Further, refractive surgeons who perform Lasik say Waxler’s petition to FDA is based on old science from the early days of Lasik. Changes in surgical procedures and patient-screening technology led to dramatically improved outcomes, says Dr. Eric Donnenfeld, who is a refractive surgeon and a past president of American Society of Cataract and Refractive Surgeons. Based on his experience as a former FDA official and an expert witness, Waxler says he has a difficult time trusting any claims about the procedure’s safety and efficacy or the science that’s produced, reviewed and published by refractive surgeons.
FLAWED APPROACH. Opponents of Lasik say cutting and reshaping the cornea—the procedure itself—is the fundamental problem.
Donnenfeld questions Waxler’s motives, pointing out that Waxler has been engaged as a paid expert witness in Lasik personal-injury cases. Waxler tells us that his high-profile opposition to Lasik and paid expert work actually cost him business and income, because he derives most of his income from advising device-makers on how to deal with FDA.
Paula Cofer, who is an injured Lasik patient and activist, says FDA’s motives and defense of the Lasik industry should be questioned, particularly because the agency issues warnings for products that cause far fewer documented adverse events than Lasik has. She says FDA never responded to injured Lasik patients’ petitions, even for lesser measures, such as warning the public about the risk of permanent vision-impairing side effects from the procedure.
“When it comes to Lasik, it isn’t that the agency has dropped the ball, it’s that they never even moved it,” says Larry Pilot, who looked into the Lasik issue as a former FDA director of compliance for medical devices.
FDA released preliminary results of its Patient-Reported Outcomes with Lasik (PROWL) study in October 2014 as evidence that the agency is attending to patient concerns. The study found that 4 percent of patients had visual symptoms that were “very” or “extremely” bothersome and that 1 percent had difficulty performing, or were unable to perform, their usual activities after Lasik. Four percent were dissatisfied with their vision. However, activists’ expectations for a serious look at the side effects of Lasik were dashed when FDA said PROWL’s goal was only to design a questionnaire that other researchers could use to assess Lasik outcomes. That’s contrary to the agency’s announcement in 2009 that the purpose of the study was to assess patient outcomes.
Refractive surgeons tout the positive results as evidence of Lasik’s overall safety. However, FDA tells us that its sample study size—262 and 312 subjects in the two arms of the study—was too small to get an accurate rate of these side effects. In fact, that sample size is larger than what FDA accepted for most clinical trials of Lasik devices!
A review of the most recent studies that were presented to FDA for laser-device approval in 2011 and 2013, as well as medical literature about Lasik, shows that the procedure has become safer and more effective since it was introduced. Critics agree, but they believe that the cutting and reshaping of the cornea—the procedure itself—is the fundamental problem.
They also say this is part of a pattern that has played out for years: New devices are approved for Lasik based on short-term data, and surgeons insist that the procedures for which the devices are used are safe. When long-term data emerge that reveal safety issues, surgeons dismiss it, saying no one uses the old technology anymore.
This turns paying customers into guinea pigs in an ongoing medical experiment, Lasik opponents say. In any event, it’s clear that refractive surgeons are selling a procedure based on short-term results.
ADVERSE EVENTS. Waxler and Everette Beers, who is a former FDA deputy director of the ophthalmic-device division, say a flaw in the approval process allowed the industry to convince FDA to downgrade adverse events to mere complications, which is how the side effects continue to be classified today. As such, more-common problems, such as impaired night vision, extreme dry eye and blurry vision—all of which can be severe and in some cases disabling—don’t count against the 1 percent “adverse event” rate that FDA made clear was the acceptable limit.
“Night-vision problems are more serious than anyone ever thought they were initially,” says Beers, who considers it a “shame” that Lasik devices were approved in the first place. “They should be a serious adverse event, not just a complication.”