Devices

FDA Evaluating Adult Dental Device Concerns

FDA says it is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders and used on adults to remodel the jaw or treat conditions. An agency safety communication says the devices of concern are:

anterior growth guidance appliance and fixed anterior growth guidance appliance;
anterior remodeling device and fixed anterior remodeling appliance;
osseo-restoration appliance and fixed osseo-restoration appliance; and
any other similar device.

The notice says the agency is aware of the 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. “However,” it says, “the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by FDA.”

The notice further says the agency is also aware of reports of serious complications with the use of the devices. “FDA is asking patients, caregivers, and healthcare providers to report any complications with these devices to FDA,” it says. “FDA is working to evaluate information from all available sources to provide additional information on this issue.”

FDA describes palatal expanders as dental devices typically used to widen the palate to make room for crowded teeth. They are generally used during orthodontic treatment for children and adolescents whose upper jaw bones are not yet fused, and FDA says it is not aware of safety concerns related to orthodontic use of the expanders in children and adolescents.

In contrast, the agency says, an adult’s upper jaw bones are fused and when a fixed palatal expansion device applies force, the palate resists expansion. “If forces are applied incorrectly to the teeth,” FDA says, “serious complications can occur including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss. These complications typically require intervention by a healthcare professional.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome