Experts New Warnings for LASIK

from:

April 28, 2008 �?? The FDA should do more to warn patients about the risks of popular laser vision corrective surgery, an expert panel has concluded.

The recommendations came after more than a dozen LASIK patients or their family members testified Friday about severe reactions to the surgery. Most said their doctors did not adequately warn them that vision loss or eye dryness could persist, in some cases, for years.

“For a small minority, their regret is profound,” said Todd Krouner, a New York attorney who represents about half a dozen LASIK patients, including the wife of a former police officer who Krouner said blamed a botched LASIK surgery for his suicide.

“It is not about the 20 minutes in surgery, it’s about what came before it and what has come after it. It’s about a lack of solution for them,” said Rebecca Petris, a former LASIK patient who now runs a network of dissatisfied patients.

The FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) to try to compile more information on the rate of poor LASIK results.

The study is likely to take years to complete. In the meantime, experts said information given to patients considering LASIK surgery should warn more clearly of the possibility of long-term vision disruptions, including “halos,” “starbursts,” blurriness, and multiple vision.

The FDA has become increasingly concerned about reports of severe complications but has acknowledged that it does not have enough studies to know how often severe reactions occur. Those reports, which include debilitating eye dryness, blurred vision, and other vision disruptions, could suggest doctors are not doing enough to inform patients about the potential risks, the agency said.

Debate Over LASIK

LASIK (which stands for laser-assisted in situ keratomileusis) is performed in more than 700,000 U.S. patients each year. One study published last month by a trade group representing LASIK surgeons suggested about 95% of all patients are satisfied with their procedure.

“Even with the stats we have, we have info that the vast majority of patients who have LASIK do very well,” said Jayne S. Weiss, MD, who chaired the advisory panel.

“It is really a referendum on the performance of LASIK by some surgeons who should really be doing a better job,” said Weiss, a professor of ophthalmology at Wayne State University in Detroit.

Experts also recommended that both patient information and FDA’s LASIK web site contain photos of potential vision problems.

“We do want something that people will read and see if they have the opportunity to,” Weiss said.

Experts also urged the agency to include more warnings about the potential risks of LASIK in women using hormone replacement therapy since the drugs can alter the cornea. And they called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.

Some advocacy groups have said the FDA’s national study lacked independence because it was being run in part by ASCRS, the group representing doctors performing LASIK and other procedures.

“The FDA will objectively evaluate the information collected,” said Eva Rorer, MD, the chief of FDA’s ophthalmic division.

Still, some experts said Friday they had difficulty knowing what new warnings to recommend for LASIK patients.

“I think there are many aspects of risk related to LASIK that we have yet to find out,” said David C. Musch, MD, a professor of ophthalmology at the University of Michigan and a member of the advisory panel.

Peter McDonnell, MD, professor of ophthalmology at Johns Hopkins University School of Medicine, says the surgery has been studied extensively. According to a news release about the FDA meeting by the American Academy of Ophthalmology, McDonnell says, “LASIK is the most studied elective procedure. …I believe it is safe to say that no elective ophthalmic surgical procedure has been as fully studied as has this procedure. But, as with any surgical procedure, there are complications that may occur after LASIK. Fortunately these are uncommon. No matter how uncommon, however, when complications occur they can be quite distressing to both patients and surgeons.”

SOURCES: Jayne S. Weiss, professor of ophthalmology, Wayne State University, Detroit; Todd Krouner, attorney, Chappaqua, N.Y.; Rebecca Petris, founder, lasermyeye.com; Eva Rorer, MD, chief ophthalmic medical officer, FDA; David C. Musch, MD, professor of ophthalmology, University of Michigan; member, FDA advisory panel; LASIK: A Global Perspective on Patient Satisfaction, American Society of Cataract and Refractive Surgery (ASCRS), March 5, 2008; News release, American Academy of Ophthalmology.


Todd Zwillich is a freelance writer for WebMD.

WebMD Health News 2008. © 2008 WebMD Inc.

These risks are explained to patients before they have the surgery.

At what point do you blame the patient for not listening and considering these risks instead of only focusing on their desire for a positive outcome?

From someone who does have to explain the risks of minor surgery often, most patients just nod in agreement with you while you state the risks. That is why you are required to SIGN that you are aware of them.

This is well known and well explained. Doesn’t the FDA have more important things to do than recycle old information?

I had Epi-Lasik and love the results. My left eye is still weaker than my right, but as long as I don’t need contacts anymore I’ll be fine.

The warnings are more than sufficient. Complications and side effects are all a part of the risks we take.

I have bad, not horrible, but bad eyesight and this will not effect my decision to have Lasik done when I am old enough. I hate the fact that they recommend you being 25 to have the procedure done because I would love to have it done now at 20.

Risks and side effects are a part of every medical procedure and like Pro X said, you sign off on those risks. If people that had the procedure done are bitching and complaining, that’s their fucking fault for signing off and agreeing that there COULD be negative effects. I swear, so many people out there are assholes today, and just looking to sue anyone and everyone. Pretty sure soon enough you won’t even be able to trust your own immediate family members.

[quote]Zap Branigan wrote:
This is well known and well explained. Doesn’t the FDA have more important things to do than recycle old information?[/quote]

Actually I heard they are putting together a new food pyramid that says you only need 10g of protein a day.

[quote]kelleyb wrote:
I had Epi-Lasik and love the results. My left eye is still weaker than my right, but as long as I don’t need contacts anymore I’ll be fine.

The warnings are more than sufficient. Complications and side effects are all a part of the risks we take. [/quote]

I had it done too and “thrilled” is an understatement. And as if the list of warnings weren’t sufficient, these people should take a moment and, you know, think;

They are slicing open your eye and burning off pieces of tissue with a laser! There’s no way they can guarantee that there will be 0% chance of side effects 100% of the time.

[quote]Professor X wrote:
These risks are explained to patients before they have the surgery.

At what point do you blame the patient for not listening and considering these risks instead of only focusing on their desire for a positive outcome?

From someone who does have to explain the risks of minor surgery often, most patients just nod in agreement with you while you state the risks. That is why you are required to SIGN that you are aware of them.[/quote]

I agree. But I think there is a lot of hype outside the medical arena, TV shows like extreme makeover are a good example, no risk is talked about. I guess thes shows basically are advertising for cosmetic surgery etc.

[quote]Old Dax wrote:
Professor X wrote:
These risks are explained to patients before they have the surgery.

At what point do you blame the patient for not listening and considering these risks instead of only focusing on their desire for a positive outcome?

From someone who does have to explain the risks of minor surgery often, most patients just nod in agreement with you while you state the risks. That is why you are required to SIGN that you are aware of them.

I agree. But I think there is a lot of hype outside the medical arena, TV shows like extreme makeover are a good example, no risk is talked about. I guess thes shows basically are advertising for cosmetic surgery etc.[/quote]

That brings us back to personal accountability. There is no way you can protect people from all dumbasses in the world…or better yet, protect dumbasses from themselves.

If you watch a tv program that shows someone going from crooked yellow/brown teeth with massive gingivitis and in 15 whole seconds they now look like a Hollywood bright teen mag cover smile, you would have to be an idiot to think that is how simple it is.

You can’t blame the media for mass idiocy, much like you can’t blame Mc Donald’s for why that 460lbs woman won’t stop eating QuarterPounders.

[quote]Professor X wrote:
That brings us back to personal accountability. [/quote]

Which is sorely lacking in today’s world. Everything is someone else’s fault. God forbid someone actually mans up and admits they fucked up.

My wife got lasik and has said it changed her life. She cried the day of when we walked into the parking lot and she could read the license plates.

[quote]football061 wrote:
Zap Branigan wrote:
This is well known and well explained. Doesn’t the FDA have more important things to do than recycle old information?

Actually I heard they are putting together a new food pyramid that says you only need 10g of protein a day. [/quote]

That high?

[quote]Professor X wrote:
From someone who does have to explain the risks of minor surgery often, most patients just nod in agreement with you while you state the risks. That is why you are required to SIGN that you are aware of them.[/quote]

Due to the litigious nature of our world I can guarantee that they signed forms, most likely in triplicate, with initials beside the important sections like “you may go blind, your eyes may fall out of your head” etc. If you call 911 for a skinned knee and then decide that you don’t want to go to the hospital, we have several forms that remind you that we can’t be responsible for your septic knee-infection death later on.

I was talking to an optometrist at the gym the other day about lasik and he says on paper I seem like a good candidate. From what I researched on the web I fit the criteria but he says they do a pretty good job of evaluation if you pick a reputable surgeon.

I am surprised at the number of people that spend more time worrying about the guy that is going to work on their car than the doctor who is treating their illness. Life is pretty much one calculated risk after another and I can hardly think of anything that I would want to be more informed about than my health risks and options.

So do some research on your surgeon and don’t just get it done because someone in your family went there and said Dr. Cataract was a GREAT doctor who hands out lollipops.

[quote]football061 wrote:
Zap Branigan wrote:
This is well known and well explained. Doesn’t the FDA have more important things to do than recycle old information?

Actually I heard they are putting together a new food pyramid that says you only need 10g of protein a day. [/quote]

You’re flirting with renal failure at those excessive numbers my friend. You’ve been warned.

I can’t wait to get lasik. I’ve had to wear glasses/contacts since I was 8 and I’m nearing the point where my eyes are finally leveling out I guess you could say. My vision is fuckig horrendous.

And who wouldn’t think there are risks?? It’s a fucking laser, cutting open your eyeball. Risk???

ill tough it out with my contacts

g

Had it done seven years ago. Saw the halos for a few months, which was annoying, but not nearly as much as dealing with contacts, repeated infections, etc. My vision before was 20/400; 20/15 immediately after. No regrets here.