FDA Reviewing Complaints about LASIK Vision Correction Surgery
The FDA is re-evaluating its position as to the safety and effectiveness of LASIK surgery. Millions of Americans have had successful outcomes from LASIK, in which a laser reshapes the eye’s cornea and reduces or eliminates dependence on glasses or contact lenses. However, members of the U.S. regulatory agency on healthcare issues are currently considering the testimony of 140 patients who are complaining of serious side effects. These individuals had LASIK procedures performed between 1998 and 2006.
Approximately 700,000 Americans elect to undergo laser surgery for vision correction each year. The majority who are selected as appropriate candidates can see with 20-20 vision or better after vision correction surgery. Unfortunately, about 25 percent of those who consult LASIK surgeons for the procedure are not appropriate patients. Those persons should clearly understand the risks they are taking if they decide to proceed with LASIK, which generally costs about $2,000 per eye.
With the LASIK procedure, doctors cut a flap in the cornea, the eye’s clear covering, and aim a laser underneath it. The laser quickly and painlessly zaps and reshapes the cornea to achieve sharper vision. Cutting the corneal flap severs the nerves responsible for tear production. If these nerves heal well, dry eye is only temporary. Some individuals endure long-lasting dry eye and intense pain which can sometimes be improved by additional surgery to help the eyes retain moisture.
Those with overly large pupils, thin corneas, severe nearsightedness, or who have difficulty with dry eyes should not be considered good candidates for LASIK. Some surgeons can be faulted for not giving adequate information on potential problems and for not ruling out those who do not meet appropriate criteria for the surgery.
About 95 percent of patients who undergo LASIK are satisfied with their outcome. In the 5 percent or less who have poorer outcomes, it is unknown how many suffer with troublesome daily side effects. It is estimated that less than 1 percent have severe complications that leave them with poor vision.
Among the complaints aired at the hearings are reports of unremitting eye pain, blurred or double vision, painful dry eyes, and poor vision even using glasses. For others, their problems leave them unable to drive at night due to glare or fuzzy vision. Headlights from approaching cars may look like huge “starbursts” of light. In extreme cases, an individual may become despondent and resort to suicide. In one testimony, a father told of his son’s suicide note in which he described his deep depression over his reduced vision and years of intolerable side effects.
Among the suggestions the FDA is hearing: (1) use photographs to illustrate the effects of poor outcomes; (2) explain how often patients suffer from side effects such as dry eyes (almost half experience this condition even months after LASIK); (3) communicate clearly the conditions that should disqualify someone from having the eye surgery; (4) explain to young persons with extreme nearsightedness that they would be guaranteed to need reading glasses in middle age if they have the eye surgery. Without LASIK, they might avoid the need for glasses in later life, as eyes become more far-sighted with age.
Although the FDA agrees with eye surgeons’ studies indicating that only about 5 percent of patients are dissatisfied, they do not yet know how many individuals suffer lasting severe problems and how many simply didn’t have the degree of vision correction they expected.
Those with overly large pupils, thin corneas, severe nearsightedness, or who have difficulty with dry eyes should not be considered good candidates for LASIK. Some surgeons can be faulted for not giving adequate information on potential problems and for not ruling out those who do not meet appropriate criteria for the surgery.
About 95 percent of patients who undergo LASIK are satisfied with their outcome. In the 5 percent or less who have poorer outcomes, it is unknown how many suffer with troublesome daily side effects. It is estimated that less than 1 percent have severe complications that leave them with poor vision.
Among the complaints aired at the hearings are reports of unremitting eye pain, blurred or double vision, painful dry eyes, and poor vision even using glasses. For others, their problems leave them unable to drive at night due to glare or fuzzy vision. Headlights from approaching cars may look like huge “starbursts” of light. In extreme cases, an individual may become despondent and resort to suicide. In one testimony, a father told of his son’s suicide note in which he described his deep depression over his reduced vision and years of intolerable side effects.
Among the suggestions the FDA is hearing: (1) use photographs to illustrate the effects of poor outcomes; (2) explain how often patients suffer from side effects such as dry eyes (almost half experience this condition even months after LASIK); (3) communicate clearly the conditions that should disqualify someone from having the eye surgery; (4) explain to young persons with extreme nearsightedness that they would be guaranteed to need reading glasses in middle age if they have the eye surgery. Without LASIK, they might avoid the need for glasses in later life, as eyes become more far-sighted with age.
Although the FDA agrees with eye surgeons’ studies indicating that only about 5 percent of patients are dissatisfied, they do not yet know how many individuals suffer lasting severe problems and how many simply didn’t have the degree of vision correction they expected.
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