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FDA Examines Safety Concerns Over Dental Devices in KHN/CBS Investigation

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FDA Examines Safety Concerns Over Dental Devices in KHN/CBS Investigation

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Following a KHN/CBS News investigation, FDA said Thursday that it was “evaluating safety concerns” regarding the use of a dental device that has been the subject of multiple lawsuits.

In a “safety communications” posted on its website, the federal agency informed the public that it is not only looking at the Anterior Growth Guidance appliance, or AGGA, but also other similar dental devices, such as the Anterior Remodeling appliance, or ARA, which was identified in a CBS News and KHN article.

FDA stated that it is aware of reports of serious complications associated with the use of these devices and asked that patients and their health care providers report any such complications to the agency.

The agency stated that it was aware of devices being used to treat sleep apnea, temporomandibular disorder of the jaw (also known as TMD, or TMJ), but cautioned that the safety and effectiveness of these devices for these purposes has not been established.

According to court records, the AGGA device has been fitted on more that 10,000 patients.

Interviews with 11 patients who claimed they were injured by the AGGA were conducted by KHN-CBS News. Also, attorneys said they represented or had represented at least 23 patients. Dental specialists also said they have seen patients who suffered severe complications from the AGGA. The FDA did not register the AGGA, despite its role in regulating dental and medical devices. Thursday’s FDA confirmation confirmed that the devices were not approved or cleared by the FDA.

Dr. Steve Galella from Tennessee, the inventor of the AGGA, stated in a sworn court testimony that the AGGA was never submitted by the FDA. He believes the FDA wouldn’t have jurisdiction.

Galella and other defendants have been sued by at least 20 AGGA patients in the last three years. They claim that the AGGA didn’t work and can’t work. Plaintiffs claim that the AGGA did not expand their jawbones but left them with damaged gums and loose teeth.

KHN and CBS News also reported that the Las Vegas Institute, a company which previously taught dentists how to use the AGGA, now trains them to use a different device. That one is the Anterior Remodeling Appliance or ARA.

KHN and CBS News reached out to Galella, the Las Vegas Institute and the manufacturers of the AGGA, and the ARA on Thursday, but did not receive an immediate response.

Galella declined to be interviewed for CBS News and KHN. In a written statement, his attorney Alan Fumuso stated that the AGGA is safe and can produce beneficial results.

All AGGA lawsuits remain pending. Galella and other defendants have denied liability in court documents. Cara Tenenbaum, a former senior adviser in FDA’s device centre, stated that reports of complications are critical and can be submitted through FDA MedWatch portal.

Tenenbaum stated that anyone can and should submit reports to the FDA, regardless of whether they are a dentist, surgeon, orthodontist, a patient, or family member, or caregiver.

Galella stated that he has used the AGGA with more than 600 patients. He also taught other dentists how to use the device for many years. Galella claimed that the AGGA puts pressure on patients’ palates and causes their jaws to “remodel”, making them more attractive and “curing” common conditions like sleep apnea or TMJ.

Galella said to dentists that it was OK to make a lot of money. “You are not ripping anyone off. They are being treated. They are your help. You are making their lives so beautiful for all eternity.

The FDA announced Thursday that it was aware of the devices being used to “remodel the jaw in adults.” However, the FDA pointed out that devices such as “fixed (nonremovable) Palatal Expanders” are usually used on children and adolescents. It stated that the FDA believes that adult’s upper jaw bones have fused and that when a fixed-palatal expansion device applies force, the palate resists expansion. Incorrectly applying force to teeth can lead to serious complications such as chronic pain, tooth dislocations, flared teeth and difficulty eating.

CBS News and KHN interviewed patients who described many of these problems. Boja Kragulj (ex-professional clarinetist) is one of the patients who sued. She said that specialists had to remove her four front teeth. She now has false teeth.

Kragulj, reached Thursday, stated that while it was too late for him and many others, it was comforting to know that the FDA is currently investigating the AGGA/ARA/ORA product claims. I pray that other patients are spared the pain and loss of years many of us have suffered.

FDA stated that it will “investigate potential violations” related to the use of the devices and that it is “identifying responsible entities to communicate.” [its] concerns.”

The American Dental Association, with 159,000 members, stated that it would inform dentists about the FDA’s evaluation and will continue to monitor FDA updates regarding these devices.

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