An unregulated dental device came under scrutiny last week. As numerous reports of severe adverse effects and lawsuits continue to surface throughout the country, the public is calling the FDA to investigate.
The Anterior Growth Guidance Appliance, or AGGA, is a fixed orthodontic appliance claiming to cure both Temporomandibular Joint disorder, or TMJ, and sleep apnea by “expanding” and “remodeling” the jaw. A metal plate is inserted into the upper palate to exert pressure on the nerve to allegedly stimulate the body’s natural growth and repair processes, resulting in the repositioning of the jaw and teeth for improved breathing.
Despite the device’s purported benefits, it appears that the AGGA falls short of its advertised claims. Over the past three years, at least 20 lawsuits have been filed on behalf of former AGGA patients against the device’s inventor, Dr. Steve Gallella, and its manufacturers. The lawsuits claim that the device caused patients to experience severe complications, such as pain, mouth disfigurement, and tooth loss – necessitating far more extensive surgeries to correct the damage caused by the device than originally required.
More than 10,000 dental patients have been fitted with the Anterior Growth Guidance Appliance, according to court records. However, it came as a surprise to many that the dental device was not subjected to evaluation by the FDA before its introduction into the medical market. The AGGA seems to have escaped the attention of the FDA, despite the agency being responsible for regulating all dental devices in the United States.
The AGGA device has been used on patients for about 15 years. Dr. Galella, who serves as the Clinical Director of the Facial Beauty Institute, trains other dentists globally on installing and utilizing the device. Additionally, The Las Vegas Institute, also known as LVI Global, offered AGGA courses for years and lists around 75 dentists across the United Stated and Canada who completed their training. Because of its widespread usage for over a decade and the deliberate noncompliance with FDA regulations, it poses significant risks to the public.
Patients who have been harmed by the Anterior Growth Guidance Appliance may have legal options to pursue compensation for their injuries. At Meyers & Flowers, our attorneys have extensive experience handling defective medical products, and have the results to prove it. Contact our team at [email protected] or 630-232-6333 to explore your legal options.