Congress approves legislation to ban decorative contact lenses from over-the-counter sale

Physicians have backed legislation to require decorative contact lenses to be dispensed by an eye care professional, even for plano prescriptions.

Issue: November 1, 2005

ByDaniele Cruz

The risk of vision-threatening infection is increased when individuals purchase cosmetic contact lenses over the counter instead of visiting an eye care professional, according to Thomas L. Steinemann, MD.

That is why Dr. Steinemann supports legislation that was passed in the 109^th Congress on October 26 and enrolled for the president’s signature. The Senate bill (S.172) basically states that all contact lenses, cosmetic or not, are medical devices regulated under the Federal Food, Drug, and Cosmetic Act, and must only be prescribed by eye care professionals.

“It doesn’t matter if the lenses are to correct vision or simply for fun. The risks posed to the eye are the same,” Dr. Steinmann said in a telephone interview with Ocular Surgery News. “Contact lenses should be sold only by eye care professionals.”

Currently, decorative lenses can be purchased at some beauty parlors, T-shirt shops, convenience stores and gas stations, Dr. Steinemann said.

“I believe strongly that lenses should only be dispensed with proper safeguards: a screening, fitting, wear and tear instructions and follow-up by an eye care professional,” he said.

A telling case series

Diffuse injection, chemosis and stromal ring infiltrate in a 26-year-old patient who purchased cat eye contact lenses at a flea market. Patient was treated for Acanthamoeba and underwent keratoplasty. His visual acuity was 20/200 after his presentation, and he failed to report for a follow-up exam.

Mucopurulent drainage, central stromal infiltrate, and hypopyon in a 39-year-old patient who purchased colored contact lenses from a hair salon. Bacterial cultures tested positive for Pseudomonas aeruginosa. Patient was admitted to the hospital for fortified antibiotic drops and discharged after 4 days. Best corrected visual acuity was 20/50 in the affected eye during a 2-month follow up.

Images: Reprinted with permission from Eye & Contact Lens (per H. Dwight Cavanagh)

In support of the need for such legislation, Dr. Steinemann and colleagues published a case series that illustrates the risks of unmonitored contact lens wear for cosmetic purposes.

Twelve patients were seen urgently for pain and redness after wearing cosmetic plano lenses they purchased from unlicensed providers, according to the report published by Dr. Steinemann and colleagues.

Four of the patients were hospitalized with blinding infections from agents including Staphylococcus, Pseudomonas and Acanthamoeba, and one patient required penetrating keratoplasty.

As a separate part of the same study, a survey of 159 patients whose mean age was 15.7 years was taken to determine the frequency of adolescents obtaining decorative lenses from unlicensed providers.

The survey showed that 37 of the patients used decorative contact lenses, and 117 reported that they had friends who used lenses for cosmetic purposes.

“Patients who acquire lenses from unauthorized providers are significantly less likely to be instructed on appropriate lens use and care,” Dr. Steinemann and colleagues stated in the paper.

Surveys show that the demand for decorative lenses is driven by teenage girls and young women seeking to alter their eye color, and at least 30% of sales are for plano lenses, according to the study authors.

Contact lens complications

For patients who desire decorative lenses but do not need refractive correction, a plano lens can be prescribed, but it should be fit by an eye care professional and followed like any other contact lens patient, Dr. Steinemann said.

“We continue to see people regularly in the emergency department with problems,” he said. “The most severe is bacterial keratitis but others include hypoxia of the cornea because the contact lenses are worn too long or are too tight, iritis, edema or corneal abrasions. This is why people should not undertake lenses without someone working with them.”

The case series outlined a dozen patients, ages 16 to 39 years, who presented with a variety of complications due to decorative contact lenses.

Some of the complaints included blurred vision, redness, pain, light sensitivity and burning, according to the case series.

The patients reported purchasing colored or decorative lenses, with designs such as cat eyes, from places including hair salons, delis, corner stores and flea markets. Several also admitted to borrowing lenses from friends or family members, a practice that carries a high risk of spreading infection, according to the authors.

Many of the patients said they slept in their lenses overnight or wore them for several weeks at a time, the authors reported.

“From these cases, it is clear that nonprescription decorative lenses pose the same physical and physiologic impact on the eye as prescription corrective lenses do and can result in the same risk to eye health,” the authors wrote.

Risk of infection

Long-term wear reported in this case series of 12 patients resulted in complications such as giant papillary conjunctivitis, corneal edema and peripheral infiltrates.

Corneal hypoxia increases the risk of infection, Dr. Steinemann said in the interview.

Cultures revealed that several patients in the case series had infections with agents such as Staphylococcus, Pseudomonas aeruginosa and other enteric organisms.

Four patients were admitted for hospitalization, while others were treated and sent home with medication.

“Risk taking and noncompliant behavior were also seen in these patients. Missed follow-up appointments and failure to follow treatment recommendations were frequently seen,” the authors wrote. “Lapses in proper contact lens care regimen are not surprising based on the study survey.”

Previous attempts for regulation

In the past, the Food and Drug Administration had issued consumer warnings regarding cosmetic contact lenses in the past, urging consumers to purchase contact lenses only from licensed eye care professionals.

The government agency has also stated that it does not have the authority to regulate the sale of decorative lenses because they are not intended as medical devices by the manufacturers, according to the authors.

“This perceived legal loophole was cause for much confusion and concern among the medical community, eye care professionals, vision advocacy groups and U.S. contact lens manufacturers,” the authors wrote.

In 2004, legislation to prohibit the sale of decorative lenses by unlicensed providers originally died in the Senate committee.

On July 29, the Senate had approved their version of the bill that was introduced in January and was awaiting an approval of a similar House of Representatives bill.

“Instead of voting on their own bill, the House voted to suspend the rules, and they passed by unanimous voice vote, S.172,” Dr. Steinemann said. “Our patients are all the better for it, because as time lagged on, more and more kids and young people are going to get harmed,” he said. “I’m thrilled they made the motion to quickly act on this and pass it, and it’s off to the president for his signature, so we are obviously pleased with the outcome.”

For Your Information:

Thomas L. Steinemann, MD, can be reached at MetroHealth System, 2500 MetroHealth Drive, Special Services Pavillion, Cleveland, OH 44109; 216-778-5830; fax: 216-778-7863; e-mail: tsteinemann@metrohealth.org; Web site: www.metrohealth.org.

Reference:
Steinemann TL, Fletcher M, et al. Over-the-counter decorative contact lenses: cosmetic or medical devices? A case series. Eye & Contact Lens. 2005;31(5):194-200.

Daniele Cruz is an OSN Staff Writer who covers all aspects of ophthalmology.