Complications With AGGA and Similar Appliances Draw FDA Safety Evaluation

The FDA is asking anyone who has experienced complications with AGGA or similar dental devices to report those problems to the agency.

The U.S. Food and Drug Administration (FDA) confirmed this week that it has launched a safety investigation to evaluate recent reports of complications with the Anterior Growth Guidance Appliance (AGGA) and similar dental appliances, which were never officially approved by the agency and have been linked to reports of tooth damage, bone loss and other problems.

The FDA safety communication about the AGGA appliance was issued on March 30, confirming recent reports that the federal regulators were evaluating the device.

In addition to reviewing reports of complications with AGGA, the agency also indicates that it is evaluating similar devices, including the Fixed Anterior Growth Guidance Appliance (FAGGA), the Anterior Remodeling Appliance (ARA), the Fixed Anterior Remodeling Appliance (FARA), the Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA).

AGGA Appliance Complications

The AGGA appliance involves a metal wire insert placed between a patient’s teeth, which is supposed to help remodel or expand an adult’s jaw without the need of surgery. However, over the past three years, at least 20 patients have filed an AGGA lawsuit against the manufacturers and designers, including Steve Galella, D.D.S, OrthroMatrix Corp, and John’s Dental Laboratory, Inc.

Although the dental appliance is supposed to cause three-dimensional changes in adult jaws, which can move the maxilla forward horizontally over time as much as 10 mm or more, plaintiffs indicate it actually pushed the upper teeth out of their housings, resulting in serious and painful injuries.

The AGGA was designed by a dentist, Steve Galella, and OrthoMatrix Corp., Inc., in order to correct dental, facial and airway abnormalities instead of using complex jaw surgery. However, individuals who have experienced complications from AGGA appliances allege in lawsuits that the device is not safe for use among adults.

While it was originally designed for children’s teeth and jaws, which are still growing, lawsuits over AGGA indicate the appliance can cause catastrophic injuries and dental complications for adults.

“The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD) of the jaw, and to remodel the jaw in adults,” the FDA safety communication states. “However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.”

The agency issued a list of recommendations for patients, caregivers and health care providers while the AGGA safety evaluation is underway. It called for them to be aware the devices are not proven or approved by the agency, and called for them to consult with a dental professional for problems or concerns with the dental devices, warning that the devices under investigation may result in serious complications, including

• Chronic pain
• Tooth dislocation
• Flared teeth
• Uneven bite
• Difficulty eating
• Damaged gums
• Exposed roots
• Bone erosion
• Tooth loss

The FDA is also calling on any patients or healthcare professionals who experience complications with AGGA or other appliances to file a report through its MedWatch adverse event reporting system.