Exposing the LASIK Scam

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 Post subject: Informed consent and Patient Information Booklet (PIB)
PostPosted: Wed Nov 29, 2006 3:39 am 
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Hi - I'm new here. I am 6 months post-LASIK. In addition to severe dry eyes post-LASIK, I experience glare, starbursting, and halos under conditions of low light as well as an overall loss of contrast sensitivity. However, unlike the sever dry eyes that significantly impairs my ability to perform even the most routine functions, the other negative effects of LASIK, while certainly very noticeable and bothersome, are not severe enough to keep me from performing routine functions.

I have read that doctors are required to give prospective patients a Patient Information Booklet (PIB) outlining quantifiable risks of LASIK. This has been required by both the laser manufacturers and the FDA since 1996. Distribution of the PIB is supposed to be done before a patient agrees to undergo LASIK surgery.

In addition to not receiving an informed consent form until a couple of minutes before the procedure, I never received a PIB.

My question that I am hoping somebody could shed some light on is ... why don't people sue for not getting a PIB or a consent form with reasonable time to review? Does the LASIK community have these "grey" areas covered somehow?


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 Post subject: Re: Informed consent and Patient Information Booklet (PIB)
PostPosted: Wed Nov 29, 2006 2:04 pm 
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Gash wrote:
My question that I am hoping somebody could shed some light on is ... why don't people sue for not getting a PIB or a consent form with reasonable time to review?


The truth? Because it's not standard of care. Meaning, if most surgeons don't provide the booklet, even though it's mandated by the FDA, then it becomes "standard of care" to not provide the booklet. :roll:

If they all stick a pencil in your eye, that becomes standard of care.

Here's a link to all of the Patient Information Booklets:

http://www.fda.gov/cdrh/LASIK/lasers.htm

Look for the pdf called "Patient Labeling".

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sun Dec 03, 2006 7:13 pm 
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Thanks for the reply. I guess the question would then be ... why don't people challenge the fact that the "standard of care" is way too low. I suppose the answer is that this is a case that is difficult to win since there is no equipment malfunction or medical negligence (although even these cases frequently do not go to court :?: ).


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 Post subject:
PostPosted: Mon Dec 04, 2006 2:17 am 
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Gash wrote:
I guess the question would then be ... why don't people challenge the fact that the "standard of care" is way too low.


The standard of care is set by LASIK surgeons.

Let me try to explain this another way.

If 90% of LASIK surgeons use 250 microns of cornea under the flap as the minimum, even though 250 microns has been proven in study after study after study to be unsafe, it remains standard of care (and defensible in a court of law) as long as they keep doing it. If they decide they are tired of having patients come back with ectasia, and start using 300 microns as the minimum, then 300 becomes the standard of care. The problem is they don't want to raise the standard of care because it reduces the potential pool of candidates and makes them look bad for using a minimum that was unsafe for years.

Here's another example... The FDA approved microkeratome blades for single use. However, LASIK surgeons reuse the blade on the 2nd eye, even though medical studies have shown problems with the blade on repeated use. Try suing a LASIK surgeon for DLK, epithelial ingrowth, epithelial defect, irregular flap, or other problems associated with reuse of the blade on the 2nd eye. The standard of care is to reuse the blade on the 2nd eye.

I know it doesn't make any sense. :roll:

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Mon Dec 04, 2006 2:56 am 
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Thanks. Do you know of any major university medical centers who refuse to do LASIK because it is simply unsafe?

It seems like most, if not all, do this surgery. Even the "dry eye expert", Dr. Pflugfelder, does LASIK at Baylor Univ.. I would think if you were a dry eye expert, it would be unconscionable to do LASIK, but perhaps he actually does proper tear testing at pre-screening. Regardless, in my opinion he nor any other MD should be doing LASIK due to the debilitating risks.


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 Post subject:
PostPosted: Mon Dec 04, 2006 1:54 pm 
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Gash wrote:
Do you know of any major university medical centers who refuse to do LASIK because it is simply unsafe?



I'm not aware of what all the university medical centers do or don't do.

I do know this -- some *leading* refactive surgeons have stopped doing LASIK, and now only do surface ablations for safety and dry eye reasons.

The flap needs to go!

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Mon Dec 04, 2006 6:23 pm 
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Thanks Broken Eyes. You and others do a great service by alerting potential patients of the dangers of LASIK. Unfortunately it is too late for folks like me. Hopefully I will continue to improve, but based on the incredibly difficult first 6 months with gash and severe dry eyes that have improved from excruciatingly painful and bone dry to constantly dry and irritated to the point of completely impacting my life, I find it difficult to get too optimistic. Also, now that I truly understand the risks and damage caused by LASIK, both short and long-term, I can no longer live in ignorant bliss like so many other patients who are "happy" with their LASIK outcome. I would love to make sense of my tragedy by trying to make a major impact on the LASIK system, but it seems like the barn door has been left open and the horses are long gone. However, sites like this do make a difference although I wish the public could be more aware of the insanity that is going on with LASIK. Keep up the good work.


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 Post subject: Hi Gash
PostPosted: Tue Dec 05, 2006 12:42 am 
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Gash,
You may still experience some improvement for up to a year and a half or so in your dry eye and perhaps a little with your GASH.

Do you have an understanding of the source of your GASH? Do you have large pupils, or are you a normal to small pupil patient who had a flap problem or just racked up a lot of higher order aberrations centrally?

I take antioxidant vitamins, lecithin, pharmaceutical grade fish oil and flaxseed oil, and I drink 64oz of green tea per day. This is equivalent to the eight 8oz glasses of water that you're supposed to drink, but green tea has antioxidants so I drink that instead.

My vision was completely trashed at a major university medical center, Duke University Medical Center, to be specific... by Dr. Terry Kim. I have striae, dry eye, and a grossly undersized effective optical zone.

_________________
We can easily forgive a child who is afraid of the dark. The real tragedy of life is when men are afraid of the light. -Plato


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 Post subject:
PostPosted: Tue Dec 05, 2006 4:08 am 
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Thanks Scientist. While I go by Gash, my life altering issue is really severe dry eyes. I guess I should have gone with Dry Eye Man instead. I do get glare, halos, and starbursts, but at this point they do not affect my quality of life nearly as much as the dry eyes. It's good to hear that the dry eyes can improve for some time. I am trying to remain as hopeful as possible that improvement will happen.

I know this may sound premature, but I have been considering taking a trip to Boston sometime early in 2007 to be fitted for the Boston Scleral Lens (BSL) if my dry eyes do not make enough improvement between now and then. My thought on this is that I continuously hear about how my eyes need to be wet in order to heal. I can't think of a better way to keep my eyes wet (aside from good, natural tear quality that I currently do not have) than to use a liquid bandage lens. Also, I would hope that the BSL would allow me to become more functional again at both work and home. From my layman's perspective, I don't see much downside aside from the time and expense. Of course, there is also a chance that my eyes will not tolerate the big lens, but I figure the only way to find out is to go up and try. I think if the BSL was relatively comfortable and helped prevent my eyes from being constantly dry, that it may prove to be therapeutic or at least make me more functional than I currently am with my dry eye condition. What do you think?

Now that I have learned about the true risks of LASIK, I would love to make a difference by doing my part to stop the insanity. I was thinking about writing to all of the major University Medical Center's that perform LASIK about why they need to stop performing LASIK. I figured if they could stop performing LASIK because of the risks, then it would make news and this news could spread. Of course, they likely will not stop since that would be admitting that they made a mistake by starting LASIK to begin with. I was hoping to use an example of a University that has abstained from joining in the LASIK insanity since that might make them think a little more self-conscious. I was shocked to find out that Dr. Pflugfelder performs LASIK at Baylor. I was almost certain that Baylor would have been my example since he is so aware of the effects that issues like dry eye can have on people's lives. Did you let Duke know that they should stop doing LASIK?

Also, I am glad that the 64 oz. of green tea is helping. I would only caution you that I heard on the radio the other morning that drinking more than 2 cups of tea a day may not be good for you. I'm not sure if this is true or not. Also, my brother told me that flaxseed oil is not as good a source of omega-3 and 6 as some other oil that he is mailing to me. He researched the omega oil business heavily and found this one company overseas is always rated the best and is actually properly regulated. If you are interested, I will let you know what it is when I get it.

I have truly been enlightened by reading your posts. Thank you.


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