Spurred by complaints of adverse events, the Food and Drug Administration announced yesterday that they would launch a multi-year study to examine the potential impact on quality of life from Lasik laser-vision correction surgery. Lasik surgery permanently reshapes the cornea with a laser but consumers face a lack of reliable data about the frequency of troubling side-effects, such as dry eyes, halos, and blurry vision.
We think that an FDA review is a good thing. Consumer Reports Health's recent Lasik survey found that many patients (53 percent) dealt with distressing side effects—some of them for up to six months after the surgery. And while most people (about 80 percent) were satisfied with the procedure, nearly two-thirds were disappointed to find that they still had to wear glasses or contact lenses at least occasionally.
Lasik surgery and similar operations are elective, not essential, medical procedures, which makes such side effects all the more distressing—and most people have to pay thousands of dollars out-of-pocket for it. The data for long term safety and effectiveness of the procedure is currently unknown, due to insufficient data. And much of what we do know comes from the doctors who make a living providing the surgery. The FDA just admonished 17 such providers for not keeping adequate records on adverse events.
We’ve also asked patients about the quality of life after the surgery. In addition, we’ve combed the latest studies and surveyed nearly 800 patients who have had the surgery. If you’re considering having LASIK, our decision guide can help you decide if the procedure is right for you.
The toolkit includes:
* A tool to help you determine whether you're likely to be satisfied based on your expectations compared to the experience of others.
* Detailed information from consumers who have had the surgery.
* A safety assessment of laser vision-correction surgery based on the latest evidence.
* A guide to choosing a surgeon, including key questions to ask and red flags that should prompt you to get a second opinion.
* What to expect before, during, and after the surgery.
* The costs of surgery, insurance coverage, and payment options.
—Kevin McCarthy, associate editor












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