Summary: The AAO is urging members to submit reports of adverse events related to DTC clear aligners to the FDA’s MAUDE database. The volume of submissions will influence the FDA’s response, potentially leading to public warnings and improved regulation of mail-order orthodontics.

Key Takeaways:

  • AAO members are encouraged to report DTC aligner-related issues to the MAUDE database to help inform the FDA’s actions.
  • The AAO continues to address patient safety concerns by advocating for better regulation of mail-order orthodontic treatments at both state and federal levels.

The American Association of Orthodontists (AAO) announced that several members and AAO staff met with key leaders from the Food and Drug Administration (FDA) in Washington, DC to discuss concerns about prescription medical devices, including direct-to-consumer (DTC) clear aligners.

The FDA oversees the Manufacturer and User Facility Device Experience (MAUDE) database, a searchable repository of medical device reports (MDRs) related to adverse events.

Encouraging Reporting of Adverse Events

AAO members shared clinical stories about the risks and harms they’ve seen in patients who used DTC clear aligners. As a result, AAO is encouraging members who have encountered adverse events following DTC treatment to submit at least one report to the MAUDE database. A detailed instructional guide is available to help members through the submission process.

The volume of submissions to the MAUDE database will inform the FDA’s response to risks associated with mail-order orthodontic treatment models. The AAO believes that consistent reporting could prompt the FDA to issue public warnings about the potential dangers of undergoing treatment with a DTC company without an in-person exam or radiographs.

Background and Recent Developments

In December 2021, the AAO’s Legal & Advocacy team helped secure a letter from 21 bipartisan Members of Congress to the Government Accountability Office (GAO), requesting an investigation into DTC advertising practices for prescription medical products. This led to a GAO study completed in September 2023, which highlighted the FDA and Federal Trade Commission’s oversight of DTC advertising, including prescription orthodontic devices.

The FDA has stated that one of the primary ways it determines areas to investigate is through complaints submitted by individuals. AAO members reporting to the MAUDE database can play a pivotal role in drawing attention to this issue.

Addressing Patient Safety

The AAO’s annual public policy survey indicates that 77% of its members have seen new patients requiring retreatment after using mail-order orthodontic services without an in-person exam. Addressing patient health and safety concerns related to DTC orthodontics remains a top priority for the AAO, and members’ participation in the MAUDE database effort is critical to advocating for necessary policy changes at both the state and federal levels.