Failure™ Magazine

Eye on LASIK

The laser vision correction industry is under fire for its failure to acknowledge potential risks.

Written by Abby Ellin   Filed under Life, Science & Technology

FDA spokeswoman Mary Long rejects the notion that the agency could have done more. “The FDA reviewed the safety and effectiveness information included in the manufacturer applications for approval,” she wrote in an e-mail. “It found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health.”

Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to LASIK ambulatory facilities last May reminding them that all risks must be mentioned in every LASIK advertisement—whether online, in print, on radio or television.
“As part of our ongoing review of LASIK and its impact on public health, we continue to look at various aspects of LASIK advertising and how we can better improve public health,” adds Long.

But an informal online search reveals dozens of doctors’ Web sites that do not mention risks or side effects.

As for the new study, Pilot is not impressed. “The FDA is beginning to do what should have been done 10 years ago,” he says. “The bottom line is that thousands of human eyes have been irreversibly damaged unnecessarily.”

Dr. Solomon disagrees, maintaining that the FDA clinical trials were rigorous and well-performed. “I think the FDA did an outstanding job at evaluating the technology,” he asserts. “And the technology and procedure have only gotten better since approval.”

As for me, if I had to do it all over again, I wouldn’t. But, of course, hindsight is 20-20.

Abby Ellin is the author of “Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can’t) Help.”

This article originally appeared in Salon.com.

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