The following letter was submitted by FDAWeb.com's editor (FDA Watchdog) questioning the FDA's ability to provide "reasonable assurance of safety and effectiveness for FDA Approved LASIK Devices: http://lifeafterlasik.com/LASIK%20FDAWeb%20ltr%20April%2019%202010.pdf.Because of this letter, Dean A. Kantis, founder of www.LifeAfterLasik.com (Hurt LASIK Patient Network), has started an investigation into this claim. This is what they have found.
Ft. Lauderdale, FL (PRWEB) May 16, 2010 -- "Any country's 'Gross Domestic Product,' any baseball player's 'Runs Batted In,' and any business's 'Profit and Loss Statements,' has daily, monthly, yearly and lifetime changing statistics and rates. Yet with irreversible elective LASIK eye surgery, the FDA and ASCRS, allows for the same 95.4% marketed 'Patient Satisfaction Rate' to be represented to the public for the past 13 years...Satisfaction by whom and how is success defined?" exclaims Dean Kantis.
"First, how did LASIK get FDA Approval and is it reasonably safe and effective? Is it true that there was a huge amount of hurt LASIK patient data (large amount of patients complained of permanent injuries called 'Adverse Events/Permanent Complications' yet were dismissed as just 'Temporary Side Effects') put aside that was not counted in the original LASIK clinical studies (performed between 1996-1997) and if used, could have been enough evidence to red flag LASIK as 'an international health hazard' further denying 'FDA Approval?" asks Kantis. Mr. Morris Waxler, Ex FDA Chief of Medical Devices, (who oversaw the group that oversaw the LASIK FDA Approval Clinical Studies) is now warning the public of the permanent damages that LASIK elective irreversible surgery yields to all of it's victims:
*There is more like a >20% Adverse Event (1 out of every 5 eyes) Permanent Complication Rate" which means that out of an estimated 16 million LASIK eye surgeries (each eye is a patient, 2 eyes per person, and many of these same eyes are getting 1,2,3 laser enhancements), there are approximately 3,200,000 ruined eyes in America alone (not to mention throughout the world). And that approximately 60% (or 9,600,000 American eyes) of all LASIK procedures will have only a "temporary dependence" from glasses and contacts?
http://lifeafterlasik.com/LASIK%20Morris%20Waxler%20ltr%204152010.pdf
http://lifeafterlasik.com/LASIK%20Morris%20Waxler%20ltr%2005012010.pdf
http://abcnews.go.com/GMA/OnCall/video/risks-lasik-eye-surgery-9935811
Like any physician, LASIK physicians (Ophthalmologists) swear a "Medical Hippocratic Oath" to first be responsible for protecting their patients. Yet, Ex FDA legal official, Mr. Larry Pilot, stated his ongoing concerns to "LifeAfterLasik" that the FDA 'is not actively investigating all questionable LASIK ASF's (Ambulatory Surgical Facilities) for mandatory Medwatch compliance (FDA's mandatory reporting system for all hurt patient outcomes so the FDA can red flag spikes in permanent consumer injuries to assess safety and efficacy) www.lifeafterlasik.com/pilot.htm .
Dean Andrew Kantis further states, "That there are absolutely no standards of care when it comes to LASIK, because the FDA continues to allow LASIK physicians to misstate 'Adverse Events' (Permanent Injuries) as mere 'Temporary Side Effects,' which then allows the LASIK center(s) and LASIK physician(s) to 'NOT' file mandatory Medwatch cases for every eye permanently injured, while giving the same or other physician(s) the power to perform 'Off Label Retreatments and Enhancements' requiring no oversight by anyone or any entity and that my friends is very, very scary!"
Because of this problem, we then ask "Are LASIK Ophthalmologists, the FDA, and ASCRS violating both medical malpractice laws as well as criminal laws?" To add further insult to injury, LASIK centers are "risk managing their own permanently damaged patients in the most egregious of attempts to push these patients past the statute of limitations" (the timeframe in which a patient has to sue the LASIK center, their staff, their physicians, and the laser manufacturer which in most states is only 12-24 months from the date of the LASIK procedure not from the date of discovery of injury). If these centers did report every dissatisfied patient (each injured eye = 1 patient) filing mandatory Medwatch cases, the FDA would then have the evidence to justify a LASIK moratorium and/or PHA "Public Health Advisory." Why aren't patients reporting their own Medwatch cases directly to the FDA? Because they are not being told by the physician(s) or commissioned staff technicians to do this, so they never will know to do this. That is why as recently as February 2010, there is a $180 million dollar Class Action LASIK Lawsuit filed on Tiger Wood's sponsor, "TLC Vision Center."
http://www.cbsnews.com/stories/2010/03/17/health/main6308419.shtml
Are LASIK centers purposely downplaying all known long-term LASIK risks? Kantis says, "Absolutely, all because of their egregious greed and accustomed phony lifestyles, which should upset all hurt LASIK patients because this money is being made off of the ruined vision from these same patients who trusted these doctors to protect them not ruin their vision, their families, and their lives." Is it true that most LASIK doctors are ignoring mandatory FDA and FTC "Advertising Laws" after having been informed by the FDA on May 22nd, 2009 that "All Known Risks Must Be Mentioned In Any Form Of Advertisement For Any LASIK Advertisement" just as the consumer would see on any given day for any prescription drug television commercial? "Yes," again states Dean Kantis, further adding, "Yet these same FDA Officials continue to allow for such deceptive marketing gimmicks such as 'LASIK guarantees you better vision and perfect 20/20 vision...it's quick, easy, painless, save money, no risks, improve your golf game, save money by throwing your glasses and contacts away forever'..."
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm154882.htm
"Remember, either the FDA Officials and ASCRS are downplaying the risks to the public that there are only about 140 LASIK cases filed in Medwatch, when the real worry that they have is if the hurt consumers realize that there should be about 3 million Medwatch LASIK cases filed. This would spark a epidemic involving outside offices to come in and investigate top FDA and ASCRS officials for possible Criminal Intent using a keratome blade and laser for Assault and Battery," says Kantis. LASIK is an elective procedure and there are known long-term damages to 100% of the eye corneas if you are open to hearing them. Why the FDA and ASCRS have not informed the public they swore to protect about these long terms risks, should worry every consumer in the world about their ability to oversee such studies without favortism to private Ophthalmologists, such as the Navy and Department of Defense, (who oversee and dictate most of these studies) who ultimately were supposed to guarantee 'Reasonable Assurance of Safety and Effectiveness.' Would you go up in an airplane that crashed 1 out of 5 times? That's about the Safety and Effectiveness of elective LASIK eye surgery!"
Media Contact:
Mr. Dean A. Kantis
Founder
www.LifeAfterLasik.com
"Hurt LASIK Patient Network"
754.234.9993
LASIK Clinical Studies Showing >20% (1 in 5 eyes) Chance Of Permanent Injury Rate:
FDA Approved Lasers yielding a >20% Adverse Event/Permanent Comlication Rates:
http://www.lifeafterlasik.com/LASIKFDAStudyCharts.htm
Bailey Study/Peer Review: Lasers From 1997-2004:
http://lifeafterlasik.com/LASIK%20Bailey%20Study%20Through%202004.pdf
Schein Study/Peer Review: 2000:
http://www.lifeafterlasik.com/LASIK%20Clinical%20Study%20Schein%202000%20Shows%2020%25%20AE.pdf
See Also:
- Boy Scouts Sued for Catastrophic Personal Injuries
- Register Now for 6 Credit Hour CLE with Browning Title & Blue Ridge Community College
- Brian Panish Wins California ABOTA Trial Lawyer of the Year Award
- International Tobacco Settlement Announced
- Small Business Owner Asks for Donations to Save Jobs and Business - Government Not Helping by Raising Taxes
[Via Legal / Law]
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