Post Update (4/6/23)
According to a motion filed, the U.S. Attorney’s Office for the Western District of Tennessee and the U.S.
Department of Justice are now conducting a criminal investigation concerning the events involving the AGGA device and the effects on victims. This could potentially lead to criminal charges against the defendants Steve Galella, D.D.S., John’s Dental Laboratory, Inc. and
OrthoMatrix Corp., Inc.
The defendants have asked to put a pause on all pending civil actions in light of the ongoing federal criminal investigation and grand jury proceedings.
Post Update (4/1/23)
The U.S. Food and Drug Administration (FDA) has announced they are finally evaluating safety concerns with the use of forward facial growth devices (like the ones we mention in this article).
These devices include, but are not limited to:
- Anterior Growth Guidance Appliance (AGGA)
- Fixed Anterior Growth Guidance Appliance (FAGGA)
- Anterior Remodeling Appliance (ARA)
- Fixed Anterior Remodeling Appliance (FARA)
- Osseo-Restoration Appliance (ORA)
- Fixed Osseo-Restoration Appliance (FORA)
- Other similar device types.
Post Update (3/15/23)
Another device has entered the the market that is similar to the AGGA device mentioned below. This device is called the Anterior Remodeling Appliance (ARA). According to Soft Touch Dental Care‘s ARA landing page, potential patients do not have to, “resort to invasive surgery to correct your overbite, underbite, TMJ disorder, or other jaw structure issue.” Patients should be aware of the potential risks this product could pose. More details below.
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Have you seen posts on Facebook and other social media platforms mentioning a miraculous dental device that is supposed to make people more beautiful or cure ailments, but then delivers horrible results? Unfortunately, some patients around the country are filing product liability lawsuits against this dental device for promising one thing and delivering entirely different results.
As technology advances, it seems like almost anything is possible. With a little investment, one can walk into a clinic one way and come out brand new. This may be the thought process that propels some to try facial growth treatments. Forward facial growth treatments, in theory, are used to help patients struggling with mouth breathing, improper tongue posture, sleep apnea and other issues related to facial structure. The latest example of a device for one of these treatments being promoted to dentists is an Anterior Growth Guidance Appliance (AGGA).
What is an Anterior Growth Guidance Appliance (AGGA)?
The Anterior Growth Guidance Appliance (AGGA), also renamed Osseo-Restoration Appliance (ORA), is a dental appliance marketed to allegedly correct dental, facial and airway abnormalities without the need of jaw surgery for adult patients.
The device was designed and manufactured by OrthoMatrix Corp. which is co-founded by Dr. Steve Galella. Dr. Galella is also the Clinical Director of the Facial Beauty Institute and speaks and trains other dentists all over the world on how to use and install the device. Construction wise, the appliance is mostly made of wire, with a small acrylic oval that presses on the upper palate behind the front teeth.
What Does the AGGA Do?
The AGGA appliance resembles a retainer and uses springs attached to the patient’s molars and applies pressure to the front teeth and upper palate. In theory, it is supposed to cause an adult’s jaw to “remodel” forward “to where the body really wants it to be,” according to video footage from one of Dr. Galella’s dentist trainings produced in discovery in an AGGA lawsuit. In the video, he states that this growth stimulation is the key to “curing” patients and making them more beautiful. “We [his company] fix the facial biology,” he said in the video. In other words, the device acts as a palate expander. In another video produced by CBS Mornings, Dr. Galella is heard talking about the device saying, “It’s predictable, it’s stable and it’s safe.” The device costs roughly $7,000 for patients and It’s typically worn for several months.
AGGA Not as Advertised?
According to court documents, more than 10,000 dental patients have had the appliance applied to their mouth. Unfortunately, many of these patients have shared a similar experience to Boja Kragulj, an accomplished clarinetist. Instead of growing her jawbone like what was promised, she claims the device pushed her teeth forward detaching it from the bone and causing severe damage and pain. Other patients that filed lawsuits detailed similar complaints about the device, claiming it left them with flared teeth, damaged gums, exposed roots, or erosion of the bone that holds teeth in place. In all cases, the device can only be removed by a medical professional.
In a joint investigation by KHN and CBS News, eight experts reviewed dental scans from patients that used the device. The experts told KHN and CBS News that the scans, “show signs of the AGGA displacing teeth instead of expanding the jaw.” Some even said the device caused tens of thousands of dollars of damage to the patient’s mouths. Patients like Kragulj now must look forward to more extensive surgeries to try to correct the damage done to their teeth.
According to Dr. Adams from the Maryland Holistic Dentist office, in order for anterior facial growth therapy to claim to be successful, the treatment needs to do the following:
The Anterior Growth Guidance Appliance (or Osseo-Restoration Appliance) device has not yet proven that it can achieve any of the benefits above. Many patients that have undergone this treatment have been exposed to serious and permanent harm. No scientific or clinical trials have proven that the device was either safe or effective and it was not reviewed by the FDA.
You can read more about the investigation conducted by KHN and CBS News HERE
The Anterior Remodeling Appliance (ARA)
A device similar to the AGGA is the Anterior Remodeling Appliance (ARA). Like the AGGA, this device is said to improve breathing problems, sleep apnea, and even severe TNJ disorder.
There are two main types of this device:
Removable (RARA)
Mainly used on children, this device is allegedly used to treat midface issues and TMJ pain. The device is typically worn at all times.
Fixed (FARA)
Used mainly on adult patients and is used to help with the underdevelopment of the upper jaw (like with the AGGA). Braces are typically worn after the treatment, if done successfully.
Were you affected by a forward facial growth device?
At Fleming, Nolen & Jez, our product liability lawyers have dedicated their careers to fighting for the rights of injured victims throughout the United States. If you were seriously injured from an Anterior Growth Guidance Appliance or another forward facial growth device, you may be able to file a lawsuit against the manufacturer to secure the compensation you deserve. Contact us today to speak with one of our specialists to review your case information.
