Federal agencies to assess LASIK problems

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The Food and Drug Administration (FDA), the Defense Department, and the National Eye Institute announced plans to launch a three-year effort to gauge how many patients suffer troubling symptoms after undergoing the vision correction procedure called LASIK. The program will be called the LASIK Quality of Life Collaboration Project.

In addition, the FDA has issued warning letters reminding 17 walk-in LASIK surgical centers of their obligation to report poor outcomes and surgery-related medical complaints. The letters were issued after the FDA conducted inspections of LASIK facilities and found many had no system for collecting and transmitting data on patients' reports of post-surgical adverse events. Legislation passed in 1990 requires that medical facilities report all device-related serious injuries or deaths to both the FDA and the device manufacturer.

No device malfunction was noted during the center inspections.

LASIK is the medical abbreviation and general term for laser-assisted in situ keratomileusis. It is a form of eye surgery that uses laser to improve vision. A surgical instrument called a microkeratome is used to cut through the top layers of the cornea to create a flap, and then the laser is used to reshape the cornea. The corneal flap is then replaced.

It is estimated that approximately 6 million people have undergone LASIK surgery in the United States. This is not the first report of safety concerns regarding the procedure. The FDA reports that it received 140 complaints between 1998 and 2006.

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In 2007 LASIK recalled all 6000 LADARVision lasers worldwide after patients experienced an unusually high percentage of serious complications. In May 2006, US LASIK clinics reported patients developing central islands after surgery. Central islands are areas of the cornea that do not receive the required amount of laser energy, creating elevated spots on the cornea.

A 2008 American Journal of Ophthalmology report found that additional surgeries were needed for 28% of the eyes treated with LASIK less than 10 years after the initial surgery, due to under correction, overcorrection, or regression. In addition, it is estimated that between 2 and 5% of LASIK surgery patients, as many as 75,000 a year, have lasting “quality of life” post-operative problems that include painful dry-eye, poorer vision, halos, glare, and even blindness.

In May 2009, the FDA circulated a letter to eye-care providers calling attention to "deceptive or misleading healthcare advertising claims" and outlining the limits of allowable claims that may be made for LASIK.

In the first phase of the monitoring effort to measure LASIK's effects, which began in July, the FDA drafted a Web-based survey of patients who have undergone the procedure. The questionnaire focuses on quality of life problems after LASIK surgery. In its second phase, the Defense Department will gauge how many active-duty military patients suffered post-surgical eye problems after surgery at the Navy Refractive Surgery Center, and whether certain populations of patients fared worse. Phase 3 will be a national multi-center clinical trial which will end in 2012. The trial will study the general patient population across the country to determine how many, and who, suffer problems from the surgery.

The FDA hopes that the results of the study will help the agency understand the adverse effects of LASIK and identify means to reduce the risks for future patients. New regulations on the safe use of LASIK may also be put into place if the FDA deems necessary.

Makers of LASIK lasers include Advanced Medical Optics Inc, Alcon Inc., and Bausch and Lomb.

Sources Include: FDA, AboutLawsuits.com, and LawyersandSettlements.com

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Comments

I think that this will be an important study.