n
Every expert had the same response: Galella\u2019s scans showed patients\u2019 teeth had moved but their jaws remained unchanged.<\/p>\n
\u201cIt is proof,\u201d said Dr. Richard Roblee, an Arkansas orthodontist who reviewed the scans. \u201cProof that the [AGGA] is not working correctly, not doing what they say. That is the proof that he has given.\u201d<\/p>\n
Roblee said he has examined at least 15 people he said were harmed by the AGGA and has never seen another dental technique cause \u201cthis much damage\u201d to so many patients.<\/p>\n
Dr. George Mandelaris, a Chicago-area periodontist and member of the American Academy of Periodontology Board of Trustees, said Galella\u2019s dental scans show \u201charm\u201d to the bone that holds teeth in place. Mandelaris said he has consulted with 11 AGGA patients, including Kragulj, who looked as if \u201ca bomb went off in her mouth.\u201d<\/p>\n
$\"A$
Dr. George Mandelaris, a Chicago-area periodontist, says he has consulted with AGGA patients who were \u201cmangled\u201d and \u201cdisfigured\u201d to the point of abuse.(Anna Werner \/ CBS News)<\/span><\/figcaption><\/figure>\n
Dr. Sercan Akyalcin, the head of orthodontics at Harvard, said the scans showed the patients\u2019 upper frontmost teeth were pushed forward but did not show that their jawbones expanded.<\/p>\n
Dr. Millie Embree, a professor of orthodontics at Columbia, and Dr. Anita Gohel, the head of oral radiology at the University of Florida, each said they saw that patients were losing teeth in the scans that Galella chose to validate the AGGA\u2019s effectiveness.<\/p>\n
\u201cI\u2019m a little surprised that this was the best evidence,\u201d Gohel said. \u201cI wonder what the rest is.\u201d<\/p>\n
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.<\/p>\n
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 if it was aware of the AGGA prior to being contacted by KHN and CBS News.<\/p>\n
The AGGA\u2019s exclusive manufacturer, Johns Dental Laboratories, located in Indiana, said in a court document it has no record of communicating with the FDA about the AGGA before beginning to make or sell it. Johns Dental said in court the AGGA falls into the FDA\u2019s least-risky classification for devices, similar to a dental retainer, and is exempt from a pre-market clearance under a statutory exemption for dental labs. Johns Dental attorney Jeffrey Oberlies declined to comment.<\/p>\n
Galella said in his deposition that he believed the AGGA was outside of the FDA\u2019s jurisdiction.<\/p>\n
Cara Tenenbaum, a former senior policy adviser in the FDA\u2019s device center, said the AGGA is within FDA jurisdiction and it was \u201cincredibly problematic\u201d that it was not registered, at least in part because that is how the FDA collects reports of negative effects.<\/p>\n
If properly registered, Tenenbaum said, the AGGA might be classified with devices that reposition the jaw or prevent snoring, which are in a more tightly regulated category than what Johns Dental cited in court. Tenenbaum said the FDA was most likely unaware of the AGGA and she suspects it will investigate once alerted to allegations of patient harm.<\/p>\n
Scott Charnas, a New York attorney who represents numerous AGGA patients, said he believed a more proactive FDA would have discovered and investigated the device years ago.<\/p>\n
\u201cIt\u2019s just going to go on and on unless someone does something about it,\u201d Charnas said. \u201cSomebody needs to step up.\u201d<\/p>\n
AGGA Inventor: \u2018It\u2019s OK to Make a Crapload of Money\u2019<\/strong><\/p>\n
Both Galella and the Las Vegas Institute have said in dentist trainings that the AGGA can \u201ccure\u201d TMJ and sleep apnea, according to the AGGA training video footage and a slideshow presentation obtained from the ongoing lawsuits.<\/p>\n
Galella is heard in the video telling dentists that customers are \u201cgonna beat your door down\u201d because the AGGA can cure patients instead of merely treating their symptoms. He says some patients who want to lessen their pain or improve their looks will \u201cpay anything \u2014 anything! \u2014 to have that problem resolved.\u201d<\/p>\n
\u201cIt\u2019s OK to make a crapload of money,\u201d Galella tells dentists in the video. \u201cYou\u2019re not ripping anybody off. You\u2019re curing them. You\u2019re helping them. You\u2019re making their life totally beautiful forever and ever.\u201d<\/p>\n
Beauty was also a focal point of AGGA classes at the Las Vegas Institute, where the slideshow presentation features photos of celebrities and models. Images of decorated Olympic swimmer Michael Phelps and Princess of Wales Kate Middleton are shown as examples of the kind of unattractive, \u201cunderdeveloped midface\u201d that the AGGA is claimed to correct. Middleton is specifically described as \u201cremarkably not\u201d beautiful.<\/p>\n
\u201cWhy are we here?\u201d reads the first page of the slideshow. \u201cTo treat ugly faces.\u201d<\/p>\n
The Las Vegas Institute frequently promoted the AGGA in a Facebook group<\/a> where many of the patients interviewed for this story say they were first persuaded to use the device. The group outwardly appears to be a discussion space for people with jaw problems, and membership is controlled by the Las Vegas Institute.<\/p>\n
\u201cWe were looking for this holy grail type of deal,\u201d said Karan Gill, who wore an AGGA for months and alleges in a lawsuit his teeth were left loose and sensitive. \u201cThe people who were promoting the AGGA in these Facebook groups and such \u2014 that\u2019s the way they were talking about it.\u201d<\/p>\n
Five former members described the Facebook group as a pro-AGGA echo chamber, where anyone who asked for proof that the AGGA works was hushed or banned.<\/p>\n
\u201cIf you seek the truth outside, you will be excommunicated,\u201d said Nick Hamilton, 40, a former member of the Facebook group who has an ongoing lawsuit against Galella<\/a>. \u201cI was asking too many questions. And I started talking openly with other people that were having issues. And they kicked us all out.\u201d<\/p>\n
$\"A$
Nick Hamilton, a former AGGA patient and member of the Las Vegas Institute group on Facebook. \u201cI was asking too many questions. And I started talking openly with other people that were having issues. And they kicked us all out.\u201d(Anna Werner \/ CBS News)<\/span><\/figcaption><\/figure>\n
A KHN-CBS News review of the Facebook group postings the past six years uncovered at least five posts in which Las Vegas Institute CEO Bill Dickerson said that the AGGA is \u201cgrowing bone\u201d or can \u201cgrow the maxilla,\u201d which is another name for the upper jaw.<\/p>\n
\u201c[I]nstead of just moving teeth \u2026 we are growing bone \u2026 it\u2019s awesome,\u201d Dickerson wrote in a 2017 post about the AGGA in the Facebook group.<\/p>\n
Dickerson has since changed his view. Last year, in a sworn deposition filed in an ongoing lawsuit, Dickerson said he did not believe the AGGA could grow the maxilla<\/a> and agreed it would be misleading to say it could. Dickerson said in the deposition he began to question the claims of what the AGGA could do in 2020, and after reviewing some patients\u2019 dental scans, he severed ties with Galella and the Facial Beauty Institute.<\/p>\n
Kragulj, the clarinetist from the beginning of this article, said she discovered the AGGA through a Facebook video from Galella\u2019s Facial Beauty Institute. According to her lawsuit, she got a device in 2018 and wore it for about 14 months, by which point she had sustained \u201cirreversible\u201d damage to the bone that holds her teeth in place.<\/p>\n
Eventually, Kragulj sought help from the man who knew the AGGA better than anyone: Galella. She said she traveled to his Facial Beauty Institute for a consultation, expecting an elite academic facility but finding only a small clinic with aging wallpaper and broken equipment.<\/p>\n
Kragulj said Galella looked in her mouth and, after an audible sigh, offered to fix her for $15,000 \u2014 plus as much as $15,000 more per tooth. Galella confirmed that meeting and approximate cost in his deposition.<\/p>\n
After the meeting, Kragulj decided she was done with Galella, according to her lawsuit. She said she returned to the traditional surgeons and specialists she once eschewed, and the first orthodontist she saw described her teeth as \u201cthe worst thing he\u2019d ever seen.\u201d<\/p>\n
\u201cThey were hanging on by a thread, and the bone was gone,\u201d Kragulj said in an interview. \u201cSo it was an extravagant process to get to a place where I could even have fake teeth.\u201d<\/p>\n
Kragulj said that since abandoning the AGGA treatment she had to remove four front teeth and was fitted with a dental bridge of false teeth. She said she will need surgery to fix the underlying problems in her jaw and will likely need to replace her upper teeth with prosthetics.<\/p>\n
Her entire treatment will cost, by her estimate, a minimum of $150,000, followed by a lifetime of maintaining and replacing dental implants, she said.<\/p>\n
Kragulj said it is unlikely she will ever play the clarinet professionally again and as of now she cannot play properly for even a minute without pain.<\/p>\n
\u201cMy inner world is very silent,\u201d Kragulj said. \u201cIt was my voice.\u201d<\/p>\n
$\"A$
Boja Kragulj performs in Novi Sad, Serbia, in February 2017.(Makris Music Society)<\/span><\/figcaption><\/figure>\n
CBS News producer Nicole Keller contributed to this article.<\/em><\/p>\n
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