FDA Reviewing AGGA Dental Device Problems Following Reports of Teeth Damage

According to a news report, FDA officials are uncertain of their ability to regulate AGGA dental devices, despite problems where users are experiencing permanent teeth damage and bone loss

A new report suggests federal regulators plan to review the safety of the Anterior Growth Guidance Appliance (AGGA); a dental device linked to a growing number of problems where patients were left with permanent and disfiguring teeth damage.

According to a CBS News report issued earlier this month, officials with the U.S. Food and Drug Administration (FDA) are looking into the potential problems with the AGGA device, which has been fitted on more than 10,000 dental patients.

The Anterior Growth Guidance Appliance (AGGA) is 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 lawsuits against the manufacturers and designers, including Steve Galella, D.D.S, OrthroMatrix Corp, and John’s Dental Laboratory, Inc.

Although the AGGA dental device 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 CBS report indicates Cara Tenenbaum, a former senior policy advisor, says FDA officials are concerned about AGGA dental device problems, but have yet to determine how much legal authority the agency has to regulate the product.

The devices were never approved by the FDA, which many patients say they did not know, assuming it was safe since it was approved for sale as a medical device.

The news report also indicates that the Las Vegas Institute, which previously trained dentists to use the AGGA, has now begun training them to use the Anterior Remodeling Appliance (ARA), which they say is almost exactly the same device, but has not been linked to the same problems with teeth damage.

The AGGA was designed by Steve Galella, a dentist, and OrthoMatrix Corp., Inc. in order to correct dental, facial and airway abnormalities instead of complex jaw surgery. However, plaintiffs in AGGA lawsuits claim the device was originally designed for children’s teeth and jaws, which are still growing. However, implanting them in adults have led to catastrophic injuries.

AGGA Dental Device Lawsuits

One recent AGGA dental device lawsuit, was filed by two separate plaintiffs who joined together on the complaint, indicating that AGGA caused permanent teeth damage for each of them, including loosening, gum recession and both loss.

The lawsuits claim the AGGA were negligently designed and manufactured, and are unreasonably dangerous, and that dentists and plaintiffs were given false representations about the device’s efficacy and safety.

AGGA dental device injury lawyers are now pursuing lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received. Settlement compensation from an AGGA lawsuit settlement 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