FDA PANEL DISCUSSION POINTS- April 25th, 2008
By Dean Andrew Kantis, #2 Guest Speaker & Founder of
www.LifeAfterLasik.com
Good morning FDA Panel, Honored Guests, and Fellow Victims
of the Flawed & Unpredictable LASIK Eye Surgical Procedure.
My name is Dean Andrew Kantis, founder of
LifeAfterLasik.com. For
the past 9 years, I have spent $30,000 seeking restoration
of my ruined vision only to find out there is NO CURE.
Through my website, hundreds of victims have contacted me
expressing their suicidal thoughts. Some have already
committed suicide. It’s always the same story. I WAS LIED
TO…The name says it all…LA...SICK!
When I began to speak out against LASIK years ago, I
encountered a severe backlash. My own doctor, Nick Caro of
Saint George in Chicago, tried to sue me for $2 million
dollars for exposing his 40+ LAWSUITS. He then caused my
family to get a divorce last year by harassing my wife
attempting to get her fired from her nursing profession. My
family has been harassed, has had death threats, and was
lied to by this doctor, yet no one has punished him for his
actions… Where was the FDA?
How is it that a doctor in this country can have 40+
lawsuits with NO KNOWN DISCIPLINARY ACTION? I feel that my
“second opinion” doctors also lied to me, and I know they
are the problem. How is a patient ever able to find out they
have a problem if all of the “follow up” doctors lie to
protect the original doctor?
After submitting complaints on these same doctors to the
Department of Regulation, backed by solid evidence, I soon
found all were DENIED. They all went up to “Probable
Cause,” and there at the top sits a Medical Doctor in order
to “cover a fellow doctor.” I feel like I have been
RAPED…Where is the FDA?
Because of the Lies, I was unable to sue my doctor before
the Statute of Limitations ran out. I guess that is why
they all kept telling me that it would take 3, 4 maybe 5
years to fully heal. Sound familiar? I had to go online to
find out the truth. I am now out of pocket for all medical
costs, lost wages and for daily suffering.
I don’t know of any other procedure where hundreds of
patients have created websites, warning the public about the
unpredictability and corruption of LASIK surgery. I have
outlined (5) KEY Emergency Points which should be thoroughly
answered by this Panel, to ensure that the LASIK industry
does not continue to DUPE the misinformed public:
Number One: What is the truth about the FLAP and
Pupil Size? I was told that the flap created heals
like a cut on your hand. But the truth is the flap NEVER
heals, is unpredictable, and leaves the patient with a
permanently scarred cornea. My pupils were measured off the
charts at 9mm, yet my doctor told me “I was the perfect
patient candidate for LASIK.” Just remember: Today’s happy
20/20 LASIK patient may regress and be tomorrow’s LASIK
casualty driving a school bus picking up YOUR children. Oh
yes, it effects every single one of you here today…
Number Two:
What is “True Informed Consent”?
I have submitted a complete pamphlet to this panel that
gives the patient “True Informed Consent” with full color
pictures illustrating the known side effects. Please
consider mandating this pamphlet for yours is antiquated.
Then educate the consumer on the Statute of Limitations so
they know the “timeframe to sue their doctor” starts from
the date of the procedure NOT the date of discovery. The
Lying LASIK Doctors all know this…
Number Three:
What constitutes a LASIK “Success?” I
see double vision, halos, starbursts, fluctuating vision,
and dry eye syndrome…Yet, I was told that I was a
“Success.” Can you believe that? In order to believe the
LASIK Industry’s reported satisfaction rate of 95%, you must
accept these complications to be “acceptable normal
outcomes.” That's the question... Do you believe a patient
who has these problems to be a “Success” because the LASIK
industry does! Shouldn’t “Patient Success” be decided by
each individual patient however THEY define “Success?” How
does this Panel define Success?
Number Four:
What is a “Breach of the Standard of Care” for LASIK
Doctors?
The FDA has stated over and over that it is NOT their job to
discipline doctors. Then who’s job is it because nobody
seems to be doing it?
I am out of a life that I once enjoyed because MONEY came
first and my Well Being came last! I ask this Panel to
hold the FDA responsible for reviewing the Ambulatory
Code: 21 CFR 803.17 requiring all LASIK facilities
since 1997 to report ALL adverse patient outcomes. I feel
every LASIK facility in this country is in violation of this
mandatory requirement, which should prompt a Class Action
Lawsuit.
If the CDRH has not even bothered to check the LASIK Centers
in their own neighborhood, why did they all of a sudden set
up “Sight Net” as a new initiative for their own
incompetence? I do hope the media here today will
investigate this.
Lastly, Number Five:
What are the unforeseen Emotional Consequences of LASIK that
Effects Every LASIK Doctor, Their Family Members, and
Patients? I
come today, at my own expense, to inform this Panel that you
have a serious problem on your hands of very desperate,
suicidal and angered patients that know their LASIK doctors
lied to them and blame their doctors for ruining their
precious lives. I ask this panel to set up an Emergency
Hurt LASIK Patient Fund, in order to help patients with
suicidal preventative therapy, ongoing medical expenses,
legal representation, and lost wages. Please take immediate
action to protect the end consumer who is paying you to
protect them. Thank you.
