FDA takes closer look at complaints from Lasik customers with medical study
Lasiks eye surgery is big business in the medical community. The question becomes is it for everyone? Are doctors opting for lasiks when other options should be pursued instead? Lauran Neergaaard, a medical writer points out:
About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea - the clear covering of the eye- aim a laser underneath it and zap to reshape the cornea for sharper sight.
The vast majority of patients, 95 percent, see better and are happy they had Lasik, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik’s safety for the American Society of Cataract and Refractive Surgery.
But doctors advise against Lasik for one in four people who seek the surgery. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.
Solomon estimates that fewer than 1 percent of patients have severe complications that leave poor vision.
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Why is the FDA doing a study of Lasik patient satisfaction and health?
Lauran continues:
Make no mistake: Most Lasik recipients do walk away with crisper vision, some better than 20/20.
But not everyone’s a good candidate, and an unlucky few do suffer life-changing side effects: poor vision, painful dry eyes, glare or problems seeing at night.
How big are the risks? The Food and Drug Administration thinks about 5 percent of patients are dissatisfied with Lasik. How many struggle daily with side effects? How many are just unhappy that they couldn’t completely ditch their glasses? The range of effects on patients’ quality of life is a big unknown.
So with a public hearing Friday, the FDA is beginning a new effort to determine if warnings about Lasik’s risks are appropriate. The agency also is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to better understand who has bad outcomes and exactly what their complaints are.
Its great that the FDA is finally waking up to this issue after a decade of lasik surgery so that the next generation of lasiks patients will be happier, safer, and ultimately healthier.
May 16th, 2008 at 11:12 am
Lasik risks are not new, but the US Food & Drug Administration (FDA) is taking another look at a patient’s quality of life after Lasik.
I work for a nonprofit Lasik patient advocacy. We do not provide Lasik, just Lasik information and we certify Lasik doctor’s patient outcomes.
On April 25th the FDA conducted a hearing about Lasik and how changes in patient information may be beneficial. On behalf of our organization I presented the preliminary results from the USAEyes Competence Opinion Relative to Expectations (CORE) patient survey. The USAEyes CORE patient survey asks patients many questions, all based around whether or not the patient’s results were what was expected. By and large, Lasik patients get what they expect, but not always.
• 99% of responding Lasik patients report quality of life as expected, better, or much better after Lasik.
• 98% report no complications or issues are seldom problematic.
• 97% would have surgery again, knowing what they know now.
• 2% report complications that are frequently or always problematic; however 22% of this 2% would have surgery again.
Newer techniques and technology have improved Lasik results since it first appeared about a decade ago, but all surgery has risks even if those risks are relatively rare.
You can review the entire presentation by visiting http://www.FDA.gov and searching “USAEyes CORE Lasik Survey”
Glenn Hagele
Executive Director
USAEyes.org
I am not a doctor