April 25, 2008 - FDA to Hear Lasik Complaints

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April 25, 2008 – Aggrieved patients who underwent elective Lasik surgery testified about experiencing negative side effects from the procedure in front of a Food and Drug Administration (FDA) panel today.

Although the majority of Lasik recipients have no complaints about the procedure, about 5% of the 7.6 million Lasik patients suffered side effects, such as poor vision, chronic dry eye, glare, or night vision problems.

Since the procedure was approved in 1997, the FDA has not studied the range of negative side effects experienced by Lasik recipients. The agency has scheduled this public hearing to help determine whether current warnings about the procedure’s risks are sufficient for prospective Lasik patients to make an informed decision about whether or not to elect to have the procedure.

During the procedure, doctors cut a flap in the cornea and use a laser to reshape it for improved vision. The majority of Lasik patients report improved vision and overall satisfaction with the procedure.

Not everyone who wears glasses is a prime candidate for Lasik surgery. In fact, one in four people who ask their doctors about the procedure are advised against it because their corneas are too thin or their pupils are too large for a successful surgery.

Dry eye is one of the most commonly reported negative side effects of the Lasik procedure. An estimated 31% of patients have some degree of dry eye before surgery and about 5% worsen afterward. Dry eye can be so severe that patients suffer intense pain and require surgery to retain what little moisture their eyes produce after Lasik.

The risks of negative side effects are low, but that offers little consolation to suffering patients. The FDA study is the first step in determining the extent of Lasik side effects to facilitate more accurate warning of the risks of the procedure before patients undergo surgery.

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