Doctors contend that Ladarvision machines are linked to adverse events
Sandy
www.timesonline.co.uk/article/0,,2-1235771,00.html
LASER eye surgery, by offering patients near-perfect sight in one
quick operation, has become a billion-pound industry, using the latest
technology to generate vast profits.
From the biggest players such as Alcon, a £2 billion eyecare company,
to the hundreds of sought-after ophthalmologists, the stakes could not
be higher.
When a number of doctors from across America began to question whether
Alcon's Ladarvision system, a machine using Nasa laser technology, was
malfunctioning, the company had two choices. It could have gone
public, and recalled the potentially defective model or, like the
three wise monkeys, it could see no evil, hear no evil and speak no
evil.
According to lawsuits in the United States, Alcon stands accused of
adopting the second position. When a group of eye surgeons approached
Tim Sear, the company's chief executive, in October 2002 to voice
their concerns, their unease was not put to rest.
In a transcript of the conference call, seen by The Times, Herman
Sloane, an eye surgeon from Illinois, described how his lasers had
been "unbelievably good" at first, but had begun to fluctuate badly.
He said the number of patients he was having to re-treat had
subsequently decreased, but he still "(got) a surprise now and again".
The doctors said that some had reported that some of their patients
had been left with astigmatisms and suffered ghost images,
debilitating glare and blurred vision.
"As it sits right now, I am not comfortable . . . I started with a
laser that was nearly perfect in my hands and I still haven't
recovered to my baseline," Dr Sloane said.
At the end of the conversation, Mr Sear, the British former head of
the Swiss-owned company, based in Texas, thanked the doctors for
raising issues "which we take very seriously".
Yet to date at least two of the doctors' concerns remain unresolved
and the company continues to deny that machine malfunction has ever
been a legitimate problem. They say that the complaints are being
fabricated by doctors and companies trying to avoid paying bills to
Alcon.
According to the US Food and Drug Administration, the country's
regulatory body, the manufacturers of medical equipment are required
to report any adverse effects that occur "with unexpected severity or
frequency".
In court documents, EBW, the company that used to lease the
Ladarvision machine and which is locked in litigation with Alcon over
unpaid bills, baldly alleges that the optical firm repeatedly told
individuals who reported a laser problem that it was the first time
they had heard of it.
Alcon suggested instead that the doctors' surgical skills or factors
such as humidity were at fault, it is alleged.
In papers responding to the EBW claims, Alcon describes the charges as
a "litany of unfounded accusations". It refers to the "loaded language
and invective" of the legal brief as "not a substitute for the
requirements imposed by law".
Brian Will, a Canadian surgeon, makes similar allegations to EBW about
laser unpredictability in documents that have been filed in Washington
State courts.
In January, Alcon won its suit against Dr Will for breach of contract
and for non-payment of $1.6 million in fees.
The physician claims that he defaulted on the payment after obtaining
leaked Alcon data showing high retreatment rates in other clinics
using Ladarvision lasers.
He is appealing in the Court of Appeals of the State of Washington on
the ground that Alcon withheld relevant documents.
While some doctors have kept with Ladarvision systems, others —
despite Alcon's assurances — still contend that little or no action
was taken and the £300,000 machines continued to be linked to adverse
events.
Sheri Rowen, an eye surgeon in Baltimore, said that her laser had also
started to malfunction. She plans to launch a lawsuit against Alcon
early next month.
"I asked Alcon if other doctors had experienced problems with their
lasers and their results and they told me no, and they seemed to
attribute my concerns to everything but the laser itself," she told
The Times. "They also told me that my laser was operating properly
when it wasn't."
Ms Rowen said that she no longer used that model of the laser. "I
changed my laser technology — and I would never be comfortable using
the Ladarvision platform again . . . There used to be three
Ladarvision in my city — now there are none. That says it all."
Although there are no industry standards for rates of retreatment,
also known as "enhancements", industry literature cites a normal level
of between 6 and 8 per cent of patients. According to leaked Alcon
data used in the EBW case, and seen by The Times, more than 40 per
cent of patients at five clinics in the United States had to return
for further surgery in 2002. A further 11 had rates over 30 per cent
and 39 clinics had rates over 20 per cent. A spokesman for Alcon said
that the data was a financial document, and of "no clinical
relevance".
In Britain, machines used in Boots clinics had rates of around 10 per
cent at the end of 2002, double the number of patients of 2001, the
first year using the system.
A spokeswoman for Boots said that last year 8 per cent of patients had
retreatments, which were nearly all "tiny little tweaks". She added
that 99 per cent received 6/12 vision — the equivalent of driving
without glasses — after one operation.
To date, Alcon categorically denies that machine error could have
caused the reported problems with their American models.
An Alcon spokesman said that retreatment rates were not a good
indication of alleged machine fault. "If there was a consistent
problem, then all the systems would have similar issues," he said. He
said that it was never Alcon's position to conceal problems from
doctors, adding that all lasers had been passed by the FDA. "We are
not going to threaten our standing with the ophthalmic community by
hiding things from them."
An FDA spokesman declined to say if it was investigating the safety of
Ladarvision devices. He said that the agency knew of allegations
against Alcon, but was "not aware" that Alcon has reported any
increase in retreatment rates.
Rebecca Petris, a campaigner for greater eye surgery regulation who
runs the website LaserMyEye, said: "If the only way to protect
patients is by removing the Ladarvision from service until this is
thoroughly investigated, then that should be done."
Glenn - USAEyes.org
Saturday, 28 August 2004
Sacramento, California, USA
Patient Advocates: No Unusual LASIK Problems With Alcon LADARVision
Despite accusations presented in a 28 August 2004 London Times feature
article suggesting that the Alcon LADARVision excimer laser used to
perform LASIK and other refractive surgery procedures had "started
malfunctioning, causing wildly erratic results", a nongovernmental
organization states that it has no reports of unusual problems with
the laser.
"We have seen nothing from patients or surgeons that would indicate
there is any systemic problem with the safety or efficacy of the Alcon
laser", states Glenn Hagele, Executive Director of the California
based Council for Refractive Surgery Quality Assurance.
"Through our www.USAEyes.org website we respond to tens of thousands
of requests for information about LASIK issues, including
complications, but have not seen any unusual complaints regarding
Alcon's LADARVision. From our vantage", says the director of the
international patient advocacy organization, "all seems normal in the
US and the UK."
US based EBW Laser Inc., which acquired 10 LADARVision lasers to lease
to clinics, and a surgeon in Washington state, filed counter-suits
over a year ago after being sued by Alcon to recover millions of
dollars for non-payment of leasing fees. "It is probably revealing
that neither of the parties in these lawsuits made public claims of
inferiority of the Alcon equipment until they were sued for
collection", says Hagele. "All medical devices have limitations, but
evidence that supports unusual problems with this particular laser
seems to be lacking."
Alcon representatives have consistently denied any systematic problem
associated with LADARVision.
The Times article did not provide specific information regarding any
patients receiving an adverse LASIK outcome due to malfunctioning
equipment built by Swiss-owned Alcon. One British LASIK center is
contacting 49 patients who received LASIK in 2001 "as a courtesy" to
determine if they have had any adverse effects. "It has been our
experience," reports Hagele, "that patients do not wait three years to
report adverse effects. If there were problems, the doctors would
have heard immediately."
Laser surgery, which costs about £1,000 per eye, is currently
performed in over 90 clinics in Britain on more than 90,000 people a
year. In the US, laser eye surgery is performed on more than 1
million each year.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
Sandy
> For Immediate Release
> Saturday, 28 August 2004
> Sacramento, California, USA
>
> Patient Advocates: No Unusual LASIK Problems With Alcon LADARVision
>
> Despite accusations presented in a 28 August 2004 London Times feature
> article suggesting that the Alcon LADARVision excimer laser used to
> perform LASIK and other refractive surgery procedures had "started
> malfunctioning, causing wildly erratic results", a nongovernmental
> organization states that it has no reports of unusual problems with
> the laser.
>
> "We have seen nothing from patients or surgeons that would indicate
> there is any systemic problem with the safety or efficacy of the Alcon
> laser", states Glenn Hagele, Executive Director of the California
> based Council for Refractive Surgery Quality Assurance.
>
> "Through our www.USAEyes.org website we respond to tens of thousands
> of requests for information about LASIK issues, including
> complications, but have not seen any unusual complaints regarding
> Alcon's LADARVision. From our vantage", says the director of the
> international patient advocacy organization, "all seems normal in the
> US and the UK."
That is correct. All brands of lasers malfunction; all have caused
damage to the eyes of unknown numbers of patients, so Glenn is
correct. Nothing unusual is happening with the Alcon lasers. This is
merely business as usual.
Ragnar Suomi
adversely affect patents. The surgeon does a daily, if not more often
test of the quality of the laser. In the rare event that the laser
quality is not right, the surgeon reschedules the surgery and calls in
a technician to fix it fast. Maybe what the article was based upon
is surgeons complaining about excessive mainentance on the unit. The
quality of the laser isn't tested on someone's corneas.
Ragnar Suomi
Glenn didn't say that at all. Keller method #21 to mislead people -
blatantly fabricate false quotes from others.
For those interested, all eximer lasers require periodic maintenance.
The lasers are calibrated DAILY if not more often. If the laser
isn't performing properly, it isn't used until the technician performs
maintenance on it.
The astonishingly low incidence of problems in LASIK procedures should
be more than enough to earn the confidene of prosepective patients.
The Queen of gloom and doom can take all her voodoo dolls and
obsolete, irrlelvant, misleading information.. and her outright lies,
and stuff them.
However, I would highly recommend that anyone that believes even half
of Keller's garbage should not have LASIK, nor have any type of
surgery done. Such a person is mentally incapable of making decisions
and discerning fact from fiction. People that mentally weak are not
likely to have the computer skills necessary to even access this
newsgroup.
Bryce Carlson
> Even if there were a problem with the Ladarvision Laser, it would not
> adversely affect patents. The surgeon does a daily, if not more often
> test of the quality of the laser. In the rare event that the laser
> quality is not right, the surgeon reschedules the surgery and calls in
> a technician to fix it fast. Maybe what the article was based upon
> quality of the laser isn't tested on someone's corneas.
>
I don't think so, Rags. I have to say that I tend to support Sandy on
this one. Although some of this may be sour grapes, when someone of
Dr. Sloane's standing says, "As it sits right now, I am not
comfortable (with the LADARVision 4000 laser)... I started with a
laser that was nearly perfect in my hands and I still haven't
recovered to my baseline," I, for one, sit up and take notice. Also,
it is naive to suppose that, "The quality of the laser isn't tested on
someone's corneas." Unfortunately, in truth, they sometimes are. Of
course, conscientious surgeons certainly perform all recommended
routine maintenance, and they also react immediately to any anomalous
results between servicings, but when the service tech says a laser is
good to go -- unless they know otherwise -- they go. That means that
a laser that randomly, intermittently, and for unknown reasons
occasionally malfunctions is likely to occasionally damage someone's
eyes. The LADARVision 4000 laser, although certainly representing
state-of-the-art technology, does, in fact, have a history of
occasional software-related malfunctions (one, in particular, I
remember involved random, unprogrammed extra laser shots sometimes
just occurring for no apparent reason). So, long story short, I take
this report seriously, and I think the issues it raises should be
thoroughly investigated by the FDA and others.
Bryce Carlson
Brent Hanson - LASIKFRAUD.COM
"Patient Advocates", when he is actually a single lasik pimp who profits
from "certification" fees that are in reality referral fees.
http://www.lasikinfocenter.net/Webpages/Websites%20to%20Avoid%20Webpage.htm
Council for Refractive Surgery Quality Assurance (CRSQA) was founded by
Executive Director Glenn Hagele (an individual who, by the way, reportedly
wears glasses). Despite its pretentious name, CRSQA is in reality a cynical
marketing ploy. CRSQA "certifies" refractive surgeons who pay it the
enormous fees of $7,000 in the first year and $5,000/year thereafter. In
exchange, they receive CRSQA's dubious seal of approval in the hope that
this will help them promote their Lasik practices. CRSQA's quality
"standards," if they can be called that, are pathetic. A doctor can become
CRSQA-certified even if he reports a 3% incidence of "debilitating
refractive surgery complications" in his practice.
Mr. Hagele's primary concern is to help refractive surgeons market
themselves - not to raise their standards of medical care, as can be seen
here.
CRSQA's "Certification" is worthless from a medical perspective. For
example, CRSQA at one time certified Glenn Kawesch as meeting its quality
standards. Yet Dr. Kawesch is considered such a dangerous doctor that the
California State authorities have tried, unsuccessfully, to revoke his
medical license. Dr. Joseph Dello Russo is another CRSQA-certified doctor
who has had a fair amount of legal trouble, as well. "Caveat Emptor" is the
operative phrase when reviewing the referrals at CRSQA.
Finally, any argument that CRSQA's not-for-profit status confers upon it a
mantle of legitimacy is spurious because Mr. Hagele draws a salary as
CRSQA's Executive Director. His livelihood is therefore directly linked to
CRSQA's financial success. Not-for-Profit status does not confer
legitimacy, and is often used by sham organizations trying to garner
undeserved credibility.
Sandy
> Even if there was a problem with the Ladarvision Laser, it would not
> adversely affect patents. The surgeon does a daily, if not more often
> test of the quality of the laser. In the rare event that the laser
> quality is not right, the surgeon reschedules the surgery and calls in
> a technician to fix it fast. Maybe what the article was based upon
> is surgeons complaining about excessive mainentance on the unit. The
> quality of the laser isn't tested on someone's corneas.
What have you been smoking?
Glenn - USAEyes.org
One must consider the credibility of the source of any information.
So let's look at Hanson's cited LasikInfoCenter.net.
LasikInfoCenter is owned by New York attorney Ariel Berschadsky who
for years clearly attempted to hide his ownership of the anti-lasik
website. One must wonder why.
Berschadsky uses LasikInfoCenter to generate LASIK malpractice
clients, although people using his LasikInfoCenter do not know that is
a purpose of the website or that they are being referred by and to the
same person. This may be considered a violation of the ethics rules
of the New York State Bar Association.
Berschadsky has published on this website over 75 articles from
journals, magazines, and newspapers for which he has not received
permission to republish them, according to my own investigation. This
is a clear violation of copyright law. Ironically, on his website
promoting his law practice, Berschadsky lists copyright as one of his
specialties. Berschadsky even went so far as to publish on
LasikInfoCenter a letter from the owner of one of the items he
filched, demanding that he remove the item immediately. Berschadsky
has refused.
Berschadsky is being investigated by the New York State Bar
Association for misconduct due to apparent inappropriate content on
his website.
Not surprisingly, Berschadsky represented Hanson when Hanson publicly
published several private email messages between surgeons without the
permission or knowledge of the surgeons or the association that
operated the private message center.
Several of the claims made by Berschadsky in the statement quoted by
Hanson are not a facts and are false. Nothing considered by a
reasonably intelligent individual support these accusations.
Yes, one should consider the source of all information.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
Wizkid
FIRST TIME VISITORS TO THIS WEBSITE - go to
http://www.lasikfraud.com/news/archives/000011.h...@savvysneaks.com
and download the PDF there to understand the broad scope of issues
facing the refractive surgery industry...issues that are not being
shared with those who have had or are considering refractive surgery.
Only good medicine is good business. WK
Glenn - USAEyes.org <glenn.hage...@USAEyes.org> wrote in message news:<103cj0hqqfoh1al95...@4ax.com>...
Glenn - USAEyes.org
According to the FDA, business as usual with the Alcon LADARVision
means safe and very effective outcomes.
http://www.fda.gov/cdrh/pdf/P970043b.pdf
http://www.fda.gov/cdrh/pdf/P970043S005b.pdf
Rebecca
> I don't think so, Rags. I have to say that I tend to support Sandy on
> this one. Although some of this may be sour grapes, when someone of
> Dr. Sloane's standing says, "As it sits right now, I am not
> comfortable (with the LADARVision 4000 laser)... I started with a
> laser that was nearly perfect in my hands and I still haven't
> recovered to my baseline," I, for one, sit up and take notice. Also,
> it is naive to suppose that, "The quality of the laser isn't tested on
> someone's corneas." Unfortunately, in truth, they sometimes are. Of
> course, conscientious surgeons certainly perform all recommended
> routine maintenance, and they also react immediately to any anomalous
> results between servicings, but when the service tech says a laser is
> good to go -- unless they know otherwise -- they go. That means that
> a laser that randomly, intermittently, and for unknown reasons
> occasionally malfunctions is likely to occasionally damage someone's
> eyes. The LADARVision 4000 laser, although certainly representing
> state-of-the-art technology, does, in fact, have a history of
> occasional software-related malfunctions (one, in particular, I
> remember involved random, unprogrammed extra laser shots sometimes
> just occurring for no apparent reason). So, long story short, I take
> this report seriously, and I think the issues it raises should be
> thoroughly investigated by the FDA and others.
>
> Bryce Carlson
Only sensible post I've seen in this thread.
C. Gates
Glenn - USAEyes.org wrote:
> According to the FDA, business as usual with the Alcon LADARVision
> means safe and very effective outcomes.
>
> http://www.fda.gov/cdrh/pdf/P970043b.pdf
This pdf does not specifically say "safe and very effective." The sample
population, and the doctors, for this FDA qualifying test were carefully
screened to ensure (game) the best outcomes.
A table in this report says shows 6.2 percent of patients with myopia
and astigmatism having an outcome of "double/ghost images." For that
same category of patients, 9.4 percent reported difficulty with night
driving.
I guess it is definitely business as usual. "Safe and very effective?"
Maybe if you don't have both myopia and astigmatism and -- if you don't
have to drive at night.
Glenn - USAEyes.org
>
>> According to the FDA, business as usual with the Alcon LADARVision
>> means safe and very effective outcomes.
>>
>> http://www.fda.gov/cdrh/pdf/P970043b.pdf
>
>This pdf does not specifically say "safe and very effective." The sample
>population, and the doctors, for this FDA qualifying test were carefully
>screened to ensure (game) the best outcomes.
Actually it does.
"Section X - Conclusions Drawn From The Clinical Studies
The data in this application support reasonable assurance of the
safety and efficacy of this device when used in accordance with the
indications for use."
>A table in this report says shows 6.2 percent of patients with myopia
>and astigmatism having an outcome of "double/ghost images." For that
>same category of patients, 9.4 percent reported difficulty with night
>driving.
These are adverse events that OCCURRED during the healing period.
These are not UNRESOLVED complications.
In the short term, many patients experience undesirable effects.
Everyone considering refractive surgery needs to understand not only
that surgery is not perfect, but that LASIK is not a 20-Minute
Miracle. LASIK is much more a six-month process.
If someone demands perfect vision immediately after LASIK with no
problems of any kind during the healing period, then that person has a
totally unreasonable expectation and should NOT have refractive
surgery.
You are no longer referring to the issues related in the London Times
article about the Alcon LADARVision laser being unreliable. You are
now discussing the general probability of problems with LASIK. These
are two very separate issues.
LASIK absolutely has its limitations and most certainly has its
downsides for an unfortunate minority, but there is nothing that
indicates LASIK outcomes with this particular laser are going to be
any more (or less) problematic when compared to other lasers of a
similar design. That was the charge in the London Times article,
which is an accusation no one has provided evidence to support.
>I guess it is definitely business as usual. "Safe and very effective?"
>Maybe if you don't have both myopia and astigmatism and -- if you don't
>have to drive at night.
It may be incorrectly inferred from your statement that a person with
myopia and astigmatism would always have night vision problems. That
is not the case. In fact, so long as reasonable consideration is
given to the issue of optical ablation zone and pupil size, the
probability for night vision problems remains quite small. See
http://www.usaeyes.org/faq/subjects/lasik_pupil_size.htm
Rebecca
> >A table in this report says shows 6.2 percent of patients with myopia
> >and astigmatism having an outcome of "double/ghost images." For that
> >same category of patients, 9.4 percent reported difficulty with night
> >driving.
>
> These are adverse events that OCCURRED during the healing period.
> These are not UNRESOLVED complications.
May we have some clarity here please.
Either these complications are:
1) known to be resolved, or
2) known to be unresolved, or
3) there is no information presented as to the actual resolution.
I haven't read the whole document, but from a skim I vote for #3.
Glenn - USAEyes.org
>> These are not UNRESOLVED complications.
>
>May we have some clarity here please.
>
>Either these complications are:
>1) known to be resolved, or
>2) known to be unresolved, or
>3) there is no information presented as to the actual resolution.
>
>I haven't read the whole document, but from a skim I vote for #3.
When you look at the FDA's 18 month data you can infer the resolution
of some of the problems, but look at all the other studies since this
1998 approval. You can use just the FDA document, but that only gives
you part of the story.
We review scores of studies and thousands of actual patient outcomes
to determine the current national norms. That is how we know that 3%
have unresolved complications at six months postop. Even then, some
of that 3% will later be resolved with further treatment or healing -
but that would be fudging a bit..
r5
> damage to the eyes of unknown numbers of patients, so Glenn is
Unknown?? More like negligible. Quit with the phony distortions
for once.