Health

The Creator of ‘AGGA’ Clarifies That His Dental Device Was Not Intended for TMJ or Sleep Apnea, Testifies as Expert Witness

**Controversy Surrounding Dental Device Raises Questions About Patient Safety**

**Introduction**
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.

**Conflicting Testimony**
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.

**Patient Lawsuits**
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.

**Unsubstantiated Claims**
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.

**Criminal Investigation**
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.

**Patient Testimonies**
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.

**Expert Opinions**
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.

Emily Thompson

Dr. Emily Thompson is a highly respected medical professional and seasoned health journalist, contributing her expertise to our news website. With a medical degree from Johns Hopkins University School of Medicine and over 15 years of experience in clinical practice, Dr. Thompson possesses a deep understanding of various health issues.
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