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Is LASIK Eye Surgery Safe? FDA Scientist Regrets Saying 'Yes'
Politics Daily ^ | 2/12/11 | Bonnie Goldstein

Posted on 02/12/2011 8:33:57 PM PST by Nachum

In Washington, D.C., a culture that embraces regulatory oversight and rule-making and where bureaucracies are everywhere, no federal agency is more warren-like than the Food and Drug Administration, which regulates the safety and efficacy of food, pharmaceuticals, cosmetics and medical devices.

The health and well-being of every American depends on the FDA's rigorous collecting, sifting and interpreting of data to approve products ranging from those that cure nail fungus to devices that electronically zap the brain to relieve anxiety. FDA regulators are scientist bureaucrats who tirelessly navigate the tedious but essential world between reports and medicine in a poorly lit building with very narrow hallways. They do important work, but FDA scientists don't always get it right.

This is a story about one scientist haunted by what, he fears, was a bad decision. Between 1996 and 2000, the scientist, Dr. Morris Waxler, was chief of the FDA's Diagnostic and Surgical Devices Branch and in charge of approving the LASIK medical device to restore visual acuity. And now, Waxler thinks that the FDA's standards were not tough enough. In 2008, an FDA advisory panel was urged by unhappy patients to re-evaluate the long-term effects of LASIK surgery and around the same time, patients began contacting him personally to report bad outcomes, including blurred and double vision.

(Excerpt) Read more at politicsdaily.com ...


TOPICS: News/Current Events
KEYWORDS: eye; lasik; safe; surgery
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To: Wissa

Hmm, I’m the same as you, in my 20’s and have considered getting it done.


81 posted on 02/13/2011 8:18:18 AM PST by BenKenobi (Don't expect to build up the weak by pulling down the strong. - Silent Cal)
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To: Nachum
Both my parents had this done about ten years ago. Still going good with no regrets.

I'm 41 and my eyesight is still around 20/20, but I've noticed that things are starting to get fuzzier at distance. I've always had the "eagle eyes", but everyone gets older at some point...

82 posted on 02/13/2011 8:30:43 AM PST by Dead Corpse (III%. The last line in the sand)
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To: Wissa
About one minute on Google showed me that people who have had the procedure CAN become pilots, both commercial and military.

Then that is a fairly recent change in policy. It certainly was NOT the case a few years ago.

My experience over time is that the info on Wiki is usually about 10 times more reliable than what I'd get with FreeRepublic as my sole source. On FreeRepublic, like most any other forum, there are often a ton of people making a ton of statements of fact about things that turn out to not be true.

I have no problem with people deciding they don't want to take the risk of getting the surgery. However, I get a bit aggravated when I see people making up a bunch of stuff to steer OTHER people away from getting it done.

Where do you have any evidence that I made up a bunch of stuff? If you read the entire Wiki article, you would have seen that it corroborates what I said, and what I said was based on a variety of sources. (Once I read something, it stays stuck in my head forever, I think.) I also encouraged people to go to slightly more reliable sources than Wiki--i.e., Pubmed and Medline, which are the official databases dedicated to cataloguing medical research. You can't just pick and choose which facts to present to promote your point of view.

If people are considering such a surgery, they deserve to have ALL the facts and to know ALL the risks. To me, a 1 in 20 risk of ending up worse than before is unacceptably high. To you, it might not be. That doesn't mean you deserve to have the risk hidden from you.

83 posted on 02/13/2011 8:39:42 AM PST by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: Nachum

I have done a ton of research on the subject - because I need my eyes!

I will share what I have discovered in hundreds of hours of research. Not all LASIK machines are the same - after looking through FDA files, there are many that are not good at all. Unless you check what laser system is being used, you are taking your chances. Some doctors have older laser machines and are still paying them off - which means they do NOT have the latest machinery - and without the best laser, the surgeon is only going to make a minor difference.

Also, the FDA is VERY SLOW at approving LASIK systems, because of this there are much better LASIK lasers outside of the USA - (thanks FDA for keeping the best equipment from the American people (/sarc)).

Also, the correction is different as to whether you are nearsighted or farsighted. Nearsightedness is easier to correct, based on reducing the curve of the corneal lens. For farsighted people the corneal curve needs to be steepened - so the laser for farsighted correction has to be much better! It’s harder to build up steepness by cutting away tissue.

After my research (I am farsighted) the best laser is the Zeiss MEL-80 with CRS Master software that customizes the treatment - of course I have to leave the country to get the right treatment (again, thanks FDA). The next best looks to be the Allegretto Wavelight (also using the custom software for that platform). The VisX Star is good for nearsightedness, but nowhere near as good as the Mel-80 for farsightedness.

Next is a very skilled surgeon. The one I have found actually has helped design the laser I will use. Avoid eye mills as they are squeezing every last dime out of their sometime old equipment.

Obviously - do your own research - ask your doctor what he is using. Look at the trial data for the laser and see how well it has hit the target correction.

I know many Doctors and I only partly trust them - they deal with so much tragedy that they really don’t see you as much more than a number - so if they screw up they will still sleep well - they have learned to not be bothered by their mistakes. Ultimately, it’s up to you to protect you health. But that is the conservative mindset - isn’t it?


84 posted on 02/13/2011 9:20:22 AM PST by LibertyLA (videos fighting libtards!)
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To: ReformedBeckite

“still have to wear the cheaters for reading, that is something they don’t tell you, “

I had Lasik done over ten years ago (was happy then, and still happy now), and that was one of the things that my surgeon made very clear to me. He told me that Presbyopia, or aging of the eye, would still occur as I got older, and I would still need glasses for that. He even went on to warn me that because of the Lasik surgery, that presbyopia would probably hit me sooner than if I hadn’t had the surgery. When I came in for my follow-up appointment the day after surgery, one of the things he did was hand me a newspaper to see if I could still read fine print at a reasonable distance. He was very honest and up-front to be sure that I had realistic expectations before I gave my approval for the surgery.


85 posted on 02/13/2011 9:23:22 AM PST by RedWhiteBlue
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To: Nachum

Ten+ years ago I went from 20/400 to 20/10. Still have it. Wife went from 20/400 to 20/10 then regressed a few years later to 20/35. Still 20/400 to 20/35 is pretty damned good.

The problem with the surgery has been the fly-by-night operation centers that bring in new doctors to perform the procedure they are not that familiar with. People think a $4,000 operation should be the same when they pay $500, not using the common sense God gave a dog to rethink such a cheap cost and what kind of equipment, doctors and staff are they really paying for.

Eyes are a two in a lifetime affair. Before considering altering them a person needs to check out the doctors and facility and equipment and see just what success rates they have had.

I chose the doctor my wife knew profesionally that had been in business for 30 years and was extremely well traiing and participated in the creation of the program. His outcomes were nearly 100% with any failures that of the patient and not his or his equipment. I wouldn’t have any procedure performed where I didn’t go to the best doctor possible.


86 posted on 02/13/2011 9:23:36 AM PST by CodeToad (Islam needs to be banned in the US and treated as a criminal enterprise.)
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To: exDemMom
Where do you have any evidence that I made up a bunch of stuff?

I never said you were the only one doing it. I see it on threads on pretty much every subject.

On this thread I'm seeing warnings that sound like "Yeah, you're fine now, but just wait. In a few years you're going to be totally blind!" Where's the evidence to support that statement?

I see a lot of completely unsourced claims about things like not being able to become a pilot and it being only a temporary fix and claims about the likelihood of your vision becoming worse as a result of the treatment. If 95% of the people are satisfied with the results, that does NOT automatically mean that 5% came out worse as a result. Some percent of that 5% most likely had their vision improved, but not as much as they had hoped for. For all I know, 95% of the 5% that weren't satisfied actually had their vision improved. Show me a legitimate source that says that 5% had their vision worse after the treatment, or retract the claim.

I agree with you that people had better do their research before letting somebody do some elective surgical procedure on their eyes, or any other part of their body for that matter. However, I'd hope their decision isn't swayed too much by people that seem to have an agenda of trying to get other people to reject getting it done based on made-up claims. It's as if the people arguing against getting it done have some need for other people to also reject it in order to feel better about their own decision.

87 posted on 02/13/2011 9:38:41 AM PST by Wissa (Gone Galt)
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To: MissMack99

My opthalmologist, who’s a surgeon, wears glasses....that’s enough of a wordless testimony for me.


88 posted on 02/13/2011 9:42:17 AM PST by ErnBatavia (It's not the Obama Administration....it's the "Obama Regime".)
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To: Nachum

I have had it since Nov 2004 with no problems.


89 posted on 02/13/2011 9:47:53 AM PST by bmwcyle (It is Satan's fault)
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To: irishtenor
I had the lenses in my eyes replaced with prescription lenses........The same procedure as catarac surgery only with the presc. lens.

I went from having to wear glasses since I was 4 years old and 20/200 in my left eye with astigmatism to glasses free.......I can read any size print and have distance sight too.

As a side note, I have to wear reading glasses for computer viewing.....

The eye surgeries were not cheap but definitely worth it.

90 posted on 02/13/2011 9:51:08 AM PST by Hot Tabasco (Oh Magoo, you've done it again.....)
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To: BenKenobi
Hmm, I’m the same as you, in my 20’s and have considered getting it done.

Do a lot of research. There are always improvements being made. My daughter in law is thinking of getting it done, but says she's seen that there is some procedure now that has less downside risks associated with it. I don't know the specifics, and I don't try to steer her toward any particular approach. Ultimately, she's the one who would have to sign the statement before any procedure acknowledging that she is aware of the risks, including the risk of becoming blind as a result.

People that are satisfied with glasses or contacts (as my son is) should stick with what they're satisfied with. LASIK should only be done for people who hate the limitations placed on their life by glasses or contacts to the point that they're willing to take that risk of blindness. The risk is low, but it is there, and it's not something to be ignored.

In my case, while I was waiting for my ride to get there to pick me up to take me in for the procedure, I remember that I sat and watched the geese walking around in the field by my house and realized I may never see that (or anything else) again if things turned out bad. I hated wearing glasses, and not being able to see without them, enough that I was willing to accept that risk.

91 posted on 02/13/2011 10:25:34 AM PST by Wissa (Gone Galt)
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To: ErnBatavia
My opthalmologist, who’s a surgeon, wears glasses....that’s enough of a wordless testimony for me.

Sometimes, wordless testimonies can be misinterpreted.

Have you considered the possibility that the procedure just might affect his ability to perform well in his lucrative career in ways that may not be applicable for most of the millions of people that AREN'T eye surgeons?

92 posted on 02/13/2011 10:35:28 AM PST by Wissa (Gone Galt)
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To: Wissa

Well in that case I should not get it done. I can see well enough now.

What concerns me is the night vision. I am starting to have night vision issues when driving, which is a bad sign.


93 posted on 02/13/2011 12:34:08 PM PST by BenKenobi (Don't expect to build up the weak by pulling down the strong. - Silent Cal)
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To: Wissa
I never said you were the only one doing it. I see it on threads on pretty much every subject.

So, you not only are not backing down from calling me a liar, but you're trying to say it's okay to call me one because lots of people on FR lie? That just digs the hole deeper.

Just because YOU were willing to take the very real (1 in 20) chance of having your vision worsened or your eyes permanently damaged to avoid having to wear glasses (for a few years, anyway, you WILL have to wear reading glasses later on, no matter what), does not mean that EVERYONE is willing to take that risk. Withholding information from people to try to sway them to have an expensive procedure that has a 5% chance of harming them is a form of lying that's much worse, IMO, than giving people all the info up front, good and bad, and letting them make up their own minds.

You MIGHT try reading that ENTIRE Wiki article, not just the parts you like, and maybe some other info, before you go around calling everyone who expresses reservations about the LASIK procedure a liar.

94 posted on 02/13/2011 1:10:27 PM PST by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom

I explained to you the reason that it looks like the 5% number isn’t accurate as a figure of the percent who have had their vision reduced.


95 posted on 02/13/2011 1:23:32 PM PST by Wissa (Gone Galt)
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To: mamelukesabre

ha


96 posted on 02/13/2011 2:30:07 PM PST by bboop (Stealth Tutor)
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To: familyop
Instead of bifocals have you considered "progressive" lenses?

I know that anything with the word "progressive" in it is suspect around here, but they have some advantages over bifocals, along with some disadvantages.

Basically the prescription changes from the bottom of the lens toward the top. The top of the lens is set for long distance vision, and the bottom for close-up. There is always some point along the lens where you can see a specific distance with extreme clarity and focus.

The only downside is that if you are looking at a particular point in space for a long time (ex. a computer screen or TV) then you tend to keep your neck in a very specific spot and it can get stiff and sore.

I have progressives which I use when moving about, driving, etc. I have another prescription which is specifically set for the distance between my eyes and my computer screen. That way I can move my neck around while working or Freeping. My computer glasses are the cheapest I could get with the cheapest frames, and no coatings. I didn't want to spring for two sets of fashionista specs.

Best of luck with your new glasses!

97 posted on 02/13/2011 2:38:12 PM PST by who_would_fardels_bear
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To: who_would_fardels_bear
"Instead of bifocals have you considered "progressive" lenses?...There is always some point along the lens where you can see a specific distance with extreme clarity and focus."

That sounds great! Thanks, and I'll try those the next time (probably not long, with the plastic lenses and all). 'Till then, I'll just wear "the line" and go around looking like an old man. ...leaving a turn signal on every now and then gives me away anyway. ;-)


98 posted on 02/13/2011 5:49:45 PM PST by familyop (cbt. engr. (cbt), NG, '89-' 96, Duncan Hunter or no-vote.)
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To: exDemMom; Wissa
Last spring USAF did away with that policy. They've been following lasik results for some time now, and finally permit such to fly their aircraft.

Army still does not allow SF HALO Operators to enter training if they've had lasik. Same for Navy divers.

Many PDs now allow lasik procedures for applicants if they've had the procedure done more than one year prior.

99 posted on 10/18/2011 10:10:57 AM PDT by donozark (Sam Walton:"It was paper when we started, and it's paper afterwards.")
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To: Nachum

I had 20/400 in both eyes with astigmatism. LASIK took that to 20/10+ and no astigmatism. I can see like a bat day or night. Perfect vision. That was 12 years ago.


100 posted on 10/18/2011 10:28:24 AM PDT by CodeToad (Islam needs to be banned in the US and treated as a criminal enterprise.)
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