THE TRUTH ABOUT LASIK

by CYNTHIA J. MACKAY, M.D., OPHTHALMOLOGIST

Few ophthalmologists are willing to have LASIK done on their own eyes, but almost none will discourage his or her patients from having it done on their eyes. I am one of the very few ophthalmologists who is willing to speak out publicly against LASIK.

Like most doctors, I am reluctant to criticize my fellow doctors. I know how challenging it is to give good care, and I always want to give others the benefit of the doubt. This may be why other eye doctors will not criticize LASIK publicly, although when I talk to them in private they readily admit how dangerous this procedure is.

I was one of the first people in the world to hear about LASIK. I was in the Eye Clinic at Presbyterian Hospital in the early 1980s, examining a patient, when Dr. Steve Trokel burst into my room. He shoved a piece of paper into my hands, plopped himself into a chair, and began to talk. I had never seen him so excited.

I realized at once Steve’s paper showed an electron microscope photograph of a cornea. (The cornea is the clear, curved window in the front of the eye.) A perfect rectangle, sides straight as a ruler, had been sliced into this cornea. Steve told me this rectangle was created using an ultraviolet excimer laser. I was impressed. I realized this excimer laser could shave the cornea with unbelievable preciseness, molecule by molecule.

I liked and respected Steve. His restless mind was always churning out new ideas. He had made a name for himself pioneering the use of the MRI to diagnose and treat diseases of the bony structure around the eye, which is called the orbit. His work greatly improved the ability of ophthalmologists to treat orbital diseases.

I listened with fascination as Steve explained his new cornea-shaping technique. The thought crossed my mind I might have this procedure myself someday, to eliminate my nearsightedness.

After Steve ran into the next room to show his picture to another ophthalmologist, I began to have reservations. What he said was far too simple. The more I thought about what he was planning to do, the more doubtful I was it was a good idea.

One of the major flaws, in my view, was that this technique would make the cornea thinner. Thin corneas are weak corneas – more likely to be injured and/or develop other serious problems. It would also create a huge wound in the cornea. A wounded cornea repairs itself by forming scar tissue. A cornea covered with scar tissue will not see well. Also, I knew the cornea has no blood supply, and therefore it would be notoriously slow to heal.

The worst flaw was how much pain this procedure would cause. Any injury to the cornea – for example, a corneal abrasion – is excruciating, because the cornea has more nerve endings than any other part of the body. Anybody who has accidentally scratched a cornea knows about this problem.

I decided Steve’s idea was great in theory, but it would never catch on because the side effects would be too horrific. I was wrong. I had vastly underestimated the desire of the public to get rid of their glasses. There is a huge market for cosmetic surgery, and that is what LASIK is — cosmetic surgery.

What exactly is LASIK, and why has it become so popular? LASIK is a cosmetic procedure that changes the curve of the cornea in order to “cure” refractive errors of the eye, such as nearsightedness, farsightedness, and astigmatism, and thereby eliminate the need for distance glasses.

During LASIK, the corned is carved into a new, different shape with an ultraviolet laser called the excimer laser. There is so much confusion about lasers and LASIK a brief explanation is in order.

Lasers have been used to treat the eye since the 1950s. Here is a description of the different kinds of lasers used by me and my fellow eye surgeons. Some of these lasers are designed for use in the front part of the eye, or anterior chamber. Others are used in the back part, or posterior chamber. The excimer laser – the laser used in LASIK – treats the cornea, which covers the anterior, or front, part of the eye.

The first laser used in the human eye was a ruby laser, not an excimer laser. The argon laser soon supplanted the ruby laser. The argon laser treats the retina, in the back chamber of the eye.

The argon laser puts minute spots of heat – typically one half to one quarter the size of the head of a pin – into the retina with exquisite precision. This technique is called “photocoagulation”, i.e. curdling tissue using light energy. These tiny spots of heat destroy abnormal and leaking blood vessels with stunning precision, and thereby restore and save sight.

The argon laser is a genuine miracle. It has revolutionized the treatment of a major cause of blindness across the world: diabetic eye disease. An estimated 4.1 million Americans have diabetic retinopathy, and a million of these have vision-threatening retinopathy. Among US adults who are 20–74 years old, diabetic retinopathy is the number one cause of blindness, according to the CDC. Since these years are the peak ages for working, untreated diabetic retinopathy has major economic consequences.

The results of the first randomized trial of the argon laser to treat diabetic retinopathy were reported in 1976 – two years before I began my eye residency. The researchers stopped the trial early because it was obvious patients who had been treated with the argon laser were doing much better than untreated ones.

Before the argon laser, all diabetics who developed retinopathy eventually went blind. Since the argon laser came into use, they almost all keep their vision – if their retinopathy is diagnosed and treated early. An estimated 50% of patients with diabetic retinopathy are not getting yearly eye exams. These people are often diagnosed too late for treatment to be effective.

The argon laser is also used to treat other blinding retinal diseases, such as retinal tears and detachments, vein occlusions and sickle cell eye disease. We once used this laser to destroy the abnormal blood vessels of wet macular degeneration, but now we inject a drug into the eye that inhibits these abnormal vessels. This drug is more effective, and less risky, and it has fewer side effects.

This laser has saved the sight of millions of people. There is an argon laser in every major eye hospital in the world today.

Another laser, the Nd:YAG laser (which stands for Neodymium-doped Yttrium Aluminum Garnet), works via photo-disruption, not photocoagulation. Instead of heating tissue, the YAG laser sends extremely short (10 to 25 nanosecond) pulses of infrared light into the anterior chamber. (A nanosecond is one billionth of a second – this technology is so advanced it makes the head spin.) These pulses create miniscule explosions that cut through anything in their path.

The YAG laser revolutionized the treatment of angle closure glaucoma. In this disease, pressure builds up inside the eye because the iris – the colored part of the eye – covers the drain and blocks it. Angle closure is treated by cutting a hole in the iris, which unblocks the drain.

When I was in my first year of residency, all surgeons treated angle closure glaucoma by putting the patient under general anesthesia, slicing the eye open, cutting out a chunk of iris, and then sewing the eye up again. This procedure produced a lot of bleeding, and a cataract would inevitably form within a few years. Of course, this operation made the eye vulnerable to infection.

When I was in my second year of residency, eye surgeons began to use the YAG laser to punch a hole in the iris and unblock the drain. What an improvement – minimal bleeding, no anesthesia except for one numbing drop, zero chance of infection, quick (five to ten minutes) surgery, and almost no pain.

We also use the YAG laser to clear away the cloudy membrane that inevitably forms after modern day cataract surgery. After a period of time – the range is as early as a few weeks, to as long as many years, but is usually three to five years – the capsule of the old lens, which holds the new clear plastic lens in place, clouds up. The patient no longer sees clearly. A procedure called a YAG capsulotomy opens a hole in the membrane so the eye can see clearly again. A YAG capsulotomy is quick – three to five minutes – and painless.

Yet another eye laser is the selective laser. This laser treats open angle glaucoma, a disease where the drain of the eye clogs, causing the eye pressure to go up. The selective laser puts tiny spots of light into the drain of the eye. These spots open the drain and increase outflow, and the eye pressure goes down again.

All three of these widely-used lasers – argon, YAG and selective – are designed to be used in eyes with a serious disease that threatens to destroy vision. They are not used in normal eyes, and they are not used for cosmetic reasons. I use at least one of these lasers, at least twice a month, and they have allowed me to save tens of thousands of eyes that would otherwise be blind.

The excimer laser used during LASIK has a completely different purpose. Unlike the other three lasers, it is not designed to fix eyes that have a serious problem. It is used for purely cosmetic reasons: to eliminate the need for distance glasses. LASIK is the eye equivalent of breast augmentation, a tummy tuck, a face lift, or a nose job.

There is nothing wrong with eyes that have LASIK, except for the fact that they need glasses for distance. They see well before the procedure. They ought to see equally well after the procedure, but LASIK does not make eyes see any better. Although LASIK patients often do not realize their vision is worse, if they are carefully tested all eyes see less clearly after LASIK (see “Night Vision Disturbances after Successful LASIK Surgery”, British Journal of Ophthalmology, August 2007.) Patients are not told this nasty little fact.

LASIK is a cosmetic procedure, so it is not covered by most 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.

Surgeons begin a LASIK operation by flattening the eye with a suction ring. This temporarily increases the pressure inside the eye to four times normal. Then they cut a flap off the flattened surface of the cornea, as if they were cutting a slice off a loaf of bread. Then the surgeons use the excimer laser to shave off part of the cornea underneath the flap, thereby changing its curvature. Finally, they place the flap back on the eye, and trust it will seal itself back onto the cornea again.

A similar procedure, photorefractive keratectomy, or PRK, also uses the excimer laser to reshape the cornea, but instead of making a flap the surgeons scrape off the top layer of the cornea. They then often put a toxic chemotherapy agent, Mitomycin C, on the cornea, to prevent haze. This drug is usually not mentioned in the consent form patient sign.

PRK was the first procedure approved to re-shape the cornea with the excimer laser. It is more painful than LASIK short term. Patients who have had PRK run the risk of all the other LASIK complications, although they do not suffer flap complications. Like LASIK, PRK is a purely cosmetic procedure.

My negative opinion of LASIK grew slowly, patient by patient, scientific article by scientific article, over many years. I saw many happy LASIK patients, but I saw more and more whose lives had been ruined.

I began warning the public about the dangers of LASIK surgery in the late 1980s. I was largely ignored. Then Dan Dorfman telephoned me out of the blue, and asked my opinion about LASIK. Dorfman was an infamous “stock picker” for CNBC. Stock market traders followed his comments closely. His opinion about a stock always caused its value to move sharply up or down.

I told Dorfman how terrible LASIK was, he reported my comments, and the next day the stock value of the excimer laser companies lost millions of dollars. Many LASIK surgeons retaliated by claiming I was “naïve” and did not know what I was talking about.

On May 18, 2008, I was interviewed by Dr. Jon LaPook, the CBS medical correspondent, for a piece about LASIK. I told him it was a horrible procedure and nobody should have it. On November 24, 2013, I discussed the many disastrous complications of LASIK on the Oz show. Both programs are on YouTube. Even that failed to discourage people from having it.

The problems of LASIK have been known for close to thirty years. Nothing has been done to curb this dangerous cosmetic surgery, and the public remains clueless about the dangers. Exhibit A: David Brooks, the New York Times columnist, wrote a column on January 13, 2017 that said: “LASIK eye surgery produces more patient satisfaction than any other surgery.” (He was using LASIK as an example of how free markets work to lower the price of surgery.) He could not be more wrong. I – and other LASIK activists – feel as if we have been talking into a vacuum.

Many of the 17 million people in the US who have had LASIK surgery are happy – at least for the moment– but many have suffered devastating side effects, including dramatically decreased vision, inability to see at night because of glare and halos around lights, excruciating eye pain that never goes away, and a weakened eye that can go blind after minor trauma.

All of the problems I foresaw when Steve first told me about LASIK have come true, and more have arisen that I did not anticipate. Today when I go to Google and type in “LASIK complications”, hundreds of pages come up.

I can personally testify LASIK has destroyed many careers. It has ended marriages. It has driven at least eleven victims to suicide. I know the names of seven of these victims. The names of four others have not been disclosed, at the request of the families. I also know the name of a woman who has had the contents of her eye removed to get rid of her unbearable pain.

A study published in 2016 in JAMA Ophthalmology confirmed a significant percentage of people who undergo LASIK develop new side effects. “To our knowledge, our study is one of the few that have reported the development of new visual symptoms” after LASIK, the researchers said.

In this study, the researchers followed two groups of people before, and up to six months after, they had LASIK. The patients filled out a web-based survey about their vision before they had LASIK, and several times afterward.

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

About two thirds of the patients reported some visual symptoms before surgery, so 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. It makes me wonder if the researchers had a bias in favor of making LASIK appear safer than it is.

Overall, people’s ability to see small letters on the eye chart without glasses did improve after LASIK. However, in the subset of subjects – roughly one third – who reported no visual symptoms without their glasses prior to surgery, about 45% percent reported new symptoms three months after their surgery. These symptoms included double images, glare, halos and starbursts. Remember, this statistic is artificially low.

LASIK surgeons advertise heavily. An ad from the “LASIK Vision Institute” states: “Wouldn’t it be nice if you didn’t have to struggle to see the alarm clock in the morning? Wouldn’t it be better if you didn’t have to take out your contacts at night to go to bed? Wouldn’t it be easier if you could participate in fitness activities without worrying about breaking your glasses? It’s just a better way to live your life. “. The ads frequently guarantee patients will have perfect vision after LASIK. They often claim all patients will be able to throw away their glasses. Neither of these statements is true.

Most LASIK patients continue to use glasses after their surgery. In a 2009 Consumer Reports survey of 793 LASIK patients, almost two thirds of them still had to wear glasses or contact lenses, either some or all of the time, for either distance, or reading, or both. The FDA website on LASIK correctly states: “Only a certain percent of patients will achieve 20/20 vision without glasses or contacts”.

Vision is far from perfect after LASIK, even in the lucky patients who see 20/20 without glasses. The FDA website states: “Some patients lose lines of vision that cannot be corrected with glasses or contact lenses.” It would be more accurate if it said: “All patients lose some vision after LASIK.” All LASIK patients lose – permanently – the ability to distinguish between subtle shades of grey, which is called “contrast sensitivity”, and all have night vision disturbances.

The reason LASIK patients inevitably lose contrast sensitivity is that when the flap is replaced back on the cornea after LASIK, it heals into place by creating multiple tiny scars. This means that LASIK patients look at life through scar tissue. Now they are looking through frosted glass instead of clear glass. One LASIK patient said: “I feel as if I am looking through Vaseline.”

LASIK surgeons measure visual acuity in dim light 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 have to distinguish between multiple subtle gradations of color and form in the real world.

LASIK surgeons take a cornea that has a smooth curve – a perfect dome – and convert into a plateau. After LASIK, all corneas have two curves: a flatter curve in the center, and a steeper curve in the periphery. The new, reshaped, central part of the cornea focuses incoming light directly on the retina. The peripheral part focuses light either in front of the retina, or behind it.

As a result, all LASIK patients have at least some double images, ghost images, halos, or starbursts around lights, even if some of them do not recognize these changes.

This distortion is especially marked in dim light, when the pupil dilates and the peripheral cornea comes into play. All LASIK patients take some risk when they drive a car, or pilot a plane, at night. I believe all LASIK patients should have drivers and pilot licenses that restrict them to day driving and piloting. They are a danger to themselves and others at night. The irony is airline pilots must have uncorrected vision of 20/20 to qualify for their job. If they do not, they often have LASIK. After LASIK, they may be able to see 20/20 with high contrast letters, but their actual vision is worse than before LASIK. I would not want to fly in a plane that is piloted by  somebody who has had LASIK. Nobody would.

LASIK surgeons define “success” as being able to see 20/40 in their office without glasses. By that definition, many miserable patients are “successes”. The unhappy patients I have seen would not agree with this definition of “success”.

One LASIK patient I know of had to quit her job as a theatre critic after she had LASIK, because she could no longer see the actors on the stage after the lights went down. An anesthesiologist I know had to retire because he could no longer see a chart in a dim operating room. LASIK destroyed their ability to do their job.

LASIK surgeons almost always do both eyes at the same time – a practice frowned on in other eye surgeries. Why do they do that? The patients who are most aware of the visual distortions caused by LASIK are the ones who have had LASIK in only one eye. They can compare their LASIK eye to their other eye, so they are aware how poorly they see out of their operated eye. Although they may not need glasses to see the eye chart, they know their vision is not good.

One of these one-eye-LASIK patients came into my office, saying: “I cannot see out of my LASIK eye. You have to give me glasses.” When I tested her eye in the usual way, using high contrast letters, her LASIK eye saw 20/20 without any correction. She was one of the lucky 33% of LASIK patients who do not need distance glasses.

The LASIK surgeons would call her a complete success, but she did not think her operation was a success. Like all LASIK patients, she had visual distortions, ghost images, and decreased contrast sensitivity, which do not show up in the usual office eye test.

“Glasses will not help you.” I told her. She stormed out of my office, saying she would get her glasses somewhere else.

Another problem created by LASIK is when the flap is replaced back on the cornea, it does not hold on as strongly as it did before (see J Refract Surg. Sept-Oct 2005). Even mild trauma – rubbing the eyes, being hit by a wave, contact sports – can dislocate the flap. The sight will instantly become blurred once that flap comes off. The dislocated flap must be replaced surgically as soon as possible.

LASIK consent forms rarely mention this, and LASIK patients who develop this problem swear their doctor never told them about it. I tell all my LASIK patients they must wear eye protection during contact sports, and goggles while swimming. I am not the one who should be warning them about this. This is the responsibility of the surgeons.

Because the flap never heals down completely, bacteria can easily creep inside the cornea – even many years after the surgery. (See Vieira et al, 2008.) All LASIK patients face a life-long increased risk of cornea infection.

Another disturbing problem is that the cornea is not an inert sheet of plastic. It is a living structure that continues to grow and remodel throughout life. Result: vision after LASIK is often not stable.

In many cases, LASIK eyes go right back to being nearsighted again within a few months or years. Other eyes go in the opposite direction, and become far sighted. I have several LASIK patients who are more far sighted every year they come to my office, and their eyes show no evidence of stopping. Again, many LASIK consent forms do not warn patients about this.

One of the major problems I foresaw when Steve Trokel first told me about LASIK was that LASIK makes corneas thinner. Some patients have corneas that are unusually thin to begin with. Their corneas will relentlessly bulge outwards in the trimmed area after LASIK (see Clin. Ophthalmol. 2012, 6:1801-1813). This problem is called “ectasia”. (In rare instances, ectasia is caused by a hereditary eye disease, keratoconus.)

As ectasia gets more and more pronounced, the eye becomes more and more nearsighted, and it develops marked irregular astigmatism. Glasses and soft contact lenses cannot correct vision destroyed by ectasia.

The world got an accurate picture of the incidence of ectasia when a company called Avedro, Inc. went public in 2016. Avedro is a medical device and pharmaceutical company that sells a drug-device combination treatment that performs cornea collagen cross-linking, using riboflavin and ultraviolet light. Avedro claims this treatment stiffens the cornea and – supposedly – halts the progression of ectasia. In a press release in July of 2016, Avedro stated that 160,000 patients in the U.S. are affected with “corneal ectasia following refractive surgery” [i.e. LASIK and PRK].

In February 2015 only 100 cases of ectasia had been reported in the literature. Where did Avedro get the number 160,000? There is only one possible source: the LASIK surgeons. One LASIK surgeon said recently at a cornea research meeting that surgeons don’t report ectasia to the FDA because of the risk of lawsuit.

Another major problem I foresaw after LASIK was pain, but I had no idea how bad this pain would be. LASIK cuts the many tiny nerves that run through the cornea and keep it healthy. Once these nerves are cut, they never grow back normally. (See Am. J. Ophthalmol, Dec 2005; Optom. Vis. Sci Sept 2015). They fire constantly, causing what is called “neuropathic pain”. This same phenomenon occurs when a patient loses a limb. In this case it is called: “phantom pain”.

All patients will develop at least some neuropathic pain after LASIK. Neuropathic pain causes a foreign body sensation, burning, and dryness. Some LASIK patients must put wetting drops in their eyes several times every hour. Yes, I mean every hour. Walk into any drug store and you will see shelves full of artificial tears labelled “For LASIK dryness”.

LASIK patients are frustrating to treat because there isn’t anything an eye doctor can do for a LASIK damaged cornea. LASIK patients are angry, and I would be angry too if I were in their position, but instead of blaming their LASIK surgeon, or getting upset at themselves for not doing the proper research, they often get angry at me. They assume I am being perverse when I tell them I cannot help them. The only thing I can do is listen and sympathize. Actually, that sometimes does help some of them.

A chilling story was told at the FDA committee hearing on LASIK in April, 2008. Larry Campbell, a police officer, killed himself because he could no longer live with the constant pain and blurred vision he suffered since he had LASIK. His suicide note states: “The pain, distorted vision, chronic dry eye is not bearable … Do not have LASIK surgery! Tell the media!”

A mother, who is a doctor herself, sent me the following letter about her son:

“My son, Max Cronin, age 27 years old, committed suicide 1-14-16, as a direct result of complications he experienced from Lasik. He left suicide letters stating this. He kept details of his complications… vision loss, constant eye pain, dry eyes, haze, and loss of quality of life resulting in depression and his suicide. He was unable to work or continue his life goals due to his eye complications.

As a medical physician, I can definitely state that Lasik complications can lead to suicide. I can also say that no one should have elective Lasik on their eyes.

For an elective procedure, the risks and long term complications are understated. The resultant complications and negative quality of life issues increase the risks of depression, attempted suicide, and suicide.”

Nancy L. Burleson MD FACOG, Gonzales, Texas

I do not understand why so few of my fellow ophthalmologists will inform patients about the complications of LASIK. Surely, they must have some empathy for all the suffering people who have been damaged by this procedure. Most seem to accept without question the right of LASIK surgeons to operate on patients who have no idea of the risks they run when they sign up for LASIK.

I can only speculate this elective surgery is so financially beneficial their judgement is affected.

The most accurate statistics about LASIK complications I am aware of come from a citizen’s petition filed by Morris Waxler with the FDA in January of 2011. Morris formally asked the FDA to revoke its approval of LASIK. Ironically, Morris knew all about the process by which LASIK had been approved, because he was the chairman of the FDA committee that approved it in 1998.

Morris was the FDA’s chief scientist in charge of all clinical research trials. When he retired from the FDA, more and more miserable LASIK patients began to contact him. He knew something was not right. He re-examined the original documents filed with the FDA by the LASIK surgeons and LASIK manufacturers – the ones presented at the time LASIK won approval – and he became convinced that the FDA had been, in his words, “hoodwinked”.

Morris discovered what the LASIK industry had called “temporary side effects” were permanent and devastating injuries. The actual data the LASIK surgeons presented to the FDA showed that twelve months after LASIK almost 60% of patients had fluctuating vision in dim light, 50% suffered from gritty eyes, and 20% had problems driving at night.

Morris heard I was one of a handful of ophthalmologists willing to speak out about the dangers of LASIK. He asked me to go with him to Washington, D. C. on September 22nd, 2010 to testify before the FDA about LASIK complications. I cancelled all my appointments, and went.

Morris told the FDA committee about the misleading statistics that tricked him into recommending LASIK be approved, 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 and disastrous. I also told them about my many patients whose lives had been ruined by this procedure. ABC News ran a special about Morris’ testimony that evening.

Today there are thousands of MedWatch complaints on file with the FDA about LASIK injuries. Three quarters of them involve dry eyes, poor vision at night, and decreased visual acuity. There are over 1,200 signatures on a petition to stop LASIK. Many of the patients make heart-breaking comments. (See Petition to Stop LASIK). Despite all the evidence, the FDA has not revoked its approval of LASIK.

LASIK is an extremely dangerous procedure. Patients have no idea of the risks they are running, because the consent forms they sign before they have LASIK is deceptive and inadequate. The risks are not explained in clear English, with the percentages of each risk.

If I designed a consent form for prospective LASIK patients, I would say this:

LASIK IS AN ELECTIVE COSMETIC PROCEDURE.

  • If you have LASIK, there is less than a 50-50 chance you will be able to throw away your glasses, according to a 2009 Consumer Reports survey.
  • Even if you see better at distance, you will have other problems you did not have before LASIK. For example, people over forty years old will almost always have to wear reading glasses.
  • There is a 100% chance you will no longer be able to distinguish between subtle shades of grey.
  • There is roughly a 50% chance you will develop a painful dry eye. This means your eyes will constantly feel as if sand is pasted inside your lids, and they will burn as if you have hot pepper sauce in them. The chance this pain will be with you for the rest of your life is close to 100%.
  • There is a significant chance you will no longer be able to function in dim light. You may have to give up driving at night and going to the movies. If your job requires functioning in dim light, you may become permanently disabled.
  • LASIK permanently bends, thins and weakens the cornea, which can lead to ectasia. Ectasia is a progressive steeping, or bulging, of the cornea – rather like a hernia, or a tire that has a weak spot. As the weakened cornea is progressively pushed further and further out, the eye develops irregular astigmatism that cannot be corrected by glasses or soft contact lenses. Ectasia can develop twenty-five years after apparently successful LASIK.
  • To cap it off, your eye is likely to go right back to being nearsighted, or it may even become farsighted. Some eyes continue to fluctuate in vision for as long as twenty-five years.

The LASIK consent forms today are nowhere near this detailed and specific. These problems are sometimes mentioned, but the forms do not give percentages, and they are not written in plain language so the patients do not understand them.

If the risks were explained to each patient like this, in plain language, with the percentages of each risk included, nobody in their right mind would have this procedure.

I will close with a recent letter from a LASIK-damaged patient. She had PRK, i.e. LASIK without the flap:

“You have renewed my faith in the medical industry. After meeting with many ophthalmologists (private and at teaching hospitals) to try to find some relief from my PRK complications, you are the first M.D. I have been exposed to that has questioned the PRK/Lasik outcomes. I have had some that said they would not have it themselves, but they still recommend the procedure to others.

My purpose in writing is to bring to your attention another documented complication (and longer term, so it is never talked about.) This is the fact that LASIK/PRK patients as a group develop cataracts much sooner than the general public.

I had bilateral retinal detachment after my PRK. At the age of 57, seven years after my PRK, I was diagnosed with a steroid induced cataract by my retina specialist. (The only steroids I have ever used were after my PRK and the enhancements.)

Before my surgery I could find no one unhappy with the surgery, and after my surgery they seemed to be everywhere. But people will not hear what they do not want to.

I tell everyone I know who is contemplating the procedure to at least record (not secretly) the conversations with their surgeons. I believe the discussion will follow much more the list that you have described and that I recently saw on my Facebook support group. (Even WebMD and MAYO Clinic websites, where I started my research, portray a surgery where all side effects are short lived and, as you know, there really are no long-term studies.) I do feel like this is a public health debacle with young people risking their life-long eye health to problems that will sometimes not show up for years.

Thank you for helping to inform the public. You are a light shining in darkness!”

A study in the February 2015 edition of the Journal of Cataract & Refractive Surgery found that LASIK patients undergo cataract surgery up to 15 years sooner than people who have not had LASIK.

I get nothing from telling the truth about LASIK except the criticism of my peers, but I could not live with myself if I did not do it. I went into ophthalmology to heal sick eyes. LASIK takes healthy eyes, and turns a hefty percentage of them – in some studies, 100% – into sick eyes.

I remember how incredulous I was at my medical school graduation in 1977 when Dr. Lowell Bellin, New York City’s chief health officer and self-described “medical cop”, told my class that some doctors do not put their patients first. Now I have proof that LASIK surgeons do not care about their patients. Instead of doing good, they do harm. They destroy eyes instead of healing them. I am turning into a medical cop myself.

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

The increasing number of malpractice suits against LASIK surgeons shows LASIK is giving ophthalmology a bad name. Ophthalmologists should save sight, not destroy it. Speak up, my fellow ophthalmologists, and share your reservations. The world is watching.

I have watched damaged LASIK patients cry uncontrollably in my office. They howl they trusted their doctor, and their doctor betrayed them, never warned them this could happen to them. I want to drag every LASIK surgeon into my office, one by one, chain them to the furniture, and force them to listen to this suffering human being until they vow they will never perform LASIK again.

The best way to stop LASIK, in my opinion, would be to require all LASIK surgeons to have the procedure before they are allowed to perform it on others.

 

Violative Medical Device Ads: Why FDA Doesn’t Act

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
01/04/2017

(Report by Jim Dickinson) FDA has statutory authority to regulate the advertising and promotion of “restricted” medical devices, but even in the face of injured patient complaints, it’s an authority it rarely uses. That’s probably because in the broad sweep of device safety issues and recalls that grab headlines and congressional attention, complaints about ads from injured patients directly to the agency’s Center for Devices and Radiological Health are few and far between. And that’s probably because injured patients don’t know that CDRH is supposed to be regulating violative device ads.

One injured patient, however, does know and in November she complained to CDRH about a violative ad by LASIK (laser-assisted in-situ keratomileusis ) eye surgeon T. Hunter Newsom, in Tampa, FL. A former FDA advisory committee consumer member, injured Tampa LASIK patient Paula Cofer complained that Newsom’s Web site omitted all risk information in extolling the benefits of his new Wavelight laser by Alcon Laboratories. CDRH regulatory counsel Deborah Wolf responded that she’d referred the complaint to the Allegations of Regulatory Misconduct Branch, with the suggestion that Cofer communicate directly with them.

When Cofer did so, she got an email form letter saying “FDA does not provide information on ongoing investigations. Such information can be obtained pursuant to a Freedom of Information Act (FOIA) request once an investigation is closed … Please note that on average, investigations take a minimum of six (6) months to complete.” There was no information on how Cofer could learn of the investigation’s completion, other than the unsaid implication that she could begin inquiring on her own schedule after the minimum six months.

For the FDA-savvy Cofer, this was “Unbelievable!” For injured patients without FDA familiarity it would likely be plain impossible, given (a) their unawareness that FDA even has a role in false or misleading medical device promotional claims enforcement, and (b) their inability to discover who at FDA might handle such complaints.

There was a time when CDRH took this issue a little more seriously than it does now. In September 2011, hard on the heels of an acrimonious campaign by injured LASIK patients against LASIK surgeons’ violative promotions, then-CDRH compliance director Steven Silverman issued a Dear Eye Care Professional letter politely urging them to be mindful of the law. In it, he reminded them that this was the second time in two years that FDA had taken this direct approach to their promotional practices. He gave them 90 days to comply with the law.

“After that time,” Silverman wrote, “the FDA may take regulatory action against eye care professional whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions and civil money penalty proceedings.”

Actually, this was CDRH’s third attempt to bring the LASIK practitioner community into compliance. The Center sent a similar letter separately to the community’s national body, the American Society of Cataract and Refractive Surgery.

Cofer and the earlier prolific complainers among the LASIK injured patient community say these efforts had no effect on the number of deceptive promotions and advertising by practitioners. Indeed, since Cofer complained about Newsom, she says she has found three additional active violative Web sites belonging to the 37-state, 68-center LASIK Vision Institute, California-based Saroudi Advanced Lasik and Eye Centers, and surgeon Manoj Motwani.

For ongoing and proliferating violations dating back more than seven years, why doesn’t FDA do more than say it can’t confirm or deny the existence of its investigations and invite FOIA requests after an investigation is complete? Probable explanations include ꟷ if the agency allowed itself to publicly discuss the matter: (1) Lack of resources to prosecute so many cases which have comparatively few reports of actual harm; (2) the agency’s dismal track record in court cases involving First Amendment issues (which LASIK surgeons would surely invoke if prosecuted); (3) the need to defend its failure to aggressively address the related issue of permanent eye injuries in a small minority of LASIK patients who were deceived; and (4) lack of congressional and media interest.

While LASIK may be dismissed as an isolated case because of its elective nature, other areas of violative promotional activity among users of restricted devices may be encouraged by its example. That’s a bet FDA appears to be confident in making.

Shuren Promises Action on Suicidal LASIK Patient

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
6/10/2016

Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s report that he/she was considering suicide because of LASIK injuries. The call on Shuren came in an email from LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer, who in two months ago launched a nationwide Internet petition for Congress to fire Shuren over the LASIK issue and his purported “capture” by industry. Continue reading

Hundreds Petition Congress to Fire CDRH’s Shuren

04-14-2016
Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

An Internet petition to Congress authored by LASIK injured patient/activist and former CDRH advisory committee consumer representative Paula Cofer has drawn more than 270 signatures from across the country in its first 24 hours, demanding the removal of CDRH director Jeffrey Shuren from office. Last October, Cofer and some of the current signatories were involved in a 1,500-message email blitz of Shuren’s government in-box calling on him to resign. Shuren and FDA shrugged off that campaign. Now Cofer and her supporters want Shuren fired by Congress. Their petition charges that his leadership has seen the Center “become mission-corrupted, placing industry interests over public health.

“Failures of the CDRH,” it continues, “have harmed countless people and led to many preventable deaths. CDRH is ‘captured’ by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers. Fraud and data tampering occurs regularly in FDA clinical trials of medical devices. The CDRH’s oversight of device trials is weak and ineffective, leading to approval or clearance of unsafe devices.

“Post-market surveillance by CDRH is lax,” the petition goes on. “Problems with medical devices go undetected, which leads to injuries to unsuspecting American citizens. Patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag about problems with a medical device have been shut out or ignored. MedWatch reports of device-related injuries fall into a black hole at the agency.

“We call on the United States Congress to remove CDRH director Jeffrey Shuren from the FDA so that a new leader can take his place. A new CDRH leader must honor the agency’s mission to protect and promote the public health.”

Among numerous comments signatories have posted to the petition are some Cofer characterizes as “brutal” about Shuren. They include this from a Tara Howie in New Jersey:

“In 2011 Shuren, when asked about the 510(k) process, Shuren said he doesn’t know where precisely it is going, but it certainly won’t be scrapped. He believes the system works well, although he knows there are those in the industry with ‘angst’ about the program — and he has seen this concern increasing. But the largest challenges pertain only to a small minority.

“This is my biggest problem with Shuren,” Howie’s comment continues, “the 510(k) process is a legal loophole for untested devices to go straight to market without any pre-market testing, simply based on the fact the device resembles a predicate device. Having had a device implanted that was based on a predicate device that was pulled from the market, yet the devices in me were not shows exactly where a huge problem exists.

“Is Shuren that shortsighted? I think not. In his time at the CDRH he has lied (kinda) under oath, he has pushed his agenda, one that benefits him, yet leaves the consumer, frankly, screwed. The ‘small minority’ Shuren speaks of is not too small actually. Perhaps in his limited view of everything that doesn’t pertain to him, or the lobbyists he’s been making extremely happy, it is small, but if you ask thousands and thousands of consumers what they think of the way Shuren has decided to run the CDRH, they will undoubtably tell you there are many, many problems. Not only ‘minor’ ones.

“How can anyone within the FDA, or specifically the CDRH, be trusted when they work so closely with representatives from medical device manufacturers? The writing is on the wall so to speak. And it’s well past time to make the changes necessary to protect the consumers, and not the wallets of the medical device industry. Greed in this country is putting dollars before clear, rational thinking. And it’s time to change this, along with the leadership at the CDRH, beginning with Shuren, and all of his cronies. Let’s put people back into the conversation, the consumers, the patients…But, don’t ask the thousands of already deceased ones, just ask their families.”

Cofer says her petition is being followed by Pennsylvania Republican congressman Mike Fitzpatrick, and she hopes he will bring it to the attention of his colleagues. Fitzpatrick has strongly supported injured patients’ criticisms of Shuren and CDRH safety management in the power morcellator and Essure birth control controversies.

FDA spokesman Eric Pahon would say only that the agency “is aware of the petition.”

Despite Protests, FDA Hangs Tough on LASIK

9/9/2015

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

Despite continued agitation on the part of patient activists claiming injuries from LASIK vision correction procedures, FDA said 9/9 it has “not found any new safety concerns associated with LASIK devices to lead it to believe that there is no longer a reasonable assurance that these devices are safe and effective under the conditions of use in the labeling of the device.” The statement came after FDA Webview asked why the agency had not responded to a 5/8 letter from LASIK activist Paula Cofer to acting commissioner Stephen Ostroffthat attached 1,073 electronic signatures supporting reconsideration of FDA’s denial of a LASIK ban petition from former CDRH ophthalmic devices chief Morris Waxler.

Cofer herself chided Ostroff for his non-response in a second letter attaching an investigative report in the September issue of Consumers Digest and advising him that two more ex-FDA officials are now speaking out against LASIK: Former CDER ophthalmic division deputy director Everett Beers, quoted in Consumers Digest as supporting Waxler’s assertion that LASIK should not have been approved, and former medical device compliance director Larry Pilot, quoted in the same article as saying, “When it comes to LASIK, it isn’t that the agency has dropped the ball, it’s that they never even moved it.”

Cofer’s second letter to Ostroff told him: “For years we’ve been complaining to the FDA about this issue. In 2008 your agency said you would reevaluate the safety of LASIK. It’s been seven and one-half years, and nothing has changed except for the growing number of injured LASIK patients. Now it’s your watch, Dr. Ostroff. Are we to expect more of the same treatment ─ injured citizens shut out of the regulatory process? Or will you do what’s right and respond to our grievances and concerns?”

FDA’s response to FDA Webview said the agency entered Cofer’s 5/8 letter to Ostroff as a public comment to the docket to Waxler’s 7/22/14 petition for reconsideration, and the agency’s failure to notify her of this was an “oversight.” As for Cofer’s latest letter, “it is currently under review. The FDA will respond directly to Ms. Cofer if necessary.”

1,073 LASIK Victims Ask FDA to Reconsider Petition Denial

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

05-08-2015

Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought the market withdrawal of LASIK-indicated device and a public health advisory. In her letter, Cofer alleges that the denial was “presumably” directed by CDRH ophthalmic devices director Malvina Eydelman who, she wrote, “has a history of protecting industry interests over public health … It is clear that under the leadership of ophthalmologist Malvina Eydelman, MD, the FDA division that oversees LASIK devices has been ‘captured’ by industry.”

The letter says Waxler asserted that “LASIK manufacturers and their collaborators successfully pressured FDA to classify surgically-induced vision problems (halos, starburst, ghosted images and glare) and chronic dry eyes as mere ‘symptoms’ so that manufacturers could claim that the adverse event rate is less than 1%. ‘The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,’ he says.”

Cofer says FDA “has failed to take action on several other citizen petitions asking for a variety of actions against LASIK, several reports of LASIK-related suicides, numerous letters and emails from the public concerning LASIK problems, countless false and misleading LASIK ads promoting specific LASIK devices, and hundreds of LASIK-injury reports filed with the agency by LASIK patients through MedWatch.”

“What seems to be lost in the LASIK controversy,” the letter concludes, “is the simple fact that LASIK is unnecessary. Visual refractive error is not a disease requiring surgical treatment. Safer alternatives ─ namely glasses and contact lenses ─ are widely available.”

FDA Panel to Consider Corneal Collagen Cross-linking

Tuesday, February 24, 2015

By Richard Smith

          As with many regulatory proceedings, a Food and Drug Administration hearing today will have effects reaching far beyond its official topic. An FDA scientific advisory panel is gathering to consider a new treatment for keratoconus, a rare but potentially disabling eye disorder. How the FDA responds could launch a new phase of the Lasik eye surgery boom–with an add-on technology that’s marketed as enhancing patient safety but that in fact greatly increases patient risk.

          First, the basics: Keratoconus affects about 174,000 Americans, with roughly 6,400 new cases a year.[1] An afflicted eye loses structural integrity, and the cornea bulges forward under the eyeball’s internal pressure. Vision may deteriorate severely as the eye gets more and more distorted.

          The procedure under review, corneal crosslinking, is simple compared to many ophthalmologic treatments. The eye is doused with a solution of riboflavin (Vitamin B2) and then exposed to ultraviolet light. This stiffens eye tissues containing collagen. (I imagine damp shoe-leather baking in harsh sunlight.)

          The idea is to help the eye hold its shape, but for minorities of patients the treatment causes problems, including significant loss of corrected distance vision in 2.9 percent; significant scarring, up to 8.6 percent; and corneal ulcers, 7.6 percent.[2] Long-term risks are unknown, but because crosslinking uses a range of ultraviolet light known to alter DNA,[3] there’s a chance it could trigger cancer.

          Such risks aren’t trivial. But the benefits may be substantial: halting the disease’s progression, which can lead to legal blindness, and avoiding corneal transplant, a frequent treatment for severe cases that is nobody’s idea of a picnic.

          But there’s more to the story. Crosslinking is being evaluated as a treatment not just for keratoconus but also for corneal ectasia. Ectasia is a kind of cousin, with the same basic symptoms and course, but unlike keratoconus its cause is known: the laser vision-correction surgery known as Lasik–a medical intervention widely touted as safe and effective.

          How can Lasik lead to ectasia? Refractive surgeries aim to improve vision by reshaping the eyeball so light focuses properly on the retina. Before Lasik, the laser was applied to the eye’s surface. Recovery was slow and painful. Lasik emerged as an easier sell: a thin flap of cornea is shaved and folded aside, underlying tissue is lasered, and the flap is flipped back into place, creating a natural bandage over the wound. Less pain, fast vision improvement–the so-called Lasik “wow!” effect.

          But the cornea doesn’t heal like most body tissues. In fact, the Lasik flap never really heals. In one study, the edge of the flap retained only 28.1 percent of its original tensile strength–and the central area only 2.4 percent.[4] That’s why, years after Lasik, a blow to the eye can knock the flap loose, like an unlatched door, and a surgeon “retouching” your Lasik can simply relift the original flap, like scraping an egg off a griddle.

          The flap’s failure to heal also leaves the cornea weaker–less resistant to the eye’s internal pressure. Sometimes the eye’s shape shifts enough to start undoing Lasik’s correction of vision. Worse corneal bulging can cause ectasia.

          How often this happens isn’t clear, as estimates vary and, as malpractice attorneys have found, some cases are hushed up.[5] Current statistics put the incidence below one percent.[6] That’s less frequent than some of Lasik’s other downsides, such as glare, halos, starbursts, ghosting, and dry eye.[7] But because such symptoms are classified by the FDA as less severe than ectasia, they’ve received less official attention and surgeons have been less concerned with them than with downplaying or even denying the risk of ectasia.[8]

          Now, however, with corneal crosslinking on the horizon, ectasia is back on their radar. In fact, some surgeons and industry leaders advocate adding crosslinking to Lasik as insurance against future deterioration. Avedro, whose procedure comes for FDA review today, is conducting a clinical trial of Lasik and corneal cross-linking performed simultaneously–a double-header already approved in Europe, where Avedro markets it under the trade name Lasik Xtra. Another company, CXLUSA, is running a trial of a Lasik-crosslinking combo for patients known to be at higher risk of ectasia.

          So let’s get this straight. The risk of ectasia after Lasik is less than one percent–way less, surgeons have insisted. But surgeons propose tacking on crosslinking, with risks several times greater than that of ectasia. And the risks of crosslinking would load on top of the known risks of Lasik. These risks have been hotly debated, but one review of FDA documents found that, across studies, 15 percent of Lasik patients had worse or significantly worse night vision than before surgery. Twenty percent had worse or significantly worse dry eye.[9] These outcomes can be far more disabling than they sound–for instance, when a Lasik patient driving at night must try to peer through streetlight starbursts that span the whole road, or when Lasik-induced dry eye hurts so much a person wants to gouge his eyes out.

          The Hippocratic Oath advises doctors, “First, do no harm.” Given that Lasik is medically unnecessary, maybe the simpler solution is not to do it in the first place.

          To make a case for Lasik plus crosslinking, surgeons have had to stop minimizing ectasia’s risks, instead maintaining that those risks justify adding crosslinking. Whatever net effect crosslinking brings to Lasik patients, it also gives crosslinking tech companies and Lasik surgeons a new option they can add to bills for some 600,000 Lasik customers a year. Big money isn’t in treating kerataconus but in promoting Lasik with crosslinking.

          That procedure will come up for FDA approval within the next few years. But if today’s advisory panel recommends approval for crosslinking, doctors could start slapping the procedure onto Lasik even before the safety and efficacy of the combo platter has been adequately studied. Doctors could claim a right to perform the procedure in what’s called an “off-label” use–that is, for purposes other than those officially sanctioned.

          The FDA regulates drugs and medical devices, not the practice of medicine,so it couldn’t stop off-label uses altogether. But what the agency can do is stipulate that crosslinking, if approved, can be marketed only for the approved purposes–treating keratoconus and ectasia. It could forbid doctors to promote crosslinking as a way to make Lasik safer. Such claims would constitute “misbranding”–essentially, misleading advertising that amounts to fraud. That might give the agency a chance to make a meaningful yes-or-no decision when Lasik Xtra and its competitors come up for approval. Otherwise, Lasik-plus-crosslinking could become so commonplace that future FDA approval would be a foregone conclusion.

          That’s how the Lasik boom got its start two decades ago. In the 1990s, Lasik became what its critics regard as a runaway train when lasers were FDA-approved for an earlier method of eye surgery, and surgeons began using them for Lasik as well–before anyone adequately studied Lasik’s safety and effectiveness. According to Morris Waxler, then branch chief of the FDA’s Center for Devices and Radiological Health, the agency got worried that Lasik was spreading without safety studies or rules, risking not only patients’ eyes but also the FDA’s reputation. So the agency tried to rush Lasik surgeons into the corral of government oversight.[10]

           Predictably, this rushed job was a botched job. For one thing, according to Waxler, the FDA allowed industry too much say in establishing official definitions of safety and effectiveness. Many of the ways Lasik can damage vision and eye health got downgraded from adverse event to complication or side effect–and thus didn’t affect Lasik’s official safety profile.

          The FDA advisory committees reviewing Lasik in the 1990s tried to slow things down. The first one voted the application under consideration nonapprovable–largely because the reported percentage of patients returning for followup evaluation was so low that the data looked cherry-picked. Nonetheless, the agency approved it, fearing a battle with the applicant’s formidable attorney (a former FDA chief counsel).[11]

          During the next round of hearings, NIH ophthalmologist Frederick Ferris acknowledged it was bizarre to see the FDA debating approval of a surgery already in widespread use: “…driving in here I heard a number of advertisements for this procedure…. I thought to myself, Well, people little note nor long remember what we do here because, as near as I know, this train is moving.”[12]

          Now another train is lurching into motion. The FDA needs to hit the brakes.

 


[1] Figures based on current estimated U.S. population and U.S. incidence rate of 0.002% and prevalence rate of 0.054% reported in Kennedy RH, Bourne WM, Dyer JA. A 48-year clinical and epidemiological study of keratoconus. Am J Ophthalmol. 1986;101:267-73.

[2] Raiskup, F, & Spoerl, E. Corneal Crosslinking with Riboflavin and Ultraviolet A. Part II. Clinical Indications and Results. The Ocular Surface, April 2013, Vol. 11, No. 2. pp. 93-108. p. 98.

[3] Steve Safran, quoted in eyeConnections: Queries about collagen cross linking. ASCRS EyeWorld, April 2010.

[4] Cohesive Tensile Strength of Human Lasik Wounds with HIstologic, Ultrastructural, and Clinical Correlations. Ingo Schmack, MD; Daniel G Dawson, MD; Bernard E McCary, PhD; George W Waring III, MD, FACS, FRCOphth; Hans E Grossniklaus, MD; Henry F Edelhauser, PhD. Journal of Refractive Surgery, 2005;21: 433-445.

[5] Interview with Todd Krouner 9-11-12

[6] Raiskup, F, & Spoerl, E. Corneal Crosslinking with Riboflavin and Ultraviolet A. Part II. Clinical Indications and Results. The Ocular Surface, April 2013, Vol. 11, No. 2. pp. 93-108. p. 98.

[7] LASIK Quality of Life Collaboration Project, FDA/NIH/DOD. Presentation by Malvina B. Eydelman, M.D., Director, Division of Ophthalmic and Ear, Nose, and Throat Devices. ODE/CDRH/FDA. Posted at http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421193.pdf.

[8] Stephen Slade, quoted in: CXL for Corneal Ectasia: Reshaping the Future of Treatment, by Annie Stuart. EyeNet Magazine, April 2014.

[9] Outcomes of Lasik of Myopia with FDA-Approved Lasers. Bailey, Melissa D, OD, PhD; Zadnik, Karla OD, PhD. Cornea, Vol. 26, No. 3 (April 2007), 246-254.

[10] Interviews with Morris Waxler, December 7, 8, and 9, 2012.

[11] Interviews with Morris Waxler, December 7, 8, and 9, 2012.

[12] FDA–Ophthalmic Devices Advisory Panel, 93rd meeting. July 22, 1999.

Device Maker Slammed by Injured Patients at FDA Meeting

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

2/24/2015

Avedro Inc. CEO David Muller was verbally battered by several injured LASIK patients during public presentations 2/24 at a joint meeting of two FDA advisory committees as he led his company’s efforts to win an approval recommendation for a new drug/device combination to treat eye disorders progressive kerataconus and ectasia. Muller, the presenters charged, headed Summit Technology in the 1990s when it won a corrupt approval for the first LASIK-indicated excimer laser that permanently damaged their eyesight and “ruined” their lives.

Now he’s seeking approval for an “orphan”-designated NDA for riboflavin ophthalmic solutions with UVA irradiation by Avedro’s KXL System for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus and corneal ectasia following refractive surgery. Despite its unapproved status in the U.S., the combination is already being promoted on Avedro’s Web site as an integrated enhancement of LASIK surgery outcomes, restoration of corneal strength, halting progression of keratoconus and ectasia, and slowing or eliminating the development of acute keratoconus.

Before they voted 10-4 with one abstention to recommend approval for the keratoconus indication and 6-4 with four abstentions for the ectasia following refractive surgery (LASIK) indication, the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee heard 14 public commenters give four-minute presentations. The first four urged approval, citing worldwide successful use of the new technology outside the U.S., and the suffering of an estimated 2 million keratoconus American victims who are without access to the therapy.

There were 1,268 corneal transplants performed in the U.S. in 2013, the Cornea Society’s David Glasser told the panel. “I couldn’t be happier if your votes today mean I will have performed my last corneal transplant,” he said.

But the remaining 10 public presenters, while frequently conceding the case for keratoconus victims in Avedro’s new technology, delivered a relentless stream of condemnations of the refractive surgery medical-industrial-FDA collaboration that they complained had ruined their lives, led to depression and suicide through an “epidemic” of dry eye, blurred vision, starbursts, haloes, night-driving difficulties and other vision problems.

The panel also heard a presentation, delivered in his absence, by former CDRH ophthalmic devices branch chief Morris Waxler, who led the team that approved the first Summit Technology LASIK device and has since recanted. Delivering for him, injured LASIK activist Paula Cofer slammed Muller’s role as Summit Technology CEO in introducing the first LASIK lasers through a corrupt FDA evaluation process. She alleged that he was responsible for “thousands, perhaps tens of thousands of LASIK patients who developed ectasia as a result of their trust” in the process. LASIK surgeons, she said, don’t report the ectasia cases they cause, and are complicit in an industry-wide cover-up. If FDA approves Avedro’s combination product, she predicted it will lead to off-label use of Avedro’s next enhancement, LasikExtra, already being promoted on its Web site and in the marketplace.

Then it came Matt Kotsovolos’ turn [speaking for Dean Kantis] to lambaste Muller for “ruining” his vision through “huge” (reportedly $1 million) contributions to the late Sen. Edward Kennedy’s 1994 re-election campaign “in exchange for political FDA access” that led to the Summit device’s approval in October 1995. Kotsovolos also read from what he said was a transcript of a presentation to a professional group by the Cleveland Clinic Foundation’s Cole Eye Institute eye surgeon Ronald R. Krueger, in which he admitted that LASIK-caused ectasia occurred much more frequently than the procedure’s FDA-accepted 1% total adverse event rate.

Muller, who has long bragged about the closeness of his FDA relationships, took to the podium several times during the panel discussions, but he did not respond to his critics. In one appearance he explained that deficiencies in the clinical data supporting the KXL System application, pointed out by many panel members, resulted from data prepared by an unnamed “small German company” that developed the technology and ran out of money before it could complete the studies and Avedro acquired them as-is.

Among the Avedro data deficiencies mentioned by panelists were the NDA’s lack of patient satisfaction surveys, which CDRH ophthalmic devices director Malvina Eydelman told the meeting FDA was “committed to,” and the complete lack of any data from studies done with the KXL device itself ─ instead the panelists were forced to accept Avedro’s contentions that this device was to all important extents, identical to a different device, the UVX which was used in all the studies.

Despite these and other deficiencies, the panel voted with barely muted misgivings for the primary indication, progressive keratoconus, and much more reluctantly for the second ─ and reputedly far more profitable ─ ectasia after LASIK indication.

Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

By Jim Dickinson

02/18/2015

Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 joint meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

The basic issue in Waxler’s opposition is the failure of the applicant to demonstrate long-term product safety in a prior LASIK PMA application as Summit Technology in 1995, which Waxler approved as branch chief.

In a presentation to be delivered in his absence, Waxler says the NDA presents “at least two public health dilemmas” for the committees because the product masks “a high rate of LASIK-induced ectasia” when the true rate is unknown, and “how many legally blind people are acceptable to you for a few years of ’20-happy vision?'”

Waxler’s presentation says that FDA’s “collaboration with the refractive surgery industry has created a LASIK-induced epidemic of sick corneas…. The true rate of LASIK-induced ectasia will be buried forever if the panel recommends approval of FDA’s plans to approve products polymerizing sick corneas.”

Waxler, who unsuccessfully petitioned against his own approval of the LASIK indication for excimer lasers because of alleged data falsification he found later, says FDA leadership on LASIK products “has a long-standing collegial and professional bias towards ophthalmic professionals in the industry. They work out many issues in regular private meetings; I know because I led many of these meetings and know of many others.”

LASIK Activists Petition for Black Box Warning

Copyright Dickinson FDA Webview at www.fdaweb.com.
Republished by permission.
01/05/2015

Notwithstanding a recent FDA-NIH-U.S. Navy collaborative study that downplayed LASIK vision-altering surgery risks, three activists petitioned FDA commissioner Margaret Hamburg 12/24/2014 to add a black box warning to the labeling of lasers approved for the procedure. The petition alleges a “high incidence of induced visual symptoms (double vision/ghosting, starbursts, glare, and halos) and dry eyes” and asks the agency to send letters to professional organizations “to advise physicians of a black box warning on excimer lasers.”

The petition says the FDA-NIH-Navy study “demonstrated that three months after LASIK eye surgery, up to 45% of patients who had no visual symptoms before LASIK report [them] after LASIK, and up to 30% of patients who had no dry eye symptoms before LASIK report dry eyes after LASIK.” It cites a 2007 published review of data from 12 FDA clinical trials showing that six months after LASIK about 20% of patients reported that visual symptoms and dry eyes were worse than before surgery, much worse than before surgery, moderately severe after surgery, or severe after surgery.

“With millions of people having undergone laser eye surgery with such frequent problems,” the petitioners write, “it follows that there is an epidemic of visual symptoms/night vision problems and dry eyes caused by this unnecessary surgery. Unless the FDA immediately begins to provide adequately strong black box warnings about the risks and adverse effects of laser eye surgery, the epidemic will continue to grow. There have already been several reports of LASIK-related suicide and countless reports of suicidal ideation. A black-box Warning would help reduce the number of such negative outcomes and therefore falls well within the FDA’s mandate of protecting and promoting public health.”