Lilly, O'Toole & Brown Blog

FDA Set to Review Lasik Warnings

The Food and Drug Administration (FDA) will be in hearings today to review the warnings given to patients before undergoing Lasik eye surgery.  While Lasik leaves many patients with good vision - some better than 20/20, the FDA has heard complaints from about 5% of patients about the procedures side effects and inability to correct their vision.

Friday's public hearing will begin the FDA's effort to determine whether the warnings given to Lasik patients are appropriate.  At the heart of the issue of informed consent is how much the patient knows about the procedure they are about to undergo.  A doctor is under an obligation to give his patient enough information about the risks, side effects, and alternatives to any operation so that the patient can make an informed decision about whether the procedure is worth it.  In many cases, the benefits of the procedure will outweigh the potential harms, but the FDA wants to ensure that all Lasik patients are aware of the side effects.

In the decade or so that Lasik procedures have been performed, about 7.6 million Americans have undergone the laser vision correction.  Lasik is a quick procedure in which doctors cut a flap in the cornea, aim a laser, and zap the cornea to reshape to enhance sight. 

Dr. Solomon, of the Medical University of South Carolina, estimates that fewer than 1% of patients have severe complications that lead to poor vision.

Labels: