AAO members and AAO staff recently met in Washington, D.C. with key leaders at the U.S. Food and Drug Administration (FDA). The AAO team shared clinical stories about risks and harms related to direct-to-consumer (DTC) clear aligners with the FDA team, which included dentists.
The FDA is interested in learning more from AAO members about their experiences with patients requiring retreatment from mail-order orthodontic treatment models without an initial in-person examination.
There is a critical need for AAO members to consider including their names and addresses to be collectively shared with the FDA and other policy stakeholders to help highlight the volume of AAO members who have seen patients experiencing adverse events after direct-to-consumer treatment. Please consider officially adding your name and address to serve as public attestation that you have:
- Encountered patients who came to you to address complications resulting from prior treatment by a direct-to-consumer orthodontic service without an in-person clinical examination.
- Patient health and safety concerns from a clinical perspective when it comes to mail-order orthodontic treatment models using Class II medical devices (clear aligners) without an initial in-person examination for that type of treatment.
You can view the letter and add your name quickly and easily by clicking here:
The FDA will have an opportunity to review the background information shared from the AAO, and this clinical feedback could potentially prompt a level of response to the mail-order orthodontic treatment model risks that can include issuing an FDA public warning to patients about treatment with a DTC company without receiving an in-person examination and radiographs first.
The AAO annual public policy survey year over year has indicated that 77% of AAO member respondents have seen new patients in their office requiring retreatment after using a mail-order orthodontic treatment model without an initial in-person exam.
As always, grassroots engagement by AAO members is vital and helps positively move the needle on the AAO’s evidence-based policy priorities. Adding your name publicly to this collective group will help advance our important advocacy work. Thank you for taking action now and making a difference for patient health and safety!
