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.

Following national reporting on patient injuries, the FDA announced it was evaluating safety concerns related to the AGGA device, as well as a similarly designed device used in some of the same dental practices. The reporting found the AGGA had been used on an estimated 10,000 patients without ever being registered with the FDA, and the device's inventor has stated in a sworn court deposition that it was never submitted for FDA review.

Federal prosecutors, through the U.S. Attorney's Office and the Department of Justice, have since opened a criminal investigation connected to the device, its inventor, and the manufacturer, according to court filings. The investigation was disclosed in a motion seeking to delay the largest pending AGGA lawsuit until the criminal proceedings conclude. Following the investigation becoming public, the manufacturer reportedly stopped producing the device.

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.

An attorney 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.