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The leader in vision correction.
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Consumers learn risks behind rosy LASIK ads

By Julia Malone
c.2001 Cox News Service

Washington - Turn on the radio or open the newspaper to the full-page advertisements, and the message is hard to miss: After a "15-minute painless" eye procedure called LASIK, you may be able to toss out your glasses.

Beyond the upbeat media blitz, however, some consumers are complaining of a knowledge gap surrounding the relatively new and essentially unregulated procedure, which uses lasers to reshape the eye.

"I am not sorry I had it done," says one California patient, who complained of having dry eyes afterwards. "I just wish I had been better informed prior to surgery."

"Why are all of the possible complications of LASIK not disclosed by the doctors?" asks another.

The comments are among more than 1,000 e-mails sent in the two months since an Internet site was launched last December by the U.S. Food and Drug Administration (FDA).

The site is aimed at offering a sober picture of the pros and cons amid the sometimes inflated promises of the highly competitive and fast-growing laser eye surgery field.

LASIK has been approved for use in the United States since 1996, after extensive use in Europe and after U.S. testing indicated a 92 percent success rate. This year, more than 1 million people are expected to undergo the operation, as highly competitive eye surgery chains have grown up around the country.

In the procedure, whose initials stand for laser in-situ keratomileusis, the surgeon cuts into the surface cornea, lifts back a flap and uses a laser beam to reshape the tissue.

In a price war early this year, fees dropped as low as $499 per eye in some areas. More typical fees are $750 to $2,000 or more, with the cost rarely covered by health insurance.

"Most patients are very pleased with the results," the FDA Web site states. However, the agency cautions that some patients are "undertreated or overtreated" and still need glasses, that the results may be only temporary, and that, in rare cases, serious complications can threaten eyesight.

Federal authorities, having approved the procedure, have little say over the surgery or the surgeons who perform it, and the FDA's role is confined to monitoring problems with the laser equipment.

"The clinical studies do show there are certain side effects, certain risks, " said Sharon Snider, an FDA spokeswoman. She said manufacturers are required to include the possible side effects in labels.

"That's all available to anyone who's considering the procedure," she said. So far, she said, the agency has detected no unexpected glitches with the technology.

The e-mail messages are not posted on the FDA's LASIK web site, although officials examine the messages for new trends in the field. A sampling provided by the FDA with names deleted offers evidence that some consumers are not fully prepared for the possible down side of the procedure.

"Very unhappy with results," one e-mailed complaint states of an operation performed two years ago. "I was never properly and thoroughly informed of the risks."

Another says that "LASIK surgeons are not adequately disclosing or discussing common post-surgical symptoms and conditions like persistent dry eye."

Dr. Keith Thompson, medical director at the Emory Vision Correction Center, a group associated with Emory University in Atlanta that specializes in treating LASIK problem cases from around the country, said the FDA Web site is a response to "the fact that there are people who are overpromoting this."

Even so, he said that he is now finding patients to be better informed. "We've been very impressed with the level of education of the patients" about the procedure, he said. The information usually comes not from a doctor's office, he said, but through searching the Internet and gathering information from friends and family members who have had LASIK.

The key to good results is picking the right doctor, Thompson said. "If you have this done by a very experienced surgeon in a very respectable institution, you're risk is very low. We see a lot of problems from the discount places."

Among those who are dissatisfied, hundreds have found a voice in a New York-based consumer group, Surgical Eyes, whose Internet site includes an electronic bulletin board for posting experiences with the procedure.

"I've gotten e-mails from 1,300 disasters," said the group's founder, Ron Link, a former firefighter who was left with impaired vision after the surgery.

His Internet site has attracted nationwide news media attention for its presentation of the dark side of LASIK. The site has recorded more than 1.5 million visits.

Link said in an interview that he believes the public is beginning to get the facts behind the hype. "There is a shift toward a more balanced perception," he said. "For all the positive spin that's out there and the use of celebrities in advertising, there is an underbelly of jobs lost, marriages broken up and lives debilitated."

Link credits the FDA for providing "even-handed," if tardy, information on its new Web site. "It's better late than never," he said.

On the Internet:
U.S. Food and Drug Administration, www.fda.gov/cdrh/lasik
Consumer group Surgical Eyes, www.surgicaleyes.com

Julia Malone's e-mail address is juliam@coxnews.com

 

* The practice changed its name to InView in 2004. Emory trained surgeons Keith Thompson, MD and George Waring, MD, founded the practice in 1994.

 

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