A number of concerns had been raised about patient satisfaction with the vision correction procedure, known as laser-assisted in situ keratomileusis, or LASIK. At a public meeting held today in Maryland, the FDA eye-related panel examined the relationship between LASIK complications and quality of life issues, hearing testimony from Lasik eye surgeons and patients of the surgery who have suffered from a variety of issues, including blurred vision and dry eyes.The committee also heard from a father whose son committed suicide after suffering from psychological problems (the result of post-op chronic eye pain and blurred vision).
Companies that could be affected by the meeting include Lasik device makers such as Advanced Medical Optics Inc (EYE-$20.33) and Lasik providers such as TLC Vision Corp (TLCV-$1.20), and LCA-Vision Inc (LCAV-$12.47).
LASIK procedures are considered relatively safe, with the number of complaints to the FDA about the outcome of LASIK surgery reported to the FDA since 1998 through 2006 at about 140—out of an estimated 7 - 8 million laser corrective procedures.
Regulators have no direct control over physicians who handle the patients.
Nonetheless, regulators will debate whether educational materials—listing the most common side effects of LASIK surgery—provided to patients considering the procedure require changing. At present, most brochures do not warn that about 25% of patients considering the procedure are not good candidates (such as those with large pupils and severe astigmatism).
Few Growth Catalysts for LASIK Providers
In our view, operators of these laser vision centers—given the lack of multiple growth drivers—need be concerned about adverse publicity affecting traffic and (incremental costs of defending against) class action lawsuits clouding forward earnings visibility, for both outcomes will pressure company margins, which are already hurting from competitive pricing issues and a slowing economy (given that these procedures are elective).
Editor David J. Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.
Companies that could be affected by the meeting include Lasik device makers such as Advanced Medical Optics Inc (EYE-$20.33) and Lasik providers such as TLC Vision Corp (TLCV-$1.20), and LCA-Vision Inc (LCAV-$12.47).
LASIK procedures are considered relatively safe, with the number of complaints to the FDA about the outcome of LASIK surgery reported to the FDA since 1998 through 2006 at about 140—out of an estimated 7 - 8 million laser corrective procedures.
Regulators have no direct control over physicians who handle the patients.
Nonetheless, regulators will debate whether educational materials—listing the most common side effects of LASIK surgery—provided to patients considering the procedure require changing. At present, most brochures do not warn that about 25% of patients considering the procedure are not good candidates (such as those with large pupils and severe astigmatism).
Few Growth Catalysts for LASIK Providers
In our view, operators of these laser vision centers—given the lack of multiple growth drivers—need be concerned about adverse publicity affecting traffic and (incremental costs of defending against) class action lawsuits clouding forward earnings visibility, for both outcomes will pressure company margins, which are already hurting from competitive pricing issues and a slowing economy (given that these procedures are elective).
Editor David J. Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.
EMERGENCY FDA PANEL DISCUSSION POINTS
ReplyDeleteApril 25th, 2008
By Dean Andrew Kantis, #2 Guest Speaker
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.
Sincerely,
Dean Andrew Kantis
Founder
www.LifeAfterLasik.com