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Since LASIK’s approval over a decade ago, 6 million patients have gone through the corrective eye procedure – making it the most popular elective surgery in the U.S. Nearly at the same time patients began to request it, complaints started to come in, leading to class action and medical malpractice lawsuits.
Although doctors do not guarantee perfect vision after LASIK, patients have found themselves in worse situations once the surgery is over. Visual disabilities have resulted: haze, halos, photosensitivity, starbursting, blindness, double vision, night vision problems, and overall worsened conditions that cannot be corrected with glasses. As a result, patients find themselves unemployed, are unable to drive at night or play sports, have permanent or temporary dry eyes, or require corrective surgery or a corneal transplant. A small group of patients so depressed by the outcome have attempted suicide.
LASIK appears to be a simple, straightforward procedure. A microkeratome cuts through the cornea’s top layers to make a flap. Then, a laser beam reshapes the cornea, and the surgeon replaces the corneal flap.
However, its simplicity has created a façade, one resulting in doctors overselling the procedure, risks being underplayed, and patients incorrectly screened for pre-existing conditions that pose significant complications, like HIV, large pupils, dry eyes, and diabetes.
Since patients began complaining in the early 2000s, the following instances have been found to result in LASIK complications:
Poor Equipment: LASIK equipment varies greatly in quality and may have a greater impact on the outcome than the doctor’s skills. Out of all possible equipment brands, the LADARVision laser is twice as likely to be associated with complications. In other instances, doctors were found to be using equipment approved by the FDA, also known as black box lasers.
Superficial Screenings: Physicians administering LASIK do not always thoroughly screen patients for riskier pre-existing conditions. This ranges from incorrectly determining a patient’s pupil size is larger than the optical zone or, post-operative, prescribing steroid drops that lead to glaucoma, autoimmune disorders, and corneal dystrophy.
Doctors Unwilling to Testify: Because of extreme retaliation from other LASIK-prescribing physicians, doctors remain reluctant to come forward to testify.
The FDA’s Role: The FDA has a limited role in how LASIK is prescribed and administered. The government organization cannot set a price for treatment, cannot require doctors to make disclosures or to provide thorough information, and cannot recommend a rating system. Nevertheless, because of the high level of complaints, the FDA held a hearing in 2008 with members of the Ophthalmic Device Panel to commission a LASIK Study Task Force to determine the surgery’s effectiveness. So far, a report has yet to surface.
Conditions: While resulting conditions vary, the following have proven to be particularly severe:
• Ectasia – Also known as a bulging cornea, this condition results in thinning and reduced structural integrity, which worsen over time. Signs start to show within a year after surgery and may result from a physician’s failure to identify a pre-existing condition.
• Central Islands – This vision-interfering condition pertains to elevations in the central treatment zone and may be attributed to a doctor not removing enough tissue, defective, or poorly-maintained equipment.
Filing a Lawsuit
As permanent vision-altering conditions resulting from LASIK fall under medical malpractice or defective product liability, anyone filing a lawsuit is advised to keep medical bills, receipts, and documents; hold onto records throughout the full process; put together a description of injuries and conditions that existed before the surgery; and to get a second opinion after the surgery. Patients are advised to be careful about signing an agreement with a doctor or healthcare provider.