FDA Investigates Lasik Eye Surgery Complaints
Tuesday, September 30, 2008
On April 25, 2008, there was a meeting of the FDA Ophthalmic Devices Advisory Panel involving representatives of the panel, the Joint LASIK Study Task Force, and members of the public. Members of the public spoke out about their negative experiences with LASIK and PRK and the depression and anxiety they have suffered since their operations.
For several years and all ads promising that laser vision surgery lets you toss your glasses is a stark reality. Not everyone's a good candidate and an unlucky few do suffer life-changing side effects that include lost vision, dry eye, night-vision problems.
How big are those risks? The FDA thinks about 5 percent of patients are dissatisfied, but can't provide more specifics and is pairing with eye surgeons for a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.
"Clearly there is a group who are not satisfied and do not get the kind of results they expect," FDA medical device chief Dr. Daniel Schultz said. The study should "help us predict who those patients might be before they have the procedure."
About 7.6 million Americans have undergone some form of laser vision correction, including Lasik. Other side effects, however, are harder to pin down. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study aims to answer.
Dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.
Even if the risks are low, that's little consolation to suffering patients.
The FDA has long known of those side effects, and thus for years has a Web site with warnings for Lasik patients and required that doctors give every potential patient a brochure outlining risks.
The agency will ask its outside advisers if its warning efforts go far enough.
Posted in Medical Devices • LASIK Eye Surgery