Update: Feds Launch Investigation into AGGA Dental Device
Following the CBS News investigation into problems with AGGA dental devices, federal prosecutors have launched their own criminal probe into the matter. The investigation was revealed in a court motion seeking to delay lawsuits over AGGA devices until further inquiry can be completed.
The motion was filed on behalf of AGGA inventor Dr. Steve Galella, his company, the Facial Beauty Institute, and AGGA manufacturer Johns Dental Laboratories, who say the inquiry is being conducted "to potentially bring criminal charges" against their clients.
What is an Anterior Growth Appliance?
The Anterior Growth Guidance Appliance (AGGA) is a dental appliance used to correct dental, facial, and airway abnormalities without the need for jaw surgery for adult patients. The appliance is constructed mainly of wire, with a small acrylic oval that presses on the upper palate behind the front teeth.
AGGA was designed by OrthoMatrix Corp and costs patients about $7,000; however, the device has never been tested or received approval from the U.S. Food and Drug Administration (FDA).
How Does it Work?
The AGGA is a fixed orthodontic appliance that is marketed to change the jaws without surgery. The device is a small, metal plate that is placed on the palate. It presses on a nerve, which activates natural growth centers in the body to stimulate new bone growth over the nerve in the palate.
What are AGGA Lawsuits Alleging?
Over the past 3 years, dozens of lawsuits have been filed alleging that Anterior Growth Guidance Appliances are not fit for adults, and cause damage to the upper jaw and teeth. The AGGA is designed to cause 3-dimensional changes in adult jaws, which can move the maxilla forward horizontally over time as much as 10 mm or more; however, plaintiffs indicate that the appliance pushes the upper teeth out of their housings, resulting in serious and painful injuries.
The first AGGA lawsuits were filed as far back as 2000, alleging that the Anterior Growth Guidance Appliance was originally designed for children, whose bones are still growing, but that it is unreasonably dangerous for adults, whose bone growth has stopped. Defendants in these cases include manufacturers and designers of AGGA devices including Steve Galella, D.D.S, OtrhoMatrix Corp, and John’s Dental Laboratory, Inc.
AGGA Health Complications
- Broken/ruined teeth
- Loosening of anterior maxillary teeth
- Flaring of the front teeth
- Tooth Sensitivity
- Tooth loosening
- Tooth loss
- Gum damage
- Gum recession
- Exposed roots
- Root resorption
- Bone erosion
- Alveolar bone loss
- Nerve damage
- Facial disfigurement
- Severe pain
- Other serious injuries
Lawsuit Alleges AGGA Damaged Patients' Teeth: CBS News Video
FDA Looks into AGGA Problems Following Investigation of Patient Harm
Following a joint investigation by KHN and CBS News  into problems with the Anterior Growth Guidance Appliance, the FDA has begun looking into the appliance.
FDA's interest in the AGGA was revealed by Cara Tenenbaum, a former senior policy adviser in the agency's device center who has said the FDA should investigate the product.
Tenenbaum said that after KHN and CBS News published their report, she was contacted by "very concerned" FDA officials who said they have begun "looking into" the AGGA, but have yet to determine how much legal authority the agency has to regulate it.
"The FDA is looking at what authorities they may have around this device — what they may be able to do," Tenenbaum said. "Now, of course, whether or not this device is FDA regulated, it still needs to be safe."
Defendants in AGGA Lawsuits
Most lawsuits filed over the Anterior Growth Guidance Appliance do not name the dentists who installed the device as defendants but are instead filed against the AGGA's inventor, Dr. Steve Galella, its manufacturer, and companies that train dentists to use it, alleging they profit from false claims about a device that fails to work properly. The plaintiffs do not claim that Galella treated them, but that he or his company consulted with each of their dentists about their AGGA treatment.
What is the Anterior Remodeling Appliance (ARA)?
Another device has entered the U.S. market that is similar to the Anterior Growth Guidance Appliance. This device is called the Anterior Remodeling Appliance (ARA), which is marketed as being able to improve breathing problems, sleep apnea, and even severe TNJ disorder without the need for surgery.
There are 2 main types of ARA:
- Removable (RARA) - Used mainly on children, this Anterior Remodeling Appliance is used to treat midface issues and temporomandibular joint (TMJ) pain. The device is designed to be worn at all times.
- Fixed (FARA) - Used mainly on adults, the Fixed Anterior Remodeling Appliance is used to help with the underdevelopment of the upper jaw. Braces are typically worn after treatment with FARA if completed successfully.
AGGA Lawsuit Alleges Dental Appliance Caused Irreversible Tooth Damage
A recent Anterior Growth Guidance Appliance Lawsuit  was filed on behalf of 2 plaintiffs in the U.S. District Court for the Southern District of Indiana.
The first plaintiff, Michael Haile of New York, was implanted with an AGGA in May 2019 due to problems he was experiencing with his airway and open bite. The appliance was removed and replaced in February 2021. However, more than a year earlier, Haile suspected that the device was causing severe damage to his teeth and gums, but was reassured by his provider that his complications were a normal part of the procedure.
The complaint alleges that Haile's AGGA caused significant dental damage, including loosening of anterior maxillary teeth, pain, flaring of the front teeth, gum recession, root resorption, and alveolar bone loss.
The other plaintiff named in the lawsuit, Melanie Pappalardi, received her Anterior Growth Guidance Appliance in August 2020, but began to experience severe tooth sensitivity and loosening within a year, and had the device removed. She claims the AGGA caused her front upper teeth to be pushed out of the alveolar bone, and also caused her to suffer nerve damage, extreme tooth sensitivity, and potential tooth loss in the future due to AGGA complications.
Both Haile and Pappalardi allege that AGGA manufacturers did not adequately test the appliance on adults, and failed to consider the difference between adult and child bone growth.
The complaint brings claims of negligence, breach of warranty, and violation of the Indiana Product Liability Act and the Indiana Deceptive Consumer Sales Act.
See all related medical device lawsuits our attorneys covered so far.
Get a Free Anterior Growth Guidance Appliance Lawsuit Evaluation with Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP national law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Anterior Growth Guidance Appliance Lawsuits. We are handling individual litigation nationwide and currently accepting new legal challenges in all 50 states.
If you or a loved one were seriously injured from an Anterior Growth Guidance Appliance or another forward facial growth device, you should contact our law firm immediately for a free case evaluation. You may be entitled to financial compensation by filing a suit and we can help.