the downside of LASIK

[cryptique]

I used to work in the optical industry, and was even a board-certified optician for a while (though I never dispensed glasses/contacts -- I was a paper-pusher at the administrative office of an optical chain).

 

While I was on that job, LASIK ascended to its dominant status among elective refractive surgical procedures, but the more I learned about it, the less I trusted it. Fast-forward more than a decade to today ... and the FDA may finally stir from its slumber to take a closer look (cough) at this booming industry, which is shockingly unregulated -- or poorly regulated, anyway.

 

I hope those of you who've had LASIK are among the lucky ones with no ill effects. Any of you who are considering the procedure may want to gather more information before proceeding -- and please gather it from sources other than your prospective doctor, who may be more interested in your money than your long-term quality of life.

 

link to Salon article

 

Lasik's blurry vision

 

Side effects continue to plague patients like me. Now, as the FDA investigates, one expert admits, "We screwed up"

 

By ABBY ELLIN

 

The other day I got a prescription for eyeglasses. This is not newsworthy in itself except for one thing: More than two and a half years ago I had Lasik (laser-assisted in situ keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I knew that eventually I would need reading glasses, but I would, I was assured, be able to see long-distance for a long time.

 

Problem is, I can't.

 

Not only is my vision blurred, but as I wrote in a 2008 article for the New York Times, I still see halos, and not the kinds with angels attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms. My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I signed an "informed consent" saying I understood all the possible side effects, but I certainly never knew that they might last indefinitely, and that they would be more than "annoying," as my doctor promised. But nearly three years later, they are still here. And while I could get an "enhancement" -- that's industry parlance for another surgery to correct errors -- frankly, the only thing I want near my eyes is mascara.

 

According to the American Society of Cataract and Refractive Surgery, most of the 13.6 million people in the United States who have had Lasik surgery since the first lasers were approved by the FDA in 1998 are pleased with the results. But others have experienced similar, if not worse, problems than I have.

 

Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical "adverse events."

 

And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who've had laser vision correction surgeries are still wearing glasses or contacts some of the time. Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.

 

Still, the American Society of Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies involving 2,022 patients that specifically addressed patient satisfaction.

 

"Based on everything we know from the literature, and everything I know from any other elective procedure, Lasik eye surgery is the most successful elective procedure performed," said Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a co-researcher on the study.

 

The experience of patients like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about four years ago, seem to support this assessment. Getting the procedure, he said, was one of the best decisions he has ever made. While he does experience some starbursts, he said "it’s not bothersome at all."

 

But the FDA and others are taking note of what they call "quality of life" issues. In October, the FDA, the Defense Department and the National Eye Institute announced in October a three-year effort to assess adverse effects of Lasik. The effort will involve gauging how many active-duty military patients at the Navy Refractive Surgery Center in San Diego suffered post-surgical eye problems, and a series of national, multi-center clinical trials that will study the impact on quality of life following Lasik surgery in the general population. In addition, the FDA has reopened a public docket to receive comments through Nov. 15.

 

"We noted that there was little consistent evaluation of the issues," said Mary Long, an FDA spokeswoman, about the reasons for why the study was initiated.

 

Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. "Lasik is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those few of us who speak ill of it are dismissed as cranks and/or loonies," he wrote in an e-mail message. "I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost -- human and otherwise -- of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through."

 

Surf the Web and you can find dozens of stories from people who have had post-Lasik difficulties: dry-eye, halos, glare. Some complications have resulted in corneal transplants. Over the last few years patient activists have bombarded the FDA with anti-Lasik e-mails, complaints and petitions.

 

Among them is John Hoge, 39, a businessman in Port Jefferson, N.Y., who suffered from night glare and halos and regrets not choosing the "zero risk option" of corrective lenses. A few years ago he got some experimental contact lenses that have largely taken care of the glare issue. They are expensive, he added, and are not covered by insurance.

 

While the FDA's recent efforts have given some patient activists a modicum of peace, many do not feel it is enough. "By not inspecting every Lasik facility in this nation, how is the FDA to know if Lasik doctors are compliant?" said Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Fla., who has experienced double vision, starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web site LifeafterLasik.com.

 

Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. "We screwed up," said Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health Office of Science and Technology from 1995 to 1999. "You know how some drugs have a black box warning -- it’s dangerous because of this, this and this -- we could have done something comparable to that. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials."

 

Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Va., agreed. "It appears that information to provide adequate informed consent was not sufficient for all prospective patients about occasions where a bad outcome could result," he said. “The present dissatisfaction rate of 5 percent is very high. Personally and professionally, I am very disappointed in the FDA."

 

Spokeswoman Long refutes the notion that the FDA was errant. "The FDA has reviewed safety and effectiveness information included in the manufacturer’s applications for approval," she wrote in an e-mail message. "We found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health."

 

Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to Lasik ambulatory facilities last May reminding them that all risks must be mentioned in every Lasik advertisement online, in print, radio or TV.

 

"As part of our ongoing review of Lasik and its impact on public health, we continue to look at various aspects of Lasik advertising and how we can better improve public health," said Long.

 

Still, an informal online search showed dozens of doctors' Web sites that do not mention risks or side effects.

 

As for the new study, Larry Pilot is not impressed. "The FDA is beginning to do what should have been done 10 years ago," he said. "The bottom line here is that upwards of scores of thousands of human eyes have been irreversibly damaged unnecessarily."

 

Dr. Solomon disagreed, maintaining that the FDA clinical trials on Lasik lasers were "rigorous" and "well-performed." "I think the FDA did an outstanding job at evaluating the technology," he said. "And the technology and procedure since approval have only gotten better."

 

As for me, if I had to do it all over again I wouldn't. But hindsight, alas, is 20-20.

[watch me fall]

One of the girls who works for me is going for a LASIK consultation on Friday.

[bleedorange]

I've always been leery of it. Although, everyone I know that has had it has had zero problems. I just never wanted to take any chances with my eyesight. Too valuable.

[Guest Speed Racer]

I know four people who have had LASIK, and two of them had to get glasses to correct errors during the surgery.

[moxiebean]

I've worn glasses since I was 10 (35+ years) and until Lasik is proven to be 100 percent safe & reliable (which no surgery would ever be) I'll stick with my specs.

[watch me fall]

I've worn glasses since I was 10 (35+ years) and until Lasik is proven to be 100 percent safe & reliable (which no surgery would ever be) I'll stick with my specs.

Ditto.

[Hoodoo Man]

My brother, who happens to be a doctor, had LASIK about 3 years ago and is now having a lot of difficulties. He is back to wearing glasses and/or contacts again but at night his vision is so bad that he can't drive. I'm afraid he may have to have a corneal trasplant before it's all over. I feel very lucky that I've never had enough money to afford the surgery because it's very tempting to try and eliminate the hassle of contacts and glasses.

[Dude]

My uncle had this surgery. And had it again to fix the first surgery. And had it again to fix the other two surgeries.

[NightOfJoy]

Ditto.

 

 

Although I'd really, really, really like to get it done, I'm not gonna risk it.

[watch me fall]

I'm skeered of it. Totally.

[cryptique]

I figure I only get two eyes in this lifetime, and even 95.4% isn't a high enough satisfaction rate when it comes to my only two eyes ... because that means a 4.6% dissatisfaction rate.

[bjorn_skurj]

I think I look good in glasses, actually.

[ih8music]

I almost did it based on a co-worker's great experience with his doctor. Went as far as scheduling my operation - but something came up at work where I had to be out of the country for the 2 weeks following the surgery (missing the post-surgery appts), so I canceled it. Life happened and I never got around to re-scheduling the operation... and am pretty happy about that. My co-worker ultimately had problems develop w/ his eyes after 2 or 3 years. I recall the LASIK surgeon was contending that it wasn't related, but he was challenging that. I've lost touch with him... not sure how it turned out.

 

As much as I hate the inconvenience of wearing glasses & contacts, I plan on staying put.

[Doug C]

I never understood what was so horrible about wearing glasses that someone would want surgery simply to never have to wear glasses again. Last summer was my Summer of Dorian Grey (the optometrist said, 'Presbyopia'). I now wear spectacles and still don't see what's so Godawful about it.

[gogo]

I think it depends on how bad your eyes are. My sister, who has worn glasses since her early teens, has considered Lasik but decided against it, for all the reasons given above. But she was saying recently that she can't believe our mother is able to just walk around the house without her glasses. The minute my sister gets up in the morning, she has to put her glasses on, or she's not even comfortable getting out of bed. I think if my eyes were that bad, I'd see the allure of a surgery like that.

 

The #1 reason she decided against Lasik was when she heard someone whose surgery did not go well describing his eyesight as the equivalent of always looking through a dirty windshield. Yikes.

 

My friend Sarah had Lasik several years ago, and she has no complaints. My complaint about her surgery is that, like bjorn, I felt she looked great in her glasses. She's still cute, but her look before was really cool and distinctive.

[ih8music]

I never understood what was so horrible about wearing glasses that someone would want surgery simply to never have to wear glasses again. Last summer was my Summer of Dorian Grey (the optometrist said, 'Presbyopia'). I now wear spectacles and still don't see what's so Godawful about it.

My prescription is pretty strong, so I'm almost blind without my glasses or contacts. I hate waking up and not being able to see the alarm clock until I fumble around and find my specs. I also play(ed) sports and glasses are a major hindrance (thus the need for contacts).

 

Contacts are their own animal as far as expense & hassle goes - I can't tell you how many times I've burned my eyes out by putting my contacts in the morning after I cooked with/ate chiles. You'd think I'd have learned by now, but it happens at least once every few months.

 

As petty as it sounds, those were the main reasons I almost did LASIK.

[Doug C]

gogo and ih8music, your points are well taken but, simply talking out of my ass, I'd venture to say that a good percentage - if not the majority - of LASIK patients think glasses spoil their looks and/or feel that wearing them in general is a pain.

[ih8music]

gogo and ih8music, your points are well taken but, simply talking out of my ass, I'd venture to say that a good percentage - if not the majority - of LASIK patients think glasses spoil their looks and/or feel that wearing them in general is a pain.

Those people certainly do exist (I was one of them when I was in HS), but I think most people who think like that turn to contacts first and then go to LASIK if/when they get tired of the hassle of wearing contacts.

[Guest Speed Racer]

feel that wearing them in general is a pain

 

I think that's what gogo and ih8music said. Being batshit blind without glasses IS a pain, and you can't wear contacts all the time. Some people lose their glasses like it's their job, sitting or stepping on them when they can't find them; for those people, LASIK is a one-time payment that they would have made over time anyway, through the cost of broken glasses, without the hassle of going to the store twice a year. Many insurance plans cover optical exams but do not cover the cost of glasses or contacts; therefore, this is something a lot of people would pay for out of pocket anyway.

 

I'm lucky enough that my vision without glasses is pretty darned good, otherwise I would have to wear them when I run/bike/figure something out for swimming, which would be incredibly annoying, if not prohibitive at times (fogging in certain weather, raining in others; fogging and freezing over in other kinds of weather). I have only stepped on my glasses once in 8 years, and I kept wearing them because I didn't want to get another pair. In fact, by the time I did they were so scratched and bent I could hardly see through them.

 

What you consider "a pain" really, truly is an expensive and time-consuming hassle for a lot of people; the cost of LASIK is less to them than the cost of going to the store for new glasses or the cost of missing out on activities they love. The convenience of LASIK is not just for the lazy, and that's exactly why the FDA needs to step-up and regulate.

 

Some people can't wear contacts because of the state of their eyes (me, for instance), and I understand that at least some of those people are also ineligible for LASIK because of that condition. Can someone else tell me whether that's ALL people, or just some? Because for glasses-wearing folk who can't wear contacts but ARE eligible for LASIK, and are active enough that glasses are prohibitive, well, that's another no-brainer.

[gogo]

I'm lucky enough that my vision without glasses is pretty darned good, otherwise I would have to wear them when I run/bike/figure something out for swimming, which would be incredibly annoying, if not prohibitive at times (fogging in certain weather, raining in others; fogging and freezing over in other kinds of weather).

Yep. My sister has prescription goggles for swimming. And we found out, when we went to Hawaii a few years ago, that some dive shops have prescription face masks available, you can arrange ahead of time to rent your prescription. But she'd have been totally out of luck for snorkeling, etc., otherwise.

[jff]

My wife just had LASIK a couple weeks ago. So far so good. One of the reasons she became interested in it was because during a roadtrip we were in a pretty bad car crash on the interstate. Her glasses were knocked off and buried under a bunch of our stuff which had been strewn all over the car. We weren't able to find the glasses for several minutes, and as a result she was pretty terrified by not being able to see what was going on. Granted, that's a rare scenario, but fear is a strong motivator, and there are a number of ways you can find yourself in scary situations of you can barely see.

 

Other reasons were fogging, difficulty driving at night due to glare, etc.

[Guest Speed Racer]

I used to bike to and from work with my glasses on in the winter, until one day it began sleeting while I was on a busy road. By the time I could safely pull over, I was watching the road by tilting my head back toward the sky, peering under my glasses, and a thick layer of ice had accumulated on the lenses. I think that's a testament to the perils of both glasses and Minnesota winters.

[Doug C]

I concede defeat. There are several sensible reasons to have LASIK. I am fortunate that, at this point, I only have presbyopia. In the future my negligible myopia may worsen and I will need to wear glasses all day rather than just for reading. I apologize if I offended anyone that has had or considered LASIK or has a loved that has done so. I wasn't considering all of the possibilities, only my own point of view and experience.

[gogo]

Just look at it this way: if you were Burgess Meredith in that episode of the Twilight Zone, would you rather have had the surgery or not? Dirty windshield or not!

[Doug C]

Ha and touche'! I love that episode. It was one of the ones that I made sure to DVR when SyFy had a Twilight Zone marathon over New Year's.