Medical Device Daily Washington Editor

GAITHERSBURG, Maryland – Last week's meeting of the FDA's Ophthalmic Devices Advisory Committee started as a forum for complaints about LASIK (laser-assisted in situ keratomileusis), but it was clear by the end of the session that with one exception, the panel was not even remotely inclined to recommend a moratorium on the procedure.

The dilemma for the panel was obvious: On the one hand, millions of patients benefit from LASIK, but a handful of patients apparently feel as though their lives have been profoundly damaged or destroyed by the procedure, so much so that a few have threatened suicide, and at least one has followed through.

The national media coverage was in evidence at last Friday's meeting as the hallway outside the hearing room was littered with cameras and spotlights, and the coverage promised to put a further damper on sales of the procedure, which by some accounts already are off due to lower consumer spending. LASIK is an elective procedure, and the cost, which can run to $2,000 per eye, is financed entirely by the patient.

One of the first witnesses, Dean Kantis, founder of the web site Life After Lasik, told the panelists "hundreds of victims have contacted me about their suicidal thoughts."

Kantis, who had the procedure, said, "[w]hen I began to speak out against LASIK years ago, I encountered a severe backlash" from the medical profession. He said the doctor who administered the procedure lied to him, and he accused other medical professionals of also lying to him.

"I feel like I've been raped," he said at one point during his five-minute testimony.

In reference to the limitation on pupil size of 8 mm, Kantis said, "[m]y pupils measured off the charts at 9 mm," but he was nonetheless described by the operating surgeon as "the ideal candidate."

"I feel every LASIK facility in this country should be responsible for reporting adverse events" for the cases of dry eye and visual distortion, and the number of adverse events "should be grounds for a class-action lawsuit." Several of the speakers also asked the panelists, who are practicing ophthalmologists, why they have not had LASIK procedures.

Glenn Heagly of the Vision Surgery Rehab Network (Rockford, Illinois) told panelists that they must "be prepared to hear the extreme sides of an argument," but added, "both sides are at times disingenuous in their arguments."

Of the relatively few patients who report problems – FDA has received 140 reports on the procedure over the past decade, which amounts to less than one complaint for every 10,000 patients – Heagly said that distortion of vision from an unsuccessful procedure imposes a unique set of problems for the patient. "Vision as perception is a more complex" psychological feature than industry often is willing to acknowledge, he said. "Clearly, a broader perspective is needed."

He discussed a quality-of-life (QOL) survey commissioned by FDA. There are three factors that affect outcomes, he said: "Expectations, expectations and expectations."

The effort included mailed survey forms to 1,800 patients, with the 553 responses winnowed down to 426. Heagly said that 96% of respondents said they make less use of glasses and/or contact lenses than expected. Almost all, or 99%, stated that their quality of life is as good as or better than expected, and 98% would recommend the procedure. The rate of complications was not high, "but we've identified a very important group," he said of the 7% who had problems. However, he said even most of them stated they would still do it again.

"The quality of life is higher than I would have expected," Heagly said, cautioning, however, that QOL is not the only thing FDA should look at in connection with the procedure.

Todd Krouner, a malpractice attorney in Chappaqua, New York, said "I am not here to criticize the safety of LASIK," but "to encourage FDA to do whatever it can to prevent the conversion of eyes to commodities."

"The surgery is not that complex, but the screening process can be," Krouner said, recommending that physicians spend more time to screen patients. He said that "the incidence of suicide in this population, while exceedingly rare, is not hard to fathom."

Lt. Col. Scott Barnes of the U.S. Army also took the podium in his capacity as the chief of the warfighter refractive surgery program. Barnes said special operations commanders are very particular. "If things don't work well, they complain," he said, describing military leaders as a difficult audience to satisfy. Upon hearing that he would testify Friday, they told him, "please don't let them take this away from us."

"If I lose my glasses when I jump out of a plane at 25,000 feet, I can't go to Pearle Vision" for replacements, he said. Any soldiers, sailors or marines who are taken captive are especially sensitive to the matter. "The first thing that's done is your glasses are taken away from you" because POWs with poor vision are a low risk for escape.

"The word from the guys who are out there standing in harm's way ... is please, do not take this away," Barnes said.

The panel discussion indicated little appetite for drastic action, with the exception of the panel's consumer representative, who had the procedure. Paula Cofer said the procedure might not allow full healing of the cornea, and she made the case that a "permanent[ly] weaker state of the cornea could present complications ... and I believe patients should be warned about" this potential problem. She also suggested "a device recall until a long-term study" can clear up some of the issues.

Her position drew little support, however, with one panelist describing Cofer's statement on flap vulnerability as a "categorical statement" that is unwarranted.

The acting panel chair, Jane Weiss, MD, professor of ophthalmology at Wayne State University (Detroit), said "it appears that the [label changes] that most of us agree on" include a notice with regard to subsequent surgery for cataracts that "there may be some issues with intraocular pressure."

"Patients with keratoconus should be more carefully evaluated," she said, "likewise those with dry-eye disease."

Weiss said "sometimes in my practice, my patient does not want to think that the adverse event could happen to me." She said the reason she wears glasses and does not get LASIK is that she can read without glasses, "and I don't want to lose that." She also said that she tells patients who just want LASIK for their golf game that they should give the idea more thought.

Weiss said it would be a good idea for ophthalmologists to underscore the fact that reading glasses will be needed when patients reach middle age or will be needed for patients who already are. She also said that many coming to the panel may have assumed it would be a referendum on LASIK, but described the meeting as "really a referendum on some surgeons who should be doing a better job" of screening their patients.