FDA LASIK hearing on 4/25

[dianat]

I got the exact same letter today. I was equally as perplexed before I opened it. I thought I failed some sort of screening...

[Lucy]

I received written notification today via snail mail that my info has been entered into the MAUDE data base. I wondered what the Department of Health and Human Services was mailing me. Duh. Lucy

[Rebecca Petris]

Let's be counted. Surely we can come up with more than 140 in 8 years. I feel that I was neglegent in NOT filling this form out before.

Would you believe I just now did the same?

Folks, LET'S MAKE SOME NEWS. There are several hundred lasik patients on this bulletin board, according to user profiles. If we could produce another 140 complaints in the next month, that is clear evidence that the reason the FDA has only 140 complaints is NOBODY KNOWS THEY CAN OR SHOULD COMPLAIN to the FDA when they have problems after LASIK.

This abuse of numbers that are so ridiculously out of whack with reality (heck, all you've got to do is prowl through the medical literature to find study after study with 140 dry-eyed folks) needs to be put an end to and soon.

[Lucy]

Fill out the form, please!

Rubyslippers, I am one who had lasik, got cataracts soon after, had one taken care of--but it was only more problems If my doc would have gone straight to iol's, my insurance would have paid for it and I would likely have eyes that weren't dirt dry. My corneas would be in much better shape and so would my pocketbook.

All, please fill in the form YGB and Rebecca have made available for us. I'm only 8 years late, but I've just done it. Let's be counted. Surely we can come up with more than 140 in 8 years. I feel that I was negligent in NOT filling this form out before. Duh. Lucy

[LasikLady]

Filed my adverse effect form

Thank you YGB for making that link easy to follow and for explaining how to do it.
Some how I feel a little bit vindicated. Might seem silly but it felt good to file some kind of comlaint about what happened to me. Hopefully if everyone who's been lied to about this surgery and taken advantage of files a report the FDA will really understand how this surgery can negatively impact lives.

[Rebecca Petris]

Because of this very thread, I convinced my friend not to have LASIK as scheduled for next week. She was adamant she was a good candidate according to the LASIK clinic. She is 56, has dry eyes mildly, has never been able to tolerate any kind of contact lense at all. Additionally, she was told she has a "mildly thin cornea". This thread prevented a tragedy for this woman, IMO. Thanks for all of you sharing. The public needs to know. Newsweek and Reader's Digest could do a lot to spread the word.

There are two additional key reasons your friend can pat herself on the back:

1) The average age in this country for cataract surgery is something like 62 or 63. During cataract surgery they can correct your vision with the lens implant anyway. Furthermore, IF your friend had LASIK, her cataract surgery would be more complicated and the doctor's ability to accurately calculate the lens power would be limited.

2) If your friend can read without glasses now, she wouldn't be able to after LASIK unless she got "monovision" (a different prescription in each eye), which 20% of the population can't adapt to.

In other words, in buying LASIK your friend would probably be purchasing 6 years of glass-free-distance vision; a more complicated cataract surgery with a less predictable outcome; and (depending on her current prescription and some other factors) possibly greater dependence on reading glasses in the meantime. - All that without even taking into account dry eye or other risks.

That's what I call informed consent.

And I'm happy to say that the FDA - for what it's worth - are going to revise their website and product labelling to include these warnings about cataract surgery and near vision loss as a result of Friday's meeting. Paula Cofer as consumer advocate on the ODP should be giving herself a hearty pat on the back for that.

[rubyslippers]

Because of this very thread, I convinced my friend not to have LASIK as scheduled for next week. She was adamant she was a good candidate according to the LASIK clinic. She is 56, has dry eyes mildly, has never been able to tolerate any kind of contact lense at all. Additionally, she was told she has a "mildly thin cornea". This thread prevented a tragedy for this woman, IMO. Thanks for all of you sharing. The public needs to know. Newsweek and Reader's Digest could do a lot to spread the word.

[Rebecca Petris]

If we want the FDA to know "how serious and widespread the problem is", it is imperative that we report our bad outcomes to the FDA.

It would be great to get more than 140 complaints in less than a month.

Speaking of guilt, I am feeling guilty for not having done more to emphasize this to all new users! This is VERY important and I thank you YGB for bringing it up again.

And it's not just for LASIK, either: ANYONE who is here because of dry eye that started from an FDA-regulated drug or a surgery using an FDA-regulated device can, and should, report their experience to the FDA! For example, today I spoke with a lady who gets Botox injections regularly as a treatment for blepharospasm. Her lids froze open after the latest injection. Our DEZ community can readily imagine what pain she is in. Has any doctor reported her to the FDA? No way, probably not even to Allergan from what I understood.

Folks, the "140 complaints in 8 years" number - bandied everywhere in the press now - should be a major wake-up call to us all. It certainly has been to me. No one is going to tell the FDA for us. We must do it ourselves.

[YGB]

FDA Maude Database

No need for guilt. However, all LASIK sufferers should report their bad outcomes to the FDA. I posted this somewhere else, but here it is again ...

If we want the FDA to know "how serious and widespread the problem is", it is imperative that we report our bad outcomes to the FDA.

If you've been wondering how you can help or what you can do, this is it. If every LASIK patient who had a bad outcome filed a MedWatch report, the FDA would be flooded with adverse events reports. The web link below will take you to the "MedWatch Online Voluntary Reporting Form (3500)".
Then click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" (assuming that is applicable to you), on #5 describe the problem, and #6 is not applicable to LASIK.

https://www.accessdata.fda.gov/scrip...tch-online.htm

Note that you can always leave fields blank and still move on from one screen to the next. However, you should be able to fill in most of the fields using the steps above. Please do this. It would be great to get more than 140 complaints in less than a month.

[dianat]

I'm feeling the guilt, too, Shells.

[shells]

Rebecca, Matt, and any others who attended,

Thanks so much for representing us at those meetings. I've also heard from a few friends who read about the hearings or saw the news reports. The word is definitely getting out there. Rebecca mentioned a poor patient turn out, and now I'm feeling a bit guilty that I didn't try to get more involved since I live in the DC area. I do plan to submit my complaint to the FDA with the link that was provided on the site though, and I hope that everyone else does the same. Thanks again for your courage and your efforts in getting our stories out there.

-Shells

[Natalie06]

[B]

Theoretically, (2) the standard of care itself is so low that it is very, very difficult to use this channel successfully. That is, the average doctor considers it acceptable to laser someone with those pre-existing conditions, then by definition... the standard of care has not been violated. No case. In other words, much of what we here would consider to be grossly inadequate screening/informed consent is not necessarily considered so by the industry at large, so the civil court system is of little use to us, despite the FDA believing that's its natural role.

If 90% of Ophthalmologists belong to the AAO (and I am quite sure I read that on their website) then by default the overwhelming majority of RS surgeons would also be members and they, the AAO and it's members, DO have a set standard of care for Lasik/RS screening and informed consent. Seems like this could be used to someone's legal advantage. I need to ask my attorney that question.

[Lucy]

The public hearing should and could have been used as an opportunity for top surgeons to underscore the importance of excellent standards of care, not abused as a platform from which to market LASIK to people who may be at higher risk.__________________

They don't want to bite the hand that feeds them. That is, their own.

[Rebecca Petris]

A friend of mine walked in there this year with these qualifications: post-menopausal dry eye, ocular and facial rosacea, and contact lens intolerance. She was told she was an excellent candidate for LASIK. So what does the FDA plan to do about that?

Nothing. If she has a poor outcome under such circumstances, then the FDA's answer (a similar question was in fact raised yesterday) is: (not the exact wording, but unmistakeable nonetheless): That's what your friendly local malpractice attorney is for.

Inadequate informed consent, inadequate screening, and poor post-operative care (the three key problems most of us would agree on) are precisely what the FDA cannot do anything about. This is the catch-22 of elective vision surgery. The FDA only regulates devices, and it sells the devices only to surgeons, not us. Once those devices are in the hands of surgeons, what the surgeons do with them is none of the FDA's business except insofar as the surgeons have certain mandatory adverse event reporting requirements (which, as was pointed out yesterday, is not happening).

Theoretically, surgeons doing a poor job of screening, informed consent and postop care of complications patients is malpractice and patients' natural recourse is through the civil court system as we were reminded by the FDA yesterday. In practice, we have a couple of problems: (1) The pain and suffering associated with dry eye after LASIK is not worth enough money in most state courts for lawyers to be able to take the cases; and (2) the standard of care itself is so low that it is very, very difficult to use this channel successfully. That is, the average doctor considers it acceptable to laser someone with those pre-existing conditions, then by definition... the standard of care has not been violated. No case. In other words, much of what we here would consider to be grossly inadequate screening/informed consent is not necessarily considered so by the industry at large, so the civil court system is of little use to us, despite the FDA believing that's its natural role.

Speaking of which:

A friend of mine walked in there with these qualifications... contact lens intolerance.

While there were many positives from yesterday which I'll get to, a couple of my sore points from yesterday were in relation to contact lenses:

1) A very highly reputed surgeon stated that contact lens intolerance is a common reason people pursue laser eye surgery, without saying a single word about this potentially being a red flag, and in fact leaving it to be inferred (whether deliberately or intentionally I cannot say) that this is a good reason to get it done;

2) At least two highly reputed surgeons suggested that LASIK is safer than contact lenses.

I was truly repulsed by these comments in this context. The public hearing should and could have been used as an opportunity for top surgeons to underscore the importance of excellent standards of care, not abused as a platform from which to market LASIK to people who may be at higher risk.

[dianat]

Brd888,

I hear you on this...now. I misinterpreted you at first. Sorry.

I would agree that a figure of 140 people reporting to the FDA on this is ludicrous. To be perfectly honest, however, aside from sending my story off last week to be included with the FDA hearing data, I haven't reported my surgery results to the FDA in any formal way. And I know darned well my LASIK surgeon didn't report it.

Rebecca is correct in stating that the FDA would not have agreed to a hearing if they believed only 140 people were affected.

All told, I'd say we all had an excellent week. There are surely would-be LASIK candidates out there who did not appreciate this week's press reports.

Perhaps the next awareness campaign can address those facilities out there who are cutting into anyone who walks in the door. There's an office right up the road from me doing just this. They offer a kickback for referrals on top of liberal standards for LASIK candidacy.

A friend of mine walked in there this year with these qualifications: post-menopausal dry eye, ocular and facial rosacea, and contact lens intolerance. She was told she was an excellent candidate for LASIK. So what does the FDA plan to do about that?