How the FDA is Going to Blind Your Child
Wednesday, December 4, 2002 at 6:25 AM ET | Written by: L. E. Leguire Ph.D., MBA | Ohio Lions Eye Research Foundation
On October 21, 2002 the Food and Drug Administration (FDA) issued a warning to consumers about the dangers of decorative contact lenses used without a prescription or professional fitting (P02-43). Well documented cases exist showing the dangers of decorative contact lenses, including corneal infection and scarring, conjunctivitis, corneal abrasions, loss of visual acuity and even blindness. OhioLionsEyeResearch.com issued an early warning last year against the use of such contact lenses.
Decorative contact lenses are the contact lenses that change eye color or/and include designs like “cat-eyes” or even sport team logos. Since an exam and a prescription for an eye doctor are not required for such decorative contact lenses, they can be purchased from regular retail outlets like video stores and game arcades. They are most often used by teenagers, who swap lenses much like they swap music CDs. One major problem and concern is that when teenagers swap decorative contact lenses they’re also swapping eye disease and infections, possibly even AIDS.
The dangers of such decorative contact lenses justified earlier warnings from the FDA as well as warnings from almost every national eye health organization including Prevent Blindness America, the American Academy of Ophthalmology and American Optometric Association. So it can as a great and unexpected surprise on April 4, 2003 when a notice appeared in the Federal Register (Docket No. 03D-0118) that the FDA reclassified decorative contact lenses as “cosmetic”, thus removing them from most FDA regulations. With this flawed FDA decision, cheap, imported contact lenses are about to flood the US market and lead to thousands of cases of eye disease, vision loss and blindness!
Based on the 2001 US census report, there are approximately 80,000,000 children and young adults between the ages of 10 and 29 years in the USA. If we assume that just 10% of these children and young adults (i.e., 8,000,000) try such “cosmetic” contact lenses and only 5% have a problem, this means that 40,000 children and young adults may suffer eye infections, corneal abrasions and possible permanent vision loss because of the flawed FDA ruling.
One has to wonder if politics came to play in having the FDA issue such an ill conceived notice? Did a congressperson, after generous donations from industry, pressure the FDA to reclassify decorative contact lenses as cosmetic? Is money more important than our children’s eyes? One thing is clear however, the FDA has failed to safeguard the public from dangerous cosmetic contact lenses.
However, all is not lost. If your child has a serious eye problem as a result of such cosmetic contact lenses, the FDA would like to hear from you. Contact MedWatch, the FDA’s voluntary reporting program, by calling 1-800-332-1088. if your child suffers loss of sight because of such lenses. But one has to wonder… is anybody listening?
Addendum:
The American Academy of Ophthalmology has issued a warning about cosmetic contact lenses.
“Report Cites Risks Associated With Over-the-Counter Cosmetic Contact Lenses
SAN FRANCISCO—One patient needed a corneal transplant and another is legally blind after wearing over-the-counter cosmetic contact lenses. These are two of the patients discussed in a report published in the October issue of Eye & Contact Lens, the clinical journal of the Contact Lens Association of Ophthalmologists.
The over-the-counter contact lenses, which are illegal in the United Stated, are not worn to correct refractive errors. Instead, they are tinted to change the appearance of eye color or have various shapes and designs, ranging from animal eyes to sports team logos. Problems associated with illegally sold contact lenses were first reported by the American Academy of Ophthalmology, the Eye M.D. Association, in July 2002. The Academy received reports from a Myrtle Beach, S.C. ophthalmologist who treated several patients for eye problems after they wore contact lenses purchased from local beachwear stores.
All decorative contact lens are not illegal, however, all contact lenses, whether corrective or decorative, need to be fitted and monitored by an eye care professional. Editor-in-chief of Eye & Contact Lens, H. Dwight Cavanagh, MD, Ph.D., F.A.C.S., said, “This report underscores the need to continue to view contact lenses as medical devices. They need to be fitted and prescribed by licensed health care professionals. As seen in this report, the unregulated sale of contact lenses represents a grave danger to the public.”
“Many people mistakenly think decorative contact lenses are just like sunglasses. If you’re not wearing the lenses to correct refractive errors, you don’t need a prescription. This is a dangerous misconception,” said one of the report’s authors, Thomas L. Steinemann, MD, of the MetroHealth Medical Center Eye Clinic in Cleveland and associate professor of ophthalmology at Case Western Reserve University’s Department of Ophthalmology. “People who wear lenses purchased from unlicensed vendors have been given no instructions and often practice risky behavior. They don’t clean or disinfect the lenses. They sleep in them. They swim in them. The even swap them with their friends.”
Six patients, from 14 to 32 years of age, are discussed in the observational case report. The patients, five females and one male, experienced vision-threatening problems after wearing contact lenses purchased from unlicensed vendors, including gas stations, beauty salons, video stores, corner stores and flea markets. They did not receive any instructions on how to properly care for or wear the contact lenses. And – all of them were sold individual contact lenses without a prescription, an examination or a fitting by an eye care professional such as an ophthalmologist. According to the case report:
- One 14-year-old patient nearly lost her eye after contracting a serious bacterial infection. She was hospitalized for four days and was left with a corneal scar that affected her vision. The patient later required a corneal transplant, and will need regular observation and treatment for the rest of her life.
- After falling asleep with her contact lenses still on, a 19-year-old woman awoke to burning and light sensitivity in both eyes. She said she had been buying the contact lenses from open-boxed sets without a prescription for the past five years and had worn contact lenses continuously for up to five months on previous occasions.
- Another 19- year-old-woman, who complained of light sensitivity and burning in her right eye, said she purchased her over-the-counter contact lenses from gas stations, hair salons and corner stores for years, along with her friends, teenage sisters and mother.
- A 30-year-old woman continued to wear her contact lenses, despite experiencing worsening symptoms over a two-week period that included right eye pain, tearing, light sensitivity and redness. In an attempt to relieve the redness and lubricate the lenses she used over-the-counter eye drops before finally seeking medical treatment.
- A 32-year-old man scratched his cornea while trying to remove costume contact lenses. He had developed painful inflammation from a lens that did not fit. He had purchased the contact lenses for Halloween a week earlier at a flea market. This required multiple treatments over several weeks.
- A 24-year-old woman became legally blind from corneal scarring in one eye, after she developed conjunctivitis (pink eye) and was treated for herpes simplex and bacterial keratitis. She reported wearing disposable contact lenses for approximately six months, often sleeping in them.
The report says the demand for decorative contact lenses continues to increase, particularly among teenage girls and young women, with consumers spending approximately $180 million on them so far. Colored contact lenses are one of the fastest growing segments in the contact lens market. Because of the growing market, the report states: “American young people remain at risk as a major target of the unauthorized sale of decorative contact lenses.”
Problems that may result from this risky behavior include corneal abrasions, epithelial keratitis, infectious ulcers and the blinding Acanthamoeba organism. Although no cases have been documented, the report also suggests HIV transmission is a potential risk among those who exchange their contact lenses with others.”
NEED WE SAY MORE? !!!!
