A CBS News and KFF Health News investigation revealed that a dental lab that produced a device intended to help patients with TMJ jaw disorder was never inspected by the FDA. The device, known as the “anterior growth guidance appliance” or AGGA, has been reported to have caused damage to patients’ mouths. The inventor of the device, Dr. Steve Galella, claimed that it could cure TMJ jaw disorder and sleep apnea. However, both the device and its inventor are currently under criminal investigation, although they have denied any wrongdoing.
Numerous patients who have used the AGGA device have reported experiencing negative effects on their mouths, raising concerns about the safety and effectiveness of the product. The lack of FDA inspection of the dental lab that manufactured the device has also sparked further scrutiny into the regulatory oversight of medical devices. The device’s inventor, Dr. Steve Galella, has faced allegations of misleading patients with claims of curing TMJ jaw disorder and sleep apnea, leading to the criminal investigation.
Despite the controversy surrounding the AGGA device and its inventor, both have denied any wrongdoing. The criminal investigation into the device and Dr. Steve Galella’s claims has raised questions about the regulatory oversight of medical devices and the potential risks to patients. Patients who have experienced negative effects from using the AGGA device have highlighted the importance of thorough inspection and regulation of medical devices to ensure their safety and effectiveness for patients with TMJ jaw disorder.
The FDA’s failure to inspect the dental lab that produced the AGGA device before it was made available to patients has exposed gaps in the regulation of medical devices. Patients who have suffered harm from using the device have called for stricter oversight and regulation to prevent similar incidents in the future. The criminal investigation into the device and its inventor has further underscored the need for transparency and accountability in the medical device industry to protect patient safety.
As the investigation into the AGGA device and its inventor continues, questions remain about the safety and efficacy of the device in treating TMJ jaw disorder and sleep apnea. Patients who have experienced negative effects from using the device have shared their stories in hopes of raising awareness about the potential risks associated with unregulated medical devices. The FDA’s lack of inspection of the dental lab that produced the device has highlighted the importance of thorough regulatory oversight to prevent harm to patients.
