The U.S. Food and Drug Administration (FDA) is evaluating safety concerns and has issued a safety alert on March 30, 2023, regarding certain dental devices used in adults to remodel the jaw or to treat conditions such as Obstructive Sleep Apnea (OSA) and temporomandibular joint disorder (TMD) of the jaw. The devices in question include:
- Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA);
- Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA);
- Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA); and
- Any other similar device types.
The FDA has received reports of serious complications related to these devices who have not been cleared or approved by the FDA. The FDA is alerting patients, caregivers, and healthcare providers that the safety of such devices is being evaluated, and that using them may cause chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion and tooth loss.
Palatal expanders are commonly used during orthodontic treatment for children and adolescents to widen the palate to make room for crowded teeth. At this time, the FDA is not aware of safety concerns related to this use. However, the safety concerns raised by the FDA apply specifically to adult patients, whose upper jaw bones are fused and resistant to expansion. If forces are applied incorrectly to the teeth, serious complications can occur that typically require intervention by a healthcare professional.
Patients, caregivers, and healthcare providers should be aware of the FDA’s evaluation and understand that the safety and effectiveness of these devices have not been established. Essentially, these devices should not be used to treat OSA or TMD in adults. If you think you are being treated with any of these devices, express your concerns to your healthcare provider and report any adverse effects to the FDA via MedWatch.
The FDA is taking actions to address these safety concerns, such as informing the public, contacting responsible entities, and planning to investigate potential violations. They will continue to monitor complaints and adverse events reports and keep patients, caregivers, and healthcare providers informed.
To read the full alert, click here
If you experience any issues with these dental devices or other medical devices, you can file a voluntary report through MedWatch or call 1-800-332-1088. Healthcare personnel employed by facilities subject to FDA’s user facility reporting requirements should follow their facilities’ established reporting procedures.