A dental device called the Anterior Growth Guidance Appliance, commonly referred to as the AGGA, is now the subject of multiple lawsuits across the country. The device was originally invented by a US dentist in the 1990s. However, according to reports, the AGGA was never submitted to the FDA for approval. The inventor has stated that the device was not subject to FDA review because it posed very little risk to the user, akin to the same risks as a standard dental retainer. Recent lawsuits however have claimed that the device has severely damaged patients’ teeth and jaws, sometimes to permanent effect. Because the FDA was not aware of it, complaints were largely unchecked for years.
What is it?
The AGGA was designed to help patients who suffered from breathing problems, TMJ, crossbites and other issues related to a small or poorly aligned jaw. The AGGA claimed to help the jaw grow or expand. This is done by using a light wire frame attached to the teeth, accompanied by a small disc that places light pressure on the nasopalatine nerve. That in turn is supposed to encourage jaw growth or “remodeling” — thus improving or resolving the patient’s condition. The AGGA costs approximately $7000 and is to be worn for several months.
Several experts have reported however that the AGGA merely pushes a patient’s teeth out, while the jaw remains in place. One maxillofacial surgeon called the mechanism “medieval” – comparing the process to expanding your house by pushing on the frame. Allegedly, for some patients the result has been lasting damage, including loss of teeth, damage to the underlying bone, and related pain and suffering. Patients have claimed to have had to have teeth removed, surgical reconstruction, and other medical care. At least one patient, a professional clarinetist, lost her livelihood because her front teeth had to be removed, and the damage was too significant for proper denture fitting. As a result, she is permanently unable to play or teach the clarinet at a professional level.
How did this happen?
In many cases patients relied on their practitioner’s advice or in some cases, their own research on sources such as Facebook (the AGGA was promoted heavily by the inventor on social media). Many of the dentists using the device learned how to use the AGGA at the Las Vegas Institute (LVI), a training facility, which is now also subject to several lawsuits. (The current lawsuits also name the inventor, his company which makes the devices, and LVI.) The AGGA flew under the radar of the FDA because it was not submitted for their approval, as the inventor didn’t believe it was subject to their jurisdiction. Additionally, not only was the AGGA never reviewed by the FDA, it also was never subject to any peer review. The inventor-dentist said his own experience with the device, which he says he has used on more than 600 patients was his proof that it worked. He recently was required to submit patient scans that supported this claim. Medical experts who reviewed the scan have pointed out that the inventor’s own evidence further documents the inefficacy – and lasting damage – of the device.
Caution: New name, same problems.
Dentists should be aware that the AGGA was recently renamed the Osseo-Restoration Appliance (ORA). It is the same device – this is simply a new name and potentially carries all the same risk and unproven claims as before. In addition, another device called the Anterior Remodeling Appliance, or ARA, while manufactured by another company, is being scrutinized because the construction is very similar to the AGGA/ORA. Dentists should be cautioned about using either of these devices and do their due diligence, even though they remain available and continue to make claims about their ability to stimulate jaw growth and/or expand the jaw.
FDA Response Unclear, Yet
At this time, it is unclear what action the FDA may take, which could include limiting or banning the availability of these devices. Separately, the legal actions against the inventor, the manufacturer, and the training facility are ongoing, and therefore it is unclear what will be the legal liability of each of those parties. In addition, more and more dentists who previously used the AGGA have removed the information from their websites, and some practices have even explicitly explained why they have concerns about its efficacy, even if they don’t directly denounce it.