AGGA Inventor Denies Recommending Device for TMJ or Sleep Apnoea

USA: In a recent twist in ongoing legal battles surrounding the Anterior Growth Guidance Appliance (AGGA), the device’s inventor, Steve Galella, has testified under oath that he never instructed dentists to use the AGGA for treating temporomandibular joint disorder (TMJ) or sleep apnoea. This revelation contradicts video footage where Galella is seen providing instructions to dentists on the device’s usage for these specific ailments.

Lawsuits and Settlements

Galella, who claims to have trained numerous dentists in the U.S. and overseas, has faced lawsuits from at least 23 patients, alleging that the AGGA caused damage to their mouths, leading to tooth loss in some cases. Despite denying wrongdoing, Galella settled most of these lawsuits in the past few months.

Galella’s deposition, conducted before settling the largest lawsuit, indicates that he explicitly stated the AGGA did not treat or cure TMJ or sleep apnoea. However, video footage from a 2017 training session with Australian dentists shows Galella asserting the AGGA’s efficacy in curing TMJ and mild to moderate sleep apnea.

Dental device at center of lawsuits was used on patients without FDA review

Device Overview and FDA Investigation

The AGGA, now rebranded as the Osseo-Restoration Appliance, resembles a retainer and purportedly uses springs to apply pressure to the front teeth and upper palate. Following an investigative report by KFF Health News and CBS News, the FDA and the Department of Justice initiated investigations into the device, questioning its safety and effectiveness.

Dentists across the U.S. have promoted the AGGA on their websites, claiming it can reshape the jaw without surgery, treating common ailments like TMJ and sleep apnoea. However, the investigation found no record of the AGGA being registered with the FDA, and there is no peer-reviewed evidence supporting its claimed effects.

Ongoing Investigations and Settlements

Following the investigation, the FDA expressed concerns about the AGGA and a similar device, the Anterior Remodeling Appliance, both allegedly used for TMJ and sleep apnoea without FDA clearance. A criminal investigation was disclosed, indicating potential charges against Galella and device manufacturer Johns Dental Laboratories.

Galella has settled lawsuits without admitting fault, and additional lawsuits have emerged in different states. Orthodontists Neal Kravitz and Jeffrey Miller are studying the AGGA’s impact and intend to publish their findings next year, while Johns Dental faces FDA scrutiny with citations related to medical devices.

The complexity of this situation underscores the need for thorough scrutiny of medical devices, ensuring both safety and efficacy.