LASIK and dry eye

[Rebecca Petris]

Dear all,

As of this morning there are 222 people on this board who cite LASIK and similar surgeries as the, or a, cause of their dry eyes. We're hearing more and more frustrations and disillusionment with poor screening and/or poor 'informed consent'.

I won't beat around the bush. This has gone on for 10 years and it WILL NOT stop on its own - notwithstanding the numbers now affected nationwide.

If you want something to change for the better, it's up to YOU - individually, collectively.

If you believe that you were:

a) poorly screened (you did not have a Schirmer and TBUT test before surgery; you reported relevant medical history such as auto-immune disease, contact lens tolerance or dry eye symptoms prior to surgery and no one discussed the implications with you, etc) and/or

b) poorly informed (you were not told about the possibility of persistent severe dry eye; you were not told about personal factors which might put you at elevated risk; you were told dry eye could easily be managed with drops and plugs; you feel you were led to believe that dry eye is a minor complaint, etc.)

then I would encourage you to do something about it.

Here are some suggestions:

1. Write to your surgeon. Try to set anger aside and write in a calm, businesslike manner. Outline your concerns about what happened to you, explain how it has affected your life, and express hopes that they will provide better care for future patients. Invite the surgeon to discuss this with you in person. Above all try and keep any "look out you might get sued" flavor out of the letter so that there is hope of opening a true dialogue. Don't underestimate the potential for truly influencing your doctor if you can approach this dispassionately and not threateningly.

If that is not fruitful:

2. Write to the clinic manager. Again, explain what happened, what your concerns are, and how you hope they will change things in the future. Explain also what steps you took to address this with your surgeon and how (un)successful they were.

If that is not fruitful:

3. File an adverse event report in the FDA's MAUDE database for medical device problems (particularly if you're one of those with severe dry eye almost immediately following surgery.) This forces the manufacturer to investigate. If the manufacturer feels it was unrelated to their laser, they will have to say why. If they say that the problem is not the laser but poor patient selection, well, there's your leverage to get the clinic to talk.

If after that you do not feel you have gotten through at all to anyone, and if you feel your doctor was grossly at fault, take it a step further. Please don't try to do this unless you are quite sure there was real negligence.

4. File a complaint with the American Academy of Ophthalmology (if your doctor is a member).

This is a professional organization - NOT a regulatory body, and they have no jurisdiction over your doctor. But an investigation will almost certainly have an impact nonetheless on how your surgeon/staff/clinic deal with dry eye. Be prepared to not get firsthand feedback about this impact - but know too that you have made a difference.

If you feel there was gross malpractice,

5. File a complaint with the state medical board.

[sazy123]

Im not a lasik victim but I agree people need to be proactive or nothing will change.

I would just file a complaint anyway

File a complaint with the American Academy of Ophthalmology (if your doctor is a member).

If we pooled all our weight together. people would have listen.

[Rebecca Petris]

For the UK, there's the Royal College of Ophthalmologists. I noticed that there is an email address for its president right there on the home page. Brenda Billington is clearly in the best demographic for dry eye so perhaps she would be sympathetic to our issues.

[YGB]

With all due respect, I really do not believe that a LASIK surgeon or even a LASIK clinic manager is going to have an epiphany if they read a LASIK complication patient's letter.

They will very likely view the patient as one of the "small" %'s that fall under the statistics. They may even play the "mental" card since no matter how well the letter is phrased, the patient basically has to say that they do not agree with the MD's actions. If the LASIK MD had a conscience to begin with, he/she would stop doing an elective surgery like LASIK once he saw the damaging effects it has on damaged patient's lives (see any one of our stories). My LASIK MD saw me at my worst and he was not impacted in the least.

I suppose you can write about the equipment, but what is there to say? The laser equipment creates damage to every eye it slices, but yet that is somehow okay in the world of the laser equipment group's eyes. If that is okay, then what is a few letters from damaged patients going to do? After all, even if they got 100 letters, they would just view the letters as part of a "small" percentage that they are already aware exists.

You can send a letter to the AAO, but what are you going to tell them that they don't already know and refuse to act on. IMO, the non-LASIK members of the eye profession view LASIK as a LASIK MD issue. They wash their hands clean of this matter.

Filing a complaint with the state medical board certainly has the best chance of pulling your LASIK MD's head out of the sand at least temporarily.

However, in the end, IMO what is needed is a class action lawsuit with sound merits. Of course, you need a good lawyer and you need to build a strong case.

[Rebecca Petris]

YGB... obviously don't do it yourself if you don't feel it's worth it. But please do not discourage others from doing so. Just because you personally consider it a waste of time, doesn't make it so.

[YGB]

I think people (especially damaged patients who are already in a vulnerable position) should have realistic expectations of what their effort will result in.

Maybe what I wrote is blunt and certainly not absolute, but it is pretty realistic in terms of expectations.

IMO, most LASIK patient's got LASIK so that that they could be "free" from glasses/contacts, not so that they could become advocates warning their very own LASIK MD's, LASIK equipment manufacturers, and the AAO of the dangers and damage caused by LASIK.

If damaged patient's want to use their effort in this regard, then they should. If they feel it is better to focus their energy on warning their friends, acquaintances, and family, then that is good too. It's up to the individual.

Therefore, if a damaged patient wants to make a difference in someway, he/she has the right to do so in a way that they feel appropriate. However, they should have realistic expectations as to the likely outcomes and whether it is worth the energy to put into the effort since energy (especially damaged eye energy) is finite.

[Rebecca Petris]

However, they should have realistic expectations as to the likely outcomes and whether it is worth the energy to put into the effort since energy (especially damaged eye energy) is finite.

Sure - but I don't think you or I have a monopoly on defining what "realistic expectations" means. I don't think I said anything suggesting they should expect some specific result. We're all adults here. People can make that determination for themselves.

[YGB]

Since energy is finite, one should decide as to whether they should commit their energy to writing a letter to their LASIK MD or to their local newspaper columnist.

My personal vote is for the local newspaper columnist since this person can shine light on the wrongs being done. Of course, one can always choose to write to both.

I will point out that it is amazing what a story like the WSJ story on dry eye can do to people. I have a relative who finally "got it" that dry eye can be debilitating simply because a patient was quoted in the WSJ as stating that dry eye can be "debilitating". Just the fact that it was stated in the WSJ made it valid in my relatives eyes. The fact that he has heard it from my wife during conversation just didn't seem to make it sink in like a media article.

Shining light on the damage done by LASIK to the media, through the law, and of course through the public are additional ways to get the word out. Shining light to those who are doing the damage (i.e. LASIK MD/site) is also worth a try (and again, I don't completely discourage it ... I even did it myself).

However, if a person has finite energy, I would recommend a letter to the media (even a student newspaper is good since young people are future LASIK candidates and media reporters). Another good thing about a letter to the media is that it can be sent to multiple media outlets. I myself have yet to go this route, but it is on my list of things to do once I can take the time to put together a good, concise write-up with just the facts ... no anger of course .

[Natalie06]

Complaints

I agree that there are multiple approaches you can take. But I do have to say the the AAO does seem to be taking my complaint very seriously. Much more seriously than my state medical board. My surgeon and his practice basically violated every rule that the AAO has in place for screening, informed consent and communications to the public. That said, I have no idea what, if any, action they will take. If the violations are serious enough the AAO can even recommend some type of action to a state licensing board. I would encourage everyone who has been hurt by Lasik and felt they were improperly screened or informed to go the AAO website and read their statements about informed consent, ethcis, etc. It can take a little digging but the information there can help guide you. For what it's worth, they have been investigating since October. They would not have started the process if there were not grounds for my complaint. It is a lengthy process and my case is in the hands of an "expert" at a renowned Eye Center. Ethics committee members are volunteers who typically have active practices. In my case, I can't imagine how they can possibly not do something, especially with 2 eye md's who have told me that I was a "high risk" candidate and with a copy of my records that proves no screening for DES and an informed consent document that doesn't even discuss DES.

My physician did offer to "honor any request" back when I wrote him 6 months ago. I elected not to take him up on whatever that meant for 2 reasons: They were so out of line that I did not believe they would do anything to change nor would they ever be monitored. He also clearly still did not understand why I was so upset, telling me they had done "everything possible" to help me. Like I should be more grateful that they were treating a condition that they caused because I was not properly screened nor informed of my high risk factors for severe dry eye. Had I felt more commitment from him, I might have acted differently.

I can say this: There have already been some changes, especially regarding this Lasik practice's communication to the public.

I am writing to the commisioner who oversees the state board, the governor of my state who appointed them, the local AMA and the state chapter of Eye surgeons.

If necessary, I will send a synopsis of my experience to every Ophthalmologist/Optometrist in a specified region. I calculated the expense and it's minimal. Just my time. I will not name my surgeon outright but will name the practice and how I was never never screened or properly informed about DES and encourage them to educate their patients and hopefully encourage these physicans to diagnose and treat DES before the patient finds out the hard way. And if that somehow affects the number of referrals to this Lasik practice, then so be it. Word of mouth is still a very effective form of advertising.


The problem with going public is that I run the risk of sounding like this is just a personal vendetta agaisnt a physician and I want to avoid that at all costs. This is a much more serious issue and I want it to come across that way. That's why I am going to explore every avenue I can through official channels.

I am still debating legal action and will at some point, attempt to use my media contacts through work to get this story told. I have time. My dry eyes and this situation are not going away any time soon.

Natalie

[sazy123]

In my case, I can't imagine how they can possibly not do something, especially with 2 eye md's who have told me that I was a "high risk" candidate and with a copy of my records that proves no screening for DES and an informed consent document that doesn't even discuss DES.

Natalie

If dry eye was not even included in the consent form and you were a high risk for dry eye then wouldnt there be grounds to sue on the basis that you did not consent to this side effect, as it wasnt in the consent form?

[Natalie06]

Sazy

Yes, in theory that sounds like grounds for a lawsuit. But understand that the state I live in is not very amenable to the injured party. I have had an initial consultation with an attorney. While I may have 2 physicians who have told me I was high risk, that does not mean they will be willing to testify against another physician to that effect. One of the reasons Lasik lawsuits are so tough to litigate is in part due to the "white Coat Society". I would need to spend $1,500.00 on an "expert witness", which I am fairly confident would be in my favor. But?

Also, what could I reasonably expect? I can see, can't I? I am just being realistic about the situation. And from my experience with the one attorney, a lawsuit is a very ugly, ugly thing. He knew my surgeon and told me that "Dr. X never settles." Now that's just one attorney and I plan on getting a second opinion. If I can't trust an Ophthalmologist, why should I trust a lawyer?

I have not ruled out legal action but I have at least another year before I need to do anything. I'd still rather do something that makes effective changes to the process and protects other people. Hopefully, ethics will rule and somehow I will at least be covered for the ongoing medical care I will require. But I am not counting on anything.

Natalie

[Guest]

Natalie

I admire you for the efforts you have taken to raise the profile of the risks of lasik and following your example am inspired to take this further in the UK.

I have contacted my clinic directly and have had an audience with the owner of the laser clinic chain. I must admit, the owner has promised me that his company will do all they can to ensure that my issues will be resolved.

I have never indicated an intention to sue as I personally don't think I have a leg to stand on, after all my consent form mentioned dry eyes and "paiin on waking", I have since discovered that "pain on waking" translates to recurrent corenal erosion that can be extremely painful and debilating but still I signed the consent form (although not really knowing what this meant at the time).

I have first hand experience of a family related personal injury lawsuit that was an open and shut case, ie, clearly negligence on behalf of the defendant, documented process of negligence, admission on behalf of the defendant's representative and yet the process placed undue stress and had such a significant personal impact that it almost resulted in the suicide of the family member involved.

My only suggestion to anyone contemplating the legal process is to make sure that you are strong enought to see it through to the end (whatever that may be). Iit is one thing to percieve negligence yet completely different animal to prove negligence in court.

For some, this is an appropriate course of action, for me and countless others I don't think there is a basis for a claim. However, this certainly won't stop me from contacting my regulatory authories in an attempt to raise the profile of how laser surgery has adversely affected my life and probably countless others.

Just my own personal thoughts

Ian

[lou]

growing evidence

.

My only suggestion to anyone contemplating the legal process is to make sure that you are strong enought to see it through to the end (whatever that may be). Iit is one thing to percieve negligence yet completely different animal to prove negligence in court.
Ian

I would tend to agree with Ian. Both methods are useful to tackle this issue, but it seems to me that we may be more effective in both after a good media coverage. If the public learns more about this then the judicial system will too and we may assume that's beneficial for future decisions.
Cheers

[desertcry]

Dear Rebecca,

Thanks for your suggestions. I supose it wouldnīt hurt to write a letter to the surgeon. In my case I was having tons of problems wearing contact lenses before surgery. I had a constant irritation in my eye. The person that examined me told me it was nothing and probably just an allergy in spring. He said I could still have surgery and that they were unrelated.

I donīt even know if a test was done for dry eyes. Iīm not sure what exactly I was told- I donīt carry a tape recorder around with me! I think the doctor said I may have slightly dry eyes for a short period - but that it could be helped with drops. In fact he seemed to think that any evt. complications he could solved.

How does it stand legally if you sign a consent form but are told so many things that seem to miss-inform?.... everything from blindness to uncorrected vision is in these forms. Is there a chance to do anything legally if thereīs a signature on a piece of paper?

Desert Cry

[Rebecca Petris]

Thanks for your suggestions. I supose it wouldnīt hurt to write a letter to the surgeon. In my case I was having tons of problems wearing contact lenses before surgery. I had a constant irritation in my eye. The person that examined me told me it was nothing and probably just an allergy in spring. He said I could still have surgery and that they were unrelated.

These stories just kill me. "Tons of problems" wearing contact lenses says it all. I am very troubled by what almost seems to be an increasing trend amongst some clinics to market lasik as a solution for contact lens intolerance.

How does it stand legally if you sign a consent form but are told so many things that seem to miss-inform?.... everything from blindness to uncorrected vision is in these forms. Is there a chance to do anything legally if thereīs a signature on a piece of paper?

Only a lawyer can answer these questions.

But from where I stand, FWIW: Even in legal terms, "informed consent" is a process, not a piece of paper. I've always thought the LASIK informed consent breakdown has a lot in common with the endowment mortgage scandals in the UK years ago. These stock-market dependent mortgage schemes were flagrantly mis-sold to people who did not in any way understand the risks - though the risks were disclosed on paper. The financial institutions responsible for this - some at least - were successfully held responsible via class-action lawsuits. The similarity with LASIK is that we're going to place more weight on the professional advice we're getting than we are on a piece of paper - especially given all the risk disclosures we deal with for everything these days. However, there tends to be a lot more sympathy for new retirees bilked out of their savings by aggressive bankers than healthy people mis-sold an elective "cosmetic" surgery.

So as a practical matter, in the US I'd say in general LASIK lawsuits centering specifically on informed consent do not fly. Lawyers won't take those cases. However, flagrant departure from the standard of care in pre-operative screening (which it sounds like your situation might be) is a completely different matter. That's a malpractice suit. Gross breakdown in the informed consent process could bolster a claim of that sort if it were already a reasonably strong claim.