Within the wake of a KHN-CBS News investigation, the FDA on Thursday said it’s “evaluating safety concerns” over using a dental appliance that multiple lawsuits allege caused grievous harm to patients.

The federal agency told the general public in a “safety communication” posted on its website that it’s looking not only at that product, the Anterior Growth Guidance Appliance, or AGGA, but other similar dental devices as well, including the Anterior Remodeling Appliance, or ARA, identified in a recent KHN and CBS News article.

The FDA said it’s “aware of reports of great complications with use of those devices” and asked that patients and health care providers report any complications experienced with them to the agency.

The agency said it’s aware the devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder of the jaw, also generally known as TMD or TMJ, but noted that “the protection and effectiveness of those devices intended for these uses haven’t been established.”

The AGGA device alone has been fitted on greater than 10,000 dental patients, based on court records.

The KHN-CBS News investigation of the AGGA involved interviews with 11 patients who said they were hurt by the device — plus attorneys who said they represent or have represented not less than 23 other patients — and dental specialists who said they’d examined patients who had experienced severe complications using the AGGA. The investigation found no record of the AGGA being registered with the FDA, despite the agency’s role in regulating medical and dental devices. The FDA confirmed Thursday that the devices “should not cleared or approved by the FDA.”

The AGGA’s inventor, Tennessee dentist Dr. Steve Galella, has said in a sworn court deposition that the AGGA was never submitted to the FDA, which he believes would not have jurisdiction over it.

A minimum of 20 AGGA patients have previously three years filed lawsuits against Galella and other defendants claiming the AGGA didn’t — and can’t — work. Plaintiffs allege that as an alternative of expanding their jawbones, the AGGA left them with damaged gums, loose teeth, and eroded bone.

Moreover, KHN and CBS News reported that the Las Vegas Institute, an organization that previously taught dentists to make use of the AGGA, now trains dentists to make use of one other device its CEO has described as “almost the exact same appliance.” That one known as the Anterior Remodeling Appliance, or ARA.

KHN and CBS News reached out Thursday to attorneys for Galella, the Las Vegas Institute, and the manufacturers of the AGGA and the ARA but received no immediate response.

Galella has declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuso, previously said in a written statement that the AGGA “is secure and might achieve useful results.”

All of the AGGA lawsuits are ongoing. Galella and the opposite defendants have denied liability in court filings. Cara Tenenbaum, a former senior policy adviser within the FDA’s device center, said reports of complications from these devices are of critical importance and might be submitted through FDA’s MedWatch portal.

“Whether that is a dentist, an orthodontist, a surgeon, a patient, member of the family, or caregiver,” Tenenbaum said in a recent interview, “anyone can and will submit these reports so the FDA has a greater understanding of what is happening.”

In a court deposition, Galella said he personally used the AGGA on greater than 600 patients and has for years trained other dentists find out how to use it. In video footage of 1 training session, produced in discovery in an AGGA 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, equivalent to sleep apnea and TMJ.

“It’s OK to make a crapload of cash,” Galella told dentists within the video. “You are not ripping anybody off. You are curing them. You are helping them. You make their life totally beautiful perpetually and ever.”

In its Thursday announcement, the FDA said it’s aware the devices have been used “to transform the jaw in adults” but identified that devices like these called “fixed (non-removable) palatal expanders” are generally used on children and adolescents, “whose upper jaw bones should not yet fused.” In contrast, the FDA said, “an adult’s upper jaw bones are fused, and when a hard and fast palatal expansion device applies force, the palate is proof against expansion. If forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”

Patients interviewed by KHN and CBS News described experiencing lots of those problems. One patient who has sued, former skilled clarinetist Boja Kragulj, said specialists later had to tug her 4 front teeth. She now wears false teeth.

Reached Thursday, Kragulj said: “While it’s too late for me and lots of others, there may be some comfort in knowing the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the injuries and lost years that lots of us have now suffered.”

The FDA said it plans “to analyze potential violations” in reference to using the devices, and that it’s “identifying and contacting responsible entities to speak [its] concerns.”

The American Dental Association, which has 159,000 dentist members, said it “will inform dentists of the FDA’s evaluation, and can proceed to observe for FDA updates regarding these devices and issues.”