AGGA Dental Device Lawsuit

The AGGA was developed by a Tennessee dentist and promoted through a company called the Facial Beauty Institute. According to a patent filing, the device uses springs to apply pressure to the front teeth and upper palate, with the goal of gradually widening the jaw. It has been used on an estimated 10,000 patients and has typically cost several thousand dollars per patient. The device was also taught to other dentists through training programs, and a similar device marketed under a different name has drawn scrutiny from regulators as well.

The AGGA (Anterior Growth Guidance Appliance) has been sold and taught under several names. It has been renamed and is also known as the Osseo-Restoration Appliance (ORA). The FDA's March 2023 safety communication lists these devices of concern: the Anterior Growth Guidance Appliance (AGGA) and its fixed version (FAGGA), the Anterior Remodeling Appliance (ARA) and fixed version (FARA), and the Osseo-Restoration Appliance (ORA) and fixed version (FORA), along with similar devices. The FDA says these are not cleared or approved, and that their safety and effectiveness for treating sleep apnea, jaw joint disorders and for remodeling the jaw in adults have not been established. If you are not sure what your dentist placed, ask for your treatment records. We can help you request them.

It is our belief that the AGGA was renamed to make it harder for patients to connect their device to the warnings about it. A new name does not mean a new level of risk. If you were treated with an appliance under any of these names, call us.

The FDA issued a safety communication on March 30, 2023. It warned that use of these devices in adults may cause serious complications, including chronic pain, tooth dislocation, flared teeth, an uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion and tooth loss. It asked patients to talk to a dental professional about any concern and to report problems to the FDA through MedWatch (1-800-332-1088).

Federal authorities opened a criminal investigation into the AGGA and its inventor, which was reported in 2023. Multiple lawsuits have been filed against the device's inventor, the dental lab that made it and others. News reports say the lab that made the AGGA stopped making it in 2023.

This coverage was first reported by CBS News and KFF Health News, whose ongoing investigation prompted both the FDA's safety review and the subsequent criminal inquiry.

This case has been covered extensively by national media, including reporting from CBS News and KFF Health News on the criminal investigation into the device and its inventor.

Source: CBS News, “Feds launch criminal investigation into AGGA dental device and its inventor” — cbsnews.com/news/criminal-investigation-agga-dental-device-and-its-inventor

Patients who were injured by the AGGA device may have grounds for a product liability claim against the parties involved in designing, marketing, manufacturing, or training dentists to use the device. Because the device was never submitted for FDA review, claims may focus on the lack of testing and disclosure to patients about the risks involved.

A lawyer can help evaluate your dental records, treatment history, and current condition to determine your legal options. See our how it works page for an overview of what to expect when you contact our firm.