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LASIK – A Laser that Blinds and Kills

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Eyes are near-sighted (myopic) either because they are longer than normal, or because their corneas – the dome-shaped, clear structure at the front of the eye – are steeper than normal, or both. Like many myopic people, I occasionally wish there was a safe, reliable technique to change the curve of my cornea, so I could get rid of my glasses and contact lenses.

There is a procedure that changes the curve of the cornea. It is called LASIK. Despite the alluring ads of LASIK eye surgeons, this technique is neither safe, nor reliable.

People are gullible. They have no idea how risky LASIK is. The LASIK surgeons do not warn them LASIK can butcher their eyes, destroy their vision, saddle them with life-long chronic pain, disable them, and even bring them to suicide.

People believe the glowing LASIK ads. They trust doctors. They think doctors will never do them harm. They do not do their homework. They don’t want to hear bad news. And – most of all – other ophthalmologists will not speak out.

The first surgical procedure to correct near-sightedness was invented by a Russian, Svyatoslav Fyodorov, in 1974. He flattened the cornea by cutting a series of deep incisions in the periphery. It soon became obvious that Fyodorov’s Radial Keratotomy technique had serious side effects – unpredictable healing, scarring, vision instability, infection, cataract formation, and irregular astigmatism – and it was eventually abandoned.

Nine years later, in 1983, Dr. Steven Trokel – a colleague of mine at the Harkness Eye Institute – discovered the excimer laser could re-shape the human cornea with dazzling exactness. The excimer laser is incredibly precise, because it gives off incredibly short bursts (1 to 8 nanoseconds) of ultraviolet light. It is a cold laser, so it does not burn tissue.

Steve called his procedure LASIK, which is the acronym for Laser-Assisted in SItu Keratomileusis. Kerato means “cornea”, and mileusis means “to reshape”, in ancient Greek.

I was one of the first people in the world to hear about LASIK. Steve Trokel dashed into my examining room at the Harkness eye clinic in the early 1980s, and shoved his now-famous photo of a cornea that had been reshaped by the excimer laser. It was hot off the press – literally, it was still warm.
As Steve told me about his technique, I knew right away this procedure would have dangerous consequences – thinning, scarring, pain. I assumed the side effects would be so horrific LASIK would never catch on. Wrong. I had vastly underestimated the desire of people to get rid of glasses. I also did not realize LASIK eye surgeons would launch a campaign to suppress the truth about this risky procedure, and my fellow ophthalmologists would refuse to speak up and tell the truth.
I have used many different eye lasers, including the Argon, YAG and Selective, to save the sight of thousands of eyes. Of course, I never have, and never will, use the excimer laser to reshape the cornea.
As soon as the FDA approved LASIK in 1998, an epidemic of eye pain and poor vision began to spread around the world. I saw many LASIK patients in my office who were happy, but I saw others whose eyes, and lives, had been irreparably ruined.
Morris Waxler was the head of the FDA committee that approved LASIK in 1998. He was their chief scientist in charge of clinical research trials. After Morris retired from the FDA, he began to see more and more LASIK patients with serious complications. He realized something was not right.
He took another look at the original data the LASIK surgeons gave the FDA when they were seeking approval for LASIK. Then he reviewed all the papers on LASIK complications in the scientific literature. (He was able to look at medical research papers not readily available to the general public.)
Morris realized the FDA-required clinical trials had only looked at how well patients could read the eye chart. These trials ignored serious side effects, including persistent night vision problems and chronic dry eye. They failed to detect these permanent long-term complications because they had small numbers of patients and short-term follow-up.
The LASIK surgeons had assured Morris these problems were “temporary side effects.” Morris realized they were in fact permanent, and devastating. The original data from the LASIK clinical trials showed that twelve months after LASIK 60% of patients had fluctuating vision in dim light, 50% suffered from gritty eyes, 40% had light sensitivity, 20% had fluctuating vision in bright and in dim light, and 15-20% had problems driving at night because of glare and halos.

Morris also discovered laser manufacturers had withheld data about adverse effects from studies – 10% from 25 studies, 20% from 12 studies, and 40% from 7 studies.

Even before LASIK was approved, I was warning the public about the dangers of LASIK. In 1994, I told Dan Dorfman (an infamous “stock picker” on CNBC) that LASIK is “experimental and unpredictable” with “worrisome complications”, including “over and under correction, fluctuating vision, poor vision at night, and pain”. Bloomberg reported my comments, and the stock of the excimer laser companies plunged tens of millions of dollars.

I warned about LASIK complications on CBS on May, 2008, and on the Oz show on November, 2013. The LASIK surgeons retaliated by claiming I was “naïve” and did not know what I was talking about.

Morris knew I was willing to speak out. He invited me to go with him to Washington, D. C. to testify before the FDA on September 22nd, 2010. I accepted.

As Morris and I rode up the shiny escalator of the brand-new main building of the FDA complex in Silver Springs, Maryland, I thought it would be a slam dunk case to convince the FDA to ban LASIK. This dazzling palace must have dazzling minds inside. It was clear LASIK was a massive public health problem. Once the regulators knew the facts, they would surely take action.

Morris told the FDA committee about the misleading statistics that tricked him into recommending LASIK, and why he had changed his mind. I told them how the cornea behaves when it is wounded, and why the side effects are unavoidable. I also told them about patients whose lives had been permanently altered by this procedure. ABC News ran a special about Morris’s testimony that evening.

Three months after we testified, on January 6, 2011, Morris filed a citizen’s petition with the FDA asking it to ban LASIK.

Morris’s petition is thirty-two pages long. It includes ten figures, six tables, and one hundred and one references from peer-reviewed scientific literature. Every statement is based on well-documented scientific research. Now that is good science. It is readily available online – simply Google Morris Waxler FDA LASIK.

His petition asked the FDA to withdraw approval for all LASIK devices, and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by LASIK.

Morris stated “LASIK eyes never completely heal, are permanently weakened, vulnerable to trauma and inflammation, develop neuropathic dry eyes, have pathology that progresses annually, are vulnerable to blinding corneal bulging, have compromised night vision, have unstable vision corrections that regress, and require eye care that otherwise would not be needed.”

Morris concluded by saying LASIK risks and long-term consequences outweigh the benefit of reduced dependence on corrective lenses.

How did the FDA respond? A drop in the bucket. It recommended LASIK patients obtain a copy of their medical record, including the consent form. The website now states the visual quality of LASIK patients at night is permanently reduced, even if patients have 20/20 or better vision in bright light. It also warns visual outcomes of LASIK decline over time.

The FDA did not ban LASIK.

Morris and I refused to give up. Eight years later, we went back to the FDA, on September 13, 2018. This time we brought along two patients whose life had been destroyed by LASIK. Nancy Burleson, M.D., joined us. Her son -an only child – committed suicide after having LASIK.

I asked the committee members if they wanted their legacy to be blindness, pain and death. I handed everybody a consent form that explains, in clear language a layman can understand, the risks of LASIK. It includes the percent chance for each risk. I told them their duty was either ban LASIK, or require that all LASIK surgeons must give their patients this consent form – at least two weeks before surgery.

Here it is. Every statement is verified in the Waxler FDA Petition.

                    LASIK IS AN ELECTIVE COSMETIC PROCEDURE

-After you have LASIK, there is a 100% chance you will no longer be able to distinguish between subtle shades of grey. (See Yamane et al, Investigative Ophthalmology and Visual Science, 2004: 100% of eyes lose contrast sensitivity after LASIK.)

-There is only a thirty percent chance you will be able to throw away your glasses, according to a 2009 Consumer Reports survey.

  • You have a 50% chance of developing “dry eye” after LASIK. Your eyes will feel as if sand is pasted inside your lids, and they will burn as if they have hot pepper sauce in them. The chance this pain will be with you for the rest of your life is close to 100%. “Dry eye” is a misnomer. The “dryness” is actually nerve pain, caused by destruction of corneal nerves during LASIK.

-You have a 50% chance of glare, a 40% chance of being sensitive to light, a 30% chance of blurred vision, and a 10% chance of difficulty driving at night because of halos around lights and ghost images. These problems are permanent, not temporary. You may not be able to see in dim light. You may have to give up driving at night and going to the theatre and movies. If your job requires functioning in dim light, you may be permanently disabled.

  • The LASIK flap never heals completely. You have a lifetime risk of flap dislocation after minor trauma, and infection underneath the flap.
  • The cornea is not inert, like a sheet of plastic. It is a living structure that continues to grow and remodel throughout life. 20% of LASIK eyes do not stay stable. They either go back to being nearsighted, or go in the other direction and become farsighted, or else fluctuate from one to the other. Some eyes continue to fluctuate in vision for as long as twenty-five years.

-Even if you see better at distance, you will have other problems you did not have before LASIK. For example, people over forty will have to wear reading glasses.

-LASIK thins and weakens your cornea, which puts it at risk of ectasia – a bulge in the cornea. As the cornea sags outwards, it gets steeper and steeper, and more and more warped. This irregular astigmatism cannot be corrected by glasses or soft contact lenses. Your vision will become more and more blurred and distorted. The only way to treat ectasia is to use hard contact lenses, or get a corneal transplant. Ectasia can develop twenty-five years after apparently successful LASIK.

-LASIK stretches and weakens your retina. The risk of retinal detachment is forty-two times greater after LASIK.

  • Seven years after LASIK, fifty-five percent of patients are unhappy with their vision.

The consent forms the LASIK surgeons do mention complications, but they are not explained in language patients can understand. Also, they do not give percentages. If this consent form were given to every prospective patient, very few people would consent to this procedure.

Eye doctors are supposed to heal sick eyes. LASIK surgeons take healthy eyes, and make them sick. There is nothing wrong with eyes that need glasses for distance. They see well with glasses before the procedure. They ought to see equally well without glasses after the procedure, but they always see worse. Patients are not told this nasty fact.

Because LASIK is cosmetic, it is not covered by insurance. (Medicare.com says: “LASIK is not considered medically necessary; therefore, it is not covered.” LASIK.com states: “Most insurance companies don’t cover LASIK…it is nearly always considered an elective or cosmetic surgery.”) This means LASIK surgery is not subject to the price limits set by insurance companies. Result: LASIK surgeons make much more money than other eye surgeons.

When I talk to ophthalmologists in private, they readily admit how dangerous LASIK is, but they refuse to criticize this multibillion-dollar industry. They know there will be serious push back.

On June 12, 2018, the New York Times published an article exposing the dangers of LASIK. It received over one million page views (one hundred thousand is considered impressive). I made this article happen, with the help of a retired NYT editor. I guided the writer, Roni Caryn Rabin, through the laborious process of making sure each statement was backed up by peer-reviewed science. She quoted me in the article. Two days later I appeared on “Good Morning America.”
Today, most people have forgotten about it.
The assault from my colleagues was swift, personal and lacking in scientific evidence. One ophthalmologist accused me of promoting “fake news,” and said I am “no scientist.” Several colleagues pointedly ignored me at a professional meeting. One told me I wasn’t qualified to criticize LASIK because I am a retina specialist. A few filed letters of complaint against me with the president of the society.
Notably, however, no one disputed the facts: LASIK inevitably causes complications, many mild, some so severe they have led to suicide.
People don’t know how LASIK is performed. If they did, they would be horrified.

-First, LASIK surgeons flatten the eye using a suction ring, squeezing this delicate structure in a vise. The pressure inside the eye shoots up to sixty or more – at least three times normal. (Normal is between eight and twenty-two.)

As the eye is squashed, the retina gets stretched, which makes it more fragile and more likely to detach. The rate of retinal detachment in normal eyes is .006%, but after LASIK it shoots up to between 0.25% and 0.36% (see www.eyeworld.org/article.php?sid=4164). In other words, the risk of a retinal detachment is more than forty-two times greater after LASIK.

The lens inside the eye is also squashed. LASIK patients will develop cataracts that need surgery FIFTEEN YEARS earlier than people who have not had LASIK.

-Next, the surgeons slice a flap off the cornea with a knife or a femtosecond laser – as if they were cutting a slice off a loaf of bread.

-Then they shave tissue from the cornea, using the excimer laser.

  • Finally, they put the flap back on, and assume it will seal itself back again normally.

The corneal flap never heals normally after it is put back on the cornea. Schmack et al reported in the Journal of Refractive Surgery in 2005 the tensile strength of the LASIK flap is only 2.4% of normal. In the same journal, in 2004, Percy Amoils said the corneal flap after LASIK provides no more corneal strength that the wearing of a contact lens. Kramer et al in Cornea, 2005, showed there was faulty healing in ever flap they examined.

This weak bond between flap and cornea means bacteria can creep under it and invade the cornea, years after surgery. All LASIK patients face a life-long risk of cornea flap infection.

The LASIK flap is attached so lightly that even mild trauma – rubbing the eyes, being hit by a wave, contact sports – can dislocate it. When the flap comes off, the eye instantly loses vision. The dislocated flap must be replaced surgically as soon as possible. It is now much more likely to dislocate again.

I tell all my LASIK patients they should wear eye protection during contact sports, and goggles while swimming. This is not my job. It should be the job of the LASIK surgeons.

A similar procedure, Photo Refractive Keratectomy, or PRK, also uses the excimer laser to reshape the cornea, but instead of using a flap the surgeons scrape off the top layer of the cornea. PRK was the first procedure approved by the FDA to re-shape the cornea. Like LASIK, PRK is primarily cosmetic.

PRK is more painful than LASIK at first, but PRK patients have one advantage over LASIK patients – they do not have a flap, so they do not get flap complications. Aside from this one advantage, PRK patients have the same complications as LASIK patients – plus a complication that LASIK patients do not get.

The risk of sight-impairing corneal haze after PRK is very high, so most PRK surgeons today treat the cornea with a chemotherapy agent, mitomycin-C (MMC). MMC has not been approved by the FDA for this use. This toxic drug kills corneal cells, so they don’t grow back normally. This reduces haze, but at a price.

PRK patients have no idea that an experimental chemotherapy agent known to produce mouth sores, hair loss and extensive tissue damage to flesh has been applied to their eyes, with unknown long-term consequences.

LASIK surgeons urge patients to have both eyes done on the same day. Some even offer discounts for the second eye. This violates a universally accepted rule of eye surgery – always let an operated eye heal for at least two weeks before you operate on the second eye.
LASIK surgeons know one-eyed LASIK patients will compare the vision in their operated eye to that in their unoperated eye. They will be immediately aware the operated eye has blurred vision, distortions, glare, etc. These patients will refuse to schedule the second eye.

Ophthalmologists – including LASIK surgeons – measure visual acuity using high contrast black letters on a white background. That isn’t the way we see in the real world. Objects are not all pitch black with straight crisp sides standing out against a clear white background. Our eyes need to distinguish between multiple subtle gradations of color, brightness and form in the real world. LASIK-injured eyes cannot do this.

LASIK surgeons define “success” as being able to see 20/40 using high contrast black letters on a white background without glasses. By this criterion, they claim the “success” rate of LASIK is 99%. They never ask the LASIK patients themselves. By their definition, many miserable patients are “successes.” The unhappy patients I have seen would not agree with this definition of “success”, even if they can see 20/40 in the LASIK surgeons’ offices.

As of this writing, roughly 11 million people in the US have had LASIK. The exact number of complications is not known, because the LASIK surgeons refuse to report them.

The LASIK surgeons claim with improved techniques the complication rate has gone way down. Wrong. These new “improved” techniques – like the old technique – invariably cut corneal nerves, thin the cornea, and cause scarring. Also, LASIK surgeons rarely report complications, so how do they know the complication rate has gone down?

The evidence for the dangers of LASIK is hiding in plain sight. The Patient-Reported Outcomes with LASIK (PROWL) study, published in JAMA Ophthalmology in 2017, evaluated two groups of people before, and up to six months after, they had LASIK. It asked patients to fill out a web-based survey about their vision before LASIK, and several times afterward.

The PROWL study showed that, overall, the ability to see small letters on the eye chart without glasses did improve after LASIK. However, the study also showed that a large percentage of patients developed new visual symptoms after LASIK. Forty-five percent of the subjects who had reported no visual symptoms prior to surgery reported new symptoms three months after their surgery – including double images, glare, halos and starbursts.

There was a major flaw in this study: one of the pre-op questions was: “Do you have glare and starbursts WITH OR WITHOUT your glasses?” Almost all nearsighted patients – especially if they have astigmatism – will have glare, double vision, and starbursts WITHOUT their glasses. These symptoms disappear when they put their glasses on.

As expected, two thirds of the patients reported some visual symptoms before surgery, and these patients were excluded from the tally of those who developed “new symptoms” after surgery. Result: the study statistics are artificially lower than they should be. The researchers must have had a bias in favor of making LASIK appear safer than it is.

LASIK ads make patients believe they can throw away their glasses after LASIK, and they will have perfect vision. Neither of these claims is true.

The FDA website on LASIK correctly states: “Only a certain percent of patients will achieve 20/20 vision without glasses or contacts.” A 2009 Consumer Reports survey of seven hundred and ninety-three LASIK patients revealed that only a third of LASIK patients are able to stop wearing glasses. Two thirds continue to use glasses, or contact lenses, either some or all of the time, for either distance, or reading, or both.

Even LASIK patients who see 20/20 without glasses do not have “perfect” vision. The FDA website also states: “Some patients lose lines of vision that cannot be corrected with glasses or contact lenses.” This is not completely accurate. The fact is ALL patients have distorted vision after LASIK.

Before LASIK, corneas have a single smooth curve – a perfect dome. During LASIK, this “dome” is converted into a “plateau”. The re-shaped cornea now has two different curves – an artificially flattened curve in the center, and the original, steeper curve in the periphery. The central portion – the “plateau” – of the re-shaped cornea focuses light directly on the retina. The untouched peripheral cornea focuses light either in front of the retina, or behind the retina.

In bright light, LASIK patients will look only through the central section of their cornea, because bright light makes the pupil constrict. Since this section has only one curve, their vision is less distorted. In dim light, the pupil dilates, and the peripheral cornea comes into play. This is why all LASIK patients see double or triple in dim light, with glare, starbursts and halos.

LASIK patients are a danger to themselves and others in dim light. A case in point is airplane pilots.

Federal Aviation Administration regulations require a pilot’s distance vision to be 20/20 or better, with or without correction, in each eye separately. Nearsighted, farsighted, and astigmatic pilots must wear glasses or contact lenses when they fly.

The FAA allows LASIK patients to fly planes if they have had a “successful outcome” as measured by high contrast letters.

The irony is the actual vision of LASIK pilots is not even close to normal – especially in dim light. All LASIK patients take a risk when they drive a car, bus, train or plane at night. All LASIK patients should have licenses that restrict them to day driving or flying. I would not want to fly in a plane, or drive in a bus or a train, that has a driver or pilot who has had LASIK. Nobody would.

Patients who perform jobs in dim light can be permanently disabled after LASIK. I have seen many such patients. One quit her job as a theatre critic, because she could not see the actors when the lights went down. Another – an anesthesiologist – could no longer read charts in a dim operating room. Another – a former banker – can no longer work on a computer. She lives on disability.

A bad LASIK outcome cannot be corrected. There is no way to get rid of glare and halos around lights at night. There is no way to restore contrast sensitivity. There is no way to eliminate post-LASIK pain. And there is no way to eliminate flap complications. One LASIK surgeon I know said he no longer performs the procedure because – and I quote – “If something goes wrong, you can’t do anything about it”.

The most feared LASIK complication is corneal ectasia – a relentless outward bulging of the cornea, rather like a hernia. If patients have thin corneas to begin with, they are at especially high risk of ectasia following LASIK. (In rare instances, ectasia is caused by a hereditary eye disease, keratoconus.) Again, most consent forms don’t mention, or explain, this devastating complication.

Ectasia is a nasty problem. As the bulging becomes worse and worse, the eye becomes more and more nearsighted, and develops marked irregular astigmatism. Glasses and soft contact lenses cannot correct vision destroyed by ectasia.

A LASIK surgeon once said at a corneal meeting he never reported ectasia, because he was afraid of lawsuit. By February 2015, only 100 cases of ectasia had been reported in the world literature.

Ans then, in 2016, Avedro, a US company, went public. Avedro invented a treatment where Riboflavin is applied to the cornea, which is then irradiated for 30 minutes with ultraviolet light. It supposedly stiffens the cornea by cross-linking collagen, thereby halting the progression of ectasia. The Avedro treatment does not work well, and it can damage the cornea.

In a press release, Avedro stated that “at least 160,000 patients in the U.S. have developed corneal ectasia following refractive surgery” [i.e., LASIK and PRK]. If you do the numbers, this means almost 1.5 percent of LASIK patients develop ectasia. How did Avedro know the number 160,000? Only one way – from the LASIK surgeons. They knew it, but they did not report it.

Now we get to the problem of post-LASIK eye pain. I knew LASIK would cause pain, but I had no idea how bad this pain would be. The LASIK surgeons call this pain “dry eye” – but these eyes do not show any signs of dryness. What they have is far worse. They have neuropathic pain.

Tiny nerves run through the cornea, keeping it safe and healthy. When these nerves are cut during LASIK, they never grow back normally. They fire constantly. This causes unrelenting, unbearable, untreatable pain. The same phenomenon occurs when a patient loses a limb. In this case it is called: “phantom pain.”

Neuropathic corneal pain causes severe foreign body sensation, burning, and dryness. Some LASIK patients put wetting drops in their eyes several times an hour, trying to alleviate the pain. Yes, I mean every hour. Walk into any drug store and you will see shelves of artificial tears “For LASIK dryness.”

The irony is that these artificial tear drops do not help, because the eye is not dry. It has chronic pain syndrome. You will learn about this life-altering syndrome when you read Chapter 22, “A Brain Devoured by Pain”.

Post-LASIK corneal neuropathic is treated successfully in Europe with drugs like Amitriptyline. LASIK surgeons in the US have not done any studies on how to treat corneal neuropathic pain. In fact, most of the scientific papers reporting LASIK complications come from the international literature.

Only a handful of US ophthalmologists treat this pain. They include Perry Rosenthal (now, sadly, deceased), Pedram Hamrah at Tufts in Boston, Anat Galor at Bascom Palmer Eye Institute in Miami, and John Cason at the Naval Medical Center in San Diego.
There are thousands of MedWatch complaints on file with the FDA about LASIK injuries. Three quarters of them involve dry eyes (i.e., neuropathic pain), poor vision at night, and decreased visual acuity. There are over 1,200 signatures on a petition to stop LASIK. (See http://www.thepetitionsite.com.). Despite all this evidence, the FDA refuses to revoke its approval of LASIK.

Dr. Lowell Bellin, New York City’s chief health officer and self-described “medical cop”, spoke at my medical school graduation in 1977. He said some doctors do not put their patients first. I refused to believe him. Now I know LASIK surgeons do not put their patients first. I have become a medical cop myself.

Damaged LASIK patients have cried in my office. They tell me that they trusted their doctor, but the doctor betrayed them, and never warned them this could happen to them. I would like to drag every LASIK surgeon into my office, chain them to my slit lamp, and force them to listen to these suffering human beings.

The increasing number of malpractice suits against LASIK surgeons shows LASIK is giving ophthalmology a bad name. Ophthalmologists are supposed to save sight, not destroy it.

Bottom line: the less eye surgery, the better. No eye surgery should be done unless there is a pressing need. If an operation is necessary to save sight – retinal detachment surgery, for example – we accept the risk. Getting rid of glasses is not a pressing need.

The only guaranteed way to stop LASIK is to require all LASIK surgeons to have the procedure themselves before they are allowed to perform it on others.