Cosmetic Lenses - That's All They Are?
BY JOSEPH T. BARR, OD, MS, FAAO, EDITOR
The FDA is considering deregulating cosmetic plano contact lenses to a non-medical device, like eyeliner or mascara. The FDA's Chief Counsel, Daniel E. Troy, has suggested that such products cannot be classified as medical devices because they are not marketed to correct a vision problem. (See "FDA Considers Deregulating Plano Colored Lenses," News Spectrum, October 2002.) I wonder if the same will apply when we use them for prosthetic purposes. Certainly this could make reimbursement even more difficult. But the issue here, even if some will say it is economic, is public health, especially for teenagers.
On Friday, September 13, ABC aired a segment about cosmetic contact lenses on its "20/20" television program (http://abcnews.go.com/sections/living/dailynews/ color_contacts020913.html). The coverage failed to mention the FDA's intention to deregulate these lenses in the plano prescription. It did, however, highlight the risks that teenagers take when they buy and wear these lenses on the black market without a prescription or proper education. Dr. Thomas Steineman of the Cleveland Metro Health Medical Center warned about this dangerous trend and cited that at least 1,500 people wound up in emergency rooms last year from all types of contact lens problems. One reporter even demonstrated how some businesses are still selling these lenses and claiming that they weren't aware that the practice was illegal. Wrapping the segment up, Barbara Walters simply advised viewers to be careful and get a prescription if they want to change their eye color.
I thought ABC's "20/20" program did a pretty good job of getting most of the facts straight on the risk of misuse of cosmetic contact lenses. I have always thought that the real potential growth of this field would depend upon these lenses being sold at cosmetic counters in department stores, but I had hoped that it would never happen without patients ending up in the office of a licensed professional. The most frightening thing about the story was the teenagers who were interviewed and their blatant disregard for the risks of contact lens wear. You should assume that your teenage (and other ages) patients will not comply and go about educating from there. Whenever we get a chance to educate people, especially young people, about eye safety, it is wise to talk about the importance of proper contact lens care whether they need an Rx or not.
We expect word any minute on the FDA's downclassification of these lenses. The three Os, pharmacists and congressmen screamed for the FDA to maintain Rx classification for these medical devices. No matter what happens as we go forward, it is our responsibility to educate our patients and others about the proper use of contact lenses and to report untoward outcomes. Give this address to as many of your colleagues and patients as you can to maximize this education effort: www.fda.gov/cdrh/consumer/buycontactqa.html.