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Is LASIK Eye Surgery Safe? FDA Scientist Regrets Saying 'Yes'

3 years ago
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In Washington, D.C., a culture that embraces regulatory oversight and rule-making and where bureaucracies are everywhere, no federal agency is more warren-like than the Food and Drug Administration, which regulates the safety and efficacy of food, pharmaceuticals, cosmetics and medical devices.

The health and well-being of every American depends on the FDA's rigorous collecting, sifting and interpreting of data to approve products ranging from those that cure nail fungus to devices that electronically zap the brain to relieve anxiety. FDA regulators are scientist bureaucrats who tirelessly navigate the tedious but essential world between reports and medicine in a poorly lit building with very narrow hallways. They do important work, but FDA scientists don't always get it right.

This is a story about one scientist haunted by what, he fears, was a bad decision. Between 1996 and 2000, the scientist, Dr. Morris Waxler, was chief of the FDA's Diagnostic and Surgical Devices Branch and in charge of approving the LASIK medical device to restore visual acuity. And now, Waxler thinks that the FDA's standards were not tough enough. In 2008, an FDA advisory panel was urged by unhappy patients to re-evaluate the long-term effects of LASIK surgery and around the same time, patients began contacting him personally to report bad outcomes, including blurred and double vision.

The FDA authorization process for medical devices in the United States requires several levels of review before a product is approved. The rigorous process is centered in Waxler's old Diagnosic and Surgical Devices branch, a part of the Center for Devices and Radiological Health that regulates manufacture, packaging, labeling and import of medical equipment as well as radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

In the early 1990s, the LASIK equipment fell under FDA review. For sufferers of myopia, corrective eyeglasses and contact lenses had long been a remedy for their impaired vision, but this new apparatus and method used laser beams to remodel the eyeball in a way that purportedly allowed patients to "throw away their glasses." The heat and precision of the laser device made the short outpatient procedure relatively painless and assured such a short recuperative period that patients barely had to miss a day of work.

LASIK -- which is neither a trademark name nor a franchise, but the acronym of a surgical method, "laser-assisted in situ keratomileusis" -- seemed miraculously easy, even though it involved a scary-sounding and delicate procedure. (It entails slicing a thin, hinged flap on the front surface of the cornea, a surgeon lifts the tissue up and, using ultraviolet excimer laser beams, reshapes the eye before folding the flap back over the cornea). Well-heeled professionals then turning 40ish, (an age in which human sight weakens), were drawn to what seemed like a medical miracle of rejuvenation. Laser eye surgery, when done correctly on appropriate candidates, painlessly turned terrible vision to nearly perfect.

In 1995, the FDA approved the first laser-assisted system for refracted surgery and by 1998, the FDA had approved mass manufacture of the laser devices. LASIK centers opened up as prices, originally several thousand dollars per eye, came down. Although health insurance claims departments typically disallow the procedure as "elective," medical providers found diagnosis codes to coax claim compliance. Shopping centers sprouted LASIK clinic chain stores and baby boomers lined up. For the ophthalmic profession, LASIK correction surgery was like a gold rush. By 2008, 12 million patients had undergone the procedure in the United States at an average cost of $1,500 to $2,100 per eye. Over 700,000 people have the surgery every year.

The device had, after all, been vetted as safe and effective by Waxler's team back in 1995. The government scientists had relied on information provided by the laser device manufacturers and ophthalmologists assuring them that the radial keratotomy procedure was safe and effective. The FDA rules required LASIK to undergo several phases of medical trials (7,830 patients participated in clinical trials from 1993 to 2005) to ensure it did not harm patients and indeed worked as hoped for.

When an item is finally approved and marketed to consumers, there are often reports of "adverse events." (Adverse can mean everything from a rash to a death.) This happens even if the medical technology company provided complete and accurate information in its approval application. When too many adverse events happen, however, the FDA will often order a recall.

But in the months and years after LASIK became ubiquitous at 25-year class reunions, stories of eye damage and subsequent depression, even suicides, surfaced. The surgery can, it turns out, induce dry eyes, halos, light sensitivity, night blindness, ghost images, keratectasia (corneal thinning and bulging) and many other serious damaging effects.

In the nearly 10 years since he left the agency, Waxler, (now a regulatory consultant who has stayed involved in FDA product approvals) has come to particularly regret the LASIK decision. Unusual for a former regulator, particularly for someone with business before the agency, in 2010 Waxler went public with criticism about FDA's approval standards. A year ago he went on "Good Morning America" and told correspondent Lisa Stark, "I did the best we could ... but in hindsight it wasn't good enough." He heard more stories that suggested when people complained to their eye doctors, their adverse effects were not reported to the FDA. The FDA issued a statement to ABC News that it considered "LASIK lasers to be reasonably safe and effective when used as intended," but has launched a two-year study to take a closer look at side effects.

Last May, Waxler became more persistent. He considered LASIK eye surgery complications "already a major public health problem" and he said so in a letter to the ophthalmic organization, American Society of Cataract and Refractive Surgeons. He told the organization's president the group was presenting data for a safety study in an "unethical" manner. The association president responded in September that the former regulator's letter was "misinformed, unsupported by evidence, and lacking in balance and perspective."

Waxler again appeared on ABC News in September claiming "half of LASIK patients experience side effects." A committee of well-regarded LASIK experts (R. Doyle Stulting, M.D., P.h.D.; George O Waring III, M.D.; James J. Salz, M.D.; James McCulley, M.D.; Douglas Koch, M.D.; Jayne Weiss, M.D.; and Marian Macsai, M.D.,) responded to Waxler's claim: "We believe he has no reputable basis for such a claim since he did not produce the scientific evidence."

Finally last month, Waxler filed a formal citizen's petition to his former government employer requesting the FDA withdraw approval for all LASIK devices and to issue a public health advisory for recalling the equipment. The industry is working on newer models and newer methods so nearsighted consumers will still be able to get their vision remodeled (insurance companies still won't pay for it, probably). Since it was filed, the petition has been reposted on the Internet by numerous supporters.

In his petition, Waxler says manufacturers and also "clinics, refractive surgeons, and agents withheld and distorted safety and effectiveness data" and, he alleges, "in a classic example of the fox guarding the henhouse," the "collaborators" routinely hide reports of LASIK injuries from FDA by settling lawsuits out of court. He also claims that equipment makers have "cherry-picked, withheld, and hid data from FDA" that he believes show LASIK with "excessive adverse event" rates of 22 percent. Waxler also submitted "confidential information" on the matter to FDA's criminal investigation arm.

The FDA has not yet commented publicly about Waxler's petition but an FDA spokeswoman told Politics Daily "it is a citizen's petition and we will review it." Waxler told Politics Daily that the LASIK experts have not commented either.

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smithmary2011

The point here is that the companies under-reported adverse events. Look at the list of doctors that participated in studies for a company and how their businesses profited as a result. Doctors were told not to report events until after submissions to FDA - vision accuracy was always excellent because method were used to create great results - that could never be reproduced when the procedure went viral. Participating doctors lied about their stock ownership in companies. i can go on and on....Eye doctors themselves never get the procedure. Look it up on the FA's website - a transcript of a hearing on the procedure quotes doctors as saying they couldn't get the LASIK procedure because their livelihood depends upon eyesight. Unlike yours and mine. It's an awful procedure - a flap in created on your cornea and it doesn't heal - it doesn't heal - there's always a flap.

February 21 2011 at 4:07 PM Report abuse +2 rate up rate down Reply
lasikharms

E-mail from a physician:

Don't Get Lasik - From an MD

Dear All,

I am a physician (not an eye doctor or eye surgeon, but I do have an MD). With every fiber in my body, I wholeheartedly recommend AGAINST getting lasik surgery. Here are a few things to keep in mind:

1) Lasik surgery is 100% elective - there is no medical indication for it

2) Worst case scenario for undergoing lasik - blindness

3) Worst case scenario for not undergoing lasik - continuing to wear glasses or contacts

4) While eye surgeons say that the risk for complications is low, there is NO ACCEPTABLE RISK if what you're gambling is your vision

5) Even if a lasik surgery is considered "successful," you still may have terrible night vision, dry eyes, and halos/starbursts. Even if these never go away (and even those that perform Lasik surgery say it might not ever go away), it is still considered "successful." You are taking a serious risk gambling for this. If you get permanent halos or permanent dryness, you will wish like hell you never got this procedure. It is not worth seeing halos of the rest of your life to be able to say "yeah but I never have to wear glasses." In fact, some say that if you're seeing halos, it can be corrected with glasses or lenses - that was the whole point of getting lasik in the first place! Just the chance of seeing halos forever (which in some people mean they can't drive at night anymore) by itself is enough of a reason to not get lasik.

6) Out of all the organs in your body that are not essential for life (like your heart and brain), your eyes are arguably the most important. DO NOT let them get butchered, leave your precious eyes the way they are and just wear glasses like millions of other people have been doing for years. Don't like glasses? Wear contacts - they don't mutilate your eyes like lasik does.

7) Sometimes people with lasik eventually revert back to their old vision - but that does not mean that the side effects of lasik also go away. So that means they have their normal (sub-optimal) vision back but they could still have the dryness, halos, and starbursts. Totally worthless.

8) If you get lasik, you'll still need reading glasses after 40-45

9) You can get stylish prescription sunglasses that don't even look like regular glasses if you still want to look "cool"

Do NOT get lasik surgery, there are other options that are more effective and infinitely safer. Please please please do not ever let anyone touch your eyes with a laser beam.

February 20 2011 at 6:32 PM Report abuse +2 rate up rate down Reply
laserking

As a Lasik surgeon and physian, I find this article to be poorly written and misleading. There is no "Lasik device" which has FDA approval, rather, the excimer laser is the device that was approved in 1995. This laser is used in corneal refractive surgery (PRK as well as Lasik), and also is used to treat corneal surface disorders. Like all medical procedures that have been developed over the decades, complications are inevitable, however, improvements have been made in Lasik with regards to the technology, complications management, preoperative diagnostic testing, and patient selection for the procedure. Overall, just as with any other medical procedure, the worldwide body of knowledge has increased dramatically in the last fifteen years, and results have consequently improved. Obviously, without the intial approval of the FDA, none of this would have been possible.

The fact of the matter is that patients with serious side effects from Lasik are a very small (but vocal) minority. Millions of patients have had their uncorrected vision restored and their lives altered dramatically by this procedure. While there were some unfortunate advertising claims and fly-by-night providers in the early stages of Lasik, most if not all physicians performing this procedure now are ethical, competent, and highly skilled surgeons who strive to only do this procedure on patients who are good candidates and fully informed about the potential complications as well as the expected excellent outcomes of Lasik. To imply that approval of this miraculous operation and technology was a mistake is not only unfortunate, it is simply untrue.

Laserking@aol.com

February 18 2011 at 3:16 PM Report abuse rate up rate down Reply
nimbus3553

i had surgery done in '06. i was born with monovision. instead of enhancing what i had, the doctor for whatever reason reversed the far and near sighted eyes. what a horrible mess. the new "near sighted" eye reverted back to far sightedness causing me to have about 20- 100 close up vision. when i confronted the "doctor" he said i would have to wait 2 months to re-evaluate the situation and 6 months to do surgery if needed. if needed????????, i was blind and my job was on the line. after daily cussing and screaming at these bozos they redid my eyes in 6 weeks. helped for 2 years and my eyes are now regressing. ever try to pass an eye exam at the DMV with monovision at age 58?? their equipment is set for the same distance with each eye. when i tell them my eyes work as a team i just get blank stares. i do what i always do and squeeze the heck out of the "bad" eye to pass. the whole experiance sucked.

February 17 2011 at 11:01 PM Report abuse rate up rate down Reply
jbluhm1951

I had the surgery a year ago, and after a few months noticed I had a floater. I pay little attention to the floater, hardly ever notice it is there. My eye sight seems to be ok for now.

February 17 2011 at 10:38 PM Report abuse rate up rate down Reply
stationers

T. Edwards
Virginia

I just had Lasik last week, after kicking the idea around for years. I'm 56 and was tired of the glasses, headaches, and eye strain every day.
It's wonderful! Yes, I'm wearing 1.5 readers to read, but not wearing glasses to drive or watch TV, etc. Get it done by a qualified Ophthalmologist who does more than just a Lasik gig. Also, listen and follow their directions closely.

February 16 2011 at 8:02 PM Report abuse rate up rate down Reply
ilenedan2

Have a cousin who went blind following this procedure. His blindness cannot be corrected with glasses or anything else.

February 16 2011 at 6:21 PM Report abuse -1 rate up rate down Reply
toddfirer

I had Lasik done about 12 years ago and went from almost blind to 20/15 vision, overnight. I'm still about 20/30 with no enhancements. It was like a miracle. It did accelerate my need for reading glasses, which was a great trade off from having to wear glasses all the time. I had a bit of dry eye for awhile, still do, occasionally, but I would have Lasik done again in a heartbeat. Tiger Woods had it done for crying out loud, and what are his eyes worth? A billion dollars (well, maybe not anymore, but at the time they were). I did have one friend who had a bad experience, but that was because his surgeon did not read his notes and reversed his eyes, ie., he did the left eye correction to the right eye and vice versa.

February 16 2011 at 1:16 PM Report abuse rate up rate down Reply
Cheryl

I had LASIK done in 2006 and I am so grateful for it. I haven't had any problems. I also suffered from dry eye before LASIK due to contacts. I had plugs put in my tear ducts that can help with this. The eye Dr. put them in in less than a minute. It helds retain moisture in the eyeballs.

That is an option for people who complain about dry eyes. I'm suprised eye doctors aren't recommending this fast and safe procedure.

February 16 2011 at 11:16 AM Report abuse rate up rate down Reply
berry24

I had LASIK in 2008 and still love it. I was very myopic since about age 10. I can wake up and read my alarm clock now, and I am so thankfully everyday. My eyes were dry from wearing contacts all the time so dry eye does not bother me. My eyes are more light sensitive. But it is worth it to be able to see all the time and not wake up to feel for my glasses. It was the best $3000 I have ever spent.

February 15 2011 at 5:38 PM Report abuse rate up rate down Reply

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