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Biomedical Innovation with Colin Stewart ~ Biomedical news and comment from Orange County, Calif., and beyond

FDA will probe Lasik, which leaves about 40,000 patients unhappy each year

March 18th, 2008, 8:10 am · 11 Comments · posted by Colin Stewart

Eye surgeryThe Food and Drug Administration plans to investigate whether Lasik eye surgery is helping patients as it promises to.

Problems with Lasik surgery are relatively infrequent – all but about 5 percent of patients report they’re satisfied with the outcome – but the procedure is so popular that even occasional problems add up fast. About 40,000 patients a year aren’t happy with the results they achieved with Lasik.

Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said yesterday (March 17) that an advisory panel will focus on whether the popular form of eye surgery is improving patients’ lives.

Complications can include dry eyes, glare, double vision, inflammation, infection and even blindness.

One recent example was recounted by reporter Abby Ellin last Thursday (March 13) in her article “Lasik Surgery: When the Fine Print Applies to You” in the New York Times. She told her own story of Lasik surgery that left her with dry eyes, seeing halos around bright objects at night:

Little did I know when I chose Lasik surgery that I would not end up satisfied like the friends and acquaintances who raved about their post-glasses existence. Instead, my days are complicated, since I am dealing with side effects that are far more bothersome than being unfashionably four-eyed. …

At night, I saw halos around streetlights; neon signs bled; the moon had two rings around it like Saturn. My eyes felt sore, a result of dry eye, which also causes sporadic blurriness.

The issue of variable quality in Lasik surgery outcomes was tackled last month by eye-care company Advanced Medical Optics in Santa Ana, which makes optical lasers. In response, it created the brand iLasik for eye surgeons to use as a label for “the most advanced laser vision correction technologies available today under the banner of one premium procedure.”

Ellin reported:

Roughly 800,000 patients have had Lasik annually since 2000, spending about $2.5 billion on the procedure every year, said David Harmon, the president of Market Scope, a research company for the ophthalmic industry in Manchester, Mo.

The American Society of Cataract and Refractive Surgery reports a 95.4-percent patient satisfaction rate for Lasik, based on a recent analysis of research worldwide. The researchers found 19 studies specifically addressing patient satisfaction from the last decade, encompassing roughly 2,022 patients. (Some had been post-op for a month; others for a decade).

Here is the Reuters report on the FDA announcement.

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11 Comments

11 Comments

  • Jess says:

    They should ask the 5% unsatisfied if they just went to the cheapest doctors or the doctors with the best reputation. As with all things I thing you get what you pay for. I just had lasik last friday and it’s great!

  • jmark says:

    I had to have PRK because I wasn’t a good candidate for Lasik. It’s a good month before your vision gets to be almost normal and up to 6 months to stabilize. I wasn’t totally satified with my procedure either. My vision is not 20/20, more like 20/25 and it doesn’t seem real stable. Sometimes my vision is better and sometimes worse. At night, street lights and headlights are fuzzy. I paid extra to get the Wave Technology which is supposed to enhance your chances of really sharper vision. Guess it didn’t work for me. So, I don’t have to wear glasses but I’m disappointed that I don’t have perfect vision.

  • Elaine says:

    I work in the medical industy and chose one of the best, most qualified physicians in OC. I would never recommend it. My eyes are chronically dry. One also needs to understand that as we age, we all become near sighted–so glasses still are needed. Also, my “far” vision has worsed since I had the procedure 5 years ago. I know of many people who have had Lasik and are not 100% satisfied. I welcome the FDA’s inquiry.

  • Pepi says:

    If a eye doctor can not do the procedure on himself and is wearing glasses, then you know you need to find another doctor.

  • CK says:

    I agree, Jess. I haven’t done it yet but my husband had it done at least 6 or 7 years ago and he couldn’t be happier. No problems whatsoever except a little sensitivity to bright light at first. He did his research and went to a doctor with a good track record. Of course it costed more, but you only have one set of eyes! I’ll hopefully do my own eyes in the next couple years.

  • Brian says:

    I had Lasik 7 months back. Many difficulties. Eye sockets very tender to touch. Both eyes have different presciptions now. Right eye took a long time to heal. Major headaches for several weeks right after the surgery. I usually have 2 - 3 “bad days” a week. I had the “best doctor” in the area… Jury still out on if it was worth it…

  • Pat says:

    Jas, here is one of the 5% unhappy and suffering. My surgeon was the most expensive one out of four consultations I had. Today, I’d pay ten times my Lasik cost if I could have my old eyes back. Don’t assume things or make such a heartless comments - especially if you just got yours done. Isn’t it a bit early for you to assume that everything will be okay with your eyes?

  • Irvine Reader says:

    I had Lasik done in 2002 and have never had a problem. I went to a reputable Lasik center and used a doctor with a lot of Lasik experience. I feel it was worth every penny. After all this time, my vision is 20/50 because I have to do a lot of reading but, originally, it was 20/15 and 20/20. I see my eye doctor once a year as recommended and he hasn’t seen a further decrease in my vision for almost three years. I’m thrilled I did it!

  • LASIK was the worst decision of my life. Since I had LASIK I have spent much of my spare time researching LASIK complications. The medical literature and FDA clinical trials report that chronic dry eyes and night vision impairment occur frequently after LASIK. But the LASIK industry doesn’t count these complications, even if they are life-altering. Some studies report complications rates around 30%. Moreover, the LASIK flap only heals to 2% of the cornea’s original tensile strength, and the biomechanical strength of the cornea is permanently reduced by about 50% after LASIK. You can read more about LASIK risks and long-term complications on my website at http://www.lasikcomplications.com

  • ladyR says:

    I am a 40 year old woman and am planning to get the LASIK surgery done. I have no reading issues as of now but can not see distance that well. I have been wearing glasses for the past 2 years. I did a lengthy assessment of the eyes and was told that if my weak eye is corrected i could still read normally and see distance well but if both eyes are corrected (where i gathered during the assessment my distant vision was absolutely perfect) i may have to wear reading glasses. In my part of the world it would cost around $1000 to get both eyes done. Is this is usual price.

    Also, on the comment that if your Dr. is wearing glasses that it is a good indicator no to do the surgery… i understand that LASIK is most effective for the age groups 18 - 40. My doctor is around 55 and LASIK is new o our country. So is that a fair assesment.

    Please give me some valuable advice… someone… Thanks

  • Suzanne says:

    Having Lasik was a great decision for me. I made sure I went to an ophthalmologist that had a lot of experience and would manage my care after surgery. I knew all of the risks before I had surgery and felt the benefitsof the surgery outweighed the risks. Where will the inquiries end - people are dying during plastic surgery - should we have all the people that are unhappy with their optional surgery come forward? We need to face the fact, Lasik is an optional procedure - you are putting yourself at risk for a procedure that does not have to be done to save or improve your quality of life. There are thousands of people everyday that make the decision to go under the knife to improve cosmetic problems - not everyone walks out happy with the results. If you are about to have any type of surgery you need to fully understand that things can and do go wrong there are no guarantees with surgery of any kind.

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