The American Association of Orthodontists is urging dentists to report adverse events with direct-to-consumer clear aligners to the FDA.
A recent survey indicated that 77% of AAO member respondents have seen new patients requiring retreatment after using a mail-order orthodontic treatment model without an initial in-person exam, the orthodontic association said Sept. 18.
The AAO said several of its members and staff met with FDA officials in Washington, D.C. over the summer and shared clinical stories about risks and harms related to direct-to-consumer clear aligners.
The AAO said there is a "critical need" for providers who have seen patients who have experienced adverse events after DTC aligners to add at least one entry into the Manufacturer and User Facility Device Experience database. After submitting a report to the database, providers were also asked to notify the AAO Advocacy team.
The organization added that the volume of reports will inform the FDA's level of response to the risks associated with the mail-order orthodontic treatment model.
The AAO said addressing concerns related to mail-order orthodontic treatment models is a top priority. In 2021, the organization got more than 20 Congress members to write a letter to the Government Accountability Office requesting that the office conduct a study of the federal regulation of DTC advertising practices for prescription medical products.
The GAO completed their study in September 2023 and submitted a performance audit to Congress detailing the FDA's and the FTC's oversight for DTC advertising of medical devices.