Use FDA MedWatch to report poor clinical outcomes from DIY plastic teeth aligners
October 29, 2019
The ADA reminds dentists of the Food and Drug Administration’s MedWatch voluntary reporting form
to report poor clinical outcomes associated with the use of medical devices, including direct-to-consumer plastic teeth aligners offered by several companies.
This resource provides important data to the FDA concerning the public health and safety of medical devices under the agency’s jurisdiction.
The period for submitting public comment to the citizen petition
the ADA filed with the FDA closed Oct. 22. In the petition, the ADA argued that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction for plastic aligners, which are an FDA Class II medical device. But dentists and consumers can still report bad clinical outcomes using the FDA’s MedWatch voluntary reporting form anytime.
“Although the comment period for the FDA citizen petition has ended, FDA MedWatch provides an ongoing platform for dentists to speak up when they encounter the negative outcomes connected to mail-order aligners and other devices,” ADA President Chad P. Gehani said. “Patients can also report any adverse experiences on MedWatch. Collectively, we can all play a part in advocating for safety and parity in dental treatment.”
Dr. Gehani also stated, “Innovation in dentistry is always welcome, but innovation should never shirk the standard of care. When patient health and safety are at risk, the ADA has a responsibility to advocate on behalf of patients. That’s why we shared our concerns about mail-order aligners with the regulatory agencies charged with protecting the public.”
In lieu of having dentists review patient dental records or perform any sort of patient exam (whether using teledentistry or otherwise) before prescribing orthodontic treatment, SmileDirectClub instead requires customers to self-report their dental condition. As the ADA explains in its citizen petition, customer self-reporting does not meet the applicable standard of care because it does not satisfy a dentist’s requisite professional due diligence.
For dentists who ultimately see patients who have had a bad clinical outcome from trying direct-to-consumer dentistry, it’s important to view their previous charts to provide the most complete care. As in most other situations involving patients who were previously treated by another provider, dentists who have treated patients with adverse outcomes from plastic teeth aligners should ask their patients to request their records from the direct-to-consumer company.
“The ADA would like to remind dentists who treat patients subsequent to direct-to-consumer aligners, that obtaining the patient’s treatment records is important for continuity of care and inclusion in the general dental treatment record,” said ADA President-elect Daniel Klemmedson. “Patients have a legal right to obtain all clinical records from treating dentists or direct-to-consumer companies.”
In addition to its citizen petition, on June 27, the ADA sent a complaint letter
to the Federal Trade Commission’s Bureau of Consumer Protection, raising concerns about what the ADA believes are SmileDirectClub’s deceptive advertising and marketing practices. The FTC also offers consumers an online form to report complaints about unfair and deceptive business practices on its website.
Dentists can visit https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
and click on “Health Professional” to start their report. They will have to fill out a questionnaire on the patient’s basic information — age, weight, race, etc. — then provide information about the problem, including a description, what the outcome was, any lab results and whether there’s a product available to evaluate. Dentists will also be asked a series of questions about the product and its manufacturer. Not all questions are required to be answered.
Dentists have to include their name but their address is optional and can check a box if they do not want their identity disclosed to the manufacturer in question.