12

I was looking into Lasik vision correction surgery and came across an article by a former member of the FDA, Dr. Morris Waxler where he states that he wishes he had never approved Lasik surgery:

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.

About Waxler, who was in charge of approving it, the article says:

In the nearly 10 years since he left the agency, Waxler, (now a regulatory consultant who has stayed involved in FDA product approvals) has come to particularly regret the LASIK decision. Unusual for a former regulator, particularly for someone with business before the agency, in 2010 Waxler went public with criticism about FDA's approval standards. A year ago he went on "Good Morning America" and told correspondent Lisa Stark, "I did the best we could ... but in hindsight it wasn't good enough."

Last May, Waxler became more persistent. He considered LASIK eye surgery complications "already a major public health problem" and he said so in a letter to the ophthalmic organization, American Society of Cataract and Refractive Surgeons. He told the organization's president the group was presenting data for a safety study in an "unethical" manner...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.

Can these statements be verified? Is Lasik eye surgery so unsafe that all devices should be recalled? How many patients have had adverse effects so as to justify such a measure and deem that the procedure, as a whole, is unsafe? Have any factors been identified that present an alternative explanation for side effects (e.g. pre-existing conditions) other than issues with the method itself?

Lastly, can it be confirmed or denied whether or not (from the same article):

A committee of well-regarded LASIK experts (R. Doyle Stulting, M.D., P.h.D.; George O Waring III, M.D.; James J. Salz, M.D.; James McCulley, M.D.; Douglas Koch, M.D.; Jayne Weiss, M.D.; and Marian Macsai, M.D.,) responded to Waxler's claim: "We believe he has no reputable basis for such a claim since he did not produce the scientific evidence."

As in, does Waxler have any evidence or does he, and the supporters of Lasik are in denial?

  • Thanks for sharing valuable information with us…I am planning to have Lasik Eye Surgery and searching information regarding for the same. I am still in dilemma what to do what not to do. Please help me out. Best resource I have gone through www.laserlasikeyesurgery.com – user4720 Sep 6 '11 at 1:36
  • 1
    Anecdotal data. I have a couple coworkers(between 30 and 50 years) that got Lasik a few years aga and they are back to needing glasses on top of complaining about reduced night vision capabilities. – Stefan Oct 11 '12 at 16:07
  • @Stefan I believe I've heard the night vision thing as well. And I think somewhere that one should be reasonably sure that their prescription isn't changing anymore. But I think many without need for glasses for the majority of life aren't immune to the need for reading glasses. Re-reading, you're saying a few years ago... I wonder how long they'd been on the same prescription? For counter-anecdotal evidence, I know three co-workers who got lasik between 3-10 years ago and have had no complaints. – Hendy Oct 13 '12 at 17:31
  • It may just be due to aging in general. I personally cant even think about Lasik without getting somewhat nauseous ;). (or anything with regards to my eyes) – Stefan Oct 13 '12 at 20:42
14

Certainly during the initial years the rate of problems (leading to deterioration of the patient or at least lack of success) was high. But from what I've hear it's improved over time.
http://www.lasiksurgerynews.com/news/lasik-risks-complications-2008.shtml mentions similar problem rates for various complications of 10-20% (with references to printed studies).
http://www.usaeyes.org/lasik/faq/lasik-risk.htm otoh mentions only half a percent failure rate, which is either far more recent, doesn't include all things the other article includes, or both.
http://lasiksurgeryrx.com/lasik_risks.php lists, without sources or risk factors, the complications that can occur.
http://www.usatoday.com/news/health/2001-06-28-lasik.htm mentions 41.5% of patients in one study had trouble driving after LASIK (but doesn't tell whether the respondents were competent drivers before :) ).
Here's a surgeon performing the procedure talking about his own experience as a practitioner (on his website where he sells it): http://www.levinsoneyeclinic.com/complications.htm mentions the risks, but no percentages.


From these, it looks to me like risk factors exist indeed but the number of serious complications has dropped over the years and can be further reduced through careful screening of patients and the use of qualified staff (both of which may not always happen under economic pressure).
As the same factors are mentioned seemingly independently by many sources (including practioners) we can assume that they're at least viable risks (even if for each the risk may be very low).

  • 1
    +1 for addressing the issue of careful patient selection which plays a significant role in the success of any surgical intervention. – Monkey Tuesday Aug 30 '11 at 11:13

You must log in to answer this question.

Not the answer you're looking for? Browse other questions tagged .