Panel Wants Warnings for Lasik Users

GAITHERSBURG, MD. – After listening to hours of patient horror stories Friday, an advisory panel recommended that federal regulators strengthen safety warnings for vision-correcting laser eye surgery.

The panel recommended that laser manufacturers add several risk factors to their patient information and that the Food and Drug Administration improve its online consumer information about who is not a good candidate for the surgery.

But the recommendations fell short of patient requests. Some want the FDA to temporarily stop the procedures or include stronger precautions, such as warnings about slow and incomplete healing of the surgical incision and the risks of serious night driving problems.

“We need better screening, better information, in some cases better doctors,” said Jayne Weiss, head of laser eye surgery at Wayne State University in Detroit and the chairwoman of the FDA’s ophthalmic devices panel.

“But we don’t need to throw the baby out with the bath water,” Weiss said. “It’s not that the device is bad.”

The recommendations now go to the FDA, which usually adopts what its advisory panels suggest.

After a decade on the market, lasik, which stands for laser-assisted in-situ keratomileusis, is successful in a majority of cases.

But the FDA started taking a closer look at the surgery in 2006 after patient petitions for a moratorium and an inquiry by federal lawmakers. The efforts came years after patients began complaining about complications from the procedure, which first received regulatory approval in 1998.

The Friday public hearing was the first the FDA has scheduled to gather patients’ stories about how their quality of life has been affected by lasik.

Matthew Kotsovolos of Raleigh was one of several patients who asked the panel to stop lasik. He experienced debilitating complications after having the procedure at Duke Eye Center two years ago.

“My children almost lost their father,” Kotsovolos’ wife, Beth, told the panel, her voice cracking.

Matthew Kotsovolos welcomed the stronger warnings, but said he was disappointed that the panel didn’t discuss a moratorium.

“This is a procedure that is not medically necessary, yet it causes patients to consider taking their lives,” Kotsovolos said, calling the recommendations “a drop in the bucket.”

Two suicides in the past year have been linked to depression brought on by lasik complications.

“Lasik practitioners must take ownership of their failures as well as their successes,” Gerry Dorrian told the panel before reading the note that his son Colin left before he killed himself.

Laser eye surgeons who addressed the panel argued that severe complications are rare.

David Tanzer, a laser eye surgeon and the commander of the Navy’s medical corps, presented clinical trial data that showed that of the 112,500 soldiers who have had lasik, only one developed complications that required retirement. That’s 0.009 percent, Tanzer said.

Scott Barnes, a Fort Bragg surgeon who performs lasik, said getting rid of glasses and contacts can be a matter of life and death for military pilots, paratroopers, divers and Special Forces.

Troops deployed in Iraq, Afghanistan and North Korea are not allowed to wear contacts. Glasses can smudge or come off, and they are quickly destroyed when solders are captured by an enemy, he said.

“We’re not talking about a cosmetic issue,” Barnes said.

A thick binder that contained e-mail messages from many patients who said lasik improved their lives sat on a table outside the hearing room.

The panel heard from Courtney Henrichs, 20, a college student from Wisconsin who has been in a wheelchair since breaking her neck in a skiing accident six years ago.

Two years ago, a Los Angeles surgeon performed lasik on Henrichs for free because she wasn’t able to use contacts, clean her glasses or pick them up when they fell. “Lasik was a positive, life-changing experience,” Henrichs said.

The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that 2 percent to 3 percent of the 700,000 patients who undergo lasik every year experience complications that typically resolve themselves within three to six months.

Long-lasting problems

But FDA statistics indicate that complications, which include chronic pain, eye dryness and vision distortions, may be more frequent and longer lasting.

A published review of safety data for all FDA-approved ophthalmic lasers showed that six months after the surgery, 17.5 percent of patients reported halos in their vision, 19.3 percent had night-driving problems and 21 percent complained of eye dryness.

The review didn’t indicate how many had complications as severe as the patients who spoke before the panel. Some were legally blind. Others said they experience nausea or cannot sleep through the night because of eye pain.

“We’ve heard your testimonies, and we are taking them seriously,” said the FDA’s Weiss, who wears glasses and admitted she won’t undergo the surgery herself because she cannot tolerate any amount of risk.

But what became clear to her after listening, she said, was that the hearing was a “referendum on the performance of some surgeons who should be doing a better job.”

SOURCE: The News & Observer