The American Association of Orthodontists is asking its members to sign a letter to the FDA highlighting the risks and harms related to direct-to-consumer clear aligners.
Four notes:
1. The AAO said the FDA is interested in learning more about orthodontists' experiences with patients requiring retreatment from mail-order orthodontic treatment models without an initial in-person examination.
2. Orthodontists were asked to add their names to the letter if they have encountered patients who required retreatment or if they have concerns from a clinical perspective about mail-order clear aligners without an initial in-person examination.
3. The feedback could lead to a response from the FDA, including a public warning to patients about this type of treatment, according to an Oct. 30 news release.
4. The letter to the FDA comes after the AAO urged providers who have seen patients who have experienced adverse events after using DTC aligners to add at least one entry into the Manufacturer and User Facility Device Experience database.