November 4, 2002 Hello! "Dr. Thomas E. Steinemann,
a Cleveland ophthalmologist, has seen his fair share of patients with
tragic eye disorders. But few have been sadder, he said, than the
teenager whose vision was permanently damaged last year by a pair
of contact lenses she wore solely to change the color of her eyes....
[She] wore her green lenses just once, to a party one night in September
2001. When she saw Dr. Steinemann the next morning, her eyes were
red and oozing pus from a bacterial infection. Dr. Steinemann put
her in the hospital for 'intensive antibiotic therapy.' She spent
four days in intensive care. The girl suffered permanent vision damage, Dr. Steinemann said, when scar tissue developed on her cornea." Are non-prescription contact lenses a medical device or a fashion accessory?
"COOL COLORFUL COSMETIC LENSES
POSE A HEALTH RISK Are non-prescription contact lenses a medical device or a fashion accessory? "Last week, the FDA
warned consumers about costume or 'decorative' contact lenses sold
illegally, without prescriptions, often from retail outlets such as
beauty salons or beachwear stores. The FDA stated, 'These products
present risks of blindness and other eye injury if distributed without
the involvement of a qualified eye care professional.' Eye M.D.s have
reported treating patients, mostly teenagers, for problems associated
with wearing costume contact lenses obtained without prescriptions
from vendors who are not licensed to dispense contact lenses." Are non-prescription contact lenses a medical device or a fashion accessory? These lenses are readily available, and the argument rages on between companies that manufacture them and the doctors who see the consequences when the contact lenses are not fit properly by an eye care professional. Companies claim that these lenses do not correct vision, and thus should be considered cosmetics. Doctors argue that these medical devices (whether prescription or not) have the potential to change and/or harm the vision of the person using the product. According to the FDA, even cosmetics need to prove that they will not harm the user. The FDA, ophthalmologists, teens, pre-teens, parents, and those who make and sell the products are all involved. Everyone sees a different side of the story. Would teens and parents view the issue differently if they had more information? Are ophthalmologists over-reacting because they only see the cases where there have been problems? Are the companies who market the product giving the consumers enough information to make an educated decision before choosing whether or not to use the product? Should ophthalmologists be using the press to inform parents of the risks so that they can talk with their teens about safe use and fitting of contact lenses? Questions of the Week: Please email me with any ideas or suggestions. I look forward to reading what you have to say. Cindy |
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