Summary:
The U.S. Food and Drug Administration (FDA) has raised safety concerns regarding the use of specific dental devices on adults, particularly fixed (non-removable) palatal expanders used for jaw remodeling or treating certain conditions. The devices in question include Anterior Growth Guidance Appliance (AGGA), Fixed Anterior Growth Guidance Appliance (FAGGA), Anterior Remodeling Appliance (ARA), Fixed Anterior Remodeling Appliance (FARA), Osseo-Restoration Appliance (ORA), Fixed Osseo-Restoration Appliance (FORA), and similar types.
These devices have been employed to address conditions like obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD) in adults, but their safety and effectiveness for these purposes remain unestablished, and they lack FDA clearance or approval.
The FDA is aware of serious complications associated with these devices and urges patients, caregivers, and healthcare providers to report any issues promptly. Adverse events may include chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. The FDA is actively evaluating available information and aims to provide further insights.
Key Recommendations:
- Recognize that the FDA is assessing safety concerns with specific dental devices.
- Acknowledge that the safety and effectiveness of these devices for treating conditions in adults have not been confirmed by the FDA.
- Consult a dental professional for concerns related to these devices.
- Report any problems with the devices to the FDA.
Background:
Palatal expanders are typically used to widen the upper jaw in children during orthodontic treatment. However, in adults, whose upper jaw bones are fused, the use of fixed palatal expanders may lead to serious complications. The FDA emphasizes that the safety and effectiveness of these devices for conditions like OSA and TMD in adults have not been established.
FDA Actions:
The FDA is actively communicating concerns to patients, caregivers, and healthcare providers regarding the identified dental devices. Responsible entities are being contacted, and the FDA plans to investigate potential violations, taking necessary action. Continuous monitoring of complaints and adverse event reports is underway, with updates promised as significant information emerges.
Reporting Problems:
The FDA encourages individuals to report any issues with medical devices through MedWatch or by calling 1-800-332-1088. Healthcare personnel in FDA-regulated facilities should follow established reporting procedures. Reports should include device information, details of adverse events, and information on medical interventions if applicable. Concerns about regulatory misconduct can be reported through the FDA’s Allegations of Regulatory Misconduct process or by contacting local FDA Consumer Complaint Coordinators