The Fixed Anterior Growth Guidance Appliance known as FAGGA (or AGGA), is an unapproved dental device intended to encourage forward growth of the jaw. It is used to improve facial profile and appearance and as part of an orthodontic treatment plan to open spaces which may have closed after tooth extraction in preparation for braces.
Implantation of the AGGA device has resulted in serious complications for some patients which may require surgery to repair.
Complications of AGGA (or FAGGA) device include:
- Severe mouth pain
- Tooth loss
- Disfigurement of the mouth
People who had an AGGA (or FAGGA) device implantation or procedure may have been placed at risk of injury or complications and may be eligible for compensation.
AGGA Device Implantation
AGGA or anterior growth guidance appliance may also be called fixed anterior growth guidance appliance (FAGGA) because when used in adults, it is fixed in place like an orthodontic device. It is used inside of the mouth to promote forward growth of the upper premaxilla and maxilla or upper jaw.
The device works through the use of a small oval plate which presses forward from the inside of the mouth to push the top part of the palate forward, encouraging new bone growth. It is intended to substitute for jaw surgery. The oval plate reportedly encourages new bone growth by stimulation of the nasopalatine nerve which may trigger a bone-building response, though some dental practitioners disagree.
AGGA may be used to improve facial profile or appearance or to improve jaw shape which may be restricting airflow. It may also be a part of an orthodontic plan to open up spaces between teeth which may have closed after extraction. Opening up or restoring the spacing may be needed for future orthodontic procedures like braces. Once implanted, the AGGA device is adjusted monthly to increase and encourage expansion of the palate or the arch on the inside of the mouth.
AGGA is intended to be a substitute for jaw surgery, however patients who experience complications may be required to undergo corrective surgeries to repair damage caused by the device.
AGGA is Not Approved by the FDA
AGGA or FAGGA was invented by dentists who founded OrthoMatrix Corp, Inc. and its subsidiary The Facial Beauty Institute. Though the U.S. Food and Drug Administration requires that medical and dental devices go through an approval process, including human clinical research trials, before becoming widely available, AGGA is not approved for use by the FDA.
Despite its lack of approval, OrthoMatrix and The Facial Beauty Institute have encouraged use and performed training in many dental clinics and facilities around the U.S. A number of dental clinics and practitioners encourage the use of AGGA and offer detailed information regarding the device and procedure as part of their informational and marketing materials. None of these materials have been examined or approved as required by medical device marketing regulations.
AGGA Dental Device Lawsuits
The AGGA dental implant which is promoted as an alternative to costly and invasive jaw surgery, may actually cost patients thousands of dollars to receive. After paying thousands of dollars, some of these patients will experience serious complications of their procedure, and ultimately require one or more surgeries to correct the damage caused by AGGA.
In addition to the cost of the device and procedure which placed them at risk, some patients experience severe side effects including:
- Severe pain
- Loss of teeth
- Facial disfigurement
- Repair or reconstructive surgery
People who received a FAGGA (or AGGA) implant may be considering lawsuits for injuries caused by the device. Those who received a FAGGA (or AGGA) device may have experienced serious side effects or been placed at risk and may be eligible for compensation.