Author name: Layla

LASIK Risks and Complications

LASIK Risks and Complications

Morris Waxler PhD.

FDA’s chief scientist in charge of the clinical trials research for laser eye surgery, popularly known as LASIK.

Long term effects reported

  • Chronic Dry Eye*
  • Unrelenting Eye Pain
  • Visual Distortions*
  • Depression & Anxiety
  • Ectasia (loss of corneal structural integrity, resulting in a bulging cornea with associated vision loss which is not correctable with eyeglasses or soft contact lenses.)

Petition to stop LASIK

The following outline summarizes LASIK risks that must be conveyed to the public

  • Safety problems (risks)
    • Adverse event percentages
      • Persistent adverse events, including dry eyes and night vision difficulties: >20%
      • Other problems: >1%
      • Sight threatening thinning and bulging of the cornea (keratectasia): at least 0.66%
    • Permanent pathology in cornea
      • LASIK flap
        • Never heals
        • May be accidentally dislodged for the rest of a patient’s lifetime
      • Mechanical strength of post-LASIK cornea only ~2% strength of normal cornea (this is specifically the flap interface)
      • Progressive loss of corneal cells for years after LASIK
      • Corneal nerve damage never fully recovers
    • Types of adverse events to expect
      • Glare, halos, dry eye and compromised night driving
      • Permanent loss of contrast sensitivity
      • Unstable vision
      • Permanent corneal haze
      • Permanent dry eye
      • Night time vision permanently impaired
      • Vision improvements from LASIK will likely decline with age
      • May require corneal transplant, expensive special hard contact lenses, or cross-linking treatment due to thinning and bulging of the cornea
      • Extreme light sensitivity
      • Potential future eye problems
        • Undiagnosed glaucoma
        • Poor outcome from cataract surgery
  • Benefits (effectiveness) – about 43% of LASIK cases may have temporary freedom from wearing spectacles or contact lenses
LASIK Conflicts Of Interest

LASIK Conflicts Of Interest

LASIK & the Department of Defense

LASIK patient advocates have expressed strong concern of bias on the part of military LASIK surgeons, particularly Navy LASIK surgeons, who have close ties with organized ophthalmology. For example, Steve Schallhorn, MD, Capt, US Navy (Retired) is a paid medical malpractice defense expert witness and an industry consultant who has made public statements and published literature denying the connection between a poor LASIK outcome and diminished quality of life has financial interests in companies that manufacture LASIK devices and is currently the medical director of one of the largest corporate providers of LASIK in the world. Furthermore, LASIK patient advocates have questioned a defense contract awarded around the time of Schallhorn’s retirement from the Navy.

In December 2006, IntraLase announced that the Dept. of Defense had awarded the company a $45 million, 5-year contract to supply its flap-cutting lasers to the U.S. Army, Navy, Air Force, Marine Corps, and federal civilian agencies. Shortly thereafter, it was reported that Schallhorn was a consultant for and had financial interests in Advanced Medical Optics, the company that acquired IntraLase. Further evidence of bias can be found in an article in the December 2009 edition of JAMA, which reported that Schallhorn is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective”.

Former Navy LASIK surgeon, David Tanzer, MD, is a member of ASCRS and AAO and co-authored several papers favorable to LASIK with Schallhorn. Tanzer is the past Director of Refractive Surgery at Naval Medical Center San Diego having retired in 2011 and currently practices refractive surgery in San Diego. Tanzer, wearing Navy dress blues, testified in favor of LASIK at the 2008 FDA hearing, characterizing LASIK as “overwhelmingly successful”, “extremely low risk”, and having “incredibly high” satisfaction rates.

Dr. Jennifer Morse, former Navy Program Director for Psychiatry in San Diego and paid ASCRS consultant, also presented testimony in favor of LASIK at the FDA hearing. Morse talked about the benefits of LASIK in military and civilian populations and asserted that there is no scientific evidence of any direct link between LASIK and depression or suicide. Several months later at a meeting of the American Academy of Ophthalmology, Morse spoke about dissatisfied LASIK patients, saying there must be some neurologic disconnect between what their eyes are seeing and what their brain is processing. ASCRS paid Morse’s travel expenses to attend the hearing.

Related story: http://lasikscandal.com/everything-you-need-to-know-about-lasik-recovery-process/

LASIK and Pupil Size

LASIK and Pupil Size

Behind the cornea is the colored part of the eye called the iris. The iris muscle controls the size of the pupil, regulating the amount of light entering the eye. In dim light, the pupil opens to gather more light. The dark-adapted pupil diameter varies widely among individuals. In 2004, researchers found the pupil size of patients seeking refractive surgery ranged from 4.3 to 8.9 millimeters with an average of 6.5 millimeters.

Laser refractive surgery alters the center – not the entire diameter — of the cornea. The area of the cornea that is fully treated is called the optical zone. In addition to the optical zone, modern laser technologies employ a blend zone, also known as the transition zone. The entire area treated with the laser — optical zone plus blend zone — is called the ablation zone. A common laser optical zone currently is ~6.5 millimeters and varies based on laser capability, surgeon preference, and patient parameters. You can ask your doctor these questions before going for surgery http://lasikscandal.com/best-5-questions-to-ask-before-choosing-lasik-surgery/

If the laser optical zone is smaller than the patient’s dark-adapted pupil diameter, the light will pass through the treated area (optical zone), partially treated area (blend zone), and possibly untreated area of the cornea, resulting in loss of contrast sensitivity and visual aberrations — starbursts, halos, and double vision. The greater the disparity between the optical zone and pupil size, the more severe the visual disturbances.

A patient should never consent to surgery where the fully treated area (optical zone) is smaller than his or her dark-adapted pupil diameter.

In reality, the optical zone may not be as large as intended due to healing responses (corneal remodeling and epithelial hyperplasia) after surgery and laser light reflection (loss of energy). The true optical zone after healing is called the “effective optical zone” or “functional optical zone”.

The risk for night-time visual disturbances is further increased for patients with high myopia due to smaller effective optical zones associated with deeper ablations. If the ablation zone of the laser treatment is decentered, even an adequate effective optical zone for the pupil size may not cover the entire pupil diameter.

The importance of pupil size in refractive surgery is well-established. There are a small number of published studies that fail to find a correlation between night vision problems and large pupils; however, upon close inspection, it becomes clear they are poorly designed and therefore flawed.

This article challenges the studies that fail to find a correlation between pupil size and night vision disturbances of the Lasik eye. You can also read Screening for LASIK, which will give you an idea of what screening should take place.

You will also find real accounts from people with nigh vision issues, in our FDA Adverse Events section under visual quality. Also, a number of patients with large pupils, have created websites due to the severity of their visual impairment.

LASIK-related anxiety

LASIK-related anxiety, depression, and suicide

Refractive surgery advertisements depict only happy patients, free of their glasses, engaging in sports and recreation—enjoying life to the fullest! There is never a mention of the “unhappy patient”.

The unhappy patient is often misunderstood because most people believe a bad outcome can be corrected with another surgery, or that the patient can simply go back to wearing glasses. In fact, refractive surgery can result in lasting dry eyes, pain, and visual disability which surgery and glasses cannot correct.

There is a huge disconnect between refractive surgeons and their patients regarding what constitutes a complication. A patient’s complaint is often dismissed as an expected “side effect” by the surgeon. Even a patient who achieves ‘20/20 vision and is considered a ‘success’ may face devastating complications. Injured patients routinely report despair and hopelessness triggered by surgeons’ denial that there is anything wrong with their eyes.

Joe Tye, discussing the psychological impact of a bad outcome.

When you go in for an assessment of whether or not you are a good candidate for refractive eye surgery, you will be given a form to sign describing the medical complications that might arise. But they will probably not talk about one of the most serious complications – one that afflicts almost everyone who has a bad outcome – which is the devastating emotional impact that anger and depression have on most refractive surgery disaster victims.

The petition that Joe Tye referred to in the video can be found at this link.

In 2007, reports of LASIK-related suicides began circulating in the mass media.(1) These reports were vigorously disputed by refractive surgeons and refractive industry consultants who openly denied any connection between a bad outcome from refractive surgery and diminished quality of life, depression, and suicide.(2)

In February 2008, preliminary findings of an Emory Eye Center study of suicides among organ donors were reported in the media.(3) These findings suggested a four-fold increased suicide rate among cornea donors who had had LASIK compared to cornea donors who had not had LASIK.

FDA hearing 2008 on quality of life issues after LASIK

In April 2008, the U.S. Food and Drug Administration (FDA) held a public hearing to address concerns with LASIK. At the hearing, injured LASIK patients and family members testified to the devastating psychological impact of post-LASIK dry eyes and night vision disturbances, including depression, suicidal thoughts, and actual suicides.

Gerry Dorrian presents at the FDA Ophthalmic Devices Panel hearing held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression

Amanda Campbell’s presentation is read aloud at the FDA Ophthalmic Devices Panel hearing held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression, and suicide.

Beth Kotsovolos presents at the FDA Ophthalmic Devices Panel hearing held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression, and suicide.

Edward Boshnick, OD (optometrist) presents at the FDA Ophthalmic Devices Panel hearing held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression, and suicide.

CORS Study

“Complications of Refractive Surgery study” or Cors was a study to show the effects of LASIK on the population.”

Dr. Roger Davis, Research Director for Surgical Eyes – the non-profit organisation set up to help refractive surgery victims states

We were writing up the data for publication, with the intent to submit the article to the Journal of Refractive Surgery. The findings of the article were damning. Approximately 80% of patients who are depressed and/or suicidal were told they were a success by their surgeon. The journal declined to published the study, as I knew they would. Had the study been published, the whole industry would have imploded. Yet, if you read the text of the study, note that we did not draw extreme conclusions. Instead, we kept close to our data, and simply asked that further research be conducted.

According to Morris Waxler, PhD, head of the FDA’s clinical trials on Lasik, the industry had deceived the FDA. Higher Order Aberrations and Dry Eye Syndrome were indeed classified as side-effects, not complications. As a result, Lasik was made to appear much safer to the FDA than it really was.

Waxler was horrified that to have been involved in such deception, even indirectly. He filed a petition with the FDA to withdraw the approval of Lasik, and documented the industry’s deception. The FDA is now actively ignoring Dr. Waxler, and has not replied to the petition, despite being legally obligated to do so under federal law. Dr. Waxler now has a website called www.HelpStopLasik.com, where he has much to say about the Lasik industry.

A number of patients have committed suicide since the CORS study was completed. To my knowledge, all reported dry eye and higher order aberrations. The FDA is not obligated to investigate side effects which, by definition, are temporary. But medical ethics requires that the distinction between side-effect and complication be supported by research. With Lasik, there was none. Despite the fact that many subjects reported their dry eye to be much worse after Lasik, subjects were not followed beyond six months.

How, then, could the FDA maintain that dry eye was a side-effect, and that Lasik was safe? The inescapable conclusion—Morris Waxler’s conclusion—is that the FDA ignored its own data. The FDA ignored its own data and people died. Is that a side-effect?

Surgeons Mocking Depressed Refractive Surgery Patients

At the April 2009 meeting of the American Society of Cataract and Refractive Surgery (ASCRS), LASIK surgeons performed comedy skits mocking injured and suicidal LASIK patients.https://web.archive.org/web/20160207124332if_/http://www.youtube.com/embed/b_HojcQsdNk?feature=player_detailpage&rel=0

LASIK surgeon Paraj Majmudar, M.D. playing Dr. I. M. Suicidal, mocking LASIK patients who are depressed or suicidal after a bad outcome from LASIK. Dr. I. M. Suicidal signs of “pushing the boundaries of ethics” to the thunderous applause of prominent LASIK surgeons at a convention of the American Society of Cataract and Refractive Surgery (ASCRS).https://web.archive.org/web/20160207124332if_/http://www.youtube.com/embed/CPbc_yjhRig?feature=player_detailpage&rel=0

LASIK surgeons perform comedy skits mocking patients who are depressed and suicidal after a bad outcome from LASIK. This skit was performed at a convention of the American Society of Cataract and Refractive Surgery (ASCRS). LASIK surgeon, Paraj Majmudar, M.D. plays Dr. I. M. Suicial.

At the 2007 annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS), Richard Lindstrom, M.D., then-President of ASCRS, played the part of the Cowardly Lion in a comedy skit, mocking patients with poor night vision after LASIK.

“The Cowardly Lion, played convincingly by Richard L. Lindstrom, MD, lamented that he could not catch his food because his cheap LASIK gave him bad night vision and halos.”

Self Submitted Reports

LASIK injuries self-reported to the FDA show a pattern of anxiety, depression, loss of enjoyment of life, and suicidal thoughts.

  • “There seems to be no solution. No one seems to understand the impact that this loss of vision has had on my life. My eye doctor talks as if I should be grateful because using the eye chart I can see around -. 05 in both eyes with a slight astigmatism. However, the crazy images I see have led me to be depressed to the point of considering suicide at times. I have not received a good explanation for why my vision is deteriorating.”Read report
  • “Due to my declining visual ability and debilitating depression, I am on [redacted], wherein I receive a monthly stipend of [redacted]. I have attempted suicide more than 5 times since my LASIK.”Read report
  • “Had LASIK eye surgery on [redacted], 2010. Now cannot see to do any of my daily tasks. Near and mid-vision are gone. I only see far away. Was only told I would need readers for the computer. Local doctor can’t believe how farsighted they made me. I am preparing to commit suicide after I get me affairs in order for my children. Only those who have gone through this nightmare understand the guilt and shame. You spend thousands of dollars and have no recourse whatsoever when the outcome is bad. It is a great scam for the LASIK centers. Where on earth could you buy a product and then not have any recourse if it does not work??? Please put a stop to this before others die or ruin their lives!!! Please listen to us!!!”Read report
  • “It has been 21 months since the surgery and my vision is still poor in the both eyes… I tried to get help from Lasik Plus, but all they could say to me was , we are sorry… If it were not for my strong relationship with Jesus Christ and many Christian brothers and sisters praying for me daily, would have most likely taken my life.”Read report
  • “I have not had one happy moment since I started having complications. I am in a severe depression.”Read report
  • “It ruined my vision, and gave me permanent eye pain and dryness… It affects my work, my hobbies, every aspect of my life is pain and difficulty… I never knew depression until lasik.”Read report
  • “My vision has progressed to the point where my left eye is legally blind… This surgery has destroyed my life.”Read report
  • “The immediate effect of my lasik and dry eye was severe depression that endured for three years post-surgery… My mental state required me to make several treatment attempts including medication and therapy. I had no prior history of depression.”Read report

In light of the facts presented here, it seems clear that the LASIK industry is engaged in a medical cover-up, and that the FDA is complicit in LASIK-related suicides.

References

1. Puglionesi, L (2007, July 6). “Haverford man found dead at the old hospital site.” Accessed 5/21/2009 from Delaware County Daily Times online at http://www.delcotimes.com/articles/2007/07/06/past%20stories/19986762.txt; “Suicide Series Part 1: Mid-Life Suicides” (2008, March). Accessed 5/22/2009 from WXOW ABC 19 online at http://www.wxow.com/Global/story.asp?s=8571827 ; “Brentwood Officer Found Dead In Apparent Suicide”. (2008, March 17). Accessed 5/22/2009 from NewsChannel5.com online at http://www.newschannel5.com/Global/story.asp?S=8029702 (LASIK blamed in suicide note presented at April 25, 2008, FDA panel meeting located at http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353oph1-07%20TODD%20KROUNER.pdf slides 6 – 8)

2. Lindstrom, Richard. (2008, March 12) Letter to the News & Observer: http://www.newsobserver.com/opinion/letters/story/996053.html Morse M.D., Jennifer (2008, April 25) FDA Special Hearing on Post-LASIK Quality of Life: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf Schallhorn, Steven C. (2008, February 3) Some link depression, failed LASIK: http://www.newsobserver.com/150/story/920341.html

3. Vollmer, S. (2008, February 3) Some link depression, failed LASIK. Retrieved 5/21/2009 from http://www.newsobserver.com/150/story/920341.html

4. See 4/25/2008 testimony of Beth Kotsovolos, Gerard Dorrian, Dr. Michael Mullery, Dr. Roger Davis, Dr. Edward Boshnick, and Todd Krouner on the FDA website at http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-01.pdf and http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf

Various informative videos

Various informative videos

Morris Waxler

Former FDA’s chief scientist in charge of the clinical trials research for laser eye surgery, popularly known as LASIK speaks out about the dangers of LASIK eye surgery and how he now concludes that LASIK risks and long-term consequences outweigh the benefit of reduced dependency on corrective lenses, even with newer LASIK surgical technologies such as wavefront custom LASIK and bladeless LASIK.

Dr Edward Boshnick Post-Lasik Lenses

Dr. Boshnick specializes in Post Refractive Surgery lenses. These comprise specialist lenses such as Rose-K and Synergies PS as well as custom-made Scleral lenses. The very fact that Dr. Boshnick does this work, should demonstrate to you the dangers of LASIK eye surgery. learn more about the laser recovery process at http://lasikscandal.com/everything-you-need-to-know-about-lasik-recovery-process/

Joe Tye on Lasik

Joe Tye’s brilliant set of videos on LASIK, and the surrounding tissues such as dry eye disease and ethics. You can see more on his website https://www.personaleyes.com.au/

FDA Lasik hearing

The FDA Ophthalmic Devices Panel hearing was held in Gaithersburg, Maryland on April 25th, 2008. The hearing focused on LASIK quality of life, depression, and suicide.