Lasik Complications Discussed At FDA Hearing
By MedHeadlines • Apr 27th, 2008 • Category: FDA, Headlines, MedTech, PreventionAlthough the majority of patients who undergo Lasik surgery to improve their vision report satisfactory results, there are some who experience complications that significantly impact their quality of life, according to testimony heard this week at a hearing hosted by the Food and Drug Administration. Patients and family members testified about problems such as double vision, blurred vision, decreased night vision and other problems.
About 700,000 Americans a year undergo the Lasik procedure, which costs about $2,500 per eye. The operation involves cutting a flap on the surface of the cornea and zapping the underlying corneal tissue to reshape it to correct nearsightedness, farsightedness and astigmatism.
After receiving complaints about the procedure the FDA began trying to get an accurate assessment of the scope of the problems and concluded that there is currently no “reliable method” for accessing patients’ quality of life after the procedure. “Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing well,” said Daniel G. Schultz, director for the FDA’s Center for Devices and Radiological Health. “But clearly there is a group that is not satisfied and do not get the kind of results they expect. What we’re really trying to do is figure out what that number is.”
The FDA plans to collect detailed information about the complications from a national network of 350 medical facilities already organized to alert the agency about problems with medical treatments.
The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means roughly 50,000 (5%) were damaged. Majority rules though, so 50,000 doesn’t mean anything to the FDA. What about 5 million? That would make 250,000 people with complications!
The FDA has been aware of complications for many years as myself and others damaged reported our complications to them (as of this date, my medwatch complaint still is not retreivable on the FDA’s website). The ‘contact form’ and ‘email the FDA’ links on their website were not (as of the week ending May 3, 2008) appropriate means of notifying the FDA of complications although the links were portrayed as such, so those who were misled into believing this and filing their complaints by those means, your complaints went nowhere. They are not part of statistics for negative outcomes.
The Quality of Life study is already biased, and based on my past experiences in dealing with the FDA as I presented to them at the ophthalmic panel, “The FDA’s capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had.”
So how many more people get damaged before the FDA determines lasik has no bearing on quality of life?
My presentation to the ophthalmic panel
My name is Dom Morgan. I am legally blind from my surgeons’ improper use of an investigational laser, a laser sanctioned by the FDA, known to be responsible for damaging over 30 people. I had Retinopathy of Prematurity, meaning that my retinas were structurally incomplete at birth. I was 20/50 and barely legal to drive when I had LASIK. I was never a candidate. The intraocular pressure created by the suction ring destroyed my retinas. My problems are permanent. As retinal problems they will never be addressed by a contact lens. I believe my doctor knew and did the procedure anyway. I was dropped from their clinical study. So were others. Those data were never reported to the FDA. The doctors sued me because I set up a website and told the truth.
I’ve addressed my concerns about LASIK to the FDA for over five years, not only on my behalf, but also on behalf of others. In 2003 I filed a petition regarding medical devices and safety of refractive surgery, which was ignored. Help was offered by Ombudsman Les Weinstein, and then retracted.
My concerns today are with those needlessly damaged by refractive surgery. Even with the most modern technology, there are still of too many people writing me telling of the nightmares they now live with on a daily basis. I received several hundred emails this past year from people seeking help. Many of those are depressed. Some of them have confided that they want to commit suicide. And this is just through one website. Having corresponded with many of those patients, I believe they are just ordinary people cause in unusual circumstances. There is nothing remarkable about them, certainly nothing to suggest perfectionism, or any of the other reasons that some LASIK doctors use to excuse their own bad results.
The FDA’s capacity to oversee the refractive surgery industry is in my opinion no different than the doctors who have tarnished it. The FDA has been ineffective in overseeing investigational studies, ineffective in enforcing the policies mandated for the industry, and ineffective in providing thus far the protection that many of us here today should have had.
Everyone in this room today is here for a reason. Please do not allow what is presented to you to continue falling on deaf ears. The public must depend on government agencies like the FDA to protect them.
In a recent press release, ASCRS volunteered to contribute funding for the FDA study on LASIK complications and quality of life. The FDA has already received copious amounts of criticism because of funding received from the pharmaceutical industry. Essentially, industry funds the FDA, which creates conflicts of interest. I ask the panel how funding received from ASCRS is any different. Most of the patents who have emailed my website feel deceived and lied to by surgeons who have exploited the public perception that doctors are healers. Why should damaged patients trust an organization of such surgeons any more than they trusted their own surgeon?
Included with my submission today I would like to emphasize are two letters previously written to the FDA, which are already public record. These letters apply not only to me, but many others:
The letter written by Dr. Steven Friedman to the FDA’s Office of Criminal Investigation summarizes not only my experience and I believe the outright criminal activity of my doctors, but also explains why the civil justice system does not work.
The letter written by Dr. James Salz, respected LASIK surgeon and principal investigator for past FDA studies emphasizes that I was not a proper candidate for LASIK and tells why.
Also included are a few documents and previous correspondence I sent to the FDA. I believe this further supports what I just outlined.
My story and more can be found at lasikdecision.com.
I ask the panel to recommend to that FDA conduct its own independent and unbiased study. Survey damaged LASIK patients nationwide, and ask how many feel lied to by their LASIK doctors. Conducted without funding from the industry, the results might be believable. I would also ask that the criminal division of the FDA conduct an investigation of specific doctors, such as mine, in regards to their actions in dealing with many of us.
I think a moratorium on advertising by doctors is an intriguing idea.
So much is made on patient selection but more should be done on doctor selection, maybe a website listing doctor qualifications in a standardized, verified format.
Thank you for your time and I will gladly post any presentation unedited on my website. http://www.lasikdecision.com.
EMERGENCY FDA PANEL DISCUSSION POINTS- April 25th, 2008
Regarding Questions Arising About The Safety Of LASIK Eye Surgery…
By Dean Andrew Kantis, #2 Guest Speaker
Founder of: http://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.
Sincerely,
Dean Andrew Kantis
Founder
http://www.LifeAfterLasik.com