Just a few weeks after a Kaiser Health News report uncovered a spate of complaints about the unregulated use of a dental device that patients say caused extensive damage, the FDA has begun looking into the issue.
The March 1 report detailed the stories of several adults who had been treated with an Anterior Growth Guidance Appliance (AGGA)—a retainer-like device that’s meant to apply forward pressure to the upper palate and front teeth to help lengthen the jawbone and create space in the mouth. The device has been marketed as a way to correct a misaligned bite, improve breathing and even correct medical issues like sleep apnea and TMJ.
Instead, however, several patients treated with the device described to KHN how the device had forced their teeth out of alignment—sometimes to a point so extreme that they must be removed—and damaged their gums and jawbones. In some cases, the issues required multiple costly surgeries to fix.
The FDA told KHN that the device had never been submitted for review and therefore has been sold without the agency’s regulation and oversight.
To date, per the report, at least 20 former AGGA users have filed lawsuits concerning the device, many of them naming the AGGA device’s inventor, Steve Galella, D.D.S., its manufacturer and training companies as defendants.
In a safety communication issued Thursday, the FDA said it has begun evaluating complaints about not only the AGGA device but also a handful of other fixed palatal expanders that are used to “remodel the jaw or to treat conditions” in adults.
As the agency notes, while palatal expanders can be used safely and successfully in children—whose upper jawbones typically aren’t done growing until their late teens—the opposite is true for adults whose jaws have already fused.
In that case, according to the FDA, “if forces are applied incorrectly to the teeth, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion and tooth loss.”
Not only have the devices in question not been submitted to the FDA for clearance, but their makers’ claims that they can help straighten teeth and treat conditions like jaw pain and obstructive sleep apnea have also been unproven, the agency said.
To start, the FDA is asking all patients, caregivers and healthcare providers who have experience with the AGGA and other devices to submit any reports of serious complications stemming from the devices. The agency said it will track and evaluate those reports and will issue additional updates as that analysis continues.
The regulator also reminded patients and clinicians that it hasn’t signed off on the safety and efficacy of the devices, so patients looking into them as a potential treatment should discuss the potential complications with a dentist beforehand.
The FDA said it’s sharing those concerns with all “responsible entities,” and that it “plans to investigate potential violations and take action if appropriate.”