FDA Evaluating Dental Devices

The Anterior Growth Guidance Appliance (AGGA) and Anterior Remodeling Appliance (ARA) are two dental devices under review by the FDA.

On March 30, 2023, the FDA announced it’s reviewing customer safety concerns regarding these two products after a CBS News report.

If you or a loved one has had these dental devices inserted during surgery, please don’t hesitate to contact us at 864-235-4999 by clicking the button below or through our contact form.

The Dangers of These Dental Devices

According to recent news reports from CBS and Kaiser Health News (KHN), these dental devices have been used to treat conditions including sleep apnea and other various joint disorders of the jaw. However, the FDA hasn’t approved these devices.

The AGGA device is designed to expand the jawbone. However, according to the previously mentioned media reports, plaintiffs in these lawsuits have reported that the device has left patients with damaged gums, loose teeth, and eroded bones. The Las Vegas Institute designed both the AGGA and ARA dental devices.

At least 20 AGGA patients filed lawsuits against AGGA’s inventor Dr. Steve Galella and other defendants claiming the AGGA did not and can’t work. Similar devices have been used to fix jaw problems in children whose jaws are still developing. Unfortunately, since the upper jaw bones are fused, the increased pressure can cause major issues.

If forces are applied incorrectly to the teeth as reported by CBS News, serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.

Next Steps

If you used one of these products and have been injured by them, we want you to focus on healing, which is why Thomas Creech Law Offices is a contingency fee-based firm. Thus if there is no recovery, then there are no attorneys fees.

For almost 20 years, Thomas Creech has represented clients in a variety of personal injury cases, including those involving dangerous medical devices. Let us bring our many years of legal experience, wisdom, and judgment to provide insight into your potential case.

Dental Devices Wrap up

We offer bold and wise representation to families who have been harmed by medical malpractice. Dentists who use one of these unapproved FDA dental devices can cause serious harm to their patients. Your dentist has a responsibility to use approved dental products when treating your jaw problems. These dentists and the manufacturer of these devices should be held accountable. No recall has been issued at this time, but we will continue to monitor this developing situation.

If you’re feeling better, give us a call. We can review your case with you and set up a FREE personal consultation. If you’re uncomfortable discussing the details of your injury over the phone, you can request your consultation using the form below.