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LASIK Surgery - Depression Link To Be Studied by FDA

Feb 26, 2008 | Parker Waichman Alonso LLP

LASIK surgery - a procedure that can sometimes lead to life-altering complications --  has caught the eye of federal regulators.  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. In response to patient complaints, the US Food and Drug Administration (FDA) plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression.  

Malvina Eydelman, an ophthalmologist with the FDA's Center for Devices and Radiological Health, says the limited clinical data "failed to suggest significant problems following LASIK surgery."  Confirming that the FDA wants a broad and systematic review, she said, "We also noted that quality of life issues related to LASIK had not been evaluated consistently and there were few reports of well-designed studies."  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."

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but don't believe LASIK complications are the root cause, arguing that patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.  "There's no cause and effect," said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from LASIK.  Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, has encountered the psychological effects that patients experience when they have trouble seeing.  "Depression is a problem for any patient with a chronic vision problem," she said.  In the case of post-LASIK patients, depression is compounded by remorse, "It's not just that they lose vision.  They paid somebody [who] took their vision away," she said.  Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications and said people at risk of depression or anxiety are generally not good LASIK candidates.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.

A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country.  The FDA is also planning a public meeting to discuss experiences with LASIK devices since their introduction to the U.S. market.