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Aggressive marketing has made the well known vision correction surgery known as LASIK surgery (laser-assisted in situ keratomileusis) a $2 billion industry, with it coming under fire for overstating the benefits of the surgery and downplaying its risks. As many as 75,000 patients a year are estimated to have lasting post operative problems including poorer vision and even blindness! Even more alarming is that the FDA has recorded only a tiny fraction of these problems. From 1998 to 2008, the agency admitted that it had received only 140 reports of post operative problems!!! Clearly, these problems are not getting recorded effectively.

The FDA issued reminders on the need to record adverse results to clinics offering the surgery after they discovered that many did not have systems to do so. Poor results include dry eye, poorer vision, halos, glare, and sometimes blindness. Not only is there insufficient data to confirm the estimated 75,000 patients experiencing these results, but the existence of such complications is often downplayed by marketing schemes.

This has led three federal agencies, the Food and Drug Administration, Defense Department, and National Eye Institute, to develop a plan outlined in this article. The plan starts with the FDA creating a website for patients to report results, followed by the Defense Dept. measuring how many active-duty military patients had poor results, and ending with a larger study of patients to determine how many had postoperative problems. The plan will end in 2012 and officials hope this more accurate data will help improve the surgery in the future.

One Comment

  1. Gravatar for Dr Fink

    Where do you get the figure 75000 from? In my practice I have a less than 1% disatisfaction rate, and nearly all of those are people who after an enhancement treatment still need glasses, and just give up, withoput any actual drop in vision or damage done.

    Patients who have irreversible significant drop in vision or unbearable dryness/halos are very unusual today with modern technology available. Most disatisfied patients with the above symptoms had treatment in the past with older technology.

    That isn't to say that problems don't occur or the FDA shouldn't be monitoring. The main concern with Lasik is the long term incidence of unexplained ectasia which nobody seems to know, and hopefully the FDA study may shed light on. For this reason many doctors including myself are doing a higher percentage of PRK treatments instead of LASIK.

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