15 February 2011

Questions raised about LASIK surgery

Excerpts from an article at Politics Daily:
LASIK -- which is neither a trademark name nor a franchise, but the acronym of a surgical method, "laser-assisted in situ keratomileusis" -- seemed miraculously easy, even though it involved a scary-sounding and delicate procedure. (It entails slicing a thin, hinged flap on the front surface of the cornea, a surgeon lifts the tissue up and, using ultraviolet excimer laser beams, reshapes the eye before folding the flap back over the cornea). Well-heeled professionals then turning 40ish, (an age in which human sight weakens), were drawn to what seemed like a medical miracle of rejuvenation. Laser eye surgery, when done correctly on appropriate candidates, painlessly turned terrible vision to nearly perfect.

In 1995, the FDA approved the first laser-assisted system for refracted surgery... For the ophthalmic profession, LASIK correction surgery was like a gold rush. By 2008, 12 million patients had undergone the procedure in the United States at an average cost of $1,500 to $2,100 per eye. Over 700,000 people have the surgery every year...

But in the months and years after LASIK became ubiquitous at 25-year class reunions, stories of eye damage and subsequent depression, even suicides, surfaced. The surgery can, it turns out, induce dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects...

Finally last month, Waxler filed a formal citizen's petition to his former government employer requesting the FDA withdraw approval for all LASIK devices and to issue a public health advisory for recalling the equipment... In his petition, Waxler says manufacturers and also "clinics, refractive surgeons, and agents withheld and distorted safety and effectiveness data" and, he alleges, "in a classic example of the fox guarding the henhouse," the "collaborators" routinely hide reports of LASIK injuries from FDA by settling lawsuits out of court. He also claims that equipment makers have "cherry-picked, withheld, and hid data from FDA" that he believes show LASIK with "excessive adverse event" rates of 22 percent.
More at Politics Daily.

9 comments:

  1. Every time I get tired of putting in and taking out and cleaning my contact lenses, I think of LASIK. And then I think of the "dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects..." and a few minutes every day on lens maintenance doesn't seem so bad.

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  2. Slicing the eye and bombarding it with concentrated light can be....harmful? Who would have guessed?

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  3. I got it done on my eyes 3years ago.. before the surgery the doctors told me about all the risks mentioned in your article. yes.. the eyes are a lil dry when i wake up in the morning, but as soo as i start blinking it goes away. and i believe all good things come with a price. and most importantly.. my vision is perfect.

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  4. Ok, the question I have is what generation of LASIK surgery is the problem? Have the techniques and equipment improved?

    For example, saying that arthroscopic surgery needs to be banned would silly since the surgery has gone from opening up the entire knee to three little dots you have from an outpatient surgery. Fill a room with the people that have 2 banana-sized scars on each side of the knee and bang a drum screaming that this process needs to be stopped will gain press coverage every time... but it's just silly in the big picture.

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  5. I'm an ophthalmologist working in a European public system. I don't perform LASIK, am a general sceptic and open to all of medical science being proven wrong, but I have huge issues with this article.

    The ophtho community has never claimed LASIK or any other refractive surgery was a panacaea or risk-free. The "dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects..." have been known since the early research in animal models and any reputable surgeon would explain these to patients prior to laser. If you weren't told about adverse effects, then the problem is your individual surgeon, not the treatment or the FDA. I've met many patients who are allergic to penicillin but we don't hear anyone trying to ban it, because most of us recognise that antibiotics can have unwanted side-effects.

    DubyaD makes a key point about modern LASIK - femtosecond lasers and other improvements have greatly improved outcome, safety and patient satisfaction. It's been 25+ years since Waxler was involved.

    Surgeons have a duty - both legal and ethical - to explain possible adverse events, but patients also have a responsibility to educate themselves and to be realistic about outcomes.

    A core part of the problem with eye surgery is the struggle to provide cheaper and cheaper treatments - people look on it as a commodity rather than a medical intervention. If the public views it as something akin to buying an iPod then it stands to reason that expectations will be exaggerated and certain physicians will provide inappropriate treatment.

    As blitherypoop said, slicing open and eye and cutting away part of the cornea with a laser beam is not exactly a walk in the park. How safe does Waxler want it to be? We all have different ideas of acceptable risk and cost-benefit ratios.

    Some people are happy to have their baby circumcised for purely cultural reasons, even though a number of boys bleed to death each year from such surgery. Way too dangerous for my liking, but many would disagree!

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  6. I opted for PRK. No slicing, but a brushing of the outer layer of cells prior to the laser zapping your cornea.
    The layer then regrows. Takes a bit longer to heal, but it is much more stable than lasik. Armed forces people use it precisely because it is more stable (I ride motorcycles, and appreciate the stability).
    From the get-go I was described the risks. But even before that, if you are thinking of zapping your eyes with a freaking laser, some research should be performed (right?).
    And yes, in low light situations, I need to try a bit harder. In the morning, eyes are a tad dry.
    But, the other 95% of the day, its pure bliss. I had forgotten how beautiful it was to see details in mountains, cities, etc.
    By far, the best money I have spent. Money, btw, which is never covered by your insurance.

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  7. My Dad had PRK done on one eye, but was left with a halo. He was scared to try anything on the second eye, but eventually opted to try Lasik. He now has perfect vision in that eye.

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  8. I've got Lasik surgery a month ago, my doctor explained all the risks and now I have 20/20 vision.

    Of course I have a little dry eyes, but it's minimal compared with the discomfort of contact lenses.

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  9. glad i had it done, but every year my eyesight deteriorates a little more. I'm back to wearing glasses for night driving and watching television. My vision is nowhere near 20/20.

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