Attorney Daily - Your source for the most important legal news

Every year, thousands of people in the United States who choose to have LASIK eye surgery experience serious complications with their vision following their procedures. The FDA recently announced that the agency will study of thousands of LASIK eye surgery patients nationwide during the next few years. In partnership with the National Eye Institute and the U.S. Department of Defense, federal health officials hope to determine the percentage of patients with significant quality-of-life problems after Lasik surgery, and identify predictors of the problems.

But while the FDA was aware of negative side effects that would occur in some, Morris Waxler, the former head of the FDA branch responsible for reviewing the data on LASIK, told ABC News in his first television interview that, in hindsight, those side effects were not taken seriously enough.

“I wouldn’t say it was pooh-poohed so much it was just sort of shoved aside as the kind of, we, we don’t know what to do with that data,” he said. “It’s right there in the record. The agencies and the refractive surgeons, people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.”

A number of patients who underwent LASIK, a procedure that uses a laser to reshape the cornea and thereby correct vision, say they now suffer from side effects such as starbursts, halos, glare double-vision and night blindness. In some cases the side effects go away within weeks or months of the surgery, but in other cases, they appear to be permanent.

Some people experience them mildly, but others have them so bad they can’t perform basic functions, such as driving, and some people have said they lost their jobs due to negative side effects from LASIK procedures.

In a statement the FDA said it “considers LASIK lasers to be reasonably safe and effective when used as intended” and said it disagreed with Waxler’s claim that they ignored problems when the procedure was approved.

Additionally the FDA said it issued a letter to LASIK providers cracking down on false and misleading advertising and said it will follow up with providers who were found to have “inadequate adverse event reporting systems.”

According to a recent NPR.org story, in excess of 17 million people worldwide have had Lasik eye surgery in hopes of relegating glasses and contacts to the waste bin. And each year, approximately 700,000 Americans opt for the procedure, which uses a laser to vaporize portions of the cornea and reshape it to improve vision. Lasik surgery can correct nearsightedness and farsightedness, as well as astigmatism, an imperfection in the curvature of the eye that can cause blurred vision.

An estimated 95% of patients are happy with the results of Lasik (which stands for laser-assisted in situ keratomileusis), the American Academy of Ophthalmology reports, based on a compilation of worldwide surveys. But there have been an increasing number of complaints from unhappy patients who say they have experienced significant problematic complications after Lasik.

They’ve been reporting that problems like dry eye, glare, double vision and starbursts (blurring around objects) have impaired their ability to function day-to-day and significantly affected their quality of life, says Dr. Malvina Eydelman of the FDA. In response, the FDA has decided to investigate further.

Unhappy Patients

One patient who resided in Tampa, Florida has experienced many of these problems. She had Lasik in 2000 and thought it made good sense at the time. The idea of not having to hassle with glasses and contacts was quite appealing. She even expected to save a bit of money, not having to buy new glasses, contacts or expensive eye drops.

Ten years later, she still suffers with severe dry eyes and blurry vision. “My eyes burn all the time,” she says, and “require constant attention.” She uses eye drops, eye rinses, eyelid scrubs, a mask at night to keep dry air at bay, and even wears moisture-retaining goggles.

Big and bulky, the goggles are nothing like small swimmers’ goggles, she says. “I look like a fly. They’re very unattractive.” She wears them inside, where fans suck moisture from the air, like at the gym. And she wears them outside when the air is dry, especially on windy days.

She can no longer drive because halos (blurring around objects), glare and starbursts from oncoming cars distort her vision completely. And the coup de grace: She still needs glasses and contacts.

Misleading Claims

The bottom line is that the Florida patient was simply not a good candidate for Lasik. Her large pupils make laser correction difficult, and she’s prone to severe dry eye. But she states no one told her about these potential problems. Eydelman says the FDA has stepped up efforts to ensure that doctors provide patients with information about risks and precautions before having Lasik. That includes things like large pupils, thin corneas and undiagnosed dry eye.

Eydelman says the agency is also looking into misleading advertising and claims that the surgery will make you “glasses-free” and have “20/20 vision.” She says patients need to make sure that they understand that even in perfect-case scenarios, they may no longer need glasses for distance vision, but there is a high likelihood that they’ll need glasses for reading.

Studying Quality Of Life After Lasik

The FDA is beginning a study of thousands of Lasik patients nationwide. In partnership with the National Eye Institute and the U.S. Department of Defense, federal health officials hope to determine the percentage of patients with significant quality-of-life problems after Lasik surgery, and identify predictors of the problems.

The study is expected to be completed by 2012. Health officials hope the findings will enhance understanding of the risks of Lasik and reduce the number of patients who experience adverse effects.

On October 15, 2009, the FDA announced plans to study the scope of problems associated with laser eye-correcting surgery, which include blurred vision and dry eyes. The FDA says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience harmful side effects following surgery.

The first phase of the project is already under way, with plans for an online questionnaire to help patients gauge their quality of life following surgery, according to an FDA statement. The project will also include a clinical trial tracking patients who undergo the procedure, which is expected to conclude by 2012.

“This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects,” said Dr. Jeffrey Shuren, the acting head of FDA’s medical device division.

An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.

Ophthalmology societies report that about 95% of patients are satisfied with their new vision.But a small number of patients have reported permanent damage to their eyes following the surgery, including double vision, dry eye and halos around objects at night.

The FDA agreed to look into the problems in 2008 after years of complaints. The agency said last summer it received 140 reports of Lasik-related problems between 1998 and 2006.

The FDA also on October 15, 2009, announced warning letters sent to 17 Lasik surgery centers for inadequate adverse event reporting procedures. Regulators periodically send letters to facilities that don’t follow federal guidelines for reporting patient complaints.

“The inspections did not identify problems with the use of the Lasik devices at these facilities,” the FDA stated.

More inspections of Lasik centers are planned in coming months, according to the FDA release.