Eye on LASIK

The laser vision correction industry is under fire for its failure to acknowledge potential risks.

A few weeks ago I got a prescription for eyeglasses. This is not newsworthy in itself, except that two and a half years ago I had LASIK (Laser-Assisted In Situ Keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I understood that at some point I would need reading glasses, but was assured that after LASIK—a surgical procedure that permanently reshapes the cornea, and can correct near-sightedness, far-sightedness and astigmatism—I would be able to see clearly for a long time to come.

The problem is, I can’t. And not only is my vision blurred, my eyes are scratchy and as dry as the desert. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms. I also see halos, and not the kind associated with angels.

Yes, before the surgery I signed an informed consent form confirming I understood all the possible side effects, but I never considered the possibility that they might be permanent, and that they would be more than “annoying,” as my doctor put it. And while I could get an “enhancement”—that’s industry parlance for another surgery to correct errors—the only thing I want near my eyes these days is mascara.

According to the American Society of Cataract and Refractive Surgery (ASCRS), the overwhelming majority of the 13.6 million people in the United States who have had LASIK since the first lasers were approved by the Food and Drug Administration (FDA) in 1998 are pleased with the results. But many have experienced problems similar to mine, and some have reported far worse outcomes.

Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected approximately 50 LASIK facilities and found that 17 had “inadequate” systems in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical complications (“adverse events”), which commonly include dry eye, blurry vision, double vision, and problems with glare and starbursts.

In August of last year, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who’ve had laser vision correction surgery still wear glasses or contacts some of the time. Fifty-three percent experienced at least one side effect within the first four weeks of surgery, and 22 percent of patients still experienced side effects six months after surgery.

Even so, ASCRS emphasizes that LASIK, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research from 1996 to 2008, says John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies worldwide—involving 2,022 patients—that specifically addressed patient satisfaction.

“Based on everything we know from the literature, and everything I know from any other elective procedure, LASIK is the most successful elective procedure performed,” says Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, South Carolina, and a co-researcher on the study.

The experience of patients like Jeremy Fox, 26, a college student in Rockford, Illinois, who got LASIK four years ago, seems to support this assessment. Getting the procedure, he says, was one of the best decisions he has ever made. While he does experience some starbursts, he claims [they are] “not bothersome at all.”

But the FDA and others are taking note of what they call “quality of life” issues. In October 2009, the FDA, the Defense Department and the National Eye Institute announced a three-year effort to assess the adverse effects of LASIK. The effort will include gauging how many active-duty military patients at the Refractive Surgery Center at the Naval Medical Center in San Diego have suffered post-surgical problems, as well as a series of multi-center clinical trials that will study LASIK’s impact on quality of life. In addition, the FDA has reopened a docket to receive public comments through November 15, 2010.

Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. “LASIK is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those who speak ill of it are dismissed as cranks and/or loonies,” he wrote in an e-mail. “I saw lots of dry eye complications in soldiers in Iraq who had undergone the procedure, ostensibly because contacts are unsafe in that dusty environment, yet the Department of Defense has done no controlled studies to look at the cost—human and otherwise—of these post-refractive issues. I’m a clinical researcher, and I know that LASIK has never been subjected to the pre- or post-marketing scrutiny that we put lifesaving drugs through.”

Surf the Web and you’ll find dozens of stories from people who have had post-LASIK difficulties. Some complications have led to corneal transplants. And over the last few years patient activists have bombarded the FDA with anti-LASIK e-mails, complaints and petitions.

Among them is John Hoge, 39, a businessman in Port Jefferson, New York, who suffered from night glare and halos and regrets not choosing the “zero risk option” of corrective lenses. A few years ago he obtained experimental contact lenses that have largely taken care of the glare issue. But they are expensive, he added, and not covered by insurance.

And while the FDA’s recent efforts have given some patient activists a modicum of peace, many feel it is not enough. “By not inspecting every LASIK facility, how is the FDA to know if LASIK doctors are compliant?” asks Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Florida, who has experienced double vision, starbursts, halos and dry eyes since getting LASIK in 1999, and operates the Web site LifeafterLasik.com.

Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. “We screwed up,” says Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health from 1995 to 1999. “You know how some drugs have a black box warning? We could have done something comparable. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in clinical trials.”

Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Virginia, agrees. “It appears that information to provide adequate informed consent was not sufficient for all prospective patients,” he says. “The present dissatisfaction rate of five percent is very high. Personally and professionally, I am very disappointed in the FDA.”

FDA spokeswoman Mary Long rejects the notion that the agency could have done more. “The FDA reviewed the safety and effectiveness information included in the manufacturer applications for approval,” she wrote in an e-mail. “It found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health.”

Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to LASIK ambulatory facilities last May reminding them that all risks must be mentioned in every LASIK advertisement—whether online, in print, on radio or television. “As part of our ongoing review of LASIK and its impact on public health, we continue to look at various aspects of LASIK advertising and how we can better improve public health,” adds Long.

But an informal online search reveals dozens of doctors’ Web sites that do not mention risks or side effects.

As for the new study, Pilot is not impressed. “The FDA is beginning to do what should have been done 10 years ago,” he says. “The bottom line is that thousands of human eyes have been irreversibly damaged unnecessarily.”

Dr. Solomon disagrees, maintaining that the FDA clinical trials were rigorous and well-performed. “I think the FDA did an outstanding job at evaluating the technology,” he asserts. “And the technology and procedure have only gotten better since approval.”

As for me, if I had to do it all over again, I wouldn’t. But, of course, hindsight is 20-20.

Abby Ellin is the author of “Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can’t) Help.” This article originally appeared at Salon.com.