The dental agency encouraged reports of adverse events or serious complications related to certain fixed palatal expanders in an April 3 news release. These include:
- Anterior growth guidance appliance and fixed anterior growth guidance appliance
- Anterior remodeling appliance and fixed anterior remodeling appliance
- Osseo-restoration appliance and fixed osseo-restoration appliance
- Any other similar device types
The FDA recently began evaluating safety concerns of these devices after the Anterior Growth Guidance Appliance was targeted in multiple lawsuits for allegedly causing severe damage to patients’ teeth.
The Anterior Growth Guidance Appliance claims it can expand the jaw without surgery as well as cure sleep apnea and temporomandibular joint dysfunction. There are no peer-reviewed studies to back these claims and the product has not been evaluated by the FDA.
Reports can be filed through MedWatch, the FDA’s medical product safety reporting program.