A medical device used in dentistry as an alternative to jaw surgery is at the center of recent personal injury lawsuits. The Anterior Growth Guidance Appliance (AGGA), which has recently rebranded as Osseo-Restoration Appliance (ORA), was designed to correct facial or dental misalignments as well as any corresponding respiratory problems such as mouth breathing and sleep apnea.
AGGA is made with a small acrylic oval that presses on the upper palate behind the front teeth. This action, AGGA marketing promises, will help “grow,” “remodel,” or “expand” an adult’s jaw without the need for surgery. AGGA is also marketed as a beauty product, claiming it can help patients look more attractive.
AGGA is not FDA-approved; however, the device, which is marketed as a cheaper alternative to oral surgery, has been implanted in dental clinics throughout the country.
Some patients who have received the AGGA appliance, which costs approximately $7,000 and resembles a retainer with a spring attached to the front teeth and upper palate, have experienced significant complications, including:
- Severe pain
- Dying teeth
- Removal of teeth
- Damaged gums
- Exposed roots
- Flared teeth
- Erosion of bone in the tooth bed
According to a collaborative investigative report by Kaiser Health News (KHN) and CBS News, approximately 10,000 patients have been fitted with an AGGA appliance in their mouth, which is supposed to be worn for several months. Lawsuits have been recently filed by patients who allege that the device has left them with significant injuries that will necessitate paying thousands of dollars to repair.
AGGA lawsuits name AGGA’s inventor, Dr. Steve Galella, co-founder of OrthoMatrix Corp., as the defendant, along with the manufacturer of the device and businesses that train dentists how to install the device in patients’ mouths.
A small group of experts who reviewed dental scans of patients fitted with AGGA told KHN and CBS News that the patients’ teeth showed signs of being displaced, rather than the device’s intended use of acting as a palate expander. The experts gained access to the dental scans after Dr. Galella submitted them in court.
According to CBS News, experts such as orthodontists, periodontists, and maxillofacial surgeons, who generally have more knowledge than dentists about facial alignment, have said that the AGGA device aggressively moves teeth, “sometimes creating an illusion of jaw growth by tilting some teeth forward and forcing gaps between others.”
At least 20 AGGA lawsuits have been filed, and in the worst patient outcomes, experts have testified that the patients’ teeth were shoved extremely out of position to the point that their roots were removed from the bone and migrated into the gums.
One maxillofacial surgeon, Dr. Kasey Li, referred to the AGGA device as "medieval" and said using it to try to expand a jaw is not unlike trying to expand the size of a house by pushing on the wooden framing in the walls.