Plaintiff says the designer of the AGGA appliance directly approved use of the device on her teeth, despite a known high risk of dental damage and bone loss.
Plaintiffs argue that they should be able to move forward with their AGGA lawsuits, even while the government decides whether to file criminal charges against the dental appliance manufacturers
The FDA is asking anyone who has experienced complications with AGGA or similar dental devices to report those problems to the agency.
According to a news report, FDA officials are uncertain of their ability to regulate AGGA dental devices, despite problems where users are experiencing permanent teeth damage and bone loss
Plaintiffs who have filed Anterior Growth Guidance Appliance lawsuits say the device is not fit for adults, and causes damage to the upper jaw and teeth.
