AGGA Lawsuit Alleges “Unreasonably Dangerous” Appliance Caused Permanent Dental Side Effects

Designers of the AGGA dental appliance made false claims about the safety of the device, which has been marketed to help straighten teeth in adults, according to allegations raised in a product liability lawsuit brought by a woman who indicates she was left with severe dental damage.

Michelle Barker filed the complaint (PDF) last month in the U.S. District Court for the Southern District of Indiana, indicating that users and dentists were not adequately warned about the risk of severe dental side effects from AGGA. Dr. Steve Galella and OrthoMatrix Corp., Inc. are named as defendants in the lawsuit, for their role in the development and sale of the device.

The Anterior Growth Guidance Appliance (AGGA) dental device 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 lawsuits have been filed by individuals left with devastating dental injuries, gaining significant attention from the media, federal regulators and law enforcement agencies due to the allegations being raised.

According to Barker’s complaint, Galella and OrthoMatrix lied about the safety of a device they knew, or should have known, would not perform as advertised.

Barker received her AGGA device in April 2018, which was supposed to expand her upper jaw and help with preventing migraines, headaches and her unstable bite. However, her dentist removed the device by September of that year.

After the AGGA was removed, Barker was told she would need braces to correct her dental problems, which she indicates she was not told when she received the device.

As a result of the AGGA dental side effects, the lawsuit indicates Barker suffered significant and permanent damage, including bone loss, shortened roots, gum damage, tipped molars, as well as loose and sensitive teeth.

Barker’s lawsuit also alleges these problems were predictable, and that the device was unreasonably dangerous and negligently designed. She presents claims for negligence and violation of Indiana product liability laws, seeking both compensatory and punitive damages.

AGGA Device Lawsuits

The filing comes as AGGA injury lawyers are continuing to investigate a number of other potential lawsuits for individuals nationwide, alleging that the dental appliance was negligently designed and that users were given false representations about the efficacy and safety.

Due to the manufacturers’ failure to disclose the potential AGGA dental side effects, lawsuits seek financial compensation for individuals who received an AGGA treatment and suffered any of the following injuries:

• Loosening 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