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A D V E R T I S E M E N T
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Shuttered Sight, Shattered Lives
LASIK has turned into a horror story for many.\r\n
Bill Martin and his family cherished those special moments together, like right before bedtime, when he read stories to his young daughter. “It was a critical part of our family life; it was a nightly ritual for us,” said the Iowa clinical psychologist. “Little things like that, you take for granted.”
As an enormously nearsighted but active parent, Martin hated fumbling for glasses or manipulating contact lenses with stiff fingers. When a respected colleague at the clinic where he practiced assured Martin in 2000 that LASIK offered a reasonable alternative for a more carefree lifestyle, he signed up.
Martin was in for a nightmarish surprise.
After surgery, he had permanent triple vision in one eye, double vision in the other, inability to distinguish shades, and intense eye fatigue that made reading all but impossible. “It’s a kind of claustrophobia,” said Martin, now 54. “You’re trapped behind these eyes that don’t function anymore.” Weeks after surgery, it took him three hours to drive 10 miles in the rain. “I was paralyzed when darkness fell,” he said. Rather than provide further treatment or referral to another specialist, his eye surgeon — the once-respected colleague — abandoned his case.
The botched surgery touched all areas of Martin’s life. He could no longer read professional journals or even menus. He opted out of the clinic setting, and set up a new practice. “Not being able to read books anymore to my 6-year-old was devastating,” said Martin. Enraged and profoundly depressed, he steadfastly refused to give up his career and go on disability.
Disheartening months passed as he searched for help. A web site called SurgicalEyes.org finally helped Martin locate Coppell-based optometrist Greg Gemoules. Martin soon traveled to North Texas to be fitted by Gemoules for custom hard contact lenses. The specially designed lenses superimposed a smooth surface over the psychologist’s ravaged eyes and restored a degree of vision. “I popped those things in my eyes, and it was the first time in 11 months I was able to see. It was an epiphany; I was euphoric,” said Martin. “Without Dr. Gemoules’ help I would be a basket case.”
Bill Martin is one of thousands of people across the country whose vision has been permanently damaged by laser eye surgery. Faulty equipment, poorly executed procedures, and inadequate risk screening have made LASIK a shattering experience for an unfortunate percentage of patients. For them, the aftermath means, at best, a host of visual aberrations — glare, halos, multiple images, star-bursts, or poor depth perception — and at worst, corneal transplants or blindness.
When their local doctors can’t undo the harm, anguished patients trek across the country or across the world looking for help. For many, the best option is specially fitted hard contact lenses that can compensate for what LASIK has destroyed. While North Texas produces its own LASIK casualties, it has also become an oasis of help for patients harmed by refractive surgery.
Most LASIK patients nationwide are satisfied with their surgery. But when laser eye surgery goes bad, it can go so bad — often disabling lives dramatically — that organizations and individuals across the country are crusading for curbs on the commonplace procedure.
New York lawyer Albert Parisi is even calling for a moratorium. “They’re selling it as if they were selling candy,” he said.
Humans look out on the world through the part of the eye called the cornea, the more pointed end of the egg-shaped eyeball. When the cornea is surgically reshaped — through what’s called refractive surgery — it can improve the eyes’ ability to focus. The most popular and widely known refractive surgery is LASIK. Last year more than 700,000 people nationwide underwent LASIK, most of them to correct nearsightedness. To date, about 3 million people in the U.S. have undergone some form of refractive surgery.
The ads now so common on television and elsewhere make LASIK — laser-assisted in situ keratomileusis — sound about as complicated and dangerous as getting a haircut. But a description of the actual procedure makes most people squirm: First, a surgical blade cuts a thin flap across the cornea. With that flap pulled back, the surgeon sculpts the remaining corneal bed with a laser. Assuming that the flap-slicing blade is completely clean and fully functional, the patients who typically enjoy the best results are those whose eyes have thick corneas and certain characteristics of pupil size relative to corneal curvature.
By contrast, people with very high prescriptions, thin corneas, or large pupils are not generally considered good candidates because of reshaping limitations. LASIK also disrupts nerves that control eye lubrication, so anyone with a previous “dry eyes” condition is likely to encounter some difficulty.
In the stories of those who have suffered LASIK tragedies, one theme recurs: People say they were never adequately warned of their individual risks. Martin, for example, made an unsettling discovery, post-surgery. “I was too nearsighted for the procedure. My prescription was at least -11, and using a conservative approach, many doctors won’t go past -6 or -7,” he said. Despite the papers he signed indicating consent before surgery, he maintains he was not fully informed.
A 44-year-old McKinney woman we’ll call Brenda Williams (she asked that her real name not be used) could comfortably wear contact lenses before her March 1999 LASIK. Now — thanks to eyes left profoundly dry by the surgery — just opening her eyes in the morning is painful. In the hopes of conserving precious eye fluids, the surgeon tried plugging up her eye drainage ducts, to no avail. She now applies wetting drops every two hours around the clock. The most continuous sleep Williams has had since surgery is five hours, and she owes that to a strategy she invented. At night, to stop her eyelids from drying onto her eyes while she sleeps, she applies lubricating drops and then seals her lids shut with plastic wrap.
Williams, who has three kids, sports dark circles under her eyes. She said medical personnel, during screening, told her that the surgery might exacerbate her dry-eyes condition — but minimized the potential difficulties. She said she was reassured that in the case of surgically worsened dry eyes, “we can always put plugs in” her tear drainage ducts. That procedure didn’t help, however. The counseling, Williams said, was “very flippant.”
In fact, she said that two different doctors told her she was a good candidate. “You hear ads constantly on the radio and you hear all these people that had success, and you can’t imagine that you wouldn’t,” she said. Now she’s back in glasses, because a test run with corrective contact lenses made her scream in pain. The only bright side, Williams said, was being able to warn off her brother and sister, who were both considering the procedure. “I’ve rescued them from doing it, from having the misery that I’ve had.”
She recognizes how lucky she is to have a helping mate at home. “I’m married and I have my husband. He can go to work and do things. My brother [is single and] has to take care of himself. If something happened to his eyes he’d be in a pickle.” Williams said she chose not to sue her surgeon out of fear that other doctors would refuse to help her if they knew she’d gone to court.
How safe is LASIK? Depends on whom you ask.
Irving Arons, publisher of the Executive Laser Briefing newsletter, called LASIK “a good procedure that’s getting better.” He was, however, careful to qualify his assessment: “The incidence of problems — with good surgeons and excluding discount providers — is less than 3/10 of a percent overall.” A little less optimistically, a top national LASIK provider, TLC Laser Eye Centers, puts the incidence of glare, halos, and starbursting after surgery at 2 percent.
Attorney Parisi, who represents a New York woman who had a LASIK blade dislodge in her eye, is not convinced. “The industry is the only keeper of the numbers,” said the lawyer, who said he has looked for, but cannot find, any meaningful numbers about people coming out of LASIK needing corneal transplants. In the broken-blade case, he said, “the doctor admits that the product malfunctioned, but I’ve yet to find where this doctor has reported this case to any federal agency. If doctors are not taking the time to fill out papers to report problems, the procedure may look a lot safer than it actually is.”
Dr. Robert Dotson, a member of the American Board of Eye Surgeons, a respected certifying organization, figures that nearsighted patients will need enhancements (the industry euphemism for additional surgeries) from 5 to 15 percent of the time.
The American Society of Cataract and Refractive Surgery represents about 9,000 eye surgeons nationwide. Dr. Doyle Stulting, chairman of the group’s refractive committee, estimated that 97 percent of LASIK surgeries are successful — meaning, he said, that the patient “achieves a visual outcome that meets their goals and expectations and allows them to be free of glasses and contact lenses for all or most of their activities.” Stulting’s assessment is in line with that of industry analysts.
Those who bother to dig through web-based U.S. Food and Drug Administration transcripts, however, will make a startling discovery: FDA experts put the dissatisfaction numbers much higher. As recently as Aug. 1, 2002, members of the FDA’s Ophthalmic Devices Panel put the number of unsatisfied or extremely unsatisfied patients at approximately 10 percent for a variety of laser-based refractive surgeries. They also expect 20 percent, or one person in five, to lose “low contrast acuity” — that is, they will be able to see less on an eye chart.
Splitting the difference between the highest and lowest estimates of “unsatisfying outcomes” still produces a figure of 150,000 people or more who have walked away from the eye surgeon’s office with significantly less vision than they had when they walked in.
Even successful surgery seems to be defined differently by doctors and patients. “My surgeon says he’s done over 30,000 successful procedures; he’s counting me as one of those, and I don’t think I was,” said Kim Gann, 27, who was a critical care nurse in Arlington until a recent move out of state.
About a week after her November 2002 surgery, while on an errand in a drugstore, something switched inside, and suddenly she couldn’t read or concentrate. “I felt like I was on nitrous oxide; it was the weirdest thing. I felt like my depth perception was off, and my eyes weren’t working together,” she recalled.
Her post-op visit showed that her eyes were healing properly, so she sought medical help elsewhere. A family doctor thought it might be allergies and put her on antihistamines. The next doctor thought it might be an inner ear infection and sent her to an ENT specialist who said she was fine. Another ophthalmologist said her eye correction was OK, but her depth perception was a little off. He suggested giving it another week. Still unable to read or administer doctors’ orders, Gann missed weeks of work. Just getting another appointment with the operating surgeon was a challenge. “I had to call and raise a big stink before I could even get back in to see him.”
More than four hours after her scheduled appointment time, the surgeon finally met with her briefly. “He looked in each eye with a light and I read the 20/20 line. He said ‘You’re healing well, you’re seeing 20/20. Whatever it is, it’s not in your eyes,’” said Gann. He told her to come back in three months. “I was just miserable. I felt like I had just screwed up the whole rest of my life, like I’d never see normal. The worst part was everyone telling me I was fine.” At times she felt so off balance and unsteady on her feet that she had to grab onto nearby furniture to right herself.
Meanwhile, her frustrated husband Andrew — who considers his own vision less sharp than it was before his LASIK procedure — scoured the internet for help. Through SurgicalEyes.org, he located Dr. Gemoules in nearby Coppell. One visit to Gemoules pinpointed Kim Gann’s problem: a long-standing eye coordination difficulty that had been minimized by eyeglasses and contact lenses but which surgery had brought to the fore.
Eye exercises have helped Gann return to work, but, she said, “I still see halos around lights, and starbursts.” Even so, she counts herself far luckier than many of the other post-surgical patients whose stories she reads on SurgicalEyes.org. As for her highly advertised doctor: “I wouldn’t go back to him if you paid me a million dollars,” she said. Neither Gann’s doctor nor his lawyer returned messages asking for comment on the case.
Dr. Clarke D. Newman, a fellow of the American Academy of Optometry, sees both sides of the debate. In his Dallas practice he counsels people considering LASIK and helps those who’ve had less than stellar results. He himself had successful refractive surgery performed on both his eyes in 1995. “If patients are diligently examined, if pre-operative assessment is done diligently, if we really examine them honestly and conservatively and rule out patients who shouldn’t have these surgeries, the overwhelming majority of severe complications can be prevented.” said Newman. “I’m not against surgery; I’m an advocate of the procedure, but I’m also the guy who has to clean up the mess.”
Patients have come from as far away as Thailand and Brazil to be treated at his office for debilitating post-LASIK glare and starbursting. “Every time I look at one of those patients I want to slap the surgeons, because we knew ahead of time they shouldn’t have had the surgery,” said Newman, president of the Texas Optometric Association and editor of its journal, Texas Optometry.
Dentist Sandra L. Ross, 48, did indeed slap her Dallas surgeon — with a lawsuit. In December 2001, she filed a civil case against Dr. Wesley Herman that as of a few days ago was still wending its way through the courts.
Ross contends that an inappropriate January 2000 LASIK procedure left her unable to practice dentistry. Further, she claims that a previous 1984 corneal transplant to treat keratoconus, a progressive thinning disease of the cornea, should have disqualified her from the procedure altogether. Phoenix ophthalmologist Edward Shaw, a cornea specialist, said in court documents that Ross was not accurately informed and that “high risk factors were missed or glossed over.”
Neither Herman nor his attorney, Charles Bell, would answer questions about the case. But Bell did write to say that “Dr. Herman denies Ms. Ross’ allegations.”
It’s hard to get a clear picture of the true risks of LASIK from court cases. Many unhappy patients, like Kim Gann and Brenda Williams, don’t sue. Even when a patient does, if an out-of-court financial settlement is reached, confidentiality is usually stipulated. There’s no way to tell how much money might have changed hands to quietly settle claims.
That’s the situation with Robinson v. Boothe, a lawsuit filed in Dallas district court in July 2001 against North Texas’ highest-profile LASIK practitioner. Court records show that John Robinson claimed he became disabled and required a corneal transplant as a result of surgery performed by Dr. William Boothe. According to documents in the case, an expert witness planned to testify that Boothe performed multiple LASIK procedures on Robinson, despite a pre-existing eye condition that made him a poor candidate.
Edward Quillin, Boothe’s attorney, said in an e-mail that the agreement reached in the case was confidential. “Dr. Boothe is a leader in the area of LASIK and works hard to ensure that each of his patients is a good candidate for the procedure,” he wrote. Neither the Robinsons nor their lawyer could be reached for comment.
“The idea that you can go to a seminar and get a free LASIK as a door prize is just nauseating,” said Fort Worth ophthalmologist Lee Anderson, president of the Texas State Board of Medical Examiners. He has voiced loud opposition to LASIK come-ons like “Have surgery now and start paying in August.” That tactic may be OK for selling furniture or shaving cream, said Anderson, but not for advertising medical procedures. Celebrity testimonials don’t get his endorsement, either. “What difference does it make to me if a sports figure had LASIK done? Does that imply that [the celebrity] did due diligence on this? Or did they get an in-kind treatment, for free” to encourage them to endorse that doctor?
“Somebody once told me that minor surgery is only performed on other people,” Anderson said. He considers LASIK a fundamentally good operation, but still “pretty major from the long-term complications standpoint. There are people who have trouble driving at night, halos, variations in their vision. There are people who had the wrong parameters plugged into the laser machine and come up with a different correction than they should have. There are people who have dry eyes and go ahead and have treatment and end up worse.”
Even a successful LASIK procedure does not guarantee a life free of glasses, Anderson said. Before surgery, “nearsighted people can take off their glasses and read in bed at night, but after LASIK and being over 40, they may not be able to do that anymore,” he said. “There are a lot of ramifications. People may not understand what they are buying into.”
LASIK providers usually offer literature on the procedure to prospective patients. But folks who want full disclosure about LASIK’s risks generally have to go hunting for it. The FDA web site is one of the few sources that provide key details in simple language. It explicitly warns against LASIK if there has been a history of serious eye problems, including keratoconus — the same condition cited in two Dallas lawsuits. The FDA also considers LASIK to be risky for people with large pupils, thin corneas, or dry eyes, such as Brenda Williams had going into surgery.
Oddly, although there is a wealth of research concluding that large pupils are a high-risk factor, large pupils are not mentioned anywhere in the 2002 patient guidelines distributed by the American Society of Cataract and Refractive Surgery (ASCRS).
When asked about the omission, Dr. Stulting, the Emory University professor of ophthalmology who co-authored the guidelines, said the news media overemphasizes the pupil-size factor — and suggested that perhaps non-physicians have no business questioning the guidelines.
“The lay press typically focuses on pupil size as a major indication or contraindication for surgery, but in fact there are many other parameters that are probably more important in determining who will have a good outcome,” he said. He admitted that among the screening tests done in his practice, pupil measurements are always included. Still, he said, “If we were to mention everything that has to be done in an exam we would have to write a 100-page book.”
The ASCRS guidelines could be seen as damage control for the highly lucrative LASIK industry. Stulting said the guidelines were created to correct public misconceptions revealed by a survey conducted in March 2002. Yet work on the patient guidelines had begun months earlier, in January 2002, according to an ASCRS staff member. Apparently, the survey was commissioned by ASCRS’ own public relations firm at the time the guidelines were already in progress. Whatever their authors’ intent, the current ASCRS patient guidelines made their inaugural appearance in spring of 2002, long after patients began having the eye-altering surgery.
Unhappy patients have been using any means available to voice their complaints. Angry California resident and design engineer Roger Bratt pays a pilot to fly this banner above beaches during busy holidays: “LASIK INJURED OUR EYES — WWW.LASIKSOS.COM.” One West Coast parent posted a diary of her horrifying and labyrinthine doctor visits and surgeries, plus links to LASIK-damning research, at lasikdisaster.com.
Brent Hanson is committed to his vendetta. The Illinois resident operates two web sites denouncing LASIK and specific surgeons. One site, tlcvisioncenters.com, is named to mimic the web address of the largest LASIK provider chain in North America. The goal is to detour potential TLC customers for an eyeful about Hanson’s own experiences, which culminated in corneal transplant. A publicly traded company, TLC Vision Corporation (TLCV), has an affiliated network of more than 12,500 optometrists and 1,000 ophthalmic surgeons. In an apparent act of cyber-retaliation, the domain name brentahanson.com mysteriously flips all of its visitors over to a TLC company website, tlcvision.com.
Unfazed, in January 2003 Hanson emailed 20,000 anti-LASIK press releases — addressed to look as if they came from TLC — to media outlets. “I plan to keep on doing this until I run out of energy,” said 39-year-old Hanson. “I think LASIK’s way too risky, and the consequences of failed surgeries are just so great that the benefits do not justify the surgery.”
The largest and most respected patients’ rights organization is the nonprofit Tampa-based Surgical Eyes Foundation, which runs the SurgicalEyes.org website. Executive director and founder Ron Link was among those urging caution and safety at the August 2002 meeting of the FDA’s Ophthalmic Devices Panel.
Six years ago, at age 35, Link was an athletic, accomplished firefighter who taught his colleagues about hazardous materials and how to remove crumpled cars from around accident victims. In his spare time, he acted in local Cleveland theatre productions.
On the advice of a trusted optometrist, and with the hopes of freeing himself from having to sleep overnight at the fire station in gritty contact lenses, Link in 1995 underwent radial keratotomy (RK) surgery, LASIK’s predecessor. The day after surgery he stumbled through theatre rehearsal, unable to see his feet on the dimly lit stage. The next night, driving the fire truck to answer an overnight alarm, he began to worry. “Things just appeared to melt into each other,” he said. He asked to be relieved of driving duty. Still, doctors assured him it was just a healing issue.
It soon became obvious that his vision impairment was permanent, that depth perception and contrast sensitivity were virtually gone. Career plans began to fade. One enhancement improved his ability to see an eye chart but had no effect on the ghosting, starbursting, and halos that clouded his vision. To add insult to injury, Link’s own research quickly revealed a body of scientific literature — dating back years before his own surgery — that correlated poor results with large pupil size. Link speculates that his trusted family optometrist never did any research before recommending surgery or that the doctor may have let a referral bonus influence his recommendation.
“I began a quest to find the best pair of contact lenses to bring me back to square one,” said Link, but a long and expensive search provided no answers. He slipped into depression. Even a professional background in crisis management couldn’t inoculate him. “Basement fires, attic fires, cliff rescues, heart attack victims ... nothing, nothing prepared me for the perpetual stress of simple daily living after refractive surgery,” he said.
After a two-year search, Link finally found a specialist in New York City who was able to help. Dr. Arthur Epstein, director of Contact Lens Service at North Shore University Hospital and chief medical editor of Optometric Physician, “helped fit me in a pair of specially designed contact lenses that no one prior had been able to accomplish,” Link said. The contact lenses superimposed a smooth surface on his ravaged corneas, providing him with more consistent vision and greater functionality in well-lit settings. It was a turning point.
A public protector by instinct, Link rechanneled his own despair into establishing the Surgical Eyes Foundation and recruited Epstein as one of its medical directors.
At last count, the Surgical Eyes web site has been visited over 2 million times and has over 5,000 registered users, mostly people with complications from LASIK. Judging from the thousands of posts on the site, finding the online community has been a key part of healing for people from all over the world. And that healing is not an easy process. The SurgicalEyes.org bulletin board ripples with pain and grief. Despite the best efforts of caring doctors and veteran patients, results aren’t necessarily positive. “The cutting edge is the bleeding edge,” said Epstein. “Patients suffer disability, depression, and suicide. Ron Link ends up doing suicide interventions.”
Malpractice insurers know that refractive surgery isn’t foolproof. The Ophthalmic Mutual Insurance Company, insurer of the American Academy of Ophthalmology, requires a separate, additional application for doctors seeking LASIK coverage, plus detailed guidelines about how LASIK patients are to be recruited and screened. In the same risk-minimizing fashion, TLC Laser Eye Centers, according to its web site, is willing to perform surgery on patients whom they refuse to cover under their “Lifetime Commitment Program.”
Parisi, the New York attorney representing the woman who eyes were damaged by a dislodged surgical blade, is preparing a class action suit against Bausch & Lomb, as well as calling for a moratorium on laser eye surgery. “What’s so frustrating for me is that they’re selling it as if they were selling candy, and they’re doing a real slick job,” he said. “You have a whole generation going into surgery. My kids and my kids’ kids will wind up with bad results.”
Parisi visited Dallas in January, meeting with two local women he expects to represent in the upcoming class action suit. Both were disabled by failed laser eye surgery procedures. One needs a risky corneal transplant; the other woman has been blinded in one eye. “LASIK is the latest cash cow in the medical profession,” said Parisi, who argues that the safety just isn’t there yet. “Whenever these procedures do go bad, it’s a catastrophe.”
Marketed like a miracle drug, LASIK and other refractive surgeries are actually a risky business with potentially sobering consequences. For those already damaged, the road to rehabilitation is slow, and many vision problems caused by the surgery simply can’t be fixed short of getting the patient a new pair of eyes.
“Contact lenses are still the most successful way to resolve the problems of refractive surgery,” said Coppell-based optometrist Gemoules. “Surgical procedures haven’t proven to be greater than 50 percent effective in even reducing them. I have treated a number of patients who had multiple surgeries to ‘fix’ the initial problem.” Gemoules is in demand across the country and overseas to advise other professionals on the intricacies of fitting patients whose vision has been damaged by LASIK.
The tricky part is that post-surgical contact lenses are not a one-size-fits-all proposition. Finding the right design and material that actually improves vision for an individual is a painstaking process. Several of the small handful of firms around the world that can actually produce suitable custom lenses are located in Texas. They work closely with optometrists like Newman and Gemoules to find solutions for these challenging patients.
Dallas-based C&H Contact Lenses is the sole manufacturer of the patented “MacroLens,” an oversized rigid contact lens approved for use with post-LASIK patients. Bob Cotie, C&H’s vice president, estimates that about 5 percent of the privately held firm’s business now comes from post-surgical patients.
In Austin, MetroOptics produces another type of lens frequently prescribed for post-LASIK patients. President Jim Webb said that he hopes to submit the rigid oxygen-permeable design for FDA approval in 2003. “Right now we’re restricted to supplying the lenses at the doctor’s request. After FDA clearance we can promote the lenses for that type of indication.”
Of his Dallas practice, Dr. Newman speaks bluntly: “People come here because of my reputation and experience, and also because I’m in the same town where the lenses are made. I can turn around two or three lenses in a day or two.” That’s a plus for patients who need to be fitted several times to find the lens that best helps their vision, and that they can tolerate wearing for hours at a time.
Over in Coppell, Dr. Gemoules recently met with a woman who traveled from Spain, desperate for his post-LASIK help. Many others have received his advice via SurgicalEyes.com under his pseudonym, Dr. Leukoma. In the span of three years, he posted more than 5,000 answers to questions from patients around the world on that site.
Gemoules doesn’t think the surgery should be stopped entirely, because too many people have benefited from it. But he feels that changes — such as better information for consumers and research into LASIK’s long-term effects — are needed. He also believes there should be tighter controls on advertising and more stringent regulation of surgeons’ qualifications.
In Gemoules’ office reception area, visitors find a map of the world hanging on the wall. At first glance it seems no more than a colorful decoration. A closer look reveals a spray of pins stuck into locales from Canada to South America to Europe —all the places from which patients have come seeking the doctor’s help. Following the Spanish woman’s visit, a new pin was added.
“I have known people who have become clinically depressed, who have become virtual prisoners in their homes at night, who have had to change careers or seek disability, whose marriages were disrupted or ended in divorce, all precipitated by a bad surgical outcome,” Gemoules said.
For people like Link, Martin, and Brenda Williams, the map is an indictment, the pins marking a trail of shattered eyes, of shattered lives.
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