The offers began arriving by email in January: a chance at clearer vision for the special price of US$299 per eye. Over the next four months, I received 20 ads from the same company – each offering the same deal for the “safe, FDA approved” surgery.
“Individual results will vary,” each ad said in the fine print. None mentioned that those variable results could include seven categories of vision-threatening complications or 17 types of non-vision-threatening side-effects, such as “increased sensitivity to light”, “eye irritation related to drying of the corneal surface”, “pain or a foreign body sensation”, or increased susceptibility “to trauma from impact”. (Bargain offers notwithstanding, average all-in costs also exceed US$2,000 per eye.)
All surgeries carry risk, and the risks associated with laser in-situ keratomileusis, or LASIK, are listed on the standard consent form that all patients must sign. For many, the rapid procedure goes off without a hitch and leaves no residual effects. Scrupulous centres also turn away the roughly one-fifth of patients who are not good candidates.
But a quarter of a century after the first ‘flap and zap’ vision-correcting surgery, controversy continues to rage over whether regulatory authorities and industry officials have repeatedly downplayed or ignored the prevalence of dry eye disease, chronic pain and other potentially serious side-effects. Has the public, in other words, been told enough to make an informed decision about an elective surgery that can’t be undone?
In response to mounting pressure from patient advocates who say they haven’t, the US Food and Drug Administration co-sponsored a quality-of-life study to help quell the debate. The recently released preliminary results of that study, however, appear to be doing exactly the opposite.
How did it get to this point? Excimer lasers, as they’re known, were first used to perform a precursor method called photorefractive keratectomy (or PRK) in the late 1980s. During the procedure, a doctor removes the thin outer layer of corneal tissue and then uses the laser to create a precise vision-correcting divot on the surface. The painful method can mean several weeks of recovery time per eye, but it doesn’t cut through the corneal nerves like LASIK does.
Surgeons soon began gravitating toward the faster LASIK method, which cuts a hinged flap in the cornea to alter its light-refracting properties. From 1996 until his retirement in 2000, Morris Waxler was chief of the Diagnostic and Surgical Devices Branch that regulated corneal resurfacing lasers within the FDA’s Division of Ophthalmic Devices. He was at the helm when the FDA branch gave the green light to the first LASIK laser in July 1998.
The approval, Waxler said, was intended in part to stem major compliance problems and bring some order to the increasingly chaotic industry while reasserting the FDA’s regulatory authority. In the process, he alleged, the agency wasn’t as attentive as it should have been to the surgery’s long-term risks, including chronic eye pain.
“We were hard-pressed to know what to do about these problems,” Waxler said. The assumption was that the pain would persist for a few months, maybe, or a year. “So we figured we would handle it in the labelling and that ‘caveat emptor’ – ‘buyer beware’ – would rule the day, and we assumed that refractive surgeons and clinics would be honest and tell their patients ‘You’re going to have pain’, and that’s turned out not to be correct.”
Carlos Belmonte, founder of the Institute of Neurosciences in Alicante, Spain, and a pioneer in studying the physiological basis of eye pain, explains that corneal nerves don’t completely regenerate after LASIK surgery. “The main risk is that in a very small percentage of cases, this regeneration is pathological, and then you get this neuropathic pain and that is a disaster,” he said. “But this is a risk that happens in surgery.”
In 2007, Belmonte published a study that suggested a form of dry eye pain called ‘phantom’ cornea could occur after LASIK-mediated damage to the corneal nerves. At the same time, Boston ophthalmologist Perry Rosenthal was compiling multiple case reports suggesting that a similar post-LASIK phenomenon was appearing regularly in patients with severe eye pain who had been referred to his clinic. Other researchers have documented phantom pain among patients who have had eye amputations or corneal transplants.
Waxler retired in 2000 and is now an independent regulatory consultant. He gave little additional thought to LASIK until a patient whose eyes had been damaged by the surgery called him about six years ago and angrily asked why it had been approved. Waxler listened, and began talking to other patients with similar stories. “I said, ‘Well, how could this happen?’” he recalled.
Based on his review of medical studies and documents on the FDA’s website, he alleges that many of the problems had been reported all along, but labelled as ‘symptoms’, a category deemed less serious than ‘adverse events’. Waxler made headlines in 2010 and 2011 when he went public to contend that the original studies actually documented an adverse event rate of about 20 per cent. The FDA later responded that symptoms like glare and dry eye are too mild to be considered adverse events.
Meanwhile, more patient advocates were going public with their own stories and documenting them on Facebook groups and multiple websites. One, LASIK Complications, created a page to track LASIK-linked suicides and attempted suicides, based on news accounts and patient reports filed with the FDA.
At a public meeting of the FDA Ophthalmic Devices Panel in April 2008, nearly 20 individuals spoke out against the LASIK procedure: optometrists who had treated patients after the surgery, patients recounting their own ordeals, and two speakers testifying about patients who had killed themselves.
New Jersey financial administrator Matthew Kotsovolos, now 46, was among those who testified. He describes his own misery after a 2006 LASIK eye surgery as “a pain that I am confident that most people do not recognise as existing in this world”. His surgeon considered the procedure a success because Kotsovolos’s uncorrected vision improved to 20/20. Even so, he suffered from constant, debilitating eye pain. “So I pretty much lived in Hell.”
In October 2009, the FDA, the National Eye Institute and the Department of Defense responded to the lingering controversy by launching the LASIK Quality of Life Collaboration Project “to help better understand the potential risk of severe problems that can result from LASIK”.
The collaborative effort tested a web-based questionnaire on 242 naval personnel – most of them male – who received free LASIK at the US Naval Medical Center in San Diego. A subsequent phase then surveyed 292 civilian patients, split roughly between male and female, who had LASIK surgery at five other clinical centres. In October 2014, Malvina Eydelman, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, presented the preliminary results from both phases of the study.
The study agreed with most previous surveys in suggesting a patient satisfaction rate of more than 90 per cent. As Waxler and other critics have repeatedly emphasised, however, satisfaction rates cannot take the place of safety profiles.
In that regard, the FDA’s study results were more mixed. Although the prevalence of patients with ghosting (seeing a faint double image) dropped significantly after surgery, for example, more than one-third still had halos and starbursts. In addition, up to 4 per cent had “very or extremely bothersome” visual symptoms, and up to 1 per cent “experienced a lot of difficulty with or were unable to do usual activities due to visual symptoms” three months after LASIK.
Among respondents who lacked symptoms before LASIK, roughly 30 per cent reported new dry eye symptoms and 45 per cent reported new visual symptoms three months after the surgery.
Instead of a randomised epidemiological study of eye pain, visual symptoms and satisfaction among the existing pool of LASIK patients, Waxler alleges that the “best-case” study used highly specific inclusion criteria for patients and LASIK devices, sharply limiting its applicability to the general population. Even so, he asserts that the FDA and refractive surgery industry have spun the study “as support for the safety and effectiveness of LASIK when in fact it confirms LASIK patients’ problems”.
In response to a request for comment, a spokesperson for the American Society of Cataract and Refractive Surgery offered a November 2014 press release as the society’s official statement. That release characterised the preliminary FDA-led study results as “overwhelmingly positive”, while ASCRS President Richard Lewis called the high rate of success for LASIK “unprecedented as a surgical procedure” and said the collaborative research effort confirms “the remarkable efficacy of LASIK”.
The press release notes that “no surgery is 100 per cent risk free” and quotes Lewis as saying: “Our understanding of those at risk for dry eyes and visual disturbances from LASIK procedures is critical and evolving…Identifying individuals at high risk for complications of LASIK is valuable. However, this must be determined in a well-controlled and timely trial.”
Separate reports suggest that many post-surgical problems will eventually resolve. Few studies, however, have followed patients beyond six months or a year to find out for sure. Rosenthal’s observations of 21 patients with post-LASIK chronic eye pain, for example, suggest that the pain didn’t even begin until a year or more after the surgery for eight of them. A separate survey by The Cornea Research Foundation found that post-LASIK dry eye symptoms actually worsened at the one-year mark before recovering somewhat at two years.
A survey of nearly 800 adults conducted by the Consumer Reports National Research Center and reviews in the American Journal of Ophthalmology, Cornea and Ocular Surface have similarly suggested that chronic dry eye and other symptoms are relatively common six months after LASIK. A new review in the journal Molecular Pain asserts that the percentage of patients reporting “persistent eye symptoms” has ranged from 20 per cent to 55 per cent, and the authors invoke corneal nerve damage as one potential contributor.
A recent investigative report from Consumers Digest details a range of other potential flaws in the clinical trials and reporting system used to assess LASIK’s safety. The FDA has not yet released its six-month results from the second group of patients surveyed. Under the heading ‘Public Health Impact’, however, Eydelman’s slide presentation concluded: “Given the large number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients.”
Based on industry estimates that more than 40 million patients have undergone LASIK worldwide, the tally of those with chronic eye symptoms could run well into the millions. Although demand for the surgery has fallen over the past five years, Waxler said the market for eye drops that treat dry-eye-associated discomfort has “exploded”, and some manufacturers are specifically aiming their ads at LASIK patients. “It’s no happenstance,” he said.
Waxler filed a petition in 2011 asking his former employer to rescind its approval of LASIK. Three years later, the FDA shot him down, responding that his allegations were unfounded and that data submitted to the agency suggested the surgery’s benefits outweighed the risks. Waxler filed another petition in July 2014 asking the FDA to reconsider. But he’s tired, he said, and has done all he can do: “I have no magical wand to fix this.”
Activists haven’t given up, however. In December 2014, three consumer advocates launched a new petition drive to force the FDA to add a ‘black box’ warning label to LASIK lasers, citing the agency’s own study results to argue that the high incidence of visual and dry eye symptoms represents an epidemic caused by an unnecessary surgery. And in May 2015, more than 1,000 LASIK patients and their supporters signed a letter urging the federal agency to reopen Waxler’s petition for consideration.
Where does the FDA go from here? In response to questions about Eydelman’s scientific presentation and the agency’s next steps, an FDA spokesperson told me the researchers were preparing the manuscript for publication in a peer-reviewed journal and couldn’t comment publicly about any findings until its publication.
And when might that be? She couldn’t say.