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AGGA Dental Device Lawsuit

Fixed anterior growth guidance appliance (AGGA) as a non-surgical substitute for jaw surgery which may have caused serious harm or required surgical correction in some patients. People who received an AGGA or FAGGA device may have experienced tooth loss, severe pain and disfigurement of the mouth or were placed at risk of serious harm and may be eligible for compensation.

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What is FAGGA or AGGA?

FAGGA, sometimes called AGGA, is short for Fixed Anterior Growth Guidance Appliance. It is an unapproved dental device intended to be used as a substitute for dental jaw surgery. It reportedly works to encourage forward growth of the jaw.

It may be used to improve facial profile and appearance or as part of an orthodontic treatment plan in preparation for braces, to open spaces which may have closed after tooth extraction.

Implantation or use of the AGGA device has resulted in serious complications for some patients. These complications may require surgery to repair and may 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.

How Does The AGGA Device Work?

When used in adults, the AGGA or anterior growth guidance appliance is cemented in place like an orthodontic device. It may be called “FAGGA” for fixed anterior growth guidance appliance and is used to promote forward growth of the upper premaxilla and maxilla or upper jaw. 

The FAGGA device works by use of a small oval plate which presses forward from the inside of the mouth. This oval plate pushes the top part of the roof of the mouth or palate forward to encourage new bone growth, reportedly through stimulation of the nasopalatine nerve which may trigger a bone-building response. Some dental practitioners disagree and may believe that action occurs due to pressure alone.

AGGA may be used to improve facial profile or appearance or may be used to improve jaw shape which is 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 the spacing between teeth may be needed for future orthodontic procedures like braces. Once implanted, the AGGA device is usually adjusted monthly to encourage and increase expansion of the palate or arch on the inside of the mouth. 

Are There Any Side Effects of AGGA?

AGGA is intended to be a non-surgical substitute for jaw surgery, however patients who experience complications may be required to undergo corrective surgeries to repair damage caused by the device.

Side effects which may be caused by AGGA include:

  • Severe pain in jaw
  • Headache
  • Bone decay
  • Tooth damage
  • Loss of teeth
  • Facial disfigurement
  • Other injuries

Some of these side effects may require surgical repair or reconstructive surgery to restore function or reduce pain.

Was AGGA Approved by the FDA?

AGGA or FAGGA was invented by Dr. Steve Galella and other 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 has not been approved by the FDA. According to court documents, Dr. Galella, has stated that neither he nor his company ever applied for FDA approval for the Anterior Growth Guidance Appliance.

Even without FDA approval for AGGA, OrthoMatrix and The Facial Beauty Institute have encouraged use of the device and performed training in many dental clinics and facilities around the U.S. Numerous 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 by the FDA as required by medical device marketing regulations.

Is There an AGGA Dental Device Lawsuit?

Numerous patients who received the AGGA dental device as an alternative to costly and invasive jaw surgery may have been harmed by the device. Some of these patients may be considering AGGA Dental Device Lawsuits against the manufacturer.

People who were injured after receiving the AGGA dental device or required reconstructive surgery as a result of the device may be eligible for compensation.

What Are the Claims in AGGA Lawsuits?

AGGA lawsuits may be filed by people who were injured after receiving an AGGA or FAGGA device. Many of these people chose a less invasive procedure to minimize recovery time and reduce costs. Unfortunately, some of these patients may require much more costly treatments including surgery to repair and reconstruct damage done by AGGA. These treatments will not only be more expensive, but they may also be more risky and require additional recovery time.

AGGA lawsuits claim that AGGA does not work as advertised and that the device was poorly designed, resulting in serious injury and disfigurement for patients who receive it. Manufacturers are accused of misleading customers into paying for a device which did not function as advertised.

Who Can File an AGGA Lawsuit?

Estimates show that there are at least 10,000 patients who had an AGGA or FAGGA device implanted. Several patients who were injured have already filed lawsuits against the manufacturer of AGGA.

Other people may be eligible to file an AGGA Dental Device Lawsuit if they experienced severe side effects including:

  • Severe pain
  • Loss of teeth
  • Facial disfigurement
  • Repair or reconstructive surgery

People who received a FAGGA or AGGA implant and experienced serious side effects or who were placed at risk by the device may be eligible for compensation.

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