On Dec. 18, the FDA sent out another round of warning letters to LASIK surgeons in California, Indiana, Florida, Texas and Georgia about their ads being misleading and not having sufficient information about potential risks and associated side effects involving laser vision correction.
The FDA states that the most common risks include:
- dry eye syndrome, which can be severe;
- the possible need for glasses or contact lenses after surgery;
- visual symptoms including halos, glare, starbursts and double vision, which can be debilitating; and
- loss of vision.
See the FDA’s official news release here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332713.htm.
We all know not to use misleading language such as “Throw away your glasses” or “See better than 20/20,” but that’s not enough. As an advertising agency, I am responsible for my clients’ marketing. Their marketing may consist of online, radio, TV, print or a combination of these. I have had issues with some clients not wanting to waste precious airtime discussing risks and side effects, but several years ago, we made disclaimers mandatory.
With the recent crackdown, my agency is taking additional steps to stay compliant with the FDA. I believe the best way to stay safe is to create a risk section on the LASIK section of your website, such as a separate section in the LASIK dropdown, and then post the FDA’s risk page verbatim. Because the FDA’s information is public domain, this is perfectly legal as well as ethical. You can find that page by clicking here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061354.htm.
For radio, TV and print, it’s difficult to list all appropriate risks and side effects, so I recommend adding the following:
“LASIK does have some risks and associated side effects such as dry eye and the continued need for glasses. For a complete list, see our website.”
The disclaimer above is not long, but it should be all you need to stay compliant with the FDA.
The FDA has warned that it may take additional regulatory action, such as seizure, injunction and civil money penalties, against providers who do not correct their advertising and promotion to address concerns raised by the FDA. This blog should help you keep from getting one of those friendly compliance letters.