Summary for Blog Post:
The FDA issued a safety communication on March 30, 2023, addressing concerns about certain dental devices, including fixed (non-removable) palatal expanders such as the AGGA, FAGGA, ARA, FARA, ORA, and FORA, used in adults for jaw remodeling and to treat conditions like obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD). These devices have not been cleared or approved by the FDA for these purposes, and their safety and effectiveness remain unverified.
The FDA has received reports of serious complications linked to these devices in adults, including chronic pain, tooth dislocation, uneven bite, and even tooth loss. These devices are typically designed for use in children, whose upper jaw bones are not fused, unlike adults whose bones resist expansion.
Patients, caregivers, and healthcare providers are advised to be cautious and report any adverse events to the FDA. The agency is working to further evaluate these devices and ensure patient safety, with potential actions to address violations if found necessary.
Key Takeaways:
- These devices are not FDA-approved for use in adults.
- Serious complications such as chronic pain, tooth loss, and bone erosion have been reported.
- The FDA encourages reporting any adverse experiences through its MedWatch system.