AGGA Appliance Lawsuit Filed Over Dental Damage, Bone Loss and Other Injuries

Plaintiff says the designer of the AGGA appliance directly approved use of the device on her teeth, despite a known high risk of dental damage and bone loss.

An Australian woman has filed a product liability lawsuit against the makers of the Anterior Growth Guidance Appliance (AGGA), indicating that the American implant caused her to suffer severe dental damage that left her with permanent injuries and disfigurement.

Marcia Noble, of Queensland, Australia, filed the complaint (PDF) on February 1 in the U.S. District Court for the Southern District of Indiana; the state where one of the defendants, John’s Dental Laboratory, Inc. is headquartered. The lawsuit also names as defendants dentist Steve Galella, the AGGA appliance’s designer, and Orthomatrix Corp., Inc., which does business as the Facial Beauty Institute and Orthologic.

The AGGA appliance involves a metal wire insert that is placed between the teeth, which is supposed to help remodel or expand an adult’s jaw, without the need of surgery. However, a growing number of reports have surfaced involving problems where the AGGA actually pushed the upper teeth out of their housing, resulting in tooth loss, gum damage, facial disfigurement, nerve problems and other dental complications, often resulting in the need for corrective surgery.

Over the last year, a number of similar AGGA appliance lawsuits have been filed against the manufacturers and developers of the dental appliance, and the allegations have gotten the attention of media, federal regulators, and law enforcement agencies.

While AGGA was originally designed for children’s teeth and jaws, which are still growing, lawsuits allege the appliance can cause catastrophic injuries and dental complications for adults, and concerns have emerged that the AGGA appliance was never properly tested or approved.

According to her lawsuit, Noble went to see a dental surgeon in 2019 for the treatment of nighttime teeth-grinding and temporomandibular joint dysfunction (TMJ). Her dental surgeon prescribed the AGGA appliance, indicating that it would alter the alignment of her bite and her jaw which would help with the TMJ, improve airway function for the prevention of sleep apnea, and improve her appearance.

However, the complaint indicates that Noble’s dental surgeon had been misled by a course on the safety and effectiveness of the AGGA device, taught by Galella.

“During the teaching of said course, the representations about AGGA were made which were unproven, not supported by medical knowledge or science, untested by any clinical trial, unsupported by peer-reviewed literature, and which were false and materially misleading,” Noble’s lawsuit states. Before the device was implanted, “Dr. Galella did inspect and examine photographs of that AGGA device and of a mold of Plaintiff’s teeth, knew or should have known that the AGGA device was for an adult’s teeth, and pronounced the AGGA fit to be used for Plaintiff.”

In March, 2022, Noble’s generalist dentist noticed what appeared to be gum disease forming around some areas of the AGGA device and had X-rays taken. The results indicated she was suffering bone loss around those teeth, but she was reassured this was normal, and that new bone growth would occur as her teeth moved into new positions.

However, she was diagnosed later that month with severe bone loss, and severe gum disease. She has since suffered significant bone loss, nerve damage, root damage, bite problems, and tooth sensitivity, which have led to permanent disfigurement and dental damage.

The lawsuit presents claims of negligence and violations of the Indiana Product Liability Act.

AGGA Dental Appliance Lawsuits

AGGA injury lawyers are pursuing lawsuits for individuals nationwide, alleging that the dental appliance was negligently designed and that users were given false representations about the efficacy and safety. Settlements and financial compensation from an AGGA appliance lawsuit payout may be available for individuals who received an AGGA treatment and suffered any of the following injuries;

• Loosing of upper teeth (anterior maxillary teeth)
• Tooth loss and/or damage
• Tooth or Jaw pain
• Flared teeth
• Gum Recession
• Tissue breakdown around tooth (Root Resorption)
• Tooth socket bone loss (Alveolar bone loss)
• Facial disfigurement
• Nerve damage
• Required corrective surgery