More Warnings for LASIK Required, Says FDA

While LASIK eye surgery has been hailed by many as a revolutionary technique that goes a long way in correcting vision, there have also been some who have raised their voice against the after-effects of the surgical procedure, some of which can be life-altering, in a negative way.

The Ophthalmic Devices Panel of the U.S. Food and Drug Administration on Friday organized a discussion to talk about issues related to the life of patients after they have had LASIK eye surgery. At the end of the day, one thing was clear: there needed to be clearer warning messages from the FDA about the risks involved in the procedure. That was the recommendation that the panel issued after the discussion was over.

There is no taking away the benefits that LASIK offers people. The success of the procedure shows in the numbers. The procedure boasts a success rate of 95.4 percent globally. Even in the United States, 7.6 million people have undergone the procedure, and only 140 have complained about the after-effects.

The above data has been gathered by the LASIK Study Task Force, a task force set up in 2007. The various bodies that make up the task force include the FDA, the American Academy of Ophthalmology, the U.S. National Eye Institute, and the American Society of Cataract and Refractive Surgery.

The review discussion held on Friday was an attempt by the FDA to do a follow-up on the complaints from the people suffering from side effects, even though they are a minority.

Friday’s discussion looked at the adequacy of currently existing warnings about LASIK surgery. It looked at whether more alerts regarding side effects of the procedure, such as eye pain, double or blurred vision, dryness of the eyes, and other related problems was necessary.

Speaking about the discussion, Dr. Christopher Starr, the co-director of New York-Presbyterian Hospital/Weill Cornell Medical College’s Cornea, Cataract, and Refractive Surgery in New York, said, “This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery.”

Dr. Starr said, “I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes.”

The discussion on Friday also included some of the patients who had suffered side effects after the LASIK procedure. This is what David Shell of Washington, D.C., had to say, “Too many Americans have been harmed by this procedure, and it's about time this message was heard.” He had undergone the procedure in 1998, and has been constantly plagued by problems ever since.

There were others as well. Present at the meeting was Gerald, the father of Colin Dorrian, who finally committed suicide after continuously experiencing blurred vision and pain in the eye for six years after he got the procedure done. In his suicide note, Colin wrote, “I can't and won't continue facing this horror,” according to an Associated Press report. Colin had been told he was not a suitable candidate for the surgery, but went ahead with it anyway.

Though immensely popular, LASIK is not a procedure all can undergo. Patients with conditions such as a misshapen cornea, extremely thin cornea, large pupils, premature cataract formation, or other conditions like rheumatoid arthritis and lupus are advised not to undergo the procedure. Side effects include a glare or seeing a halo around light at night.