Lawsuits claim dental device sold to fix patients’ jaws wrecked their teeth
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.
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.
Kragulj said she discovered the device — invented by a Memphis area dentist — through Facebook, and it sounded “miraculous.”
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.
Now Kragulj’s 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.
More than 10,000 dental patients have been fitted with an anterior growth guidance appliance, according to court records. But the unproven and unregulated dental device, often costing patients about $7,000, has not been evaluated by the Food and Drug Administration, according to a monthslong joint investigation by Kaiser Health News and CBS News. The FDA relies on device companies to submit new products for evaluation, and because the
guidance appliance was never submitted, it has been sold to patients without that government review.
“They’re still selling it. And still teaching classes. And still putting it in people’s mouths,” Kragulj, 42, said in an interview.
Dentists across the nation promote the guidance appliance on their websites, often claiming it can “grow,” “remodel” or “expand” an adult’s jaw without surgery, sometimes saying it has the potential to make patients more attractive and treat common ailments like sleep apnea and temporomandibular joint disorder.
However, after reviewing dental scans that the guidance appliance inventor submitted in court to prove the device works, eight experts told KHN and CBS News the scans show signs of the device displacing teeth instead of expanding the jaw. Some experts said, based on their experience with former guidance appliance patients, the device caused tens of thousands of dollars in damage to the patients’ mouths.
Dr. Marianna Evans, a Philadelphia orthodontist and periodontist who has examined multiple guidance appliance 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.
“These studies could not be done on humans because it was ethically wrong,” Evans said. “So 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.”
At least 20 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.
Most of their lawsuits do not name the dentists who installed the device as defendants. Instead, they are filed against the guidance appliance’s inventor, its manufacturer and companies that train dentists to use it, alleging they profit from false claims about a device that does not — and cannot — work.
TEETH DYING
All the 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.”
The Las Vegas Institute, which previously held guidance appliance classes for dentists and promoted the device on Facebook, denied liability in court and has a pending motion to end claims in one lawsuit in which it is named as a defendant. And the manufacturer, Johns Dental Laboratories, has settled one lawsuit for an undisclosed amount but continues to fight allegations in the rest of the cases.
Galella, 70, a Collierville, Tennessee, dentist who invented the guidance appliance 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 “had not been made aware of any complaints” about the device prior to the recent lawsuits.
The guidance appliance, when used properly, is safe and can achieve beneficial results for the patient, Fumuso said.
“This is not only the personal observation and experience of Dr. Galella, but also the experience of other dentists as well,” Fumuso said.
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 guidance appliance treatment.
For this article, KHN and CBS News journalists interviewed 11 dental patients who said they were harmed by the device — eight of whom have active lawsuits concerning it — 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 guidance appliance would not be for sale unless it was proven safe and effective.
None of their jawbones expanded, the patients alleged in lawsuits and interviews.
The guidance appliance, 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 the application intended for adults is affixed to a patient’s molars, typically worn for several months and must be removed by a medical professional.
Galella said pressure from the device causes an adult’s jaw to “remodel” forward “to where the body really wants it to be,” according to video footage from one of his dentist trainings produced in discovery in a lawsuit. In the video, Galella describes this transformation as the key to “curing” patients and making them more beautiful.
“We fix the facial biology,” Galella said in the video.
However, in a series of interviews with orthodontists, periodontists and maxillofacial surgeons, 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 the guidance appliance 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.
Dr. Kasey Li, a California maxillofacial surgeon and sleep apnea specialist, last year published a study — the abstract of which appeared on a National Institutes of Health website — describing loose teeth and bone loss among device patients he has examined.
In an interview, Li described the device as “medieval” 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.
“The entire concept of this device, of this treatment, makes zero sense,” Li said. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”
‘MAGICAL STUFF’
The appliance has been used on patients for about 15 years. Its biggest promoter is Galella, who operates out of clinic in a strip mall in the Memphis suburbs.
Galella said in a 2021 sworn deposition in one of the lawsuits that he has applied the guidance appliance to about 600 patients and prepared treatment plans for patients getting the device from another dentist on about 9,800 occasions, collecting a royalty of $50 to $65 each time the device is made.
The Facial Beauty Institute has also taught an undisclosed number of dentists to use the guidance appliance during three-day courses costing about $5,000, according to the company’s website. The Las Vegas Institute, also known as LVI Global, offered similar device classes for years and lists on its website about 75 dentists across the U.S. and Canada who have taken that class.
Dave Hornblower, 36, of Ontario, who was fitted with the device in 2019 by a dentist who trained at the Las Vegas Institute, now expects to lose multiple teeth, according to his lawsuit against the company, the inventor and other defendants.
Hornblower said in an interview the guidance appliance did not improve his breathing and he now feels pain whenever he makes a “th” sound, brushing his tongue against the back of his front teeth.
“My dentist said he’d went to courses, seen the evidence and he seemed very sure of himself, so I was sure of him,” Hornblower said. “He told me it would do all that magical stuff, and I believed him.”
William Schuller, an attorney for the Las Vegas Institute, said in a phone interview that the institute disputes claims the device is “inherently dangerous” or “has no utility to adults.” Schuller said training to use the guidance appliance is no longer offered at the institute and disputed that the institute ever taught dentists to use the device.
According to a sworn deposition filed in one of the device lawsuits, the guidance appliance training at the Las Vegas Institute was for years taught by the company’s “co-orthodontic directors,” 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.
When pressed during his deposition, Galella said he was not aware of any peer-reviewed studies or clinical trials demonstrating that the guidance appliance 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.
“It proved it to me,” Galella said. “But for the rest of the world, I hadn’t posted anything. Sorry.”
FACEBOOK VIDEO
Kragulj, the clarinetist, said she discovered the device through a Facebook video from Galella’s Facial Beauty Institute. According to her lawsuit, she got a guidance appliance in 2018 and wore it for about 14 months, by which point she had sustained “irreversible” damage to the bone that holds her teeth in place.
Eventually, Kragulj said she traveled to Galella’s Facial Beauty Institute for a consultation. Kragulj said Galella looked in her mouth and, after an audible sigh, offered to fix her for $15,000 — plus as much as $15,000 more per tooth. Galella confirmed that meeting and approximate cost in his deposition.
After the meeting, Kragulj said she returned to the traditional surgeons and specialists she once eschewed, and the first orthodontist she saw described her teeth as “the worst thing he’d ever seen.”
“They were hanging on by a thread, and the bone was gone,” Kragulj said in an interview. “So it was an extravagant process to get to a place where I could even have fake teeth.”
Kragulj said that since abandoning the device 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.
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.
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.
“My inner world is very silent,” Kragulj said. “It was my voice.”
CBS News producer Nicole Keller contributed to this article.
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 Kaiser Family Foundation, an endowed nonprofit organization providing information on health issues to the nation.
“The entire concept of this device, of this treatment, makes zero sense. It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”
– DR. KASEY LI, A CALIFORNIA MAXILLOFACIAL SURGEON AND SLEEP APNEA SPECIALIST