In the wake of a joint investigation by Kaiser Health News and CBS News into a dental appliance that multiple lawsuits allege caused grievous harm to patients, the Food and Drug Administration has begun looking into the product, the anterior growth guidance appliance, according to a former agency official.
Additionally, KHN and CBS News have learned that the Las Vegas Institute, a training company that previously taught dentists to use the product, now trains dentists to use another device it has described as "almost exactly the same appliance." That one is called the Anterior Remodeling Appliance.
The FDA's interest in the guidance appliance was revealed by Cara Tenenbaum, a former senior policy adviser in the agency's device center who has said the FDA should investigate the product, which has been fitted on more than 10,000 dental patients, according to court records.
Tenenbaum said that after KHN and CBS News published their report, she was contacted by "very concerned" FDA officials who said they have begun "looking into" the product but have yet to determine how much legal authority the agency has to regulate it.
"The FDA is looking at what authorities they may have around this device -- what they may be able to do," Tenenbaum said. "Now, of course, whether or not this device is FDA regulated, it still needs to be safe."
KHN and CBS News have reviewed online messages verifying that an FDA official has communicated with Tenenbaum about the guidance appliance. The FDA declined to comment on the product or confirm whether it was evaluating the device.
The KHN-CBS News investigation of the guidance appliance involved interviews with 11 patients who said they were hurt by the device -- plus attorneys who said they represent or have represented at least 23 others -- and dental specialists who said they'd examined patients who had experienced severe complications using the product. The investigation also found no record of the device being registered with the FDA, despite the agency's role in regulating medical and dental devices.
The product's inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the device was never submitted to the FDA, which he believes doesn't have jurisdiction over it. Tenenbaum has said the lack of registration is "incredibly problematic" because that is one method by which the FDA collects reports of a device's negative effects.
She encouraged anyone who has witnessed complications from the guidance appliance to assist the FDA by submitting a report through its MedWatch portal.
"Whether that's a dentist, an orthodontist, a surgeon, a patient, family member or caregiver," Tenenbaum said, "anyone can and should submit these reports so the FDA has a better understanding of what's happening."
Victor Krauthamer, a former FDA official who worked in a division regulating medical devices at the agency for three decades, said it was normal for an FDA probe of a device to begin by researching the boundaries of the agency's authority, ensuring any future action has a solid legal foundation.
Krauthamer said he expects the FDA to take regulatory action against the guidance appliance, including sending a warning letter to the manufacturer and potentially taking custody of the devices.
"At this point, I would be surprised if there wasn't some sort of compliance action, such as a seizure," Krauthamer said, adding later, "I think that's probably where the FDA is -- trying to make a case that will hold in court and won't be thrown out."
Jeffrey Oberlies, an attorney for guidance appliance manufacturer Johns Dental Laboratories, said in an email that the company "looks forward to resolving the allegations against it" and declined to comment on the product or the FDA's interest in the device.
Galella said in his deposition he personally used the product on more than 600 patients and has for years trained other dentists how to use it. In video footage of one training session, produced in discovery in a device lawsuit, Galella said the device puts pressure on a patient's palate and causes an adult's jaw to "remodel" forward, making them more attractive and "curing" common ailments like sleep apnea and temporomandibular joint disorder, or TMJ.
"It's OK to make a crapload of money," Galella told dentists in the video. "You're not ripping anybody off. You're curing them. You're helping them. You're making their life totally beautiful forever and ever."
Dentists across the country have drawn from Galella's teachings on their websites, often saying the guidance appliance can "grow," "remodel" or "expand" an adult's jaw without surgery. At least 11 of those dentists' websites appear to have removed any mention of the device since the KHN-CBS News investigation was published March 1.
"I think that's good to hear," said Boja Kragulj, a former professional clarinetist who has alleged in a lawsuit that the device did catastrophic harm to her teeth. "I think when you take away this information from patients that are searching for the appliance and seeing these claims, that's generally a good thing."
Kragulj is one of at least 20 guidance appliance patients who have in the past three years filed lawsuits against Galella and other defendants claiming the device did not -- and cannot -- work. The plaintiffs allege that instead of expanding their jawbones, the product left them with damaged gums, loose teeth and eroded bone.
Some allege in lawsuits they will lose teeth because of the device and added in interviews that they no longer have enough healthy bone to replace those teeth with dental implants.
"I can take my finger now, and I can literally wiggle my front teeth," said Melanie Pappalardi, 28, who said she wore a guidance appliance for a year and filed a lawsuit in Indiana. "I can't bite into absolutely anything."
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.
Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, has said in a written statement that the device "is safe and can achieve beneficial results."
All the guidance appliance lawsuits are ongoing. Attorneys for Galella and his company, the Facial Beauty Institute, have denied liability in court filings. Johns Dental Laboratories settled one lawsuit for an undisclosed amount but continues to fight allegations in the other cases. 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.
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.
Brett Kelman / Kaiser Health News/ Dr. Steve Galella, the inventor of the anterior growth guidance appliance, declines Feb. 9 to speak with Kaiser Health News and CBS News journalists near his clinic in the Memphis suburbs.