Informed consent dry eye quote

[YGB]

The quote below is from the LASIK consent form on the risk of dry eyes ...

"I understand that there is an increased risk of eye irritation related to drying of the corneal surface following the IntraLASIK procedure. These symptoms may be temporary or, on rare occasions, permanent, and may require frequent application of artificial tears and/or closure of the tear duct openings of the eyelid."

I suppose the LASIK group does its usual good attempt at legally covering themselves by mentioning that this "eye irritation ... on rare occasions can become permanent".

It is also interesting that if I did not know about dry eye, I would think that if I was one of the unfortunate ones to get this "eye irritation" from LASIK, I would need to at worst use artificial tears and possibly close the tear ducts to return to feeling normal again. Ah, if it was only that simple.

Also, if dry eyes are permanent, then they are not truly an "eye irritation" anymore. At that point it is really called "chronic dry eye disease". I wonder why the word "eye irritation" is used instead of "eye disease"? I suppose they might lose a few customers if people actually knew they could potentially end up with a chronic painful eye disease from having LASIK.

Also, I suppose an consent form does not have to list the laundry list of other things that can come along with this "eye irritation" like anti-inflammatory drugs, topical steroids, alternative treatments like autologous serum and further surgery such as AMT. In addition, this "eye irritation" can ultimately lead to further eye problems such as corneal erosions, reduced vision, conjunctival thinning, and other eye diseases.

While I know Kitty and others explained some of the legaleze to me relating to informed consent, I still find it hard to undertand how such a big risk can get such little play in such an insufficient way.

I am not looking to restart the previous open forum dialogue on "why don't people sue due to lack of informed consent". I am just stating that it is yet another example of how the LASIK community downplays the risks of LASIK. And the beat goes on ...

P.S. I also know this thread does not dovetail nicely with my other thread of having more hope that things will get better, but in staying true to my inner self, I am trying to keep hope for myself and all of us, but I must admit that I am frustrated with the apathy I have come to learn exists for the sake of the almighty $ at the mere potential cost of peoples total quality of life.

[neil0502]

I have the distinct feeling that the ONLY time we get a FAIRLY clear picture of the TRUE risks and the TRUE statistics associated with a procedure is when the "next generation of procedure" comes out to replace it.

Then, to get people to buy off on the latest and greatest, the practitioners of Technology B (usually also the ones who were hard-selling Technology A, incidentally) are only too happy to say that LASIK hurts less than PRK or that LASEK results in fewer starbursting/halo complaints, reduced rate of DES, etc., etc, than did LASIK.

In other words, trot out the downside of the LAST procedure ONLY as a sales technique to push THE CURRENT procedure ... designed to reduce those downsides. You know: the downsides that nobody really talked about when the LAST procedure was so in vogue....

It's not particularly pretty, but I think it does tend to work that way.

[YGB]

Neil - in the absence of hitting LASIK in its own pocket through lawsuits (which doesn't appear to be a typical option since they have insulated themselves with the almighty "informed consent") then I have to reluctantly agree with you that the truth about LASIK will likely only be learned when LASIK comes out with something better. They hold all of the cards and are in essence a self-policed industry. The FDA wipes its hands clean of the procedure by simply overseeing the equipment. I wonder if an elective surgery like breast implants would be allowed if patients ended up with complications that completely altered their quality of life in a permanent way? I tend to doubt it since the media let's us know whenever there is a breast implant complication. Why is an elective procedure like LASIK different? I suppose the answer is that elective procedures on breasts tend to make bigger news than elective procedures on eyes in our society.

[kitty]

Before I experienced the onset of DES, if someone told me that a risk of Lasik was dry eye, I would probably think to myself, "so what? I'll just use some Visine now and then". That's the way my friends respond when I tell them I have DES. "Before I judge a man, let me first walk a mile in his moccasins." I doubt any consent form could actually describe the severity of the pain that we all feel.

[Guest]

I'm with Kitty on that one.

Before Lasek, I had no idea or appreciation what dry eyes were - a few drops here and there was no major inconvenience for promised crystal clear vision and "brilliant sight within hours" (didn't get that either).

My consent form even went as far to mention pain on waking. Again, not sure what that was until I had my first severe corneal abrasion that severely altered my already compromised post lasek vision.

I have been through my consent form time and time again, not sure why, I feel stitched up more and more every time I read it and just so cheated. I must have really drawn the short straw on 20 October 2005.

Unfortunately, I can't change it, I can't go back, I just have to learn to live with it, not a great position but I feel it is my only option.

Ian

[YGB]

Kitty and Ian - this once again gets to my point of why does the LASIK community get a free pass when they do not truly inform the patient of the MAJOR risks involved?

I suppose you can say that no words can actually describe severe dry eye. Well I do not agree with that statement. What if the informed consent form in essence stated that if you end up with permanent, chronic severe dry eye disease, then the world as you once knew it will be over! Forget about reading, home projects with any eye irritants, TV, movies, staring at your PC or anything else for that matter for more than a couple of minutes, you can't blow the heat or a/c in your car vents on the top level anymore, constant pain and irritation on bad days, etc. I think something like this on the informed consent form would catch people's attention who know little if anything about dry eye and ... gasp ... it would make these peole TRULY informed of the risks they are undertaking. It wouldn't even have to be so blunt, but to soften the wording to the point they have done is disingenous and unethical. However, by most expert opinions, it also appears be legal .

Should I have done more research? Obviously yes. But should the LASIK MD's be allowed to sugarcoat the wording on the informed consent form and at the same time not even let you know that the form exists until just a few days or even minutes prior to the procedure. No friggin way! (I figured if Rebecca can say "friggin" on this BB, then so can I ).

I know my mantra has a consistent theme on this point, but I am finding some therapy in venting (at least I think I am). Thanks for all of your input.

[neil0502]

Medicine: Powerful, organized, well funded lobby

Patients: No lobby at all

Not only that, but ... as I've alluded to before: there's money in "fixing" us, AND there's money in trying to patch us up when we break [1]. That may not be one of the BEST aspects of free-market capitalism, but ... free-market capitalism it is....

[Decidedly cynical]

[1] Include the legal field in that bunch....

[kitty]

I suppose you can say that no words can actually describe severe dry eye. Well I do not agree with that statement.

Would you sign a consent form for an angioplasty that lists a potential complication as a stroke? Or would you expect that consent form to say that you could have a stroke which could render you immobile, unable to speak and unable to wipe your own (_;_)? If the consent form spelled out what it would be like to suffer each complication, the form would be 3 inches thick, would take you a month to read, and probably would still not answer all of your questions.

[Rebecca Petris]

Informed consent has always been a major hangup for me with LASIK. I have written so much about it in the past that I haven't been motivated to jump into the recent threads about it. But I will say that it is my personal opinion that no piece of paper is anywhere near as important as the human processes involved.

There some very important aspects of the informed consent process that it IS POSSIBLE for patients to lobby for and to do so successfully. This is what I did as a hobby when I was living in the UK. A little of the right sort of press coverage, find creative, constructive ways to get some of the best doctors on board (i.e. pay attention to the WIIFM factor) and present a compelling and sound enough case to government representatives to motivate them to take action. If you want to see what can be done when you try, try googling "Regulation of Laser Eye Surgery Bill". Nothing perfect, but hey, as a minimum, the process and discussions it involves can mean progress.

[YGB]

Kitty - I'm not medical expert but I think an angioplasty is a medically necessary procedure that can be the difference between life and death. In this case, one must consider the cons (i.e. risks), but one must also consider the pros (i.e. possibly living versus dying).

In the case of LASIK, it is an elective procedure with the pro being "freedom" from glasses and/or contact lenses and the con being complete loss of quality of life and diseased eyes where eyes were once healthy with a refractive error.

While both forms should CLEARLY spell out the risks so that patients can be informed, the medically necessary procedure such as angioplasty will likely have a more compelling argument for a patient to procede even with proper information of risks (assuming the benefit outweighs the risk). LASIK should simply not be allowed to be done without a clear concise consent form since it is a purely an elective procedure that can result in very severe conditions that are incurable. The consent form can be as simple as about 2 sentences ... "Be aware that you stand a 5% chance of completely ruining your quality of life for 1 year, 2 years, or in some cases permanently (although even this % stated is likely lower than true reality). However, the odds are still in your favor so do you feel lucky today?"

By the way, Kitty, can you improve your Vegas odds for me having a case for lack of informed consent. Your first set of odds were a 0%. I would think that you could at least give me a 1% chance or something like that. I'm already depressed due to my eyes so please cut me some slack or at least throw me a bone. What da' ya' say?

Rebecca, thanks for the link. I'll do some research sometime on this and see what the best next steps are.

[kitty]

By the way, Kitty, can you improve your Vegas odds for me having a case for lack of informed consent. Your first set of odds were a 0%. I would think that you could at least give me a 1% chance or something like that. I'm already depressed due to my eyes so please cut me some slack or at least throw me a bone. What da' ya' say?

I might be able to stretch that to 3% chance. The secret will be finding an attorney to convince a jury that the consent form was woefully inadequate and that no other person with your IQ would have proceeded with the procedure without asking a few more questions.

[YGB]

Kitty - the way I see it, my case would be simple ... I was not in a proper state of mind to review and digest the informed consent information in the limited time period provided with the additional stress and distraction of my pending surgery that was just a minute or so from beginning.

The nurse gave me the form a couple of minutes before surgery. I have not had experience with surgery so I did not know enough before hand to ask about what I have since learned is the sacred informed consent form.

I think most people with my average IQ would be on the same boat as me in how they would have reacted in that setting. Also, I would think the burden would be on the clinic to provide the informed consent form at least a week ahead of time and not on the patient to ask if such a form exists ahead of time.

At pre-screening I asked about what the biggest risk of the procedure was and was told the biggest risk was corneal infection, but that they give drops to patients to use to avoid infection. The MD and I talked for about 5 minutes or so but if anything, my conversation with him gave me more comfort that all was okay. I wish I had asked more questions, but again shouldn't it be the clinics responsibility to review a protocol checklist of risks with the patient at pre-screening?

I really don't know the next steps. I am waiting to see how I improve over the next several months. I am hopeful that I will keep getting better and then my approach will be different. I will still challenge the current informed consent process, but it will likely be from a different perspective than if I am in severe pain and suffering mode. I truly hope that I am feeling good eye wise if I decide to challenge the system. My bad eyes will not allow me to handle major bureacracy and stress.

The reason why some nursing homes get away with such poor treatment of patients is because the patients are too weak to fight. It seems like major LASIK complications work in a similar manner since the eyes are so important to ones life and psyche and then when one looks for support, they get a bunch of BS from many MD's, lawyers, and the system in general.

At that point, the fragile patient can likely feel like he/she has entered a version of The Twilight Zone or as I've stated before, The Mad Hatter Tea Party (whichever you prefer, Sci. Fi. or animation).

Thanks for the 3% odds. I'll take it for now.

[Lucy]

I might be able to stretch that to 3% chance. The secret will be finding an attorney to convince a jury that the consent form was woefully inadequate and that no other person with your IQ would have proceeded with the procedure without asking a few more questions.

I'd put that right up there with the possibility of me becoming a lasik surgeon.

[YGB]

Lucy - don't take the wind out of my sails. After all, 3% isn't very good odds. Heck, that's less than the chance of having LASIK complications. Oops. Maybe that's a bad analogy.

Besides, you probably have a 3% chance of becoming a LASIK surgeon if you choose. I think the LASIK machine does most of the work and you just have to gently brush the cornea flap back on after the cut is complete and the lasering is done. Then if anybody has a complication like dry eyes, just show them the informed consent they signed and have them see another MD for further consultation so that you can keep lasering.