AGGA Dental Device Disfigurement

What Is the AGGA Device?

The AGGA dental device is a retainer-like structure affixed to patients’ teeth in a similar manner as braces or other orthodontic appliances. The inventor of the device, dentist Dr. Steve Galella, claims the device is a proven alternative to jaw surgery to correct temporomandibular joint disorder (TMJ or TMD) and sleep apnea. He also states the device may be beneficial in beautifying facial structure.

How Does AGGA Work?

The AGGA builds on the work of orthotropics, which uses orthopedic devices to make changes to the head and jaw bones to make dental corrections. Orthotropics is traditionally used for treating children as their bones have not fused and can be moved. Dr. Galella states his device can use the same approach in adults and will apply pressure to the upper palate of the mouth to encourage bone growth and move the jaw forward.

Is There Any Evidence Supporting the Use of the AGGA?

Dr. Galella indicates that he has been using the device for decades on hundreds of patients who have shown safe, effective treatment of TMJ and sleep apnea with the use of the device. However, peers in the dental community have concerns that there is no peer-reviewed research to indicate that the device functions safely or provides the results Dr. Galella claims.

Both the American Dental Association (ADA) and the American Academy of Dental Sleep Medicine (AADSM) have issued statements pertaining to the devices urging professionals to be aware that the safety of the devices has not been proven.

Who Is Marketing the AGGA?

Dr. Steve Galella is the inventor of the AGGA. He is a dentist based out of Tennessee who invented the device in the 1990s. Over the past 15 years, Dr. Galella has traveled the world training and promoting the use of his device to dental professionals. Over 10,000 patients used AGGA in their orthodontic treatment. 

What Companies Are Training Dental Professionals to Use the AGGA?

Dr. Galella markets the AGGA to dental professionals through his company, the Facial Beauty Institute, which is owned by OrthoMatrixCorp, Inc.

The Facial Beauty Institute indicates they provide training courses for dental professionals in:

• General dentistry
• Orthodontics
• Facial growth and remodeling
• Breathing issues
• Sleep apnea
• Craniofacial pain/TMD
• Neuromusculature dentistry
• Cosmetic dentistry
• Team training

Have Other Companies Promoted the Use of the AGGA?

Prior to the complaints of severe injury and filing of lawsuits, the Las Vegas Institute (LVI) was another dental training organization that was training dental professionals in how to use the AGGA for dental corrections. The LVI no longer promotes the use of the AGGA, but has switched to training use of a nearly identical device, the Anterior Remodeling Appliance (ARA). 

What Other Names Are Being Used To Market the AGGA?

The AGGA has been marketed under various names, including:

• Anterior Growth Guidance Appliance (AGGA)
• Fixed Anterior Growth Guidance Appliance (FAGGA)
• Osseo-Restoration Appliance (ORA)
• Anterior Remodeling Appliance (ARA)-this device is made by a separate manufacturer, but is nearly identical in design and function and is also being investigated by the FDA.

Who Is Manufacturing the AGGA?

The AGGA has been manufactured by Johns Dental Laboratories, a full-service dental laboratory operated in Terre Haute, Indiana. Johns Dental provides appliances for multiple dental specialties, including orthodontics, dentures, and airway obstructions.

What Is TMJ?

TMJ, or temporomandibular joint disorders, are conditions that can cause pain in the jaw. The temporomandibular joint is the hinged joint that connects the skull to the jawbone. What causes the pain can vary from person to person. In many cases, TMJ disorders are temporary and can be managed without surgery. However, surgery may be necessary for some if their condition is more serious and other treatments aren’t successful.

What Causes TMJ?

The temporomandibular joint is a sliding hinge with cartilage and a shock-absorbing disc designed to cushion the bones and keep joint movement smooth. It’s not always clear exactly what causes this to occur, but TMJ can happen when that shock-absorbing disc erodes or isn’t aligned properly. TMJ can also occur if arthritis damages the cartilage or if an injury damages the joint itself.

The following factors can increase the risk of developing a TMJ disorder:

• Arthritis
• Jaw injury
• Bruxism (grinding your teeth)
• Connective tissue disease

What Are the Symptoms of TMJ?

The symptoms of TMJ may include:

• Pain in the jaw
• Tenderness in the jaw
• Pain in either one or both temporomandibular joints
• A grating sensation when chewing or opening your mouth
• A clicking sound when chewing or opening your mouth
• Aching in the face
• Pain while chewing
• Difficulty chewing
• Aching near the ear
• Difficulty opening or closing your mouth
• Joint locking

A clicking sound or a grating feeling when chewing or opening and closing your mouth is a symptom of a TMJ disorder, but by itself doesn’t require any treatment. It’s only when there’s pain or difficulty chewing or opening your mouth that treatment may be required.

How Is TMJ Treated?

How TMJ is treated depends on its cause, but common treatments include:

• Heat packs
• Ice packs
• Eating soft foods
• Splints or night guards
• Anti-inflammatory pain relievers (NSAIDs)
• Corrective dental treatments
• Surgery

What Is Sleep Apnea?

Sleep apnea is a sleep disorder in which you repeatedly stop breathing and then start again.

There are three different kinds of sleep apnea:

• Obstructive sleep apnea, in which breathing is obstructed by the tongue falling back into the throat
• Central sleep apnea, in which breathing stops because the brain isn’t properly sending signals to the lungs
• Complex sleep apnea, which is the combination of obstructive and central sleep apnea

What Causes Sleep Apnea?

There isn’t one specific cause of sleep apnea, but the following factors can increase the risk of the sleep disorder:

• Obesity
• Having a thicker neck
• Narrow throat
• Being male
• Older age
• Genetics
• Drinking alcohol
• Smoking
• Nasal congestion
• Medical conditions like high blood pressure, diabetes, or heart disease

What Are the Symptoms of Sleep Apnea?

The symptoms of sleep apnea can include:

• Snoring loudly
• A partner reporting episodes of stopped breathing
• Morning headache
• Dry mouth
• Gasping for air at night
• Insomnia
• Hypersomnia
• Difficulty paying attention
• Irritability

Many of the symptoms of sleep apnea are similar to those of insomnia, or an inability to sleep. This is because sleep apnea prevents restful sleep and may cause you to wake up repeatedly during the night so that your breathing can start again.

How Is Sleep Apnea Treated?

Sleep apnea is typically treated either with a CPAP, APAP, or BiPAP machine. Other options include treating the condition that causes the sleep apnea, such as losing weight or treating allergies that result in nasal congestion. Alternatives to a CPAP machine can include mouth guards that prevent the tongue from falling back into the mouth.

Why Is the FDA Investigating the AGGA?

Although Dr. Galella has been using and marketing the AGGA for approximately 15 years, and over 10,000 patients have used the device, it has never been registered with the FDA. As the FDA has become aware of serious claims of injury caused by the device, they have issued a statement indicating the devices are being evaluated for safety concerns.

Does the FDA Make Any Recommendations About the AGGA?

In their statement, the FDA recommends providers, patients, and caregivers be aware that the devices have not received FDA approval and are being investigated due to complaints of serious complications from the use of the device. They additionally advise that there is no evidence proving the safety and effectiveness of the devices.

Why Wasn’t the AGGA Registered With the FDA?

Per a statement made by Dr. Galella during a court deposition, he did not believe the device falls under FDA jurisdiction. However, according to FDA regulations, all dental devices to be used commercially must, at minimum, receive premarket approval. This would require the completion of an application with the FDA making them aware of the device and granting approval for commercial sale without further approvals. The FDA is currently investigating its jurisdiction in this matter.

Why Are People Filing AGGA Lawsuits?

For some patients, use of the AGGA device has resulted in significant, life-altering changes. Rather than correcting their existing dental complications, the device has caused lasting damage to the patient’s oral health.

The FDA has listed the following complications that may occur due to the use of the AGGA:

• Chronic pain
• Tooth dislocation 
• Flared teeth
• Uneven bite
• Difficulty eating
• Damaged gums
• Exposed roots
• Bone erosion
• Tooth loss 

In addition to the damage to patients’ oral health, for some, the use of the AGGA has resulted in a significant financial burden due to additional dental treatments, the loss of jobs, restrictions to physical intimacy, and decreased self-esteem. 

What Types of Treatment Are Available for Conditions Associated With AGGA Use?

For most patients experiencing possible AGGA-related complications, corrective treatment plans will need to be identified by a dental professional such as a periodontist, orthodontist, or dentist. Some corrective actions that have been required for patients include:

• removal of the AGGA device
• braces
• dentures
• tooth removal

Has the AGGA Been Recalled?

AGGA has not been recalled from the market and may still be used by dental professionals, although many have chosen to remove the device as an offering on their websites. Additionally, the American Dental Association (ADA) has issued a statement advising professionals to be aware of the safety concerns regarding the AGGA and to monitor any patients using the device carefully. The FDA strongly urges all patients, caregivers, and professionals to report any complications that may occur due to the device to better understand the safety risks of its use.

How Many AGGA Lawsuits Have Been Filed?

Over 20 individuals have come forward with complaints of serious complications from the use of the AGGA. At this time, the U.S. Attorney’s Office for the Western District of Tennessee and the U.S. Department of Justice are carrying out a criminal investigation of the AGGA. The attorneys for Dr. Galatea, the Facial Beauty Institute, and Johns Dental Laboratories have requested a delay for the proceeding of personal injury lawsuits pending the criminal investigation results.

What AGGA Lawsuit Settlements Have There Been?

Dr. Galella and the Facial Beauty Institute have denied all liability regarding the injuries sustained by AGGA users, and the lawsuits are still pending trial. Johns Dental Laboratories has settled one lawsuit for an undisclosed sum. However, the company remains in legal battles concerning the other cases.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.