The FDA has reportedly begun to look into the Anterior Growth Guidance Appliance, a retainer-like device that has been the source of several lawsuits alleging that it caused severe damage to patients' teeth, CBS News and Kaiser Health News reported March 15.
The device claims it can expand the jaw without surgery, as well as cure sleep apnea and temporomandibular joint dysfunction. A joint CBS and KHN investigation found no peer-reviewed study to back these claims.
Cara Tenenbaum, a former senior policy adviser at the FDA's device center who had voiced concerns about the device in news outlets' investigation, told CBS and KHN that she was contacted by FDA officials who said they are "looking into" the AGGA device but have not yet determined how much legal authority the FDA has to regulate it.
CBS and KHN have reviewed online communications verifying that an FDA official has communicated with Ms. Tenenbaum about the device. However, the FDA declined CBS and KHN's request to comment on the AGGA or confirm whether it was evaluating the device.