Following complaints of blurry vision and dry eyes and other complications several patients encountered after having eye surgery, the U.S. Food and Drug Administration plans to take a closer look at laser eye surgery and the possible dangers that come with it.
“Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing fairly well. But clearly there is a group that is not satisfied and do not get the kind of results that they expect. What we're really trying to do is figure out what that number is. We want to provide people with accurate, timely information to help people make decisions,” Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, told reporters during a telephone briefing, according to the Washington Post.
The FDA’s announcement on Wednesday comes before a public
meeting scheduled for Friday to discuss patient satisfaction with the LASIK
procedure. The surgery was first approved in the mid-‘90s and since then more
than 12 million Americans have undergone Lasik by some estimates.
About 95 percent of patients report being satisfied with the
outcome, said Dr. Kerry Solomon of the Medical University of South Carolina,
who led a review of Lasik’s safety for the American Society of Cataract and
Refractive Surgery. However, critics believe there is a higher proportion of
patients encountering problems after a Lasik surgery.
“I have no night vision. I can’t drive at night. When I look
across my living room, it’s like looking through used wax paper,” Barbara
Berney, who underwent the procedure in 2001 and now, is president of the Vision
Surgery Rehab Network, which helps patients who have experienced complications,
said. “I deal with people every day who are miserable and depressed after Lasik
surgery.”
To prevent such events from happening again, the FDA said it
would ask its outside experts to discuss what information is currently available
for patients considering or undergoing Lasik and whether changes must be made.
"Panel members will be asked to recommend modifications/additions to
the FDA's patient labeling and LASIK Website," the FDA wrote on its Web
site.
Moreover, the agency is planning to conduct a study on Lasik patent satisfaction along with National Eye Institute and two industry groups.
Some analysts said negative patient testimony could weigh on shares of LASIK
device makers such as Advanced Medical Optics Inc, Alcon Inc and Bausch &
Lomb, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.
This will add to the 5 to 15 percent decline in Lasik
procedures expected to take place this year as the costs between $1,500 and
$5,000 won’t fit the pockets of many