The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
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Saturday, 11 July 2009 12:10

 

-Long-Term LASIK Safety Study-
(July 8th, 2009:  IS LASIK SAFE?)  Complications from LASIK? PLEASE FILL OUT FORM.

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.comwww.LasikFda.com, www.lasikpatientadvocacynetwork.com  (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.  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 "Complication and 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...

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