November 4, 2002
"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
Making a Fashion Statement Not Worth Losing Your Sight. Schaumburg,
IL - On the surface, it seems like a very cool, hip way to impress
your friends. Wearing crazy, colorful contact lenses in myriad patterns
and designs is quite a way to make a fashion statement. Movie stars
and rock stars wear them..."
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:
Who should decide whether non-prescription contact lenses are a medical
device or a fashion accessory? Would either classification make a
difference to the teens who are wearing them? What could be done to
make use of the products safer for those who are interested in trying
Please email me with any ideas or suggestions.
Note: Due to increasing amounts of SPAM sent to this account, please include "QOW" in the subject line when sending me email.
I look forward to reading
what you have to say.
Health Community Coordinator
Access Excellence @ the National Health Museum