LASIK industry braces for U.S. FDA meeting

The laser eye surgery industry is steeling itself ahead of a Friday meeting expected to draw complaints from patients with blurred vision and other complications of a popular vision procedure.

Millions of patients have hailed the LASIK procedure for freeing them from glasses or contact lenses, but others have have become a vocal bloc railing against the surgery, citing everything from dry eye to surgical gaffes that left scarring.

Those complaints are set to be the focus of a U.S. Food and Drug Administration public meeting over patient satisfaction with LASIK, or laser-assisted in-situ keratomileusis.

The FDA is seeking the advice from a panel of outside experts about issues surrounding patients’ experiences after the procedure.

“Industry is very concerned about this,” said Glenn Hagele, head of a patient referral group, the Council for Refractive Surgery Quality Assurance.

FDA’s meeting comes as the LASIK industry faces weakening demand for the procedure amid a softening U.S. economy. The elective procedure is not covered by most health insurers and can cost several thousand dollars.

The slowdown has hit LASIK device makers, which include Advanced Medical Optics Inc, Alcon Inc and Bausch & Lomb.

LASIK providers such as TLC Vision Corp and LCA-Vision Inc also have seen sales slip.

The meeting “could become an overhang for LASIK companies such as EYE (Advanced Medical Optics) because of the uncertainty of the panel outcome and the potential for negative media coverage,” Wachovia analyst Larry Biegelsen wrote in a research note last month.

Biegelsen added that it could turn positive if the FDA’s panel of outside advisers concludes that patients experience a “relatively high” quality of life in part because of newer, more accurate lasers.

The FDA, which has said LASIK is safe and effective, has received 140 reports of patient dissatisfaction between 1998 and 2006 on a variety of complaints from injuries and device malfunctions to dry eye and other side effects, FDA spokeswoman Peper Long said.

Known complications from the procedure include lost vision, severe dry eye, glare and double vision. Patients may also still have to wear glasses or contact lenses and can experience a loss of the surgery’s effectiveness over time.

While the FDA does not oversee surgeons or companies that perform LASIK, it does regulate the device makers and in 2006 received four citizen petitions asking the agency to review the devices used in the procedure.

A variety of industry studies have shown that 95 percent of patients say they are satisfied with the procedure, with the remaining 5 percent saying they are very unhappy with their results.

“Even though it’s a small number, LASIK is a very widespread procedure,” Long told Reuters. The FDA is expected to release documents related to the meeting on Wednesday.

About 12.4 million patients have undergone LASIK since the mid-1990s, or about 700,000 a year, according to the research firm MarketScope.

Hagele, whose group screens doctors and charges them to appear on its Web site, said the meeting is likely to draw patients with extreme opinions on LASIK, both good and bad.

“It’s going to be the people who did not get what they expected,” he said.

Doug MacHatton, a spokesman for Alcon who said LASIK devices were a small part of the company’s business, said the procedure has a high rate of customer satisfaction, but it was unclear what could result from the FDA’s panel. “It’s a little difficult to project what it could mean,” he said.

In addition to the FDA meeting, the agency is joining with the National Eye Institute and two other industry groups to conduct a study on LASIK patient satisfaction.

Steve Chesterman, spokesman for Advanced Medical Optics, said the company supported the study and any effort to improve LASIK patients’ experience and “possibly help screen out patients who are not appropriate for the procedure.” He added the company would not make a presentation at the FDA meeting.

TLC spokesman James Hyland said the company was waiting to see what the panel decided.