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View Full Version : FDA Regulator Says LASIK Side Effects Weren't Taken Seriously Enoug



Shadow
03-07-2010, 10:58 AM
I was thinking about having LASIK done this year,so found this article interesting. Not sure about it really, a friend who had it done did experience double vision problems. Plus, I already have poor night vision.



"LASIK eye surgery has provided the promise of a quick vision fix for millions of Americans, but now one of the Food and Drug Administration regulators who approved the procedure in the 1990s is publicly expressing concerns about its safety.

Former FDA official says agency focused on eyesight improvement.Some 700,000 people a year in the U.S. get LASIK surgery to correct their vision, and in the years since the procedure was approved, the majority of patients have been happy with the results.

But while the FDA was aware of negative side effects that would occur in some, 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."

http://abcnews.go.com/GMA/OnCall/lasik-eye-surgery-side-effects-fda-regulator/story?id=9933008

From FDA..

When is LASIK not for me?

You are probably NOT a good candidate for refractive surgery if:

You are not a risk taker. Certain complications are unavoidable in a percentage of patients, and there are no long-term data available for current procedures.

It will jeopardize your career. Some jobs prohibit certain refractive procedures. Be sure to check with your employer/professional society/military service before undergoing any procedure.

Cost is an issue. Most medical insurance will not pay for refractive surgery. Although the cost is coming down, it is still significant.

You required a change in your contact lens or glasses prescription in the past year. This is called refractive instability. Patients who are:

In their early 20s or younger,

Whose hormones are fluctuating due to disease such as diabetes,

Who are pregnant or breastfeeding,

or Who are taking medications that may cause fluctuations in vision,

are more likely to have refractive instability and should discuss the possible additional risks with their doctor.

You have a disease or are on medications that may affect wound healing. Certain conditions, such as autoimmune diseases (e.g., lupus, rheumatoid arthritis), immunodeficiency states (e.g., HIV) and diabetes, and some medications (e.g., retinoic acid and steroids) may prevent proper healing after a refractive procedure.

You actively participate in contact sports. You participate in boxing, wrestling, martial arts or other activities in which blows to the face and eyes are a normal occurrence.

You are not an adult. Currently, no lasers are approved for LASIK on persons under the age of 18.

More information...

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061366.htm

darin
03-07-2010, 12:13 PM
bah...any thing the FDA says I take with a boulder of salf, because the FDA sucks. That's all :)

Missileman
03-07-2010, 12:53 PM
Had it done 2 years ago...best $3,000 I ever spent.

LiberalNation
03-07-2010, 02:39 PM
would like to have this done but think you need to be 21.

Shadow
03-07-2010, 04:09 PM
Had it done 2 years ago...best $3,000 I ever spent.

That's cheaper then my daughter's braces were. I am looking into having it done though. I'm sick of contacts and glasses,they are getting expensive to replace every year. The $3,000 is probably well worth it as long as all goes well. Too bad my insurance wont cover part of it...that's one of the draw backs.

Monkeybone
03-08-2010, 07:26 AM
That's cheaper then my daughter's braces were. I am looking into having it done though. I'm sick of contacts and glasses,they are getting expensive to replace every year. The $3,000 is probably well worth it as long as all goes well. Too bad my insurance wont cover part of it...that's one of the draw backs.

it's worth it Shadow. Trust me. I love it. If it makes you iffy about it, check out PRK i believe it is called. Just a different version of it.

glockmail
03-08-2010, 08:46 AM
I was waiting for it to get cheap, then I stared to need two sets of glasses, one for near and the other for far. So if I get it done now I'll still need glasses. :eek:

Shadow
03-08-2010, 09:00 AM
it's worth it Shadow. Trust me. I love it. If it makes you iffy about it, check out PRK i believe it is called. Just a different version of it.

I found this article online. I will check into it further when I have more time...thanks!

Laser Eye Treatment News – PRK, LASIK and Lazy Eye

Which Laser Eye Treatment For Me? PRK vs LASIK
Each day more and more people are looking into getting laser eye treatment performed but a lot are confused over which form of surgery is the best choice. This article talks about the ongoing debate – PRK vs LASIK.

http://www.lasereyetreatment.info/laser-eye-treatment/which-laser-eye-treatment-for-me-prk-vs-lasik/