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LASIKtruth website illegal activities page
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| LASIKtruth website contents 2005-09-24, 2:38 pm |
| 'Bermuda cards' allow off-label use of Visx laser
by Keith J. Croes
Executive Editor
An off-shore modification of Visx keycards
allows U.S. surgeons to employ excimer
laser treatments widely used elsewhere
around the world.
A number of refractive surgeons in the United States are using Visx keycards
that have been reprogrammed in Bermuda to override a software change ordered
by the Food and Drug Administration a year ago, according to sources in
private practice and industry.
At a rate of $40 per card, the Hamilton, Bermuda-based company,
Technological Health Care Products (THCP) Ltd., "enhances" prepurchased Visx
keycards meant for U.S.-sited lasers, a THCP official said. The card's
original "international" program, used extensively outside the United
States, is thus restored and available for use on the U.S. machine.
Legal issues
An FDA official charges that the cards are "illegal," which is probably
technically correct, according to Wayne Matelski, an attorney who
specializes in FDA regulations. "A component of a regulated device is a
device itself, and the card is unapproved," he said. The FDA would argue
that [the cards] are illegal and would probably seize them if given the
chance."
The approved cards, which cost $260 each when purchased from Visx Inc., of
Santa Clara, Calif., are hand-carried to Bermuda, or even sent by express
mail, by laser center or practice representatives, not necessarily the
surgeons themselves. Surgeons who use the reprogrammed cards point out their
practice-of-medicine privilege to use an approved device for off-label
applications.
"There is definitely a practice-of-medicine issue here," Matelski said. "It
would be up to the court to decide. A pro-government court might be expected
to favor the FDA over the surgeon. However, a well-respected surgeon in a
regional court might prevail."
The reprogrammed cards allow the treatment of higher degrees of myopia and
astigmatism than permitted by the approved labeling of the Visx laser. THCP
believes that the company's service violates no U.S. or Bermuda laws. "We do
not market directly in the U.S., and word-of-mouth is the only way we
market. U.S. doctors personally contact our office here for keycards," said
a THCP official, who declined to reveal his name. The FDA has not contacted
the company, he said.
Numbers unavailable
The THCP official declined to reveal the number of cards the company has
reprogrammed and the number of customers served. "The volumes have not been
as large as we originally expected," he said.
A U.S. laser center executive, whose operation includes three Visx lasers,
acknowledged sending one shipment of about 800 cards to THCP for
reprogramming. "We think this is the high road compared to custom lasers and
gray-market lasers. These are approved lasers with proven software," said
the executive, who requested anonymity.
In a number of public statements, Morris D. Waxler, PhD, acting branch chief
for the Diagnostic and Surgical Devices Branch of the FDA's Center for
Devices and Radiological Health, has called the cards "illegal." Waxler
pointed out that the agency recently outlined a regulatory pathway for
surgeons who wish to apply for an investigational device exemption (IDE) for
treating these patients.
"We are very sympathetic to the forces at work here, which is why we've
developed a process so that surgeons who want to do these procedures can get
an IDE or get into an established study," Waxler said. "The surgeons who are
using the cards are not contributing to the data collection and
interpretation going on in order for us to understand what we're doing to
these patients."
CRS-USA reaction
CRS-USA Inc. is pursuing one such IDE with a study coordinated by Guy
Kezirian, MD, of SurgiVision Consultants, Inc., Scottsdale, Ariz. "The
Bermuda cards raise concerns for patients and surgeons alike," Kezirian
said.
"Undergoing surgery with unvalidated technology that is obtained from an
off-shore source leaves them with little recourse should a problem occur.
The problem for surgeons is that they are left holding the entire bag for
liability. Will their malpractice insurance cover them for activities the
FDA says are illegal?"
With the recent approval of the Visx laser for low to moderate astigmatism,
the demand for Bermuda cards will likely shrink, at least temporarily,
industry sources predict. The pressure on the FDA to approve treatments for
high myopia, however, is likely to grow.
Although Visx has heard reports of reprogrammed keycards, the company is not
involved with the activity in any way, according to a Visx spokesperson. The
THCP official also noted that THCP has no association with Visx.
(From www.eyeworld.org)
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| Glenn - USAEyes.org 2005-09-24, 2:38 pm |
| Keith Croes, who is on our governing board, has not been editor of
Ocular Surgery News in over five years. Perhaps you could come up with
something that happened in this millennium?
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| LASIKtruth website contents 2005-09-24, 2:38 pm |
| The conflicts of interest present at the time of approval of LASIK are what
are most interesting and relevent because they
call into question the validity/legitimacy of FDA approval of LASIK.
"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:6hv1h1ptm1qob7irhfg46c9h82nal51c9n@4ax.com...
> Keith Croes, who is on our governing board, has not been editor of
> Ocular Surgery News in over five years. Perhaps you could come up with
> something that happened in this millennium?
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
| |
| Glenn - USAEyes.org 2005-09-24, 2:38 pm |
| The only way that your accusation could have any merit is if
subsequent studies and trials came to different conclusions.
Subsequent studies have affirmed and further refined virtually
everything found in the original studies. The sky did not fall in the
late 90s, and it is not falling now.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| LASIKtruth website contents 2005-09-24, 2:38 pm |
| Yes, subsequent studies found that refractive surgery still causes nerve
damage resulting in dry eye that
can be perment, it still induces distortions in the cornea that cannot be
fixed by glasses, it still reduces contrast
sensitivity...yet it persists because of all of the money and greed that
drives the industry. There are so many LASIK
surgeons out there willing to harm people permantly to make some cash. It's
sickening.
"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:ldn2h1d6lkrlmb6nns63i2it77j948cnb4@4ax.com...
> The only way that your accusation could have any merit is if
> subsequent studies and trials came to different conclusions.
> Subsequent studies have affirmed and further refined virtually
> everything found in the original studies. The sky did not fall in the
> late 90s, and it is not falling now.
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
| |
| serebel 2005-09-24, 2:38 pm |
| Exactly what studies find that this happens in RS as often as you
state? Your statement that so many surgeons are willing to harm is
ridiculous.
SErebel
| |
|
| From elsewhere on this site, which clearly you don't read. That must be why
you don't learn.
Study shows permanent pathologic changes present in all post-LASIK corneas
--------------------------------------------------------------------------------
Pathologic Findings in Postmortem Corneas After Successful Laser In Situ
Keratomileusis.
Cornea. 24(1):92-102, January 2005.
Kramer, Theresa R MD, MBA; Chuckpaiwong, Varintorn MD; Dawson, Daniel G MD;
L'Hernault, Nancy; Grossniklaus, Hans E MD; Edelhauser, Henry F PHD
Abstract:
Purpose: To examine the histologic and ultrastructural features of human
corneas after successful laser in situ keratomileusis (LASIK).
Methods: Corneas from 48 eyes of 25 postmortem patients were processed for
histology and transmission electron microscopy (TEM). The 25 patients had
LASIK between 3 months and 7 years prior to death. Evaluation of all 5
layers of the cornea and the LASIK flap interface region was done using
routine histology, periodic acid-Schiff (PAS)-stained specimens, toluidine
blue-stained thick sections, and TEM.
Results: In patients for whom visual acuity was known, the first
postoperative day uncorrected visual acuity was 20/15 to 20/30. In patients
for whom clinical records were available, the postoperative corneal
topography was normal and clinical examination showed a semicircular ring of
haze at the wound margin of the LASIK flap. Histologically, the LASIK flap
measured, on average, 142.7 [mu]m (range, 100-200). A spectrum of abnormal
histopathologic and ultrastructural findings was present in all corneas.
Findings at the flap surface included elongated basal epithelial cells,
epithelial hyperplasia, thickening and undulations of the epithelial
basement membrane (EBM), and undulations of Bowman's layer. Findings in or
adjacent to the wound included collagen lamellar disarray; activated
keratocytes; quiescent keratocytes with small vacuoles; epithelial ingrowth;
eosinophilic deposits; PAS-positive, electron-dense granular material
interspersed with randomly ordered collagen fibrils; increased spacing
between collagen fibrils; and widely spaced banded collagen. There was no
observable correlation between postoperative intervals and the severity or
type of pathologic change except for the accumulation the electron-dense
granular material.
Conclusions: Permanent pathologic changes were present in all post-LASIK
corneas. These changes were most prevalent in the lamellar interface wound.
These changes along with other pathologic alterations in post-LASIK corneas
may change the functionality of the cornea after LASIK.
"serebel" <serebel@aol.com> wrote in message
news:1125278711.527473.59630@g49g2000cwa.googlegroups.com...
> Exactly what studies find that this happens in RS as often as you
> state? Your statement that so many surgeons are willing to harm is
> ridiculous.
>
> SErebel
>
| |
| Glenn - USAEyes.org 2005-09-24, 2:38 pm |
| I'll just repost this from RT's response in another thread. It is more
eloquent that I would have responded.
>Please if you are going to post definitions as if you know what you are
>talking about, PLEASE make sure you use the word properly. It is
>absolutely false to write a sentence like "All LASIK corneas have
>permanent pathology" don't be too embarrassed, it is a common mistake.
>
>Pathology in medicine doesn't mean disease--it means the study of the
>manifestation of "stuff" that deviates from its normal and original
>state (sometimes caused by disease and other morbid causes but not
>always--think scar tissue)--usually through the study of microscopic
>samples of tissues.
>
>by your logic the scar on my knee is diseased tissue.
>
>The word "pathology" CANNOT be substituted with the word "disease." It
>just doesn't make sense grammatically and for people who understand the
>meaning of the word it is completely non-sensical to write a sentence
>like you did above.
>
>Anyway, the study you cite talks about "pathological changes" to the
>eye--ie. changes from the normal state of the eye. Of course the eye has
>changed--Doh! The study doesn't even mention "pathology" as a branch of
>science or in relation to LASIK.
>
>Actually the study concludes that there is no evidence these pathologic
>changes have any effect on visual acuity whatsoever.
>
>and it doesn't prove it in ALL LASIKed eyes--only in 48 eyes of 25 dead
>people who left no treatise on how well they saw or not.
>
>Maybe you'll read this post and finally understand that you just really
>don't understand what this study is concluding Henry, Barb, Tabby etc.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Dennis 2005-09-24, 2:38 pm |
| What is it about the words;
"Conclusions: Permanent pathologic changes were present in all post-LASIK
corneas. These changes were most prevalent in the lamellar interface wound.
These changes along with other pathologic alterations in post-LASIK corneas
may change the functionality of the cornea after LASIK."
That you do not understand? Pathology as a noun means disease. Pathology as
a science is the study of structural and functional aspects of diseased
tissue.
Since I'm DOCTOR X and you're not, perhaps you're the one who isn't getting
it. Performing and interpreting medical studies is what I do for a living. I
have three advanced degrees in the medical sciences.
Post-LASIK corneas are sick. They have sick cells undergoing sick processes
in an unhealthy environment. Nerves continue to degenerate. Keratocytes
continue to apoptose (die). There is an accumulation of electron-dense
granules in the lasik interface that increases over time. The farther out
you are from your surgery, the more grainy junk you have under your flap.
Isn't that nice?
"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:91u4h1tl087i5lknmvad3ba2kleltug5qf@4ax.com...
> I'll just repost this from RT's response in another thread. It is more
> eloquent that I would have responded.
>
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
| |
| Ragnar 2005-09-24, 2:38 pm |
| Dennis, you are wrong.
What is your problem?
On Mon, 29 Aug 2005 19:12:42 -0400, "Dennis" <Dennis@nospam.com>
wrote:
>What is it about the words;
>
>"Conclusions: Permanent pathologic changes were present in all post-LASIK
>corneas. These changes were most prevalent in the lamellar interface wound.
>These changes along with other pathologic alterations in post-LASIK corneas
>may change the functionality of the cornea after LASIK."
>
>
>
>That you do not understand? Pathology as a noun means disease. Pathology as
>a science is the study of structural and functional aspects of diseased
>tissue.
>
>
>
>Since I'm DOCTOR X and you're not, perhaps you're the one who isn't getting
>it. Performing and interpreting medical studies is what I do for a living. I
>have three advanced degrees in the medical sciences.
>
>
>
>Post-LASIK corneas are sick. They have sick cells undergoing sick processes
>in an unhealthy environment. Nerves continue to degenerate. Keratocytes
>continue to apoptose (die). There is an accumulation of electron-dense
>granules in the lasik interface that increases over time. The farther out
>you are from your surgery, the more grainy junk you have under your flap.
>Isn't that nice?
>
>
>
>
>
>
>
>
>
>"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
>news:91u4h1tl087i5lknmvad3ba2kleltug5qf@4ax.com...
>
| |
| serebel 2005-09-24, 2:38 pm |
| Of course permanent changes are made to the cornea. That's the whole
point of RS. Dennis and the other nut Tina just love to throw around
the word pathology. Dennis is as much a doctor as Sandy is sane. He's
really full of crap about the grainy junk under the flap.
SErebel
| |
| Glenn - USAEyes.org 2005-09-24, 2:38 pm |
| Okay "Dennis" "Tina" "Paula" "Whomever", you confirmed my suspicion.
Your are simply going to latch on to an incorrect meaning of the term
no matter what the reality and no matter how many people show you are
wrong.
I was just checking.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Glenn - USAEyes.org 2005-09-24, 2:38 pm |
| If the changes were not permanent, the anti-LASIK zealots would be
having a fit about LASIK being temporary.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
|
| In article <1125357188.56ed56b5195c51f862c6848156a9694a@teranews>,
"Dennis" <Dennis@nospam.com> wrote:
> Since I'm DOCTOR X and you're not, perhaps you're the one who isn't getting
> it. Performing and interpreting medical studies is what I do for a living. I
> have three advanced degrees in the medical sciences.
Lord help us. Pathological only begins to hint at what's ailing you and
your LASIKed eyes.
--
~RT
| |
| Glenn - USAEyes.org 2005-09-24, 2:39 pm |
| Hey RT, that's two days in a row that you have got me to laugh out
loud...thanks!
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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