CLINICAL STUDIES SHOW LASIK WILL NEVER BE SAFE...EVER!

 

LASIK devices received FDA approval despite an approximately 20% incidence of the complications ‘dry eyes’ and ‘night vision disturbances’ at six months after surgery.


Did your LASIK doctor and caring staff at least go over the following KNOWN LONG TERM DAMAGES with you prior to swiping your credit card for $5,000 so that you are aware of the permanent injuries that you are paying them?  After all, you are paying them to make your HEALTHY eye become SICK AND DISEASED:

LASIK reduces the biomechanical integrity of the cornea, which may lead to late onset corneal ectasia requiring corneal transplant.

 

LASIK reduces the biomechanical integrity of the cornea, which may lead to late onset corneal ectasia requiring corneal transplant.
 

Corneal nerves responsible for comfortable wetting of the eye, which are severed and burned during LASIK never fully regenerate normal densities and patterns resulting in dry eye disease that can be permanent and debilitating.
 

The importance of pupil size in LASIK screening and surgical planning has been systemically ignored in LASIK clinical trials, and dismissed by the FDA. Objective tests demonstrate that visual aberrations induced by LASIK increase with increasing pupil size.

The emotional toll that lasik injuries have on the patient and family.
 

LASIK complicates intraocular lens power calculations for future cataract surgery. This may result in poor vision following cataract surgery and increased risk of repeat surgeries.
 

LASIK results in inaccurate intraocular pressure measurement, exposing patients to risk of undiagnosed glaucoma and associated vision loss.
 

LASIK causes a reduction in quality of vision.
 

LASIK can lead to many known and unknown eye related injuries.

Dr. Morris Waxler's 81 Minute Presentation Explaining KNOWN Long Term

Damages & How LASIK Takes A Healthy Eye & Makes It Sick & Diseased For Life:

http://www.odwire.org/forum/content/175-The-Evidence-LASIK-Makes-Healthy-Eyes-Sick?utm_source=Copy+of+New+LASIK+Forum+Back+Online&utm_campaign=Life+After+Lasik&utm_medium=email

 

Proof The "LASIK FLAP NEVER HEALS:"
http://www.lasikcomplications.com/flapdislocation.htm

Proof The Military "SAYS LASIK IS NOT SAFE:"
http://www.ncbi.nlm.nih.gov/pubmed/22480669

Hundreds/Thousands of Post LASIK Patient Videos Explaining Their Sick/Diseased Eyes:
http://eyefreedom.com/patient_videos.php

Because The LASIK FLAP NEVER HEALS...LASIK Leaves The Victim At  Risk For "FLAP DISLOCATION:"
http://www.lasikcomplications.com/flapdislocation.htm#articles

An Estimated 98% of Strength Is LOST After Having "Irreversible LASIK Eye Surgery:"
http://www.ncbi.nlm.nih.gov/pubmed/16209440?dopt=Abstract

Thousands & Tens of Thousands of Post LASIK Eyes Are & Will Develop "Corneal Ectasia" From LASIK...The Sad Truth & Fact Is That Their Own Doctor(s) Are & Will Lie To Them Stating It's Kerataconus (a natural eye bulging development) When In Reality It's Caused From Thinning Out The Patient's Cornea:
http://www.lasikcomplications.com/ectasia.htm
http://en.wikipedia.org/wiki/Corneal_Ectasia

The LASIK Report:
http://thelasikreport.com/TheLasikReport_April2008.pdf

Dr. Morris Waxler's Petition To STOP/END LASIK:
http://lifeafterlasik.com/LASIK%20Morris%20Waxler%20ltr%204152010.pdf

Dr. Morris Waxler's Letter To President of American Society & Council Refractive Surgeons Warning About The Known Long-Term Damages From All Elective LASIK Eye Surgeries:
http://lifeafterlasik.com/LASIK%20Morris%20Waxler%20Letter_to_Doyle_Stulting_5-6-2010revd_docx[1].pdf

Dr. Morris Waxler's Letter Showing How LASIK Is ONLY A TEMPORARY FIX But Has Permanent Known Long Term Damages:
http://lifeafterlasik.com/LASIK%20Morris%20Waxler%20May%202010%20Letter%20To%20Whom%20It%20Concerns.pdf

Kluting Studies: Germany:
http://lifeafterlasik.com/LASIK%20BioShape%202004.pdf
http://lifeafterlasik.com/LASIK%20BioShape%202005.pdf
http://lifeafterlasik.com/LASIK%20BioShape%202006.pdf



-Peer Review Clinical Studies/Proof
Of Permanent LASIK Damages-

 

Yes of course there are risks with any surgery! However, when it comes to "LASIK," the stated success rates are 95.4% when it's more like 75.4%. How or why does the FDA allow this? Read on...Happy LASIK patients may not realize or acknowledge the harm they suffered from LASIK for years; nonetheless, the damage is there.
 

The 1999 LASIK Clinical Study is severely "flawed," as it clearly shows "Permanent Complication" rates well over the agreed <1%:
http://www.fda.gov/ohrms/dockets/AC/99/transcpt/3528t1.rtf .

Medical research demonstrates (a) that the LASIK Flap Never Heals and may be accidentally dislodged for the rest of a patient's lifetime, (b) that the cornea is permanently weakened and may develop Ectasia (thinning and bulging of the Cornea) weeks, months, or years later, leading to vision loss, (c) that the corneal nerves which stimulate tear production are severed and destroyed during LASIK, and that these nerves never fully recover -- potentially leading to permanent "DES" Dry Eye Syndrome disease, (d) that having LASIK causes problems in the future for Glaucoma Screening and Cataract Surgery -- prompting the FDA to recommend that LASIK patients obtain a copy of their LASIK Medical Record, (e) persistent decrease in Corneal Cells (keratocytes) -- it is unknown how this decrease affects long-term viability of the cornea, and (f) that Visual Quality at night is permanently reduced after LASIK, even when the patient has 20/20 or better daytime vision. "LASIK success" is like saying "the surgery was a success but the patient died".


The FDA is NOT supposed to approve anything with a higher than 1% Adverse Event/Permanent Complication Rate or higher than 5% loss of 2 lines Best Corrected Visual Acuity (BCVA) yet LASIK is well over these limits, and the FDA continues to ignore this further failing to protect the public from further deception, fabrication of success rates, and fraud: (see 3.2.1): http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080249.htm. 

 

The FDA's Website: 1997-Present Clinical Studies: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?search_term=LZS . 

Here is this same information gathered from FDA's Website put into "graph format" here showing an average of 20%+ Adverse Event/Permanent Complication Rates, 20+ times higher than the FDA is supposed to allow.
  

FDA Clinical Charts Showing Well Over 20% Permanent Complication Rates- There are peer review Post Laser/LASIK studies that clearly show the FDA has serious problems with ALL "FDA Approved Lasers" for refractive surgery that are averaging a 20%+ Permanent Complication Rate, yet the FDA was supposed to ONLY approve a <1% Permanent Complication Rate: 

 

Bailey Study/Peer Review: Lasers From 1997-2004: http://lifeafterlasik.com/LASIK%20Bailey%20Study%20Through%202004.pdf .              

 

Schein Study/Peer Review: 2000:      
http://www.lifeafterlasik.com/LASIK%20Clinical%20Study%20Schein%202000%20Shows%2020%25%20AE.pdf  .    

Kluting Studies:
http://lifeafterlasik.com/LASIK%20BioShape%202004.pdf or     

http://lifeafterlasik.com/LASIK%20BioShape%202005.pdf or     

http://lifeafterlasik.com/LASIK%20BioShape%202006.pdf .  
 

"INJURED FROM LASIK?  MAKE SURE YOU LET
THE FDA KNOW AND SUBMIT A CASE NUMBER!"

 

1. Had A BAD LASIK Outcome? Fill Out FDA Complaint Form By Clicking Below and write down your case number. Did you know there have been about 1,200 Medwatch Adverse Events filed at the FDA? https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

2. See how the FDA has over 1,200 LASIK Maude/Medwatch Complaints, not the 142 they released to the press:  Enter dates from 01/01/1997 to 05/01/2010 using bottom right Product Code Box: LZS. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

3. Injured as a result of LASIK in one or both eyes? Please email your complete story to 'LifeAfterLasik" detailing how (1) or (BOTH) eyes and how your clarity of vision was made worse because of LASIK.-{Click Here}- To Fill Out Online Form So That We May Contact You. The FDA is soliciting comments from the public on their negative experience with LASIK. Click below to comment: http://www.regulations.gov/search/Regs/home.html#%20submitComment?R=0900006480a56cc2 First, what is LASIK? "LASIK" (laser-assisted in situ keratomileusis) pronounced: "Lay Sick," not "Lay Six," an elective procedure that slices a permanent "Flap" into the patient’s cornea(s) using either a femtosecond laser microkeratome (laser) or a mechanical microkeratome (steel blade). The flap is then peeled back using an excimer laser to reshape the under surface central area of the cornea. The flap is hopefully put back into its original place and the surgery is concluded.

LASIK Study: The purpose of this study is to see if the LASIK patients feel satisfied with the long-term results, and whether or not the patients agree with the “pro profit LASIK industry’s” stated 95.4% Patient Satisfaction Rate, which means that there is a 4.6% Patient Dissatisfaction Rate. What has not been made known to the international public yet, is that we feel the original "clinical study for LASIK" did not meet the strict requirements for "FDA Approval" requiring a "Less than 1% Adverse Event/Complication rate," FDA’s website:  

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080249.htm .

 

The FDA and CDRH were put on notice just last year about this very serious concern, at the April 25th, 2008 Emergency LASIK Ophthalmic Panel Discussion in Wash, DC, where hurt LASIK patients came from all over the USA asking the “FDA for an immediate LASIK MORATORIUM:” http://www.youtube.com/profile?user=FDALasikHearingVideo&view=videos .

Recent news about a LASIK surgeon found guilty on June 13th, 2009, of "artificially aging a note in the his own patient's medical chart"...a clear violation of the Hippocratic Oath, which is supposed to mean “first do no harm to a patient,” causes further concern about the credibility of all LASIK physicians. This should prompt a complete investigation by the Department of Justice. NY County/Supreme Court, Case# 107637/07: http://www.prweb.com/releases/2009/06/prweb2530734.htm .

 

"Anti-LASIK Campaigns," voicing their concerns online, in an attempt to prevent further victims include: www.TheLASIKReport.com, (a scientific study and approach, debunking that LASIK is safe), www.Lasik-Flap.com (an online forum where hurt LASIK patients share ideas), www.LasikComplications.com , www.LasikDecision.com , www.LasikFda.com, http://apps.facebook.com/causes/227958 (LASIK Patient Advocacy Network Facebook), and http://www.eyefreedom.com/lasikadvis.php.



 

 

 These same patients are demanding that the

FDA answer the following concerns:  A, B, and C: 

 

A. Is It True That The Flap Never Heals? It either does or does not fully heal back to normal strength and integrity. Research shows that the "epithelial cells" run to the edge of the flap sealing it like a "Tupperware lid," able to be "re-lifted" 1,2,3,4,5,6,7,8+ year out because the interior surface never fully heals: http://www.journalofrefractivesurgery.com/showAbst.asp?thing=7429 . 

 

Medical Doctors too are complaining, as recent as this year, warning the public that LASIK elective surgery is very dangerous to the long-term health and function of the cornea as stated here by world renowned Dr. Mercola: http://www.youtube.com/watch?v=3Lk_xD_0wPg .

 

FDA's own website, starting on page 315, has more proof that the flap never heals: http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-04.pdf .

“The LASIK Flap loses 98% of its original strength:" http://www.journalofrefractivesurgery.com/showAbst.asp?thing=7429. 

 

B. "Where Are The Long-Term Studies To Prove LASIK Is Safe?" "Is it true that the "Original LASIK Clinical Studies," used "mincing of words" put into the wrong columns on the clinical studies, columns called "Symptoms and Side Effects", so that the "Permanent Injury/Complication/Adverse Event" columns would only be counted in order to pass “FDA Approval?” Putting "permanent patient Complications and Adverse Events" such as "Difficulty Driving At Night," or "Contrast Light Sensitivity," under other columns called "Side Effects/Symptoms," so that the "Patient Satisfaction Rates" would seem higher than it really is should be a Federal Crime and considered to be Fraud, says Kantis. This should be investigated by the DOJ. The “Original LASIK Clinical Studies and Approvals" only go out 3,6,9 months post LASIK: http://www.fda.gov/ohrms/dockets/AC/99/transcpt/3528t1.rtf -OR- http://www.fda.gov/ohrms/dockets/AC/99/transcpt/3528t2.rtf .

 

An estimated 16 million American eyes have elected LASIK (8 million Americans), or "about 736,000 eyes now having permanent “AE/Complications” daily, using the 4.6% dissatisfaction rate mentioned by the LASIK industry but the FDA continues to state that there are only 142 Medwatch cases filed." But what if there is a “20% - 30% AE/Complication Rate," then there are more like 3-5 million American eyes permanently damaged from LASIK, which is now an epidemic, and the FDA continues to allow this to happen…” says Kantis.
 

We feel that "LASIK Enhancements/Retreatment’s (considered "Off Label" procedures at the discretion of the surgeon whom reports to no one) “are also not being reported into the Medwatch database…If counted, the satisfaction rate could be 50%:” http://www.youtube.com/watch?v=P397X2YncGc&feature=related .

 

C. " Is the FDA Investigating The 2,500 LASIK Ambulatory Surgical Facilities (ASF's) in the USA To Make Sure They Are Reporting LASIK AE/Complications?" FDA's Daniel Schultz, stated the FDA's continued negligence in a letter to Michael Patterson, PHD whom petitioned the FDA in 2006/2007 asking to investigate all LASIK ASF's: http://www.lifeafterlasik.com/fax002116100.pdf. Not regulating LASIK ASF’s, is a immediate “violation of the Ambulatory Code: 21 CFR 803.17 requiring all LASIK facilities since 1997 to report ALL adverse patient outcomes:” http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm

  

So we ask, “Is there a standard of medical care when it comes to LASIK elective surgery and has it been made safer in 2009 than in 1997?" Investigational health reporter, Ms. Deborah Shelton, Chicago Tribune, on July 5th, 2009 writes that “LASIK Dr. Nicholas Caro and Saint George Vision, Chicago, IL have amassed 50 LASIK lawsuits, yet has zero disciplinary action taken by the Department of Regulation, AMA, ASCRS, FDA or CDRH:” http://www.chicagotribune.com/features/lifestyle/chi-bad-eye-doctor-bd05-jul05,0,4426814.story?page=1. 

 

LASIK Study Summary: The pressure is now on the FDA/CDRH, led by Dr. Margaret Hamburg, to further answer: (A). Whether LASIK devices should have the “FDA Approval” immediately removed, (B). Whether the FDA/CDRH will immediately investigate new long-term clinical studies headed by an unbiased team, that will investigate all LASIK ASF’s, (C). Whether the FDA/CDRH will immediately initiate a LASIK Moratorium, until long-term safety studies can prove that LASIK is safe. The FDA wants to hear from you regardless of whether you are 1 or 12 years post LASIK: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Until then, we wish you well, we look out for your safety and well being, and we prompt you to further investigate LASIK elective irreversible surgery...

There Is Proof All Around You That Shows
LASIK Causes PERMANENT DRY EYE ISSUES:

 

http://www.youtube.com/watch?v=LUIyE_q7SAo

https://www.google.com/search?q=dry%20eye%20lasik%20drops&hl=en&rls=com.microsoft:en-us:IE-Address&rlz=1I7ADRA_en&biw=1920&bih=934&ie=UTF-8&sa=N&tab=iw&ei=M9hJUemsGYeI9QTVxoHYBg .

(Walk into any drug store, go to the eye drop section and see all of the bottles that say "FOR LASIK DRY EYE" on the outside...Do you really think the manufacturers would put that on the outside if it wasn't for MILLIONS OF POST LASIK DRY EYE SICK/DISEASED EYES).

 

NEED MORE PROOF:

 

Lastly, just go to Amazon's website or Google, and type in:  LASIK COMPLICATIONS BOOKS. You'll see how there are literally hundreds of books/seminars/writings on this subject.  It just goes to show you that it is an epidemic that has always had KNOWN PERMANENT LONG TERM INJURIES.

https://www.google.com/search?tbm=bks&hl=en&q=lasik+complications&btnG=