Monica's Story
My LASIK Experience - By Dawn
http://www.lasikmemorial.com/Story_Dawn.htm
I’m an optometric technician who has worked in the business for twenty six years. I had the opportunity to have Lasik done for free by the Lasik corporation that my employers co-manage. That way, I could promote the surgery to patients who came to our office. Little did I know that I would end up permanently visually impaired, and that I would spend much time in the future warning patients about the dangers of Lasik.
Actually, I thought that I knew everything about Lasik. I had read all the information that the Lasik corporation had given our office in order to prepare the doctors to co-manage patients for them. I wondered why the statistics for visual complications on the back of the Lasik pamphlets often listed “Not Available” for very nearsighted people like myself but I figured that it probably took a year or more to put together enough data to list. Looking back, since a year and a half has now passed, and the pamphlets still say “Not Available“, I realize that perhaps Lasik corporations don’t want high myopes to know that their risks are much higher than those who are moderately nearsighted.
There were other warning signs that I should have noticed, but I trusted that the surgeon would tell me if I wasn’t a good candidate. After all, I had my optometrist with me, and I was “in the business.” Actually, the surgeon never mentioned whether I was a good or bad candidate. She joked with us, “Couldn’t you find someone LESS nearsighted in your office?”, never mentioning that at -9.00 with -2.50 diopters of astigmatism, I was risking far more than the average patient. If she had said it in a serious voice, I would've taken her remarks at face value, but this doctor was highly respected in the field, and she said nothing to discourage me from going ahead. She did caution me that since my corneas were steep, I could have a buttonhole flap, but if that happened, she would close up the flap, let it heal, and do the surgery a few months later. She made it sound like we were talking about nothing more serious than skinning your knee. However, this was the first time I had heard any mention that I was at risk for a possible complication. After all, as nearsighted as I was, I was still within the guidelines that the Lasik corporation published for it's co-managing optometrists. “Should I go ahead and do it?“ I asked, looking for her advice. “Absolutely,” she assured me with a smile, “you’ll be very happy!“
So with her seal of approval, I went ahead. The surgery went well and she assured me that everything was going perfectly. She cautioned me that it would take me “longer” to heal, having been very nearsighted, so I figured it would take a few weeks as opposed to the few days that the testamonials liked to flaunt. But a few weeks went by and my vision wasn’t clearing up even though my “flaps” looked great and I had no signs of infection or epithelial ingrowth.
In fact, my vision was beginning to scare the life out of me. Everyone looked like they had two sets of eyebrows and two pairs of glasses on their faces. When measuring people for bifocals, as my job required, I couldn’t tell which line was the real one. The lines on the streets hovered six inches above the pavement, and in low light people appeared to have two heads! I couldn't recognize faces or make out their expressions even when a few feet in front of me. Once, while waiting in a doctor's office, I was embarassed when I answered someone's question only to have them reply, "I wasn't talking to you!" Reading, which is my favorite hobby, was next to impossible. Besides all the letters being doubled and tripled upon themselves, the print was washed out like newspaper left out in the sun for a long time. Glasses didn’t help at all. Soft contacts were next to useless. What was going on?
Part of my job requires taking each patient’s visual acuity as part of their pre-testing for their exam. I would take one look at the eye chart tripled upon itself and start to cry. It was extremely difficult for me to work as everything looked tripled on the back-lit instrumentation that I used. I was taking night classes at the time and couldn’t drive on the highway because there were three stop signs instead of one and my night vision was horrible. I started to think that I should sleep in my car in the parking lot and drive home in the morning when daylight would allow me to see enough to drive.
Worse, the depression was crushing. I blamed myself over and over for having risked my excellent, corrected vision, and cried all the time. Every moment of the day I was reminded of my predicament by the absurd visual distortions. The only relief was sleep and even that was next to impossible, as I beat myself up for being so "stupid". The trust that I had that a doctor has the patient's best interest in mind was irrevocably broken. I was nothing more than a statistic, the unlucky 1 - 3% with complications. The information that I read said that the worst that could happen would be the loss of a couple of lines from the "bottom of the chart." Nowhere did it mention that the quality of the rest of the chart, including the “Big E” at the top, could be so distorted that it was nearly illegible. I had reasonable expectations and understood that I might need a pair of glasses or contacts after surgery, but no one warned me that there was a possibility that glasses and contacts would be useless to improve my vision! Moreover, I understood the risk of an interoperative complication or an infection afterwards, but none of that happened to me. What happened to me is that the present day lasers are not accurate enough and the technology to fix the lasers' shortcomings does not presently exist.
I started to see a psychologist who helped me to work through my grief and the anger that I felt from being betrayed by the very medical society which is supposed to save patients' vision. Over time, I began to understand why depression was crippling me as I read about others, with worse outcomes than mine, who sadly, had comitted suicide.
When I questioned the surgeon about my vision, she was somber and very vague. She thought my problems might be due to striae (tiny wrinkles), but then again, maybe not. She did a flap lift on one eye to see if that would improve my vision, and it seemed to help a little. She had warned me not to read the “horror stories” on the internet so that I wouldn’t get nervous, and assured me that it would get better over time. By her manner, I judged that she seemed to be witholding information from me.
The turning point in my life came when I disregarded her advise and finally typed “Lasik complications” into an internet search engine. What I found was www.SurgicalEyes.org, a website that is like the “Consumer Report” for Lasik surgery. I was astonished to find that not only did hundreds, if not thousands, of patients have the same complications that I did, but that there were names for these abberations! “Ghosting” for the irregular astigmatism (the two sets of eyebrows I was seeing); loss of contrast (the bleached out newspaper print) ; and central islands. Apparently, the very popular large-beamed lasers can leave raised areas on the cornea (central islands) that weren't properly treated because the large plume of smoke and debris can block the beam. These central islands prevented the cornea from healing in a smooth optical surface, causing irregular astigmastism.
At Surgical Eyes, I also found doctors that dared to answer frightened patients' questions. I found links to professional journals that discussed these very same complications, and I found friends to support me in my quest for the truth, as the surgeon wasn't offering any helpful information.
And the truth did set me free. I no longer felt like a puppet on a string when I went back to the lasik center. I asked outright about the central islands and irregular astigmatism. At first the staff would not confirm my suspicions, even while looking over my topographies. But when I mentioned a new office owned by the corporation that was going to try a new laser treatment to fix irregular astigmatism, the director smiled and suggested that I might be a candidate. I finally had my answers, no thanks to the surgeon who, by the expression on her face, knew that she could not fix what she had broken. But no one would be experimenting on my corneas again, anyway. I had asked for a copy of the operative report and was astonished to find out that my pre-op corneas were thin, very close to 500 microns. Considering the amount of tissue that had to be removed, and the thickness of the flap, which is an educated guess, I probably have close to, or less than, the bare minimum (250 microns) of untouched tissue thought to preserve the integrity of the cornea. Considering that some patients with 250 or more microns untouched have experienced breakdown of the cornea leading to the need for a transplant, some doctors are now calling for at least 300 microns left alone. Why aren't patients' corneal thickness measurements being discussed with them? I think we deserve to know how close to that "bare minimum" lasik will take us so that we can make better informed decisions.
As I learned more about the disasterous outcomes of thousands of patients, I became angry. If I, who read everything that our office had on lasik, had been so ill-informed about the true risks that I was taking, how could anyone be truely informed without spending hours and hours researching information that is not readily available from their surgeons? Why was I learning more about lasik complications from the internet than was present in optometric or opthalmic journals? Why are optometrists being courted by lasik corporations to promote the surgery to their patients, but not given adequate information with which to properly screen their patients and advise them?
As many patients have found out (but never saw mentioned in their consent form), there is only one thing that can possibly restore some of their lost vision after refractive surgery: hard contact lenses. I had read about special reverse geometry gas-permeable lenses on Surgical Eyes and was hopeful that I could be rehabilitated with them. I printed out every article that I could find for my optometrist, and together with the contact lens consultant, he was able to achieve a pretty good fit. While they are not perfect, and my eyes are so red that I look like I have a hang-over most of the time, they have improved my vision to almost normal and I have been able to get on with my life. Hopefully, I will not have any problems in the future because my corneas are so thin now.
Unfortunately, there are a lot of reasons why many post-refractives can not wear these lenses. The number one reason is that we are very difficult to fit as our corneas have been altered and are no longer normally shaped. Also, there are very few doctors who have any experience fitting post-refractive patients or even know that these lenses exist. I am one of the lucky ones who have been to Lasik-hell and back again and don't want anyone to have to go through what I did. If this hadn't happened to me, I'd be out there right now telling everyone how wonderful lasik is because I wouldn't know any better. And that's the way that many in the the lasik industry want to keep it.Anonymous Patient Letter #3
Reprinted with permission:
I went to Ellis Eye in San Francisco as they were the most advertised, though not the cheapest. They said I was a "perfect canidate." On my moms request I got a second opinion from Dr. Scott Hyver, a much fancier place. After WAY more tests (free of charge) and computer print outs, Dr. Hyver met with me personally (at Dr. Ellis's I only saw his assistants) Dr. Hyver said I was absolutely not a candidate, and that if I had had it done, after a year my eye sight would deteriate, permanently. Dr. Hyver said one of my eyes was eligable for PRK, a little different than Lasix. The total price over a fifteen hundred dollars cheaper. I hope this gets printed so people stay away from Elis Eyes in the San Francisco area.
LASIK: Another Insiders Experience
Name Witheld By Request
Dear Dom,
I'm sorry to hear about your experience. I am a laser tech. I have been for a number of years, and have assisted in over 30,000 procedures with over 20 different surgeons. I have seen it all...
From A Prior LASIK Website Owner
Anonymous Patient Letter, Name Withheld by Request.
Many of the individuals below are frankly damaged. Others exhibit what is known as cognitive dissonance, meaning that they minimize the significance of their complications to themselves and others, or even deny that they've had complications at all. Inevitably, patients who are severely injured end up wishing that those they'd talked about LASIK with before their surgeries would have revealed the true extent of their injuries.
Lasik Complications aren't rare. They are EVERYWHERE!
Here is a list of the people I have encountered with LASIK complications since my surgery a number of months ago:
1. A young man (mid 20'S) sitting in my surgeon's waiting room with me also had large pupils and has severe night vision starbursts and halos from LASIK. For him, the TV screen has huge smeary ghosts extending beyond the set itself. The night vision complications are a problem since he must travel a great deal at night for his job.
2. In the office of one of my 2nd opinion docs I met a young woman who had LASIK resulting in blurry vision in one eye and double vision in the other. A young mother and a real shame.
3. A technician in the office above, sporting a button that said "Ask me about my LASIK" was blinking uncomfortably from dry eye because she had taken a cold tablet. She admitted that she was eyedrop dependent. And only in her twenties... what will happen to her as her eyes dry naturally with age?
4. I went to an optometrist for glasses. He is only in his 30s but has dry eye from LASIK and must wear lower plugs. Since when do young males have dry eye? Can you say "LASIK CORNEAL NERVE DAMAGE"?
5. My dental hygienist is uncomfortable driving at night after her LASIK.
6. I went to a hair salon for a cut. The proprietor has a sagging eyelid from LASIK and dry eye for which she has been cauterized - and she takes the expensive Restasis eye drop regimen. She reports loss of contrast sensitivity and night vision problems. She had double vision for a while, luckily that went away.
7. Same salon, an employee had LASIK and has dry eye.
8. A sales rep I deal with often is married to a man who had a horrific post-LASIK visual and dry eye experience. They took me out to lunch to tell me about it. He still has blurry vision in one eye and has plugs. He is in his mid 30's. He said the psychological strain of the problem nearly pushed him over the edge.
9. A man in the building across the street from where I work had a bad LASIK with blurry vision at all distances. He claimed that he was misled by the practice. "What they tell you before [surgery] and what they tell you after are two different things" he said. I can second that, because my surgery was at the same practice, same surgeon.
SMEARED VISION AND CHRONIC DRY EYE PAIN FROM CUSTOM LASIK DEVASTATES 21-YEAR-OLD
Reprinted with permission:
Anonymous Patient Letter, Name Withheld by Request.
Whether conventional or custom wavefront LASIK, there are still severe complications that change life forever. The letter below illustrates most of the features that patients with complications report, including being told that everything is normal, and the futile and costly search for solutions.
Read more: SMEARED VISION AND CHRONIC DRY EYE PAIN FROM CUSTOM LASIK DEVASTATES 21-YEAR-OLD
Anonymous Patient Letter #2
Reprinted with permission:
Anonymous Patient Letter, Name Withheld by Request.
This letter illustrates several issues that concern LASIK victims who are conscientious about the public health. First, there's the issue of cognitive dissonance, that is, the fact that some individuals, though obviously injured, continue to minimize their problems in spite of the objective evidence. Second, many of these individuals, and even many of those who acknowledge damage, do not want to confront the LASIK industry. Some fear that they will no longer receive help for their eyes should they do so. Others are so emotionally distressed by their injuries that they need to "keep it calm." To many individuals who believe that truth is the only way forward, these individuals have become "enmeshed" with an industry that seeks to conceal the true risks of LASIK.
If you are considering LASIK, you should know that the writer's allegations of "patient doing well," are heard over and over and over again. Take time to get to know injured patients, it's your best informed consent.
Anonymous Patient Letter #1
Reprinted with permission:
If you would have difficulty handling lifelong, permanent, irreparable and debilitating damage to your vision and/or eye pain, then do NOT under any circumstances have any elective surgery (refractive or otherwise) on your eyes. Even an extensive review of this website will show only a fraction of the numerous complications and side effects that COMMONLY occur (that's right- saying they are "rare" as LASIK is commonly practiced on the public is a bold faced LIE). If you think there is justice in the United States of America or if you would be willing to accept the minimal standard of care for LASIK is something you would accept, then you shouldn't have LASIK. The standard of care commonly practiced on American Citizens is horrific and frequently results in nightmarishly bad vision. The Doctors cover it up and in many cases directly lie to patients, the FDA, and the public.
Anonymous Letters From an MD:
"If there is a Hell, there is a special place in it for Refractive surgeons"
The individual writing below is a Physician who was damaged by Wavefront LASIK. Here is his honest, candid appraisal of the LASIK industry, presented in two letters. Reprinted with permission.
Still Considering LASIK?
Read on...
http://www.lifeafterlasik.com/
http://www.tlcbigskylasercenter.com/
http://www.lasermyeye.org/forums/showthread.php?p=5570#post5570
http://www.doctormyeye.com/bulletinboard/viewtopic.php?t=103
http://doctormyeye.com/bulletinboard/home.php
http://www.lasikreality.com/links.htm
http://drjoeross.com/refractivesurgery.htm
http://www.eyefordesign.com/lasik.html
http://www.escrs.org/eurotimes/March2003/primesite.asp
http://www.visionsimulations.com/
http://www.geocities.com/pifanon/oath.html
http://www.geocities.com/pifanon/fda.html
http://www.geocities.com/pifanon/dismay.html
http://dryeyezone.com/main.html
http://fda.gov/cdrh/pdf/P930016s016c.pdf
http://www.lasikfraud.com/news/archives/000011.html
http://www.lasikfraud.com/articles/a_promise_not_kept.pdf
http://www.webmd.com/content/article/18/1685_52814
http://www.webmd.com/content/Article/62/71498.htm?pagenumber=2
http://www.webmd.com/content/article/61/68084.htm
http://www.webmd.com/content/article/25/1728_57876.htm
http://www.keepmedia.com/pubs/BusinessWeek/2002/05/20/21130?oliId=255
http://www.eyeworld.org/article.php?sid=2707
http://www.tlcbigskylasercenter.com/SubStevenPost.htm
http://www.lasermyeye.org/keratoscoop/columns/rebecca/rebecca26oct2004.html
http://www.consultwebs.com/lasik_eye_surgery_risks.html
http://www.revoptom.com/index.asp?ArticleType=SiteSpec&page=osc/3201/lesson.htm
http://www.fda.gov/cdrh/LASIK/default.htm
http://home.comcast.net/~joewills/LASIKSTORYKEITH.html
http://www.kathygriffin.net/lasik.php
http://www.nydailynews.com/news/local/story/333039p-284621c.html
http://www.foxchicago.com/_ezpost/data/16747.shtml
http://www.foxchicago.com/_ezpost/data/26861.shtml
http://www.dellorusso.info/index.htm
http://www.nj.com/healthfit/ledger/index.ssf?/news/ledger/stories/021102lasik.html
http://www.geocities.com/terrellevans2003/links.htm
http://consumers.lasikfraud.com/
http://www.icare4u.com/surgery.htm#Surgery
Global Keratoconus support group at: http://www.kcglobal.org
http://directory.google.com/Top/Health/Medicine/Medical_Specialties/Ophthalmology/Refractive_Correction/LASIK/Personal_Pages/Kevin's Story
Kathy Griffin's Story
Here’s the deal. I’ve had severe complications from lasik surgery. My doctor WAS Dr. Robert Maloney of the Maloney Vision Institute in Los Angeles and “Extreme Makeover”. I will not be going to him again. You can read Kathy's story.
John Hoge's Story
My name is John Hoge and this is the chronicle of my personal experience under the care of Dr. Eric Donnenfeld of The Laser center of Garden City, New York. You can read more of John's story:
Keith Wills Story
LASIK Gone Wrong
What happened to Keith Wills
When EYES, Windows To The Soul, are broken
By Jo Wills
My husband, Keith R. Wills went to Dr. Herbert Nevyas of Bala Cynwyd, PA, for an evaluation to determine if he was a candidate for LASIK surgery on July 26, 1997. Dr. Robert Levy of Burlington, NJ, recommended Dr. Nevyas, a doctor that was performing LASIK in the area, evaluate Keith for LASIK surgery.
LASIK surgery was scheduled to be performed on my husband’s first eye on August 28, 1997, and the second was scheduled for September 11, 1997. Dr. Nevyas and Dr. Sterling were both present when Keith and I discussed his need to see in detail since he was an amateur astronomer and worked with small parts and wires in computers. Keith discussed his new purchase of a telescope and how his job duties required clear vision. He was told that his vision would be “crystal clear”. Dr. Nevyas even patted my husband on the back and speaking to me said we’ll “take care of this big guy”. Dr. Nevyas followed up with a letter dated July 26, 1997 to Dr. Robert Levy; stating that Keith was an “excellent candidate for LASIK surgery.”
Dr. Nevyas did not inform us that he was using laser that did not have FDA approval. None of the information that he provided prior to the day of the surgery indicated that my husband was going to be a “guinea pig” for the Doctor’s own financial advancement. Apparently he wanted his invention approved by the FDA and then he could market the device as he had done with his other inventions.
One day we got a call and a representative from the doctors office told us that the surgery was going to be delayed because the FDA “had to approve” Keith’s surgery since he had a high degree of myopia. The first surgery was initially scheduled for August 8, 1997 and was pushed back to October 7, 1997. When he was informed that the delay continued, Keith became extremely concerned and had a “gut” feeling that the delays were an indication that he shouldn’t have the surgery. He was concerned about the possible problems that could result from this surgery so he told them he was canceling the surgery. Dr. Nevyas was so concerned over Keith canceling his surgery that he called and went over Keith’s concerns at length. He told my husband that since he was an “excellent candidate” and he had virtually no chance of having any of the problems that he was concerned over. The doctor was aggressive in his attempt to “save” his business and assured my husband that he was not going to have complications so that he would agree to continue with the scheduled surgery. Before the doctor would perform any surgery, we had to submit $5,000.
On the day of surgery, my husband was picked up at our home by a van that was provided by one of Doctor Nevyas’ holdings, The Delaware Valley Laser Institute. The doctor now had a captive audience.
Dr. Nevyas had told Keith that he was not to be concerned about the adverse conditions listed in the “Informed Consent” document that the doctor had Keith sign. [How can a patient have informed consent when a doctor makes verbal representations that differ from the document that he requires his patient to sign before he will perform surgery?]
On October 7, 1997, my husband was seated in the operatory chair and the laser was set in front of him. He was told to look at the red light in the laser, but he told Dr. Nevyas that he could not see the red light. There was some whispering but Keith could not determine what was being said and then the Dr. Nevyas asked him if he could see the red light again and Keith responded “no”. Then Dr. Nevyas told Keith to look straight ahead and not move his eyes. He told the doctor that he couldn’t see so he wasn’t sure if he was looking straight ahead. Dr. Nevyas proceeded with the surgery anyway. AN ADVERSE EVENT!
The same happened during the surgery on his other eye on October 9, 1997. He again could not see the red light but Dr. Nevyas performed the LASIK any way. ANOTHER ADVERSE EVENT!
When the LASIK surgery did not turn out as was expected and Keith was not able to see clearly, Dr. Nevyas performed additional procedures to correct the problems that were created by the LASIK surgery. Each succeeding surgery was called an “enhancement” where the doctor told Keith he would “fine tune” his sight. Enhancements created new problems. When my husband would ask at each visit why he was not seeing any better, Dr. Nevyas would tell Keith to “be patient, it takes time”. The doctor would see Keith at specific intervals, having him wait until each procedure healed.
When another doctor told Keith that his eyes would not get better, and that there was virtually no cornea left to correct, Keith sought the advice of an attorney. A lawsuit was filed in Philadelphia, PA. We were told that the doctor’s malpractice insurance company was bankrupt and that the State’s insurance fund would cover the liability up to a certain limit. If we did get a settlement, no matter how high, it was limited by the State fund’s maximum coverage.
We got our day in court in December 2003, the trial started off with Dr. Levy, Keith’s treating eye doctor testifying against Dr. Nevyas. Dr. Kenyon, an expert witness, from Boston, MA, followed explaining that Keith was injured by the LASIK surgery. Both Keith and I testified. Dr. Nevyas’ expert witness testified at night and the video taped testimony was presented to the jurors the next day. The main point that I got from his testimony was that even Dr. Nevyas’ own defense expert did not agree with Dr. Nevyas and that this expert was confused on pertinent matters.
Then it was Dr. Nevyas turn to defend himself, and he testified that he didn’t have to report my husband's failed surgery as an adverse event. His reasoning was that he had to perform additional surgery on Keith to correct his eyes so he took Keith off the “investigational device study” and did not report his adverse events. He didn’t report Keith’s surgery to the FDA at all.
The purpose of the FDA “investigational device study” is to see if the FDA should approve the equipment for use. He should have noted on the report that Keith, a patient entered into the study had an adverse event and required further surgery which would preclude him from being reported in follow up reports for the study. Keith should not have been dropped off the report, which hid the fact that there was a problem with the laser. The FDA does require that all “adverse events” be reported, not excluded/covered up as had happened in this matter. [I wonder how many other adverse events weren’t reported because Dr. Nevyas had his “own” interpretation of the study requirements.]
I made numerous contacts with the FDA regarding this matter, but have been unable to get anything from them. The FDA has stated that it has previously investigated the Nevyas Laser and will not investigate unless new information is presented. I informed the FDA that we have new information that they did not have previously, the failure of the doctor to include “Adverse Events” on my husband and why. I am disturbed that an agency that is supposed to protect the public from injury by medical equipment, will not address our concerns.
Keith was not able to see the red light in the laser. He was not a candidate for the surgery. He did not give his informed consent.
The FDA requires many documents to be signed before a doctor can enter into an “investigational study” and use equipment that has not been FDA approved. The documents I have seen do not have the required signatures, but the Doctor continued to use his invention, refusing to sign a document that was to be part of an agreement. The FDA should have reviewed Dr.’s files, reports and agreements to determine if he was following the rules, regulations and laws set forth to protect the public.
Since my husband’s surgeries were never reported as adverse events, Dr. Nevyas failed to report as required by law and his agreement, which included parts that he refused to sign. He covered up the problems of his laser by reporting to the FDA that there were NO ADVERSE events on all his reports to them.
Documents that Dr. Nevyas filed the following year indicated that he made a change from the red light in his laser to a green light; he didn’t just make this modification without a reason. The red light was difficult for some patients to see so he made a modification to his laser, my husband was one of those people and now his eyes are permanently damaged.
Is there a pattern here? Dr. Nevyas lied to my husband about “informed consent issues” to convince him to have the surgery. When the Doctor submitted reports to the FDA that omitted required information, he covered up a severe disabling event. It doesn’t even stop here, in Civil Court, Dr. Nevyas lied under oath about the fact that he was not required to report my husband as an adverse event to the FDA. Lies, Lies, Lies.
Just one month before our trial, a Louisiana doctor was found guilty of violations of the same federal laws. The FDA publication, P03-92, dated November 5, 2003 states that a Louisiana Doctor was violating federal laws related to the conduct of clinical studies. FDA Commissioner Mark B. McClellan, M.D., Ph.D. made this statement: “This penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community.” For example, studies of high risk devices such as ophthalmic lasers must be conducted according to an investigational plan reviewed and approved by FDA and an investigator must obtain informed consent from each participant. In addition, the device cannot be used on patients before the study begins. The Louisiana Doctor’s violations are listed below and almost mirror what happened to my husband when he went to Dr. Nevyas.
· Used an unapproved laser on patients before the study began;
· Treated more subjects than allowed under the study plan that was approved by FDA;
· Ignored parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients;
· Failed to submit complete, accurate, and timely reports to FDA about the ongoing study; and
· Misrepresented that he was using an FDA-approved laser to treat patients when, in fact, the procedures were performed with an unapproved, experimental laser.
The Nevyas Excimer Laser’s ablation [removal of tissue from the body by surgical or other means] zone was 5 mm, and my husband pupils were 6.25 mm, which is considered relatively large. Using a laser on a patient with pupils larger than the laser’s ablation zone was known to cause the same problems that my husband suffers from. Clearly Dr. Nevyas should have informed my husband that this almost guaranteed that he would have an adverse result. Due to the fact that Keith had large pupils, Dr. Nevyas should never have considered Keith a candidate for LASIK let alone report that he was an “EXCELLENT CANDIDATE” as in the letter to Dr. Levy.
Dr. Nevyas did not perform the Pachemetry test, it has been indicated by experts that this test would have shown that my husband was not a candidate. My husband’s cornea is now too thin to perform further corrections to his eyes.
On 7/21//97, we visited a website “QuackWatch”, where Dr. Herbert J. Nevyas, MD, authored a page on Refractive Surgery. It stated: “Laser-in-situ keratomileusis (LASIK): The first corneal flap is made as in
ALK, and an extremely precise underlying cut is made with an Excimer Laser. LASIK techniques can be used to correct astigmatism and farsightedness as well as myopia. The results are nearly always predictable, there is no postoperative discomfort, and glare is uncommon. The operation is preferred by eye surgeons throughout the world who have sufficient experience and have access to the necessary equipment. Several eye-surgery centers in the United States have FDA approval to perform LASIK, and some individual ophthalmologists have acquired unapproved but high-quality devices through foreign channels.”
“About the Author:
Dr. Nevyas, who specializes in refractive surgery, is Clinical Professor of Ophthalmology at the Medical College of Pennsylvania. His main office and ambulatory surgical center is located in the Philadelphia area at Two Bala Plaza, Bala Cynwyd, PA 19004. Telephone: (610) 668-2777.”
Only recently when I searched the “QuackWatch” website I discovered it is operated by Dr. Stephen Barrett who married Judith Nevyas and they live in a suburb outside of Philadelphia. When the above article was published on the website, it appeared to be an official site endorsing Dr. Nevyas by allowing him to publish with them since they had investigated Dr. Nevyas as an authority on the matter. It appears that I was misled and this was only a “health promotional” site for a family member.
On 2/13/2003 that same website included a revision dated 4/24/1999, which included an expanded list of complications. [This may have been a result of lawsuits filed against Dr. Nevyas and his associates.]
I would like to know why we were not protected against this doctor and why the FDA failed us in this matter. We tried to obtain copies of the official documents to use in our medical malpractice lawsuit, but the FDA, stated they were confidential and they would not be released.
Those documents could have been presented to the jury showing that this was not an approved laser, and that the doctor had even misled the government by providing inaccurate reports, documents and representations.
After the civil court trial was over, jury members stated that if they had known this information it would have changed their decision. The documents were requested from the doctor but he refused to present them in court. They were requested as part of the pre-trial discovery, but not submitted by either the doctor or the FDA. Just prior to the doctor’s testimony, my attorney informed his attorney to bring the documents to court but they were never provided.
I have contacted numerous local agencies; the Attorney General’s of NJ and PA, the Court System, even the local authorities. Each has told me that the FDA is the agency responsible in this matter. The FDA claims no responsibility; they oversee equipment, not the doctor’s use or practice.
We are a family of 4, two teenage girls who have not been able to spend time with their daddy doing things they enjoy. I have a husband that is no longer the man I married, he cannot enjoy his hobbies and interests and it interferes with the way my husband performs his job duties. I am concerned that we have had to radically change our way of life, not because of an accident, or the aging process, but because someone willfully misled my husband changing the way we all live.
After seeing what happened to Martha Stewart for lying to investigators, I cannot understand why this doctor gets away with his actions, ones that caused actual physical pain and permanent disability to other human beings.
Any assistance in helping us understand why the “system” failed us along with any recommendations as to a direction we may take would be appreciated.
You can visit the Wills' webpage Here
Mr. & Mrs. Wills were also threatend with a lawsuit by the Nevyases attorneys (Click READ MORE to read threat).
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