FDA Advisers Find LASIK Safe But Oversold

By Peggy Peck
26 april 2008 -- Laser-assisted in situ keratomileusis (LASIK) is safe and well accepted, an FDA advisory panel concluded today.
Although overzealous marketing may lead to inappropriate use of LASIK, such questionable clinical decision-making does not detract from the device's overall safety, found the agency's Ophthalmic Devices Advisory Committee after a day of hearings.
Jayne Weiss, M.D., of the Kresge Eye Institute in Detroit, who chairs the panel, said that based on available information "the vast majority of patients with LASIK do very well and are very happy and see very well."
Dr. Weiss said that one common theme during public testimony that occupied most of the morning session was "aggressive marketing. The other was LASIK as a commodity. The FDA does not regulate marketing, but I agreed that it is a problem."
Another issue, she said, was patient selection. The testimony suggested that there was "inadequate informed consent and the fact that some patients were poor candidates. That comes under malpractice and that is something that the field should monitor."
She said the day's hearing was "really a referendum on the performance of LASIK by some surgeons who should be doing a better job."
Nonetheless, Dr. Weiss said it was clear from testimony that the FDA's "LASIK postmarketing assessment surveys don't adequately address the severity of adverse effects."
The panel cited three major concerns -- the possibility of cataracts, endothelial cell loss, and induced astigmatism. It recommended that these concerns be reflected in the LASIK label.
The panel said that intraoperative complications such as flap complications should be differentiated from postoperative complications in the list of adverse events that must be reported to the FDA. Moreover, adverse events should include halos and glares as well as significant loss of visual acuity.
The panel suggested labeling changes to more fully state what and how problems can occur, including extreme blurriness, haze, glare, halos, and starbursts. It also suggested that the label take note of possible depression or psychological problems.
The panel agreed that LASIK labeling should include additional information or guidance about postoperative intraocular pressure, additional guidance for implant measurement for post LASIK cataract surgery, and stronger cautionary language concerning risks in patients with a strong history of keracatonis. The panel also recommended adding language about risks associated with hormone replacement therapy or a history of depression.
The panel also recommended that the FDA's LASIK Web site should include photographic illustrations of visual disability, detailed statistics as to risk of side-effects or complications, and an expanded explanation of the benefits of LASIK, i.e. that improving distance vision will mean the need for reading glasses.
The advisory panel set aside the entire morning for public testimony, much of it dominated by patients and family members of patients who claimed that LASIK surgery left them disabled, depressed, and in some cases suicidal.
A father told the story of his son, a law student who had LASIK because he had developed dry eye as a result of contact lens use. Before LASIK, the son was successful, outgoing, with no history of mental health issues, his father said.
Before surgery, the son was told that postoperative glare and halos would be no worse than with contacts. According to the father, after surgery the son had large starbursts and halos at night, triple overlapping images, and ghosting off white objects in low light, as well as painful dry eye.
The father read a suicide letter in which his son wrote that he fell into a suicidal depression because of his eye problems.
But the panel also heard testimony from a number of patients and surgeons who praised the surgery. An Army ophthalmologist testified that members of the Army's special forces units were especially pleased with LASIK results.