A Hard Look at LASIK Surgery

A Hard Look at LASIK Surgery LASIK surgery is an unnecessary procedure on a very necessary part of your body. Almost no one needs LASIK, though many want it. That s why it s important to know the possible risks as well as the potential benefits. You ve heard about the benefits in countless LASIK commercials. The Dr. Oz Show wanted to balance out the picture, by presenting the risks. Read more on some of the benefits of LASIK by Dr. Julius Shulman. More than 20 million people worldwide have had LASIK surgery and many report they are thrilled with the results. But our investigation found this eye operation isn t the foolproof fix it s often made out to be. LASIK can have bad results, from unclear vision to visual distortions, from excruciating eye pain to a weakened eye structure. Every year, an estimated 600,000 people get LASIK, according to the FDA. Those people may be responding to advertising like this: Throw away your glasses! You re only minutes away from 20/20 vision! No more need for expensive contact lenses! Have your vision permanently corrected! Your eyes will have high-definition vision clarity! According to FDA rules, eye centers are not supposed to overstate the benefits of LASIK or understate the risks and yet we easily found hyped up LASIK commercial claims with a simple YouTube search. The LASIK advertising promises above are not necessarily true. So here s what all patients need to know about some of the complications of the procedure to make an informed decision about LASIK. 1

Loss of Visual Acuity Visual acuity is the sharpness of your vision. It s what your eye doctor is measuring when you look at those little lines of letters on an eye chart. You may also know it by the numbers. Vision that is at least 20/20 is considered ideal visual acuity. But LASIK surgery does not guarantee perfectly sharp visual acuity - like some of the ads promise - and you might not be able to ditch your glasses and contacts after all. For example, The Dr. Oz Show analyzed data from the clinical trial submitted to the FDA during thelaser approval process. This data is contained in "patient information booklets" that, ironically, are often not given to patients. It shows that even the most modern laser on the market left 1 out of every 5 patients seeing worse after LASIK than they used to with glasses. Some were left with better than they used to with the naked eye, but not as well as they used to with glasses. So how can some LASIK centers offer a "20/20 Guarantee"? That usually means if you don t receive 20/20 vision from your first LASIK surgery you will either get your money back or they will operate on you again for free. This is often called a touch up or LASIK enhancement." You should know that these additional LASIK surgeries are not FDA approved, though they are perfectly legal. "LASIK lasers are not indicated for enhancements, which are considered 'off label' uses," the FDA explained. Once the FDA has approved or cleared a product for a specific use, physicians are allowed to use their discretion when using the device for a different indication. Another variation: some people achieve 20/20 vision or better at first, but then their vision starts to degrade again over time. Consumer Reports surveyed LASIK patients and nearly two-thirds of them reported that they still had to wear glasses or contacts some or all of the time, for either reading or distance vision. That s discouraging since the reason many people get LASIK in the first place is to ditch their glasses and contacts. The FDA spells it out bluntly on the LASIK page of its website: Only a certain percent of patients achieve 20/20 vision without glasses or contacts... Some patients lose lines of vision on the vision chart that cannot be corrected with glasses [or] contact lenses... 2

Next: Visual distortions, dry eyes and weakened corneas... Visual Distortions Even patients who do achieve 20/20 visual acuity post-lasik can have other problems. They can read the tiniest lines on an eye chart, but they may be seeing them in double, or with halos around the letters. One of the most common LASIK complications, as described by the American Academy of Ophthalmology, on page 7 of this patient guide, is night driving difficulty. In some cases, oncoming headlights can cause glare and starbursts so severe that it can be hard for some LASIK patients to see the road. The post-lasik distortions described above cannot always be corrected by glasses or contacts. Paula Cofer of Tampa, Florida had the surgery in 2000, and says she became an anti-lasik activist when she had terrible results. I wear glasses, but even with glasses I see multiple images, huge starbursts, halos and ghosts, said Cofer. Hard contact lenses would be able to correct some of this, but I m intolerant to lenses thanks to LASIK-induced dry eyes, as are many LASIK patients. The other visual distortion you should know about is the possibility of losing your ability to see well in situations with low contrast, like you might encounter on a foggy day. I think this is outrageous. I think it s not right, said ophthalmologist Dr. Cynthia MacKay. She s one of the few eye doctors willing to speak out against LASIK. Vision measured in an ophthalmologist's office is done with high contrast letters in a dark room. That isn t the way we see in the real world. When you get out in the real world, you have problems with contrast, distinguishing between subtle shades of gray... It s distorted vision. Dry Eye Pain 3

Studies show that dry eyes are another common side effect of LASIK. You may be thinking, Dry eyes? My eyes are dry. What s the big deal? For some patients, their eyes are not just dry -but painful. Some say their eyes are so dry they have to put drops in several times an hour and also get up in the middle of the night to add drops for relief. Browse the aisles of any drug store and you will see shelves lined with artificial tears labeled For LASIK Dryness. Dean Kantis of Fort Lauderdale, Florida, a dissatisfied LASIK patient, who operates the website LifeAfterLasik.com, takes issue with the fact that some of the same companies that manufacture lasers for LASIK also sell drops for LASIK dryness. Suzanne Buie of Knoxville, Tennessee, said starting right after the surgery, it felt like somebody threw gasoline in my eyes. At one point Suzanne says she experimented with winding plastic wrap around the top of her head to try to keep her eyes moist. That unorthodox attempt didn t help either. Finally, she says she got so desperate that she had an electrostimulator implanted in her head to disrupt the pain signals from her dry, light-sensitive eyes. The dry eye pain and other complications can be so severe that a few patients have reportedly committed suicide. In 2008, Gerry Dorrian testified before the FDA that his son Colin killed himself over a bad LASIK outcome. Katie Dean told The Dr. Oz Show that her father, police officer Larry Campbell, also took his own life because of LASIK complications. "All he would talk about was his eye pain and his eyes," she said. "He couldn't live that way and it eventually cost his life." A Canadian television show featured Campbell s story, and showed his suicide note, which reportedly said, The pain, distorted vision, chronic dry eye is not bearable... Do not have LASIK surgery! Even for people with more moderate Lasik dryness, it can be a problem. As the FDA warns on its LASIK page, Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required. Weakened Corneas In LASIK, the surgeon cuts a flap in your cornea (the clear, outermost surface of your eye) with either a blade or a laser. Some studies have shown the cornea may 4

not heal to be as strong as it used to be. Consequently, there have been instances reported of LASIK flaps getting dislocated by everything from vigorous rubbing to ocean waves, from contact sports, to auto airbags. Corneal ectasia is a worst case scenario. It s not common but it is alarming. As the outermost layer, the cornea helps the eye hold its spherical shape. When the cornea is weakened, the eyeball can begin to steepen and bulge as seen in these photos taken by optometrist Dr. Edward Boshnick of Florida, who specializes in treating post- LASIK patients who develop problems. This pointy shape interferes with good vision, sometimes to the point of legal blindness. The LASIK industry acknowledges all of the injuries listed above and more. Where? In the Informed Consent forms patients sign before having the surgery. Type LASIK Consent Form into a search engine and you will get more than 71,000 results, such as this one and this one, which list the litany of things that can happen to your eyes but usually don t state the likelihood that those injuries will occur. That s where the dispute lies. Next: More about LASIK... LASIK History So how did LASIK get FDA approval in the first place? The FDA was hoodwinked, said Morris Waxler, now retired from the agency. He was one of the FDA officials responsible for getting LASIK approved, but now he s campaigning to get it banned. Haziness, halos, dry eyes, pain," said Waxler. What the industry did is they convinced the agency to discount those injuries. That is, those were not really important injuries. They were just side effects... minor irritants. They convinced the agency, by their heavy lobbying that that was the case. 5

To gain FDA approval, at the time, a new laser could not have an injury rate of greater than 1%. Waxler says that s why LASIK laser manufacturers wanted complications like double vision and dry eyes classified as something less than injuries, and called them side effects. Waxler says he did not realize he and the agency had made a mistake until he was retired. He says he started hearing from LASIK patients who had been suffering from dry eye pain and visual distortions for years. He says that s when he decided reclassifying permanent injuries as temporary side effects was wrong. In January 2011, Waxler filed a citizen s petition with the FDA, asking his former employer to revoke its approval of LASIK. Waxler argued that those so-called side effects are actually injuries and if you count them correctly, LASIK harms about 20% of patients. If he s right, that s 1 out of every 5 people with complications from an elective procedure. An independent study published in the journal Corneafound a similar injury rate. The FDA In 2009, the FDA launched a LASIK quality of life study. When it announced the study the FDA said, The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems. The LASIK quality of life study was reportedly supposed to be complete at the end of 2012, but as of October 2013, it is still not done and has been delayed again. The study is being conducted in San Diego and subjects are still being enrolled, The FDA told us. The FDA will make study findings available when the research is completed. Among other things, the study was supposed to look at the side effects like dry eyes and double vision that the FDA had originally discounted when it approved LASIK. LASIK critics raised red flags when they learned that the Naval Medical 6

Center would partner with the FDA to conduct the study, because some high-ranking navy eye surgeons also work for LASIK centers. Anti-LASIK activists were also angered when one of the private LASIK centers chosen to participate in the study turned out to be one of 5 centers the FDA warned about improper advertising. We asked the FDA about this and the agency said, Enrollment was completed at the site prior to the investigator being notified of the issues raised in the warning letter regarding advertising. It is an obligation of every site to complete follow up for all patients enrolled in a study. Therefore, it would be inappropriate to stop following the patients from this site. Today there are thousands of MedWatch complaints on file with the FDA about LASIK injuries. They are called adverse events in FDA-speak. There are probably more bad outcomes than that out there. The FDA has issued warnings to at least 30 LASIK Centers for failing to report adverse events to the agency as required by law, but it has never levied fines or seized lasers to punish LASIK centers for their lack of reporting, though it has the power to do so. The Medwatch complaints on file continue to show a disconnect between what LASIK surgeons and LASIK patients consider to be injuries. An anti-lasik group called Lasik Surgery Watch conducted an analysis in 2012 and says 73% of the injuries patients reported to Medwatch involved dry eyes, night vision problems, poor vision quality and corneal bulging. By contrast, the group says just 16% of injuries reported by medical professional involved these complications. The Dr. Oz Show asked the FDA to comment for this story and the agency said, The FDA considers LASIK lasers to be reasonably safe and effective when used as intended. Clinical data submitted to the FDA by manufacturers of the currently approved LASIK lasers showed that their benefits outweigh the risks... Next: The investigation... 7

Going Undercover The Dr. Oz Show wanted to know how LASIK centers present potential risks to patients, so I went undercover to three large LASIK centers. First I asked whether I could really throw away my distance glasses like the ads say. All three centers said yes. One displayed a bowl of glasses in the lobby, purportedly donated by patients after their LASIK surgeries. Here s what the most effusive LASIK center employee said about glasses: You can toss them out right after surgery. The surgery is 15 minutes and right after that you can leave your glasses at home. Employees at all three centers did note that I might need reading glasses after LASIK. Since the debate continues about permanent injuries versus temporary side effects, I asked about that too. LASIK center number one told me, You do see halos sometimes. That s just after the surgery. It s not a forever thing. The second LASIK center said: The changes in laser technology have really minimized the long term risk of glares and halos. And when I asked, You re saying the dry eyes are temporary and they re not that big of a deal? The third LASIK center said, Correct. I also asked I shouldn t worry about the night vision? the third center said, No. All three centers characterized the risk of injury as minuscule. None of them acknowledged that it could be anywhere near 20% if you include complications like dry eyes and night vision problems. One LASIK center employee even said, It s pretty foolproof at this point. At times it felt like I was in a business office rather than a doctor s office. One LASIK center employee interrupted my questions about risks to tell me their current special price and to inform me that financing is available through a large bank. Another LASIK center asked if I was interested in having LASIK surgery that day! Employees said there were already 14 surgeries scheduled. The average price for LASIK in both eyes is approximately $4,000, so that could add up to $56,000 in revenue just that day -roughly $14 million a year. None of the LASIK centers we visited gave us the Patient Information Booklet for the laser they use. The FDA requires laser manufacturers to make these booklets available to LASIK centers, but it has no power to force the centers to give them to patients. That s a shame because they contain a wealth of detailed information about 8

the injury rates experienced by patients during clinical trials conducted in order to get the lasers approved. Want more information? Find detailed instructions on how to get these Patient Information Booklets on your own. The Eye Academies Weigh In The Dr. Oz Show reached out to the major eye doctor academies for input into our LASIK story. Here s some of what they had to say. The American Academy of Opthalmology has a broad viewpoint, because it represents all kinds of eye doctors. The AAO told us: Millions of patients worldwide have been successfully treated with LASIK... While the risk for major complications... is low, there are common side effects associated with the surgery, including dry eye pain, poor night vision and glare, halos or starbursts... The Academy urges patients to discuss these factors with their doctor and carefully weigh the benefits and risks before deciding to undergo this and any surgery. Read the entire AAO statement here. The American Society of Cataract and Refractive Surgery is focused specifically on LASIK and other eye operations. The ASCRS told us it takes the study of the risks and benefits of LASIK surgery seriously, and we are very concerned about patients who have had negative outcomes. We support additional research to determine why these occur and how best to resolve them. Read the entire ASCRS statement here. Both groups cited nuances that are important to note when analyzing LASIK complications. For example, they explained that some people who complain of dry eyes after LASIK also had dry eyes before LASIK. It s true that many early LASIK clinical trials surveyed patients about their symptoms after LASIK without having asked them about their symptoms before the surgery, so they had no basis for comparison. However, the clinical trial for the newest laser on the market, did compare symptoms before and after LASIK, and 34% of patients reported that their dry eyes were worse nine months after the surgery. 9

The eye academies also said that some of the complications patients experience are treatable and that when patients give doctors a chance to address their symptoms, many can be resolved. For example, some patients who aren t happy with the sharpness of their vision visual acuity were given second LASIK operations, and were then satisfied. Both groups often cite this study when touting the benefits of LASIK. The study, a review of other LASIK studies worldwide, found that the LASIK surgery satisfaction rate was as high as 95%. That sounds like an impressive figure, but if you flip it over, it means that 5% were not satisfied with an operation on a critical organ, their eyes. A spokesperson for another group, the American Refractive Surgery Council pointed out that some complications may be part of the healing process and go away with time, comparing it to knee surgery and the understanding that your knee will be stiff for weeks or months after surgery. Indeed, the FDA clinical trial data only goes out 6 to 12 months, so it doesn t shed light on longer-term complications or resolutions. Individual patients say they have been suffering with LASIK-induced injuries for years, but more systematic research of the long term effects is lacking. And that raises one final, important point. The first LASIK laser received FDA approval in 1998. That means the early adopters who first tried the approved procedure had their surgeries 15 years ago. The peak time, when the most surgeries were performed, was even more recently. How will these LASIK patients eyes fare as they age? Will the surgery hold up well over the decades? The true long-term effects of LASIK are a mystery. 10