Reuter's Article on lasik & FDA

[lboogie]

http://www.reuters.com/article/gover...BrandChannel=0

Being a new lasik victim -- I just feel so sick to my stomach when I read about all of this. I just keep wishing I never had this done. It has consumed and ruined my life these past 5 months. I just can't believe that I was so cavalier with my healthy eyes -- it's not like me at all............I was just so sure it all had to do with selecting a good sugeron and facility.

Nobody that I encountered made me stop and think about it -- they either said oh cool! Or yeah, I had it done, and it was great. Will I ever stop second guessing myself?

It's hard to clear my mind of anything but my eyes. I'll be listening with great interest to this panel and what happens as a result.

[Rebecca Petris]

Would it be terribly inappropriate of me to bring in some comic relief at this point...?

Tiger Woods' Secret Reverse-Lasik Surgery Revealed

[kurt]

...said Dr. Isaac Myopia in a blurry videotaped interview from his Lake Buena Vista hotel room...

That was pretty funny.

[kurt]

Blurry Outlook for LASIK

A Blurry Outlook for LASIK
Some will recognize familiar names in this ABC website report dated April 22, 2008.

[bassfan]

A Blurry Outlook for LASIK
Some will recognize familiar names in this ABC website report dated April 22, 2008.

Slightly sad that theres only 140 "real" problems with lasic. I bet theres plenty more than that on here alone. I was almost tempted to write in to the FDA when Rebecca posted about it...but my DES isn't lasic related and i've never had it, figured I better not.

bassfan

[YGB]

From the Reuters article ...

"Known complications from the procedure include lost vision, severe dry eye, glare and double vision."

The LASIK industry considers dry eye, glare, and double vision to be "symtoms" and not complications. This keeps the LASIK complication rate artificially low. It's interesting that Reuters, and anybody who is not tied to the LASIK industry, would consider these to indeed be complications. Anything that can last a person's entire lifetime after LASIK should be a complication. The FDA should change its labeling to correct this major oversight.

[Rebecca Petris]

Slightly sad that theres only 140 "real" problems with lasic. I bet theres plenty more than that on here alone. I was almost tempted to write in to the FDA when Rebecca posted about it...but my DES isn't lasic related and i've never had it, figured I better not.

bassfan

The 140 figure being bandied about has greatly angered me because it is being used so inappropriately to play down concerns. First the ASCRS put it out in their press release and now it's being picked up by all the general press.

The percentage of complications that 140 complaints in 8 years would imply is a TINY fraction of what the rates have been PROVEN to be in published medical literature and in the FDA's own documentation and labelling of the devices.

The simple fact is that unhappy LASIK patients don't complain to the FDA. (Why would they, and if they even want to, how many will figure out how?) At the very most if they are very angry with their doctor they might go to the state medical board.

On the other hand, the surgeons producing those unhappy LASIK patients - if the unhappiness is due to injury - have a legal responsibility to report them to the FDA via the medical device reporting system, irrespective of whether they believe that the laser was at fault. But they don't. All you've got to do is look through the MDRs in the MAUDE database to figure that out.

[YGB]

The 140 figure being bandied about has greatly angered me because it is being used so inappropriately to play down concerns. First the ASCRS put it out in their press release and now it's being picked up by all the general press.

The percentage of complications that 140 complaints in 8 years would imply is a TINY fraction of what the rates have been PROVEN to be in published medical literature and in the FDA's own documentation and labelling of the devices.

The simple fact is that unhappy LASIK patients don't complain to the FDA. (Why would they, and if they even want to, how many will figure out how?) At the very most if they are very angry with their doctor they might go to the state medical board.

Rebecca - you raise an excellent point. I hope you will put the FDA Maude database link up as a "sticky" and ask that each LASIK patient suffering from LASIK complications on this site take a few minutes to fill out the online form.

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.

[kurt]

Thanks for posting the medwatch link.