Dental News - Creator of Anterior Growth Guidance Appliance is now under federal investigation

Creator of Anterior Growth Guidance Appliance is now under federal investigation

Photos submitted to CBS News of a 21-year-old male patient who was fitted with an AGGA device and later examined by Dr Kasey Li, a California maxillofacial surgeon. Dr Li says that images A and C show the patient at the start of his AGGA treatment and images B and D show the end, after the AGGA had created gaps behind his canines. (Image: Kasey Li/CBS News)

Anisha Hall Hoppe, Dental Tribune International

Wed. 19. April 2023

save

SILVER SPRING, US: The Anterior Growth Guidance Appliance (AGGA) was already undergoing a US Food and Drug Administration (FDA) investigation into its safety, when the US Attorney’s Office for the Western District of Tennessee and the US Department of Justice announced that they were also conducting an investigation which could result in criminal charges for AGGA inventor Dr Steve Galella, his company, the Facial Beauty Institute, and product manufacturer Johns Dental Laboratories.

Nearly three dozen patients have sued for injuries caused by the device, which was never registered with the FDA as a medical device. Dr Galella argues that he did not submit it for FDA evaluation because he did not believe the entity had jurisdiction over his product, although it is a medical device. Pitched as being able to treat conditions such as temporomandibular joint disorder and obstructive sleep apnoea, the device has never been clinically evaluated. According to the FDA, injuries can include tooth dislocation, bone erosion, exposed roots, tooth loss and damaged gingivae.

The device was rebranded as the Osseo-Restoration Appliance and is intended to produce mandibular “remodelling” through using pressure. In video training footage shown as evidence during an AGGA lawsuit, Dr Galella states: “You can sell good health. You can help people and at the same time you’re going to make a wheelbarrow full of money. And it’s all OK, and it’s all fair. We’re not cheating anybody and we’re not being greedy, but that just comes with the territory.”