A dental device, AGGA, has been making the news in recent months. The device, advertised as a miracle fix for multiple diseases, ruined patients’ teeth. Over 20 lawsuits have been filed, and more may come. Here is what you should know about this device and what you should be wary of with dental devices.
What Is AGGA?
Anterior Growth Guidance Appliance, or AGGA, is a device used to expand the upper palate with springs and a wire frame. It claimed to fix breathing problems like Obstructive Sleep Apnea (OSA), crossbites, TMJ, and other issues associated with small or misaligned upper palates. A dentist invented it in the 1990s, costing about $7,000. The Las Vegas Institute held classes on AGGA and heavily promoted it on Facebook, where many customers discovered the device. In 2019, AGGA was rebranded under a new name, Osseo-Restoration Appliance, so that these lawsuits wouldn’t hinder future sales.
What Do the Lawsuits Claim?
Patients and experts alike say AGGA doesn’t work as it claims; rather than moving the jaw, it moves the teeth, making it seem like the jaw is moving. Patients have widely reported that the device ruined their teeth, with some losing dozens of teeth after AGGA is removed. There are an array of other issues associated with the device, including flared teeth, damaged gums, exposed roots, nerve damage, and bone erosion.
How Did This Happen?
There is a lot that went wrong with AGGA. The device and its dangers flew under the radar because it was never submitted to the FDA, which is now investigating it. The inventor claims he thought it was out of the FDAs jurisdiction. Because of this, the device never had to be adequately tested and peer-reviewed. The inventor said his research before selling the device used AGGA on over 600 patients. Patients often took their provider’s discretion before installing the device or just relied on the advertising on Facebook.
Caution: This Can Happen Again
While this may seem like a shocking case, it is not a unique one. Here are some things to look for to know if you should avoid a dental device.
- FDA Approval: Part of the job of the FDA is to regulate dental devices. They ensure that the product is safe for use and will categorize dental devices into classes based on the risk of use. Without approval, these devices are illegal.
- Research: To ensure that medical devices are safe, they should also have peer-reviewed research. In the case of AGGA, they marketed that research was done about the product, but it was all anecdotal, and none of it was peer-reviewed.
- Sensationalist Advertising: More often than not, advertising that is too good to be true isn’t true. This is especially true for devices that claim to cure otherwise uncurable medical conditions like OSA. Always research that advertising claims are valid and attainable.
Be wary of any new dental device with significant claims related to OSA. These can have detrimental effects on your health.
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