Lasik alums talking to FDA

Concerns about the safety of, satisfaction with eye surgery has agency's attention today

Nine years after it approved vision-correcting laser eye surgery, the Food and Drug Administration is coming under increasing pressure to step up oversight of the procedure.

Lasik -- which stands for laser-assisted in-situ keratomileusis -- is successful in the majority of cases. But today, several patients will ask FDA regulators at a Gaithersburg, Md., public hearing to require stronger warnings about the surgery's risks, better tracking of complications and stronger monitoring of lasik surgeons' advertisements to detect false claims.

For years, patients dealing with health problems after having lasik surgery have asked the FDA for stricter regulations. The agency started taking a closer look at the complaints after federal lawmakers inquired about regulatory oversight of the lasik industry in December 2005.

Today's hearing is the first the FDA has scheduled to hear how patients' quality of life has been affected by lasik surgery.

One patient, Matthew Kotsovolos of Raleigh, wants the agency to temporarily stop the surgeries until more safety data are available. He experienced debilitating complications after having lasik at Duke Eye Center two years ago. He has started a patient support group and will be among about two dozen speakers at the hearing.

"I hope they'll do the right thing," Kotsovolos said. "My hope is that they not ignore what people who stood up said and move on to business as usual."

The FDA panel could recommend changing the regulatory guidelines for vision-correcting lasers, including monitoring of results and consumer information. But the panel could listen to the speakers -- about half are patients or patient advocates, and at least six are laser eye surgeons -- and do nothing.

But the possibility of FDA action comes as the economic slowdown is expected to hit companies that sell laser equipment or operate lasik centers. Research firm Market Scope projects a 17 percent decline in the number of lasik procedures this year as consumers cut back on expenses.

Guidelines for surgery

Also in the lineup of speakers is Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, which regulates lasik equipment. Eydelman has acknowledged that clinical data about complications from lasik and their effect on patients' quality of life is incomplete, at best.

To fill the void, Eydelman aims to start a national study next year. Practicing eye surgeons are working with the FDA to establish guidelines for the study. At least two will speak at the hearing.

Eye surgeons who use lasers are willing to learn from patients' experiences, Richard Lindstrom, co-chairman of the group of surgeons collaborating with the FDA, wrote in an e-mail message. We "are listening, we hear them, we care, and we are responding in a tangible and constructive fashion," he wrote.

Lindstrom is also president of of the American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery.

The surgeons recently reviewed 19 studies measuring patient satisfaction. After the results of the review came out last month, Kerry Solomon of the Medical University of South Carolina's Storm Eye Institute said he planned to report first results of the literature review at the public hearing.

Of about 2,000 patients who participated in the 19 studies, an average 4.8 percent were not satisfied with the outcome of their laser eye surgery. In the study that showed the lowest satisfaction rate, more than 12 percent of patients were unhappy. The study showing the highest satisfaction rate had no dissatisfied patients.