The ADA is encouraging the public and dental profession to follow the Federal Food & Drug Administration’s process of promptly reporting adverse events or serious complications related to certain dental devices that are fixed (nonremovable) palatal expanders.
The palatal expanders of concern were named in a March 30 FDA announcement and include:
“The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea and temporomandibular joint disorder of the jaw, and to remodel the jaw in adults,” according to the announcement. “However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.”
The FDA asked patients, caregivers and health care providers to report any complications with those named devices to the FDA.
The ADA further is encouraging the public and dental profession to report concerns to MedWatch to ensure any pertinent information related to these devices can be thoroughly evaluated by the FDA with regard to safety and efficacy. The ADA will continue to monitor for FDA updates regarding these devices.
If someone experiences any issues with any medical device, the FDA encourages them to file a voluntary report through MedWatch or call 800-332-1088 for more information on how to mail or fax the form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
According to the announcement, the FDA is not aware of safety concerns related to orthodontic use of palatal expanders in children and adolescents . The safety and effectiveness of fixed (nonremovable) palatal expanders being used to treat conditions such as OSA and TMD, or to remodel the jaw in adults, have not been established and these devices have not been cleared or approved by the FDA.
For questions, email the Division of Industry and Consumer Education at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.