At least 20 patients have taken legal action against the makers of a dental device that promises to improve jaw function and breathing issues among other jaw-related issues. The Anterior Growth Guidance Appliance or AGGA device was developed by Dr. Steve Galella and was marketed as a device that could help expand an adult's jaw bone in order to correct issues like an uneven bite, TMJ, and other jaw-related health issues.

With the avoidance of surgery, the device is permanently fixed into a patient's mouth and can only be removed by a dentist. Akin to a retainer in design, the device is designed to put pressure on a patient's upper palate in order to extend the jawbone. However, after being utilized on over 10,000 patients, dozens have come forward arguing that the device did more harm than good.

The face of the defective product has been Boja Kragulj, an accomplished clarinetist who has performed across the country including New York, Florida, and Philadelphia. Kragulj shared with CBS news that after seeking dental treatment to fix her bite and improve her breathing, she settled on trying out the AGGA dental device after coming across it online. However, instead of the promise of improving her jaw, Kragulj shares that the device puts an immense amount of pressure on the front of her teeth, ultimately pushing her teeth out of the bone that anchors their roots in place. After using the device Kragulj was subjected to severe pain when eating and talking. After undergoing corrective procedures which include at least four false teeth, Kragulj shares that she will continue to need treatment to repair the damage done. As a result of the pain and bone damage she suffered because of the AGGA, Kragulij shares that she is no longer able to play clarinet and pursue her livelihood.

In some cases, some defendants claim that the damage done to their jaws was so severe that they no longer have enough jawbone to replace missing teeth with dental implants. Many of the defendants argue that they endured damage to their gums, suffered exposed roots, and erosion to their overall jaw bones.

Dr. Galella Invented the AGGA device in the 1990s and touted it as a way to achieve safe and “beneficial results for patients” when used properly. Although it was promoted as a revolutionary device and would go on to be installed in over 10,000 patients, the AGGA has never been evaluated by the FDA. According to an investigation conducted by CBS News and Kaiser Health News, Dr. Galella never submitted his product for evaluation to the FDA, a requirement to have a product sold to patients.

The lawsuit highlights that despite the damage caused, dentists who partnered with Dr. Galella in marketing the AGGA to patients continue to offer the device as a remedy to patients with jaw issues. Meanwhile, other dentists and orthodontists have shared with reporters that upon inspecting the device, it's unfathomable how or why dentists would recommend the device to their patients.

Dr. Kasey Li, a California maxillofacial surgeon and sleep apnea specialist, published a study in which he examined loose teeth and bone loss associated with AGGA patients. Dr. Li described the device as “medieval,” adding, “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."

While at least 20 patients have filed lawsuits against the doctor and his device, it's likely more lawsuits might trickle forward in the coming months. For the most part, the dentists who provided the treatments are not named in the lawsuit. The primary targets have been Dr. Galella, his company the Facial Beauty Institute, and other parties that help manufacture and teach dentists about the device.