Is LASIK Elective Surgery Safe For The Long-Term?
(PRWEB) July 8, 2009 -- (www.LifeAfterLasik.com, "LASIK Advocacy Network")
First, what is LASIK? "LASIK" (laser-assisted in situ keratomileusis) pronounced: "Lay Sick," not "Lay Six," is 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 then put back into its original place and the surgery is concluded.
The purpose of a "long-term" LASIK study is to see if the LASIK patients feel satisfied with the long-term results (3, 5, 7, 9, 11 years later), asking them to all come forth and tell their own personal stories, to measure whether or not the patients agree with the LASIK industry's stated 95.4% Patient Satisfaction Rate, which means that there is a 4.6% Patient Dissatisfaction Rate. It is LifeAfterLasik's opinion that the "Original Clinical Studies for LASIK did not meet the strict requirements for FDA Approval" requiring a "Less than 1% Adverse Event/Complication Rate," as stated on FDA's website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080249.htm. Kantis believes "the long-term results of LASIK could easily regress to about a 20-30% patient disssatisfaction rate;" Thus, the reason Kantis and others want to perform these studies.
The FDA and CDRH were put on notice just last year about this very serious concern, at the April 25, 2008, Emergency LASIK Ophthalmic Panel Discussion in Washington, 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.
Due to a very recent article citing a LASIK physician's medical malpractice case, it is LifeAfterLasik's opinion that more concerns are "raised about this LASIK surgeon found guilty on June 13, 2009, of artificially aging a note in 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.
Dean Andrew Kantis asks in the report, "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?" Current Investigational health reporter, Ms. Deborah Shelton, Chicago Tribune, on July 5th, 2009 wrote 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." A special hearing will take place in Chicago next week to decide Dr. Caro's fate (Illinois Department of Regulation, Monday, July 13th, 2009). http://tinyurl.com/l32scv
Therefore, the Long-Term LASIK Study will focus on the following criteria:
A. "Is It True That The Flap Never Heals?"
B. "Where Are The Long-Term Studies To Prove LASIK Is Safe?"
C. "Are The 2,500 LASIK Ambulatory Surgical Facilities (ASF's) in the USA Being Investigated By The FDA/CDRH (And Are They Reporting LASIK AE/Complications To Medwatch?"
D. "Are LASIK doctors still re-using microkeratome blades on their patients?"
E. "Are the reported success rates accurate and are the original clinical studies flawed?"
To learn more about the "Long-Term LASIK Study," hurt LASIK patients are being prompted to fill out a form telling their LASIK dissatisfaction story here: http://www.lifeafterlasik.com/form.htm .
Kantis states, "Hopefully the media and society as a whole, will put the pressure 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.
"On a positive note," exclaims LifeAfterLasik, "the FDA appears to be concerned by a exponential rise recently in Medwatch LASIK complaints, (from 1999-2008, there were 142, from 2008-present, that number has jumped to over 1,500 and climbing) and they are urging consumers to report their LASIK complaint (whether it be regression of one or both eyes) by filling out this online form into the Medwatch LASIK Reporting system so that the FDA is aware of all LASIK patients that are "dissatisfied with their surgery, the physician or clinic, and/or LASIK device, by initiating the complaint into the Medwatch LASIK Reporting System here: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.
The FDA has also asked the public to report any LASIK facility that is "Not Stating All Known Risks" in any advertisement online, radio, print, or TV here: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm154882.htm.
"LASIK Advocacy Network"
Fort Lauderdale, FL
###
Related Articles:
New Vision-Lasik Eye Surgery
The information about lasik eye surgery does not constitute a patient doctor relationship. LASIK eye surgery is still considered new technology.
LASIK Eye Surgery: Is LASIK Right For You?
If you are considering refractive surgery such as LASIK to correct your vision problems, your eye care provider will screen you to see if you are a suitable candidate for LASIK surgery. Here is what you need to know when deciding if LASIK surgery is right for you.
Simple Facts About Lasik
LASIK is a surgery, and with surgery comes possible risks and complications. Before opting for surgery to correct any type of health related problems, it is recommended that patients do some research and learn about the procedure. Having said that, here are some simple facts about LASIK refractive eye surgery.
Laser Eye Surgery Complication - 6 Dangers Of Eye Surgery
Why laser eye surgery complication is real and can affect you. Find out more in this revealing report!
Lasik Education
Lasik education is something that everyone with vision impairments needs to learn about. There are many different types of vision correction procedures today, but none compare to Lasik. Lasik is the highest in advanced technology and offers the best equipment for your procedure. By learning about Lasik you are bettering your education when it comes to your eye care and health.
Pros And Cons Of Lasik
LASIK eye surgery has been the most recent development in correcting visual problems and thus, an alluring option for people suffering from similar diseases. However, like all the other developments in medical science, a LASIK surgery also has its advantages and disadvantages contributing to the pros and cons of a LASIK surgery. The best way to reap the utmost benefits of LASIK surgery would be to gain enough knowledge about the pros and cons and then decide whether opting for a LASIK would be really beneficial or not. Comprehensive tests and screening combined with consultation with the concerned doctor would then, help the patients in evaluating the consequences.
LASIK Can Fix A Number of Refractive Errors
Many types of refractive errors are correctable by Lasik. The end result of the Lasik procedure can be influenced by varying degrees of severity. There are still benefits of having surgery for those with very bad eyes, but they still may need glasses.
Wavefront LASIK Surgery
This article describes the new adaptation to LASIK eye surgery known as Wavefront LASIK or Custom LASIK.
The Cost of Lasik Eye Surgery
Lasik eye surgery is the most commonly suggested treatment for myopia in the United States. Lasik eye surgery cost has come down considerably in recent years. Earlier, it was not affordable for the common man.
Lasik Risks and Lasik Complications
Many people are looking at Lasik procedures to correct their vision problems, but are concerned with Lasik complications and risks involved. The procedures have more predictable outcomes for many types of vision corrections. A Lasik surgeon will carefully analyze the patient's individual vision problems, with and without corrective measures, in addition to making sure they will be correctable with Lasik, as some vision problems are not.
How To Choose A Lasik Surgeon
After you have decided to undergo a Lasik corrective eye surgery, it is time to learn how to choose a Lasik surgeon. There are many different ways and services that can help you locate and choose the best Lasik surgeon to perform your corrective eye surgery.
LASIK Vision Correction: The Basics of LASIK Eye Surgery
If you are considering LASIK surgery there is much to learn before allowing someone to vaporize part of your eyeball with an ultraviolet laser. Here are the basics of LASIK surgery to get you started.
Wavefront Lasik Vs Traditional Lasik Surgery
Trying to decide between Waverfront Lasik and Traditional Lasik surgery? Become familiar with the pros and cons of each type of Lasik surgery so that you may chose wisely between the two.
Lasik Boston - Give You A New Vision
LASIK eye surgery has come up with the answer to all the questions of the ophthalmologist related to correction of cornea defects that results in Hyperopia, Myopia and Astigmatism. LASIK Boston also provides the right treatment to corneal flaws and does not bring any pain or side effects with it.
LASIK Surgery - The 5 Key Advantages of LASIK Eye Surgery
When considering any type of surgery, it's important to consider the risks versus the reward, the pros and cons, and the advantages and disadvantages. This is true of LASIK eye surgery as well.