Controversial Dental Device AGGA Under Fire: Patient Harm Allegations Spark Federal Investigations

A Dental Innovation or a Health Hazard?

The Anterior Growth Guidance Appliance (AGGA), a dental device invented by Tennessee dentist, Steve Galella, has sparked a wave of controversy and legal scrutiny. This device, developed to stimulate jaw growth, has been hailed by some as a revolutionary non-surgical solution to common conditions such as temporomandibular joint disorder (TMJ) and sleep apnea. However, at least 23 patients have sued Galella, claiming the AGGA resulted in significant oral damage and tooth loss.

Contradictions in Claimed Benefits

Galella testified under oath that his invention was never intended for the treatment of TMJ or sleep apnea. However, video footage contradicts his statement, showing him instructing dentists on how to use the AGGA specifically for these conditions. Despite the allegations, Galella has denied any wrongdoing and has settled almost all of the lawsuits brought against him.

Investigations by FDA and Department of Justice

In light of these claims, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have launched investigations into the AGGA. These investigations were triggered by allegations of patient harm, with many reporting permanent damage and disfigurement caused by the device. The inquiries have found no supporting evidence for the device's claimed benefits and no record of the AGGA being registered with the FDA.

AGGA Promotions and Criticisms

Despite the ongoing scrutiny, dentists across the country continue to promote the AGGA on their websites. They often claim it can 'grow,' 'remodel,' or 'expand' an adult’s jaw without surgery, potentially enhancing their attractiveness and treating common ailments like TMJ and sleep apnea. However, these claims have been heavily criticized by dental specialists, who have witnessed severe complications in AGGA patients.

Further Research and Legal Developments

Orthodontists are conducting independent research into the alleged harmful effects of the AGGA, with a view to publishing their findings. The DOJ has taken an interest in these studies, sending an official to photograph the unboxing of the device for a criminal investigation. Meanwhile, Johns Dental, the company behind AGGA, has been inspected by the FDA and issued citations pertaining to medical devices. A spokesperson for the company invoked the Fifth Amendment in response to all questions during a deposition.

Conclusion

The AGGA saga serves as a stark reminder of the importance of rigorous testing and validation of medical devices before they’re marketed and used on patients. The conflicting claims around this device, coupled with the serious allegations of harm, highlight the need for transparency, regulation, and rigorous scientific evidence in the field of dental health. As consumers, it's crucial to consult with trusted healthcare professionals and to research any treatment extensively before proceeding.