https://www.medlegal360.com/agga-appliance-lawsuits-haunt-anterior-growth-guidance-appliance-makers/
A joint investigation by the KHN and the CBS News brings the dental appliance AGGA under the radar of the FDA.
The Anterior Growth Guidance Appliance (AGGA), which is used in patients without the approval of any governmental agencies, is now facing more than a dozen AGGA lawsuits.
Around 9-months long investigation by the KHN and CBS News has unearthed shocking revelations that this dental device claimed to be enlarging the jaws actually uproots the teeth.
A Tennessee based dentist Dr. Steve Galella invented this device in 1990s to “remodel” the jaws to treat sleep apnea and breathing difficulties due to TMJ.
He himself fixed the device to more than 600 patients and gave training to dentists to implant the device. Training sessions were conducted through his company, the Facial Beauty Institute and the Las Vegas Dental Institute.
Both the inventor Galella and the manufacturer, Johns Dental Laboratories claimed that the device was safe and effective in its intended work.
However, the stories of plaintiffs like Boja Kragulj, the famous clarinetist proved that instead of enlarging their jawline, the device caused severe dental damage, tooth loosening, gum recession and alveolar bone loss.
Plaintiffs alleged that they were convinced by the dentists and Facebook ads that the device was capable of expanding their jawline and cure their sleep issues.
It was said to have been implanted in more than 10,000 patients.
Dr. Galella was found to be telling the dentists during the training, “It’s OK to make a crapload of money.” “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.” This shows that he was ready to compromise the health of the patients for money.
Though he claims his device to be safe and beneficial, he admitted in a deposition that there was no literature to prove its efficacy.
Every device should be registered with the FDA before the marketing. If any risk to the consumer is detected it would be made to undergo pre-market review to assert its safety and efficacy.
However, the FDA came to know of the dental device and the adverse events only when the CBS and the KHN enquired it if the device had FDA approval.
The investigation and the ongoing lawsuits have turned its attention to the device and it is believed that the FDA has started its evaluation of the device.
The lawsuits contended that the defective device led the plaintiffs to undergo many dental procedures and tens of thousands of dollars of financial burden. Plaintiffs like Boja Kragulj alleged that it spoilt their profession too.
The AGGA lawsuits are expected to boom in the recent future. But if there will be a class action lawsuit on AGGA appliance is still unpredictable.
If you are affected by the device, keep your medical records intact with all your damages noted down. It will fortify your claim.
To know more about the lawsuits read our latest blog on AGGA appliance lawsuits.
