Sept. 22, 2010 -- A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA.
Morris Waxler, who is now an independent regulatory consultant, plans on filing a citizens petition urging the agency to take steps to stop what he calls "the epidemic of permanent vision problems" caused by LASIK.
Waxler's petition will implore the FDA to take actions to crack down on the procedure, including issuing a public health advisory that warns the public about the dangers associated with LASIK and implementing stricter controls over LASIK device manufacturers and practitioners who perform the surgery.
In the petition, Waxler will include data that he said were evidence that "LASIK causes persistent vision problems with an overall success rate of less than 50 percent; a failure rate of more than 50 percent."
Waxler said his change of heart came about after he retired from the FDA in 2000. He started getting complaints from people who suffered serious side effects from the procedure, including seeing halos, impaired night vision and excessive glare.
He was surprised when he looked back at the data presented when LASIK was undergoing the approval process in the late 1990s.
"When I looked back at that data, there was a tremendous consistency that show these problems exist in about 18 percent of people who had LASIK, most of them after I left the FDA," he said.
Some doctors, however, say while they agree with the estimate that thousands of people have had problems after having LASIK surgery, they stress that the vast majority of people are very happy after having the procedure done.
"Ninety-nine percent of people who have had LASIK have excellent results," said Dr. Robert Cykiert, clinical associate professor of ophthalmology at NYU Langone Medical Center. "Millions of people have had the procedure done with a high success rate."
Doctors, Patients Say LASIK Procedure Is Safe and Effective
One of those satisfied patients is Andy Ng of Long Island, N.Y.
Ng had LASIK in 2004. He decided to go through with the procedure because he got tired of spending hundreds of dollars on glasses that needed special lenses and would get banged up because of his participation in sports. He also found contact lenses cumbersome and time-consuming.
He said he already knew about the side effects before he went in for the surgery.
"I knew for a fact I was going to have halos at night," Ng said. He added that aftewards, the halos didn't make much of a difference for him.
"I have no other problems, such as floaters, dry eyes, etc.," he said.
Doctors stress that LASIK is no different from any other medical or surgical procedure.
"We always would like to have any medical procedure or surgical procedure that works 100 percent of the time, but that doesn't exist," Cykiert said.
"Complications do happen, but it's rare, and often, we're not sure why," said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai School of Medicine.
Doctors also say that even if a patient is an ideal candidate, the surgeon is very skilled and the equipment is top-of-the-line, problems can still occur, so it's difficult to predict whether someone will suffer from LASIK-associated side effects.
Communication, Information Vital to Minimizing LASIK Risk
Not everyone is a candidate for LASIK, and doctors say it's important for prospective patients to understand that. People with vision that continues to get worse, extremely poor vision, certain characteristics of the cornea and some diseases may not be suitable candidates for the procedure.
"Doctors need to take time with a patient and get all the information they need," Asbell said. "Doctors also need to learn what the patient's expectations are. If a person wants 20/15 vision, they may not be the best candidate."
Experts also say there are still things about LASIK that they just don't know.
"It's very hard to quantify these side effects, such as determining how to measure how bad things like glare and halos are," Asbell said. "It's hard to pin down risk factors that differentiate the people who have problems from the ones that don't so we can try to learn more."
"There are many things we still don't know about the cornea, such as physiology and variability in structure, so we don't know why some patients bounce back and others don't," Cykiert said.
Cykiert also said that the thousands of people who have problems have a legitimate reason to complain to the FDA, and that information they provide can be helpful for everybody.
"That's how we're going to make the procedure safer and better," he said.
And that's also how there may eventually be more people like Andy Ng, who has no complaints about his LASIK experience.
"The procedure is one of the best things out there for the eyes," he said.