FDA Looks Into Dental Device After KHN-CBS News Investigation of Patient Harm
The FDA’s interest in the AGGA dental device follows a KHN-CBS News investigation, according to a former agency official.
A los pocos meses de usar AGGA, una paciente dijo que sus dientes estaban tan flojos que podía sentir cómo se movían cuando se untaba crema hidratante en las mejillas. Besar a su novio le resultaba incómodo.
This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.
A dental device called AGGA has been used on about 10,000 patients without FDA approval or proof that it works. In lawsuits, patients report irreparable harm. The AGGA’s inventor and manufacturer have denied all liability in court.