Ex-FDA Chief, Dr. Morris Waxler, states that "LASIK MAKES HEALTHY EYES SICK AND DISEASED FOR LIFE." LASIK irreversible eye reshaping surgery has been marketed in a deceptive way stating: "There are no known long term damages." Yet, there have always been "known-long-term damages." Dr. Waxler has requested a CRIMINAL INVESTIGATION into those responsible for possibly "COOKING THE LASIK SAFETY STUDIES." This is our cause...
Consumer Reports found that 55% of Americans who had LASIK surgery continue to wear glasses or contact lenses at some time. And many of them say they were misled by advertising for the procedure that led them to expect they would not need other eye correction after surgery."Laser vision correction surgery is a largely unchecked industry, and consumers need to know the right questions to ask to be sure they're protected and that they're getting good quality care for their money," says Consumer Reports Health Rating Center director John Santa. "Vision correction surgery is increasingly popular but there is a concerning lack of unbiased, concrete evidence about its safety and efficacy."
Survey results showed that 53% of patients experienced at least one side effect within the first four weeks after surgery, and 22% experienced them six months after surgery, especially dry eyes and visual symptoms like halos, glare, and starbursts around lights. Lasik eye surgery may be pitched as a "safe and easy alternative to glasses," but more than half of the people who have it or other laser vision-correction surgery still need to wear glasses at least some of the time. That's according to a Consumer Reports National Research Center survey of 793 adults who had laser vision-correction surgery in the past eight years. Side effects such as dry eyes, halos, and blurry vision were common among our respondents, and sometimes lasted at least six months after the surgery. That's particularly distressing, since Lasik eye surgery and similar operations are elective, not essential, medical procedures.
In our survey, 53 percent of the respondents reported at least one side effect after surgery, and 22 percent of the respondents were still experiencing side effects six months later. We found that 12 percent of the patients had to repeat the procedure. But nearly a quarter (24 percent) of not highly satisfied respondents said they regretted not learning more from people who had laser eye surgery before them... Side effects were a key factor in lack of satisfaction. Laser eye surgery is often viewed as safe, but 53 percent of the respondents experienced side effects, and 22 percent were still experiencing them six months later.
Consumers who experienced two or more side effects at four weeks after the surgery and people who continued to experience any side effects at six months were not as satisfied as those with fewer problems, or problems that didn't last as long. "While it's clear from the survey that many people have been very happy with their laser vision surgery, I worry about the patients who were not highly satisfied,"said R. Linsy Farris, M.D., a professor of clinical ophthalmology at Columbia University in New York and a consultant for our survey. All may not be as rosy as the advertising suggests. In our data, the year of surgery made no difference in satisfaction, but it's important to recognize that techniques change.
One thing is for certain, I don't know anyone and no one I have asked knows anyone that has had depression or even suicidal ideation from wearing contacts or glasses! But charge a patient $5,000 to have an elective-cosmetic irreversible reshaping eye surgical procedure that they didn't need in the 1st place, which can regresss and ruin their ability to afford normal things in a normal life, then lie to these same permanently injured patients, then look out LASIK DOCTORS...and STAFF...you're going to have a lot of very disgruntled customers that want to avenge their situation that their doctor/staff put them in!
"First, by FDA and Consumer Laws, every LASIK AMBULATORY FACILITY (ASF) operating legally in the United States of America, is supposed to provide the PIB's to every potential LASIK patient so they have informed consent, which is giving the prospective patient(s) all known risks and known long-term injuries involved with this elective-irreversible eye reshaping surgery. READ EVERY PAGE...IT WARNS OF PERMANENT DAMAGES!"
SHOWING THE PROBLEMS THAT CAN'T BE CURED AFTER UNGOING LASIK...LIKE THESE:
Lasik Enhancement surgery Hundreds of thousands of patients had lasik enhancement surgery in usa, but fda still doesn't know if it's safe or not. Many lasik doctor's call 'touch up' to enhancement surgery because it's easier to sell lasik. Many lasik centers advertise lifetime commitment It's illegal to advertise a procedure that the fda still don't know if it's safe or not. The biggest laser center in north america advertise lifetime commitement for more than 15 years. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061270.htm
"It is also important to note that no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery." Many lasik doctors at the first consultation say "there is a % of needing a touch up". Touch up looks much simple than second surgery. It´s easier to sell lasik this way. Lasik doctors say bad results happen with old lasers, but 'old' lasers are still approved by the FDA. The FDA still consider these safe Those lasik doctors who say "bad results happen with old lasers" did many lasik surgeries with those "old" lasers, not informing patients about the problems "complications" they now admit. It´s always the same thing. In the year 1998 they said the same thing "bad results happen with old lasers", in 2000 the same, in 2002....... and now in 2013. Some naval aviators hide laser eye surgery complications..." http://www.airwarriors.com/community/index.php?threads/starbursting-after-prk.30543/
"Don't tell anyone. Wait awhile." "Starbursts will keep you from getting the waiver, and as I was told, they will forever be in your med history, whether or not you still have them, and can permanently DQ you..." "I'm 2+ years out and still have them. All I can say is you can get used to them to where they don't affect your performance. So just sssssssssssshhhhhhhhhhhhhh." http://www.airwarriors.com/community/index.php?threads/starbursts-after-one-year.23107/
"Be careful what information you give MEPS or any other military doctor. They often will make a big deal out of nothing and put you through several tests and delays. I've seen it happen to several buddies. Ask yourself this - just how bad is your condition? Can you drive safely at night? Do you believe that you could fly safely at night the way you are? If the answer is no, then get checked out immediately, otherwise let sleeping lions lie."
"Remember the saying You should keep your mouth shut and let everyone think you are an idiot rather than opening it and confirming that you are......this sort of applies here."
"Your eye problems are not detectable on any test that the Navy will run you through. Most likely, your problem stems from an issue with your pupil size and/or the blend zone that was created during surgery. Unfortunately, it probably won't improve much. If you want specifics, PM me (don't worry, I'm not a Navy doc)."
"The China Post--Ray Tsai (蔡瑞芳), one of Taiwan's pioneers in laser eye surgery, said yesterday that he will no longer perform the procedure because it violates his medical ethics. In an unlikely twist, Tsai told local press yesterday that he will cease performing the LASIK procedure as it goes against his medical ethics. He has observed situations in which visual acuity worsens suddenly and rapidly long after the LASIK procedure itself. Such vision loss deals a huge blow to patients' careers and daily lives. Tsai cited the case of a 45-year old woman who, ten years after receiving surgery, experienced such drastic vision loss that she is now unable to drive her children to school." http://english.eastday.com/e/120216/u1a6366414.html
"It is against my ethics to not tell them all the possible consequences," he said, likening it to cheating in order to do more business. "After a full consideration, I decided to quit LASIK." Eye doctor Cynthia Mackay says "lasik is a terrible idea, don't go near it" http://www.youtube.com/watch?v=SYss7yOacHk Watch 1.15
"I am an optometrist, and I have seen many many patients who had bad LASIK outcomes. I cannot recommend this procedure to any patient after what I've seen in my exam chair. The rigid contact lenses required to correct corneas butchered by LASIK are complicated to fit, very expensive, and much less comfortable than most people's glasses or soft contact lenses. As a glasses-wearing myope myself, I would NEVER risk ruining my eyes with LASIK." http://www.swellinfo.com/forum/showthread.php?18562-Lasik
ARE THE NAVY'S TOP OPHTHALMOLOGISTS POSSIBLY "COOKING THE LASIK SAFETY STUDIES?" IF CAUGHT, THIS WOULD BE A MEDICAL CRIME CORRECT?
Ties to Navy Ophthalmologist and Department of Defense:(They are handling the "LASIK QUALITY OF LIFE STUDIES" and before the study has even begun, they are boasting a 95.4% patient satisfaction rate that it will AGAIN PROVE LASIK to be safe and effective...WITH NO KNOWN LONG TERM DAMAGES!)
The Department of Defense and Navy are covering all of this up. They control the fabricated studies, and then report back to the FDA that LASIK is safe. They try to back it up using “navy and army guys in the field of battle and in “live or die” “intense situations,” which of course they will do better than having to wear contacts or glasses! But you can’t compare that to daily, un battle like situations behind a desk, on the computer, driving a car, as eye pain post surgery is “UNACCECPTABLE” etc…
Below is a timeline, showing a huge “medical cover-up” with a $45 Million dollar DOD contract on Intralase: “the laser that never had any clinical studies, yet Dr. Steven Schallhorn, who has financial interests in AMO parent company, owns an interest in the company that received a lot of these profits, one month after he resigned from the DOD…” This is corrupt! Now the Navy is urging “happy patients” to go online and issue “happy” comments here: www.regulations.gov
For clarification, very few people ever submit a comments to the LASIK docket on www.regulations.gov . It's not like MedWatch reports on the FDA’s website. When you have 15 submissions on the LASIK docket from one source, that sticks out like a sore thumb. And that source just happens to be the Navy, who is supposed to conduct an investigation of LASIK for the FDA?.... Here is what Sargeant Scott Barnes said at the FDA Panel I spoke at: http://www.youtube.com/watch?v=AVFh0vNX60M
HERE ARE THE PIECES TO THE "THE LASIK BLUEPRINT PUZZLE" that further shows how the Navy's Top Ophthalmologists have tightly controlled the "SAFETY" studies for LASIK:
Steven Schallhorn(NAVY Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies at the Navy and resides on the board of Optical Express...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Jennifer Morse(NAVYPsychologist) addresses the "Emergency LASIK Ophthalmic Panel stating that she was paid by the LASIK INDUSTRY, ASCRS, to present her statements...and also stated that anyone having a bad outcome from LASIK and then became depressed had previous pyschological disorders...and that LASIK couldn't be held responsible for such depression..." at the April 25th, 2008 FDA Hearing:
Richard Lindstrom(ASCRS ex President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Peter McDonnell (Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes on behalf of Doyle Stulting (ASCRS current President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes (ARMY Ophthalmologist) that oversaw special/secret operations and was also involved in the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing: (By the way...it should be known to the public that doesn't hear the other side to this story, that Mr. Barnes is wanting LASIK because he's comparing acts of war, so of course someone getting by with no glasses falling off or contacts falling out, is going to be preferred during war and fighting scenarios, but why isn't he comparing this to those in daily jobs behind a computer, driving a truck at night, etc... Do you see the point? Here's what Mr. Barnes again failed to mention:) ARMY SURGEONS AT FORT BRAGG DROP LASIK IN FAVOR OF PRK, September, 2008 EyeNet Magazine: "At Fort Bragg in North Carolina, Army surgeons have moved toward surface ablation [PRK] procedures for all refractive surgery candidates because of the rare but real potential for traumatic flap dislocations after LASIK."
On March 10, 2008 an online publication of the America Society of Cataract and Refractive Surgery (ASCRS) reported: “In a ground breaking interaction, the U.S. Food and Drug Administration (FDA), approached the American Society of Cataract and Refractive Surgery (ASCRS) in the fall of 2006 for guidance in designing a study to that would identify extremely dissatisfied post-LASIK patients, define their significant symptoms, and the impact of those symptoms on quality of life.” http://www.eyeworld.org/ewweek.php?id=507
On March 17, 2008, the America Academy of Ophthalmology (AAO) issued a press release announcing, “Organized Ophthalmology and Government Agencies Discuss Study Design for Dissatisfied LASIK Patient Clinical Trial”. http://www.aao.org/newsroom/release/20080317.cfm
On April 24, 2008, Bloomberg.com quoted Daniel Schultz, then-director of FDA’s Center for Devices and Radiological Health (CDRH), as saying that the LASIK study involving organized ophthalmology would begin no later than 2009: “The Food and Drug Administration, working with doctors' groups and the National Eye Institute, plans to study how Lasik affects patients' quality of life no later than next year, Daniel Schultz, head of the agency's medical devices center, said today. Identifying why complications occur will help those considering Lasik make more educated choices, he said.” http://www.bloomberg.com/apps/news?pid=20601124&refer=home&sid=aX6SKlifKQvU
On April 25, 2008, the FDA held a public meeting of the Ophthalmic Devices advisory panel to discuss post-marketing experience with LASIK. LASIK patients, family members of LASIK patients, physicians, psychologists, and optometrists spoke about the high incidence of LASIK complications and the emotional toll that a bad outcome from LASIK takes on patients. Several LASIK-related suicides and suicide attempts were reported at the meeting. Organized ophthalmology representatives and active-duty and retired Navy and Army physicians gave testimony asserting that LASIK is safe and effective, and denied any connection between a bad outcome from LASIK and depression. Patients had to come at their "OWN" expense and speak out as shown here: http://www.youtube.com/results?search_query=lasik+hearing&aq=f
At the public hearing, Dr. Jennifer Morse, ASCRS consultant and former Navy Program Director for Psychiatry in San Diego, 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 an AAO annual meeting, Dr. 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 Dr. Morse’s travel expenses to attend the hearing. LASIK surgeon, Dr. Steve Schallhorn who retired from the Navy in early 2007, also spoke at the April, 2008 FDA hearing. Dr. Schallhorn is a paid medical malpractice defense expert witness, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, and is currently medical director of one of the largest corporate providers of LASIK in the world. Said Schallhorn: “While in the Navy, I founded the Department of Defense Refractive Surgery Program and directed the Navy program since its inception in 1993… For disclosures, I currently [sic] as a consultant to AMO, a company that markets an excimer laser… LASIK is safe and effective… Patient satisfaction after LASIK is excellent, higher than that reported for other forms of elective surgery.” http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf
On April 8, 2008, just prior to the FDA hearing, Dr. Schallhorn was quoted in OSN Supersite online saying: "I think it's important that there's an appreciation that what we're talking about here is not the safety and effectiveness of LASIK. That has never been an issue.” http://www.osnsupersite.com/view.aspx?rid=27476
-Proof that Schallhorn and others
may have already "cooked" the outcome-
Dr. Schallhorn was quoted in a December, 2009 article in the Journal of the American Medical Association (JAMA) asserting that the FDA LASIK study will find that LASIK is safe and effective and improves patients’ quality of life.Steven C. Schallhorn, MD, chairman of the Optical Express International Medical Advisory Board, said he is confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective. Schallhorn, who is currently a consultant to 2 LASIK companies, bases his opinion on his prior work as a captain in the Navy… "But in the context of the military and looking at issues of quality of life and the impact LASIK has, it is not only a life-changing event, but a performance-enhancing procedure," Schallhorn said. "The FDA study will come to the same conclusion," he predicted.bbSource: Mitka M. FDA focuses on quality-of-life issues for patients following LASIK surgery. JAMA. 2009 Dec 9;302(22):2420, 2422. Interestingly, in December 2006, approximately one month before Dr. Schallhorn’s retirement from the Navy, IntraLase announced that the Department of Defense had awarded the company a $45 million, 5-year contract to supply its FS femtosecond (LASIK flap maker) lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies.http://www.osnsupersite.com/view.aspx?rid=20499 .
-Dr. Schallhorn has ties to AMO,
the parent company of IntraLase-
A third Navy physician, David J. Tanzer, M.D., Program Director of the Navy Refractive Surgery Program in San Diego, was an invited guest speaker at the April, 2008 FDA hearing. Dr. Tanzer asserted that LASIK is safer than contact lenses.Dr. Tanzer emphasized the success and operational benefits of LASIK in the military, and reported that satisfaction is high. Dr. Tanzer is co-author of a February 2009 peer-reviewed study with Dr. Morse and Dr. Schallhorn which states that patients who are depressed before LASIK are more likely to be dissatisfied with their vision after LASIK. Dr. Tanzer has published several papers with Dr. Schallhorn, all favorable to LASIK. TLC Laser Eye Centers, a large corporate provider of LASIK, lists Dr. Tanzer among its LASIK surgeons on the company’s website. http://www.tlcvision.com/centers/lajolla/doctors.fxml#item3. Also appearing at the April, 2008 FDA hearing was Lt. Col. Scott Barnes, MD, an Army eye surgeon, who made an impassioned plea on behalf of soldiers at Fort Bragg in North Carolina: "Please don't take [LASIK] away from us." http://www.youtube.com/watch?v=AVFh0vNX60M
However, Lt. Col. Scott Barnes, MD coauthored an article in the July, 2008 issue of Current Opinion in Ophthalmology, which apparently contradicts his FDA testimony: "At Fort Bragg, North Carolina, the Army surgeons have moved [from LASIK] to 100% surface ablation in the past 2 years; the five known traumatic flap dislocations (out of 2500 procedures) due to 'typical' soldier activities contributed to this change but not as much as an analysis of the visual outcomes." Obviously, Lt. Col. Scott Barnes was already aware of the potential for traumatic flap dislocation and poorer visual outcomes with LASIK eye surgery when he testified.
In April, 2009, ASCRS held its annual convention in San Francisco. At the convention, LASIK surgeons performed skits making fun of suicidal LASIK patients. One skit poked fun at patients who complain of halos and glare after refractive surgery. Another skit featured Dr. Parag Majmudar as "Dr. I. M. Suicidal" singing of "pushing the boundaries of ethics". The skits were published on YouTube by Dr. Majmudar. In May 2009, Scott Tolchin, a LASIK patient advocate, sent a letter to members of the U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Oversight and Investigations and others members of Congress seeking an immediate moratorium on the use of excimer lasers for LASIK surgery based on an approximate 20 percent incidence of complications, including dry eyes and night vision problems, reported by patients in FDA LASIK clinical trials.
The letter states, in part: The FDA announced that further study of LASIK dissatisfaction was needed and reported that it had formed an unprecedented partnership with LASIK professional groups to conduct a prospective LASIK study to begin in 2009. The proposed study amounts to putting the fox in charge of the hen house. Surgeons selected to lead the study include those with direct ties to LASIK device manufactures - a clear conflict of interest. On October 15, 2009, the FDA announced that it had launched a collaborative study with the National Eye Institute (NEI) and the Department of Defense to examine the potential impact on quality of life from LASIK. “Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center at Naval Medical Center San Diego.” http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm
The FDA did not, however, explain the sudden departure of ‘organized ophthalmology’ from the proposed LASIK study. In November 2009, the FDA reopened a public docket to continue to receive public comments to assist the agency in identifying ways in which it can improve its public outreach efforts regarding the safety and effectiveness of LASIK devices. Recently, many of the positive comments about LASIK have been submitted by military LASIK patients at the direction of Navy LASIK surgeons in an obvious attempt to slant the FDA's LASIK investigation findings.
In light of the financial conflicts of interest and bias exhibited by current and former Department of Defense physicians, and tainting of the public docket, the FDA should remove the Navy from phase 2 of the proposed LASIK study. To date, the FDA has not explained the 3-plus year delay (from the time it approached ASCRS) in investigating LASIK dissatisfaction. Although new safety concerns have been raised, LASIK continues to be performed unabated in direct conflict with FDA’s mission to protect the American public from unsafe medical devices. Considering the elective nature of LASIK and the fact that LASIK carries significant risk to patients’ vital sense of sight, this is unacceptable.
EXHIBIT 1: In December 2006, approximately one month before Dr. Schallhorn’s retirement from the Navy, IntraLase announced that the Department of Defense had awarded the company a $45 million, 5-year contract to supply its FS femtosecond (LASIK flap maker) lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies. http://www.osnsupersite.com/view.aspx?rid=20499
LASIK Case in Point: Dean Andrew Kantis who operates the website www.LifeAfterLasik.com , in order to warn the public that LASIK is dangerous, is very profit-oriented, the Ex Chief of Medical Devices, Dr. Morris Waxler, whom approved LASIK is now AGAINST LASIK, and petitioned the FDA to end the procedure saying it causes a "healthy eye" to become "sick and diseased" and the cornea is permanently scarred and damaged for life! Dean Kantis was sued by his own doctor for $2 million dollars, Nicholas Caro of Saint George Vision in Chicago, because of this page which exposes his doctor's evil / dark side...showing 50+ LASIK LAWSUITS and why his physician should be in jail...stating "MEDICAL CRIMES" and knowingly injuring his own patients: www.LifeAfterLasik.com/nickcarolawsuits.htm .
Because of Dean Kantis' persistent effort to win against evil, even being sued by his own doctor, the Chicago Tribune even persued this doctor because of Dean Kantis' effort(s) in seeing this through to the end. Here is a recent article showing this LASIK DOCTOR and his wife, accused of (5) CRIMINAL INDICTMENTS:
If you review this page, near the bottom, you will see the lawsuit verdict. However, even though Dean Kantis' LASIK doctor tried to shut his website down so no one else could see his lawsuits, Mr. Kantis won and his website still perpetuates and continues to warn everyone to stay clear of this dangerously-irrevesible procedure.
"Proof that LASIK makes healthy eyes sick & diseased" 81 MINUTES OF PROOF...THAT SHOW STEP BY STEP...HOW EVERY LASIK PROCEDURE LEAVES IT'S VICTIMS WITH PERMANENT KNOWN LONG TERM INJURIES...POSSIBLE BULGING CORNEAS FROM HAVING THE LASERS THIN OUT THE CORNEAL WALL...AND PERMANENT DRY EYE PAIN DISEASES (TO NAME BUT JUST A FEW):