**Controversy Surrounding Dental Device Raises Questions About Patient Safety**
A recent investigation has uncovered troubling allegations against a Tennessee dentist who invented a dental device called the Anterior Growth Guidance Appliance (AGGA). This device, originally marketed as a treatment for TMJ and sleep apnea, has been the subject of multiple lawsuits from patients who claim it caused significant damage to their mouths.
In court depositions, Steve Galella, the inventor of the AGGA, denied teaching dentists to use the device for TMJ or sleep apnea, despite video evidence showing otherwise. This contradiction raises concerns about the accuracy of information provided to both dentists and patients.
At least 23 patients have filed lawsuits against Galella, alleging that the AGGA led to tooth loss and other oral complications. Galella has settled most of these lawsuits, but the controversy surrounding the device continues to grow.
**Device Rebranding and FDA Investigation**
Galella recently rebranded the AGGA as the Osseo-Restoration Appliance, but investigations by both the FDA and the Department of Justice have been launched in response to the allegations of patient harm. The safety and effectiveness of the device are now under scrutiny.
Dentists across the country have promoted the AGGA on their websites, making bold claims about its ability to “grow” or “remodel” the jaw without surgery. However, there is no peer-reviewed evidence supporting these assertions.
Following the FDA and DOJ inquiries, it was revealed that criminal charges may be brought against Galella and the device manufacturer, Johns Dental Laboratories. The existence of a grand jury subpoena suggests serious legal repercussions for those involved.
Several patients have come forward with harrowing stories of the damage caused by the AGGA. One individual, Alice Runion, described how the device resulted in permanent impairment and disfigurement, leaving her with significant dental issues and ongoing health concerns.
Orthodontists Neal Kravitz and Jeffrey Miller, who have studied the AGGA, have voiced concerns about the device’s negative impact on patients. They intend to publish a research paper documenting their findings, raising further questions about the safety and efficacy of the device.
This edited and condensed version of the original article focuses on the key points of controversy surrounding the AGGA and its implications for patient safety.