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FDA to Hear from Lasik Surgeons, Unhappy Patients

Apr 24, 2008 | Parker Waichman Alonso LLP

The US Food and Drug Administration (FDA) is finally going to review complaints from patients who underwent Lasik eye-correcting surgery and who have suffered from a variety of issues, including blurred vision and dry eyes.  The FDA received 140 reports of Lasik surgery injuries between 1998 and 2006, according to an agency spokeswoman.  Lasik was approved a decade ago and an estimated six million Americans have undergone Lasik surgery.  The surgery permanently reshapes the cornea; there are no guarantees of 20/20 vision and the long-term safety of Lasik remains unknown.

The FDA will hear from Lasik eye surgeons and dissatisfied patients at a meeting Friday with its outside panel of eye experts and will ask the panel whether educational materials provided to patients considering Lasik require change or update.  Regulators agreed to hold the meeting after years of complaints from some patients who say their eyesight has been permanently damaged by Lasik.  "My life is a blur," Dean Kantis said. "When I look at a computer screen, I see two pages; when I look up at the moon, I see three of them."  Kantis is one of Friday’s scheduled speakers.

Double vision, night-vision disturbances and dry eye are among the side effects listed in literature given to Lasik patients; however, Kantis and others argue that physicians don’t generally focus on these risks.  "Just before the procedure, they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.

An FDA spokeswoman said the FDA has no authority over physician handling of patients; however, regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' post-surgical quality of life.  As part of the study to examine the relationship between Lasik complications and quality of life issues, are plans to look at psychological problems such as depression.  When patients undergo vision-correcting laser eye surgery—such as Lasik—they sign a release form with an extensive list of risks; however, researchers and former patients say a potential complication is not mentioned:  Depression leading to suicide.  While frustration and sadness can result from any unsuccessful surgery, when left with constant eye pain or permanently impaired vision, the response can be severe.  For instance, Colin Dorrian, 28, a patent lawyer and aspiring medical student from Philadelphia committed suicide last summer, six years after Lasik surgery left him with visual distortions.  The surgery was conducted at a Lasik center in Canada that has since closed.  "If I cannot get my eyes fixed, I'm going to kill myself," he wrote in a note police found, adding, "I have other problems like most people do.  But this is something else.  As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it."

Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb are under analyst radar as Lasik procedures are expected to decline five to 15 percent this year because it cost—between $1,500 and $5,000—may not be affordable to many consumers.