AGGA Lawsuit | 2025 Latest Updates

AGGA Lawsuit Overview

The Anterior Growth Guidance Appliance (AGGA) lawsuits involve allegations that the dental device causes severe and permanent damage to patients’ teeth, gums, and jaw structures.

Over the past 3 years, dozens of lawsuits have been filed against the device inventor, manufacturer, and related companies.

The device was never tested or approved by the FDA yet costs patients approximately $7,000 for treatment that plaintiffs claim causes irreversible harm.

Latest AGGA Lawsuit Updates

• April 2023 – Federal prosecutors have launched a criminal probe into AGGA devices, as revealed in a court motion seeking to delay lawsuits. 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.
• March 2023 – Following a joint investigation by KHN and CBS News [1] into problems with the Anterior Growth Guidance Appliance, the FDA has begun looking into the appliance. FDA’s interest was revealed by Cara Tenenbaum, a former senior policy adviser in the agency’s device center who said “very concerned” FDA officials have begun “looking into” the AGGA.
• March 2023 – A new lawsuit [2] was filed on behalf of 2 plaintiffs in the U.S. District Court for the Southern District of Indiana, alleging significant dental damage from AGGA devices, including loosening of teeth, pain, gum recession, and bone loss.

FDA Reports and Statistics

The Anterior Growth Guidance Appliance has never been tested or received approval from the U.S. Food and Drug Administration (FDA). Unlike other dental devices from Johns Dental, the AGGA was not registered with the FDA despite being invented by Tennessee dentist Steve Galella in the 1990s.

Following the CBS News investigation into problems with AGGA dental devices, the FDA has begun investigating the device to determine how much legal authority the agency has to regulate it.

According to former FDA senior policy adviser Cara Tenenbaum, “The FDA is looking at what authorities they may have around this device — what they may be able to do. Now, of course, whether or not this device is FDA regulated, it still needs to be safe.”

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 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 Injuries & Side Effects

Patients who have had the Anterior Growth Guidance Appliance have reported numerous serious and often permanent dental and oral complications.

• Tooth Damage: Broken, ruined, loosened teeth requiring extensive repair or extraction.
• Dental Displacement: Flaring of the front teeth and loosening of anterior maxillary teeth.
• Gum Problems: Significant gum damage, recession, and exposed tooth roots.
• Bone Deterioration: Alveolar bone loss and bone erosion affecting the stability of teeth.
• Nerve Complications: Nerve damage leading to chronic pain and sensitivity.
• Facial Alterations: Facial disfigurement and changes in appearance.
• Chronic Pain: Severe, persistent pain in the teeth, gums, and jaw.
• Permanent Tooth Loss: Complete loss of teeth requiring implants or dentures.

Do You Qualify for a AGGA Lawsuit?

You may qualify for an AGGA lawsuit if:

• You received treatment with an Anterior Growth Guidance Appliance
• You experienced serious dental or jaw complications after AGGA treatment
• Your injuries required medical treatment, corrective procedures, or caused permanent damage
• You can provide medical documentation linking your injuries to the AGGA device

Evidence Required for a AGGA Lawsuit

To strengthen your AGGA lawsuit, you should maintain:

• Complete dental and medical records from before, during, and after AGGA treatment
• Documentation of the AGGA device installation and removal
• Records of all treatments needed to address complications
• Photographic evidence of dental changes or damage
• Documentation of all related expenses

Damages You Can Recover

Victims of AGGA-related injuries may be eligible to recover compensation for:

• Medical and dental expenses for corrective procedures
• Future treatment costs
• Lost wages due to recovery time
• Pain and suffering
• Emotional distress
• Punitive damages against the manufacturers and promoters

Lawsuit Alleges AGGA Damaged Patients’ Teeth: CBS News Video

Statute of Limitations for AGGA Lawsuits

The statute of limitations for filing an AGGA lawsuit varies by state, typically ranging from 1-6 years from the date of injury or date of discovery of injury.

It’s crucial to consult with an attorney promptly to ensure your claim is filed within your state’s specific deadline.

Failing to file within the statute of limitations period will likely result in losing your right to seek compensation.

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Frequently Asked Questions

1. What is The Anterior Growth Guidance Appliance (AGGA) Lawsuit About?

The Anterior Growth Guidance Appliance (AGGA) lawsuit is about claims that the use of the Anterior Growth Guidance Appliance has caused significant dental and skeletal harm to patients. Plaintiffs allege that the device, intended to guide the growth of the jaw, led to severe complications such as misalignment, pain, and permanent damage.

2. Is The AGGA Appliance Safe?

The AGGA appliance is not safe for adults as it does not work as promised and can even cause permanent damage. Lawsuits have been filed by individuals who used the AGGA device and subsequently developed serious dental problems. These complications include misalignment, severe pain, and irreversible damage to the dental and jaw structure, leading to extensive corrective treatments.

3. Who Can File a Lawsuit Related to AGGA?

Individuals who have experienced adverse effects or harm from the use of the AGGA device can file a lawsuit related to AGGA. This includes patients who suffered dental issues, jaw misalignment, or other health complications as a result of using the appliance.

4. Is AGGA FDA-approved?

The AGGA is not FDA-approved. Unlike other dental devices from Johns Dental, the device, invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA. This means that the safety and efficacy of the AGGA device have not been evaluated or endorsed by the FDA, leading to significant concerns regarding its use and potential risks.

5. What Types of Damages Can Be Sought in an AGGA Lawsuit?

The types of damages that can be sought in an AGGA lawsuit includes compensation for medical expenses, corrective dental procedures, pain and suffering, emotional distress, and any other related costs. In some cases, punitive damages may also be pursued to hold the responsible parties accountable.

6. What Are the Common Complications Associated With the AGGA Device?

The common complications associated with the AGGA device include jaw misalignment, severe dental pain, teeth displacement, and irreversible damage to the jaw structure. These issues often require extensive corrective treatments and surgeries.

7. How Much Does AGGA Treatment Cost?

AGGA treatment typically costs patients approximately $7,000, which is a significant investment that many patients make based on promises of non-surgical jaw correction. This cost often does not include additional expenses for corrective treatments needed to address complications caused by the device.

8. How Long Has The AGGA Device Been Used?

The AGGA device was invented by Dr. Steve Galella in the 1990s and has been used for over two decades despite a lack of FDA approval or rigorous clinical testing. Lawsuits regarding the device date back as far as 2000, indicating long-standing concerns about its safety and efficacy.

See all related medical device lawsuits our attorneys covered so far.

Get A Free AGGA Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for AGGA-related injuries. Most states only allow 1-3 years from the date of injury or discovery of injury to file a lawsuit. Waiting too long could permanently bar your right to compensation.

Our experienced AGGA lawsuit attorneys offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees for our legal services
• Payment only if we win your case or secure a settlement
• Nationwide representation with expertise in medical device litigation

References

1. https://www.cbsnews.com/news/agga-dental-device-lawsuits-teeth-damage/
2. https://www.schmidtandclark.com/wp-content/uploads/2023-3-3-agga-haile-complaint.pdf