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Bill Coughlin > Intel > The LASIK Nightmare Continues

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The LASIK Nightmare Continues

By Bill Coughlin

About 700,000 people a year in the United States get LASIK surgery to “correct” their vision.

Some walk away happy — while others walk away with permanent damage. And, as the website Life After LASIK reports, “Happy LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there.”

Now, in a stunning development, one of the FDA regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety.

Morris Waxler, the former head of the FDA branch responsible for reviewing the data on LASIK, told ABC News in his first television interview that, in hindsight, those side effects were not taken seriously enough.

Life After LASIK notes many long-term problems arising from the surgery, including:

· A permanent weakening of the cornea, which may lead to ectasia (corneal thinning and bulging) weeks, months, or years later, leading to vision loss

· Severing and destruction of the corneal nerves which stimulate tear production, potentially leading to permanent Dry Eye Syndrome

· Future problems when undergoing routine glaucoma screening and cataract surgery, prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK medical record

· A persistent decrease in keratocytes (corneal cells): it is unknown how this decrease affects long-term viability of the cornea

It’s not just the surgery itself, it seems, that’s causing problems. In an under regulated, multimillion-dollar industry, shortcuts and mismanagement abound.

Waxler said he thinks the FDA erred in not setting tougher standards for LASIK outcomes: it should have required fewer adverse effects before approval. He thinks the FDA should force manufacturers and LASIK surgeons to be more forthcoming with patients about potential side effects.

"I think we screwed up," Waxler said of the 1998 approvals. "Nobody's going to admit that. Basically, I think people made some of those judgments incorrectly.

We were getting advice from very renowned ophthalmologists -- more renowned than anyone we had in the agency. We dropped the ball with regard to enhancements with in excess of 10% re-treatment rates because there was a great deal of pressure from individual doctors who said they had the freedom as a physician to re-treat when they felt it was necessary for the sight of the patient.

We waffled on that, we collapsed on that issue. In some of the clinical trials we were very tough on particular companies that came in with high re-treatment rates, and none of that got translated into a requirement for all the manufacturers. So I think we screwed up.

You can read more here:
http://www.lasiknewswire.com/2009/09/former-fda-official-says-fda-screwed-up-in-approvi...

I had Mono-Lasik 5 years ago and I’m fine (I think) but I read reports like this and wonder how many people have a problem.

Have you had Lisik?

When our eyes see our hands doing the work of our hearts, the circle of Creation is completed inside us, the doors of our souls fly open, and love steps forth to heal everything in sight. ~ by Michael Bridge

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Contributed by Bill Coughlin on May 10, 2010, at 1:34 PM UTC.

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I had LASIK done 10 years ago. I had horrible vision, but after the surgery it was better than 20/20. It was like a miracle. Unfortuantely my eyes gradually got worse and are now little better than they were before the surgery. I've had no other problems however. Only time will tell. I had extreme dry eyes before the surgery, but they acutally seem a bit better now.

mulberry May 10, 2010 13:37
Seems to me that mainstream has done it once again and recommended something that has yet to be proven! I suppose that they have a vested interest in people having this kind of treatment and then they can get them onto drugs so they 'don't have any adverse reactions'!
We have found that Carotenoid Complex and Flavonoid Complex are able to help eye health.

adge747 May 10, 2010 14:35
This is very interesting. I had tests for LASIK recently, but it turns out I'm not suitable. Probably a good thing...

Frann Leach aka tiggsy May 10, 2010 16:56
This is a very interesting intel. I hadn't seen this report before. Many of my friends and relatives have had this surgery and they are all well. My eyesight is great, it must be frustrating and incompacitating to have poor eyesight. No wonder so many have LASIK done.

Laraine May 10, 2010 16:58
Hi Bill

Great intel.
I have not had lasik done but one of my many brothers has. Now when we play golf I have to tell him where his ball went. He can not see at a distance. I believe the dry eyes comes with any eye surgery I had cataract surgery on my right eye and now have a problem with dry eye.

iamjim May 10, 2010 17:24
I had not heard this before. I have not had this surgery and don't plan to. Thanks for the info.

June Campbell May 10, 2010 19:30
That picture gives me the shivers. I am SO lucky I have had great vision my entire life. My brother had Lasik and ended with better than 20/20 but now, its been over 10 years, his vision is deteriorating again and he sees little spots at night. My husband refuses to get the surgery and I have been encouraging him to get it, however after reading this I am not so sure! I didnt realize there were so many possible complications. And I am not surprised at all about this being put out there for use without being properly tested and then millions suffering and some make millions. Sounds a little like the aritificial sweetener industry...

lotuspetal May 11, 2010 18:55
I have often thought about getting this done. But have heard mix things, like this screw up.

Sandyspider May 15, 2010 01:40
LASIK surgery has been recommended to me as well but I've always resisted - and it seems that I was wise to do so.

This was a most interesting intel, which I hope will be of use to many folks !

Andrew Goulding Aug 6, 2010 19:52

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This intel was contributed by Bill Coughlin


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