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."
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.