A victory for patient safety: decorative contact lens wearers to be protected by new law

As many teenage and adult ‘trick or treaters’ don decorative contact lenses as part of their costumes, Congress passed legislation that may help keep their eyes healthy.

WASHINGTON – The American Academy of Ophthalmology celebrated an important victory for patient safety Wednesday with the House of Representatives’ passage of legislation to regulate cosmetic plano contact lenses. The bill, passed earlier this summer by the Senate, amends the “Federal Food, Drug and Cosmetic Act” to say that all contact lenses are considered medical devices, regardless of their use, including those that are mainly used in costumes or for decorative or cosmetic reasons. Primary House sponsors are Reps. John Boozman, R-Ark., and Henry Waxman, D-Calif. Senate sponsors are Sens. Mike DeWine, R-Ohio, and Edward Kennedy, D-Mass.

Prompted by reports of teenagers developing serious eye problems after using nonprescription cosmetic lenses from unauthorized vendors, the Academy initiated efforts three years ago to regulate plano contact lenses. Academy members Gail M. Royal, MD, of Myrtle Beach, S.C., and Thomas L. Steinemann, MD, an associate professor of ophthalmology at Case Western Reserve University in Cleveland, provided clinical information to support these efforts.

Dr. Royal first reported 12 emergency cases seen in Myrtle Beach over spring break 2002 with significant eye problems related to nonprescription contacts, bringing attention to this important, but often overlooked, safety issue. Dr. Steinemann also had treated similar cases in Cleveland, including one youth who suffered a blinding corneal infection following her use of decorative lenses. She was hospitalized and eventually underwent corneal transplant surgery. Appalled at the number of new cases with similar injuries, Dr. Steinemann then testified in 2002 before Congress and the FDA on this emerging problem.

With support from eye care professional groups and American contact lens manufacturers, the issue was quickly brought to the attention of legislators in the form of a bill and nearly passed Congress in 2004.

“No matter what their purpose, all contact lenses need the same regulations to help provide the same protection for all wearers," Dr. Steinemann said. He was the principal investigator of a study released in September that provided further evidence of the dangers caused by improperly dispensed decorative plano contact lenses.

A constituent of Sen. DeWine, Dr. Steinemann presented in his study 12 new case studies involving severe eye injuries caused by misuse of plano decorative contact lenses. All the patients obtained the lenses from vendors without a prescription, proper fitting or proper instructions on the care and use of the lenses. The study included findings from a survey of 159 patients, 23 percent of whom used decorative contact lenses. Of the plano lens wearers, 51 percent responded that they obtained the lenses from vendors without a prescription. He also authored a similar study in 2003. Both studies reported cases of blinding infections and several cases that required corneal transplants. “

It doesn't matter why you wear contact lenses – to correct your vision or just for fun – the risks posed are the same when there is no professional involvement. That's why all lenses must be properly dispensed and fit," Dr. Royal said. The new law will mandate that all contact lenses sold in the United States must be fit and dispensed by an eye care professional. “When contacts are purchased in this fashion – not from an eye care provider – chances are you are not going to get any education on how to wear or care for the lens. This lack of education contributes to the health risks,” Dr. Steinemann added.

“We’re very pleased that this initiative enjoyed support from both the Senate and the House and both sides of the aisle,” said Catherine G. Cohen, Academy vice president for governmental affairs. “It was especially gratifying to see the contact lens industry and all eye health care providers come together and support this very important issue. We want to particularly thank Sen. DeWine and Senate Health, Education, Labor and Pensions Committee Chairman Michael Enzi for their leadership on this issue. We are excited that it will soon be on the president’s desk for his signature.”