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(Fort Lauderdale, FL: LASIK Safety
Study, July,8th, 2009)
IS LASIK SAFE?
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. 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, 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
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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