Lasik Surgery: Have the risks been properly communicated?
The federal government says eye care providers aren't being totally honest
Tuesday, January 1, 2013
Back in the day if a doctor told you they would be able to shoot a laser directly into your eye to correct your vision one day, you might have thought they were either a quack or a sadist.
Well, today Laser-Assisted in Situ Keratomeleusis -- Lasik surgery -- is a commonly-used procedure to permanently correct one’s impaired vision, specifically those with nearsightedness, farsightedness and astigmatism.
The procedure involves reshaping the eye’s cornea with a laser to correct vision.
According to the research firm Market Scope, there were over 600,000 Lasik surgeries performed in 2011 and although many people have reported improved sight with no vision problems after the procedure, the Food and Drug Administration (FDA) still warns consumers about many potential side effects.
One of the first things to do before opting for Lasik surgery is to determine if you’re really a candidate for the procedure, says the FDA, as the surgery isn’t the answer for all people who have vision problems. (Watch related YouTube video here)
Side effects, contraindications
Those who aren’t good candidates for Lasik surgery include people who had changes in their glasses or contact lenses in the past year, those who have certain chronic ailments like diabetes, and those who take medications like Prednisone, which can slow down post-surgery healing.
The FDA also says those with a history of eye diseases such as glaucoma may also be ineligible for Lasik, which is why it’s important to do all the research you’re able to before speaking to your doctor, so you’re able to ask the questions that are most pertinent to your specific case.
The FDA put up a Lasik website and informational video (below) and emphasizes the importance of patients speaking to their ophthalmologist about any previous eye injuries or eye surgeries.
Experts say if used on the right candidate, Lasik can be a very effective type of surgery.
“The FDA reviews the clinical data from Lasik Laser manufacturers,” said Anita Rayner, an expert on FDA patient safety regulations. “These data showed that when Lasik is done properly, and on the right patients, the benefits outweigh the risks.”
According to statistics from the American Academy of Ophthalmology (AAO), over 90 percent of people who have undergone Lasik achieved 20/20 to 20/40 vision and are able to fully function without glasses or contact lenses in their daily lives.
However the AAO also warns that although many achieve 20/20 after the surgery, it may not be the 20/20 that most people are used to through their contact lenses, as many people have reported that their vision was improved by leaps and bounds, but their sight still wasn’t as sharp as it was when visual aids were worn.
In fact, this dullness of vision has been so prevalent among some Lasik patients that the ophthalmic community has coined the term “loss of contrast sensitivity” and warns people who are in jobs that require a lot of visual focus like an editor, painter or numbers cruncher, to give an extra amount of consideration to determine if undergoing Lasik is really worth the risks.
Other serious side effects patients can encounter include night vision problems, halos, starburst, light sensitivity and double vision, which can either be temporary or permanent depending on several factors that should be discussed beforehand with your doctor.
Take it seriously
In an published interview Morris Waxler, who directed the FDA’s initiative to regulate Lasik, said although the FDA revealed the side effects and dangers associated with the procedure, the general public -- the health community included -- should have taken the warnings much more seriously.
“I wouldn’t say it was pooh-poohed so much as it was just sort of shoved aside,” he said. “It’s right there in the record. The agencies and the refractive surgeons' people know these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.”
To assure that eye care providers properly communicate the risks involved with Lasik surgery, the FDA sent letters to eye-care facilities in Georgia, Indiana, Florida, Texas and California this week, warning them to halt their misleading advertising that fails to warn consumers about the many risks involved with Lasik.
The letters are part of an ongoing effort by the FDA to provide a better balance of information about the benefits and potential harm of Lasik and what consumers should keep in mind before going forward with surgery.
“Providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection,” said FDA’s compliance director for its Center for Devices and Radiological Health division.
“The FDA reminds consumers that eye surgery such as Lasik is irreversible, that not all patients will achieve optimal results, and that some patients may need additional procedures.”
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