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.
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