When LASIK Goes Wrong
After considering testimony about unfavorable LASIK outcomes, an FDA panel in early 2008 declined to consider a moratorium on the procedure as some speakers had urged.
Instead, FDA officials recommended clarifications in information presented on the organization's website and in patient disclosure forms that would make the risks of LASIK surgery clearer. The FDA also launched an ongoing LASIK Quality of Life project to collect detailed information about safety and patient satisfaction.
Although the vast majority of LASIK surgeries go well, some experiences with poor outcomes presented at an April 2008 FDA hearing provide cautionary tales.
By all accounts, Dominic Morgan should never have had LASIK. At birth, he had retinopathy of prematurity. This condition limited his vision to about 20/50 (not good enough to drive in most states), even with eyeglasses and before he ever underwent LASIK.
The surgeon who performed his LASIK procedure in 1998, in the early days of laser eye surgery, used an unapproved laser. Pressure from the eye suction ring used in the procedure effectively destroyed his fragile retinas, leaving him legally blind.
Morgan maintained that the surgeon illegally advertised the procedure and didn't give him the appropriate information before surgery. In retaliation, he founded his own website to share his experience with others.
Gerard Dorrian testified that his son, Colin, had LASIK surgery in 2001, when he was a law student at the University of Michigan. At the time, Colin couldn't wear his contact lenses in fact, his eyes may have been too dry for him to have LASIK successfully.
In any case, Colin did have LASIK and ended up with poor quality vision and painfully dry eyes. Unable to cope, Colin took his own life, telling his family in a note that it was the only dignified choice.
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Psychiatrist Jennifer Morse, MD, emphasized at the hearing that depression and suicide are complex and influenced by multiple factors, rather than caused by a single event.
Still, patients who have had a poor outcome from LASIK can easily fall into depression, said Terri Lynn F. Bankas, MD, who counsels a LASIK support group in Tampa, Fla. She explained that many of the people she has worked with suffer from sleep difficulties, loss of autonomy and self-anger.
She said they have experienced financial problems and estrangement from family and friends as their obsession with their vision intensified.
Some people with disabling outcomes from LASIK, like Dominic Morgan, were treated years ago with early lasers that are no longer on the market today. Modern lasers and other devices used in the LASIK procedure have generally produced very good outcomes. Nevertheless, there continues to be a small minority of cases in which, whether through bad surgery or just bad luck, the outcome is undesirable.
Joseph Schnell knows that all too well. He had LASIK in both eyes in 2007, partly because his union vision insurance covered a portion of the cost. Unfortunately, he was left with LASIK complications such as glare, halos, starbursts and generally poor vision at night.
Schnell endured periods of depression, anxiety and physical ailments including nausea, which he believes were directly related to his visual problems. Although circumstances are better now, he told FDA officials that he regrets his decision to have LASIK.
Matt Kotsovolos had wavefront-guided LASIK in 2006 at an eye center where he was then the senior financial executive. Although he has 20/20 vision, he explained that he suffers from debilitating and unremitting eye pain from dry eyes.
Dry eye after LASIK is a common symptom that typically resolves in a matter of weeks or months and can usually be alleviated with artificial tears or other treatments. But for a minority of patients, like Kotsovolos, dry eye may be severe and longer lasting.
"Complications classified as 'symptoms' get buried in the medical literature," Kotsovolos told the panel of experts.
The Bigger Picture for When LASIK Goes Wrong
Although these patients had devastating outcomes, taken in context they represent a very small group the worst possible outcomes in a largely favorable universe of LASIK results.
A recent worldwide review of LASIK by the American Society of Cataract and Refractive Surgery (ASCRS) showed that more than 95 percent of patients who had the procedure were satisfied. The worldwide review examined the results of peer-reviewed studies in major scientific journals that comprise more than 32,000 patients treated in the past decade.
David J. Tanzer, MD, director of the U.S. Navy Refractive Surgery Program, reported to the FDA panel that, of 224,000 laser vision surgeries performed to date in the U.S. military, only one person has gone on medical disability retirement because of the procedure.
"If I did not believe in the safety of this procedure, I would certainly not be recommending it or performing it on naval aviators, let alone civilians," he said, noting that LASIK is overwhelmingly safe.
In a survey of Navy pilots, 95 percent said the procedure had made them more effective in their job; none said it hindered their effectiveness.
LASIK Safety Tips
These patients' stories are compelling reminders that with LASIK, like any other surgical procedure, the risks and benefits must be weighed. What can you do to stay on the right side of the statistics and avoid becoming one of the horror stories?
- Read more about LASIK, including questions to ask your surgeon, at www.allaboutvision.com/visionsurgery/.
- Get a second opinion before surgery.
- Don't feel pressured to sign paperwork in a rush. Take it home, read it carefully and ask the surgeon or staff about any concerns or questions.
- There are always risks in any surgical procedure. Carefully consider your own level of risk tolerance.
Ongoing LASIK Research
FDA data showed that, although approximately 12 million people had LASIK in a 10-year period following initial approval in 1995, only 140 complaints were filed with the agency.
The FDA is partnering with the National Eye Institute and and U.S. Department of Defense on a large, multi-site prospective study on patient satisfaction and quality of life after LASIK.
Called the LASIK Quality of Life project, the study as of early 2011 included these phases:
- Design of a Web-based questionnaire to assess patient satisfaction, created in part from interviews with those who have undergone LASIK.
- Launch of a clinical study among U.S. military personnel who were to answer the questionnaire and provide self-reported outcomes after undergoing LASIK.
- Expansion of the clinical study to include self-reported outcomes from people who have undergone LASIK at different U.S. surgical centers.
All phases of the LASIK Quality of Life project are expected to be completed in 2012. AllAboutVision com will provide updates as research continues.
[Page updated March 2011]
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