People, Protect Your Eyes; FDA Issues 2nd Warning 
Author Message
 People, Protect Your Eyes; FDA Issues 2nd Warning

From the FDA's  Web site, An Important Letter to Ophthalmologists  about
ophthalimic lasers.
Link:   http://www.***.com/
If the above link comes up 'not found', use
http://www.***.com/
Then, select New Items to get to this screen.
FDA server has a bug.

The entire  text is below, and regards both black box lasers (illegally
constructed) and gray market lasers (Summit lasers sold overseas without
keycard needed and possibly using small and nonhomogeneous beams and
re-imported to the U.S.):
----------------------------------------------------

Information about Lasers

An Important Letter to Ophthalmologists
About Lasers for Refractive Surgery

Dear Doctor:

This is to provide an update on the cooking.net">food and Drug Administration's (FDA)
policies regarding lasers for refractive surgery. When we last wrote you
on October 10, 1996, we described two situations in which unapproved
lasers were being operated without FDA approval: (1) unapproved lasers
manufactured by the owner, by someone else for the owner, or by a
corporate entity ("black box" lasers); and (2) importation of Summit
lasers originally manufactured in the United States and exported for use
overseas, or manufactured overseas before the company had received FDA
approval to market its devices in the U.S. ("gray market" lasers). We
have new information for you with respect to both types of lasers.

First, we have uncovered through our own investigations what appears to
be a pattern of serious patient injuries attributed to the use of some
"black box" lasers. These include several injuries requiring corneal
transplantation, additional (and repetitive) corneal surgery, severe
night vision problems, and frequent overcorrections ( >+2.00D).These
injuries and overcorrections appear to be caused by a laser beam that has
a relatively small optical zone, has considerable inhomogeneity, and
produces a non-spherical ablation pattern.

The injuries from "black box" lasers demonstrate the importance of
evaluating the safety and effectiveness of lasers for refractive surgery
with a limited number of patients under an FDA-approved Investigational
Device Exemption (IDE) and the oversight of an Institutional Review
Board, as required by the Federal Food, Drug, and Cosmetic Act (the
Act). Data from such studies is critical in establishing the risks and
benefits of particular laser designs.

In addition, "black box" lasers may not have adequate fail-safe
mechanisms and equipment hazard analyses; furthermore, software
validation and verification may not have been performed. We therefore
regard the use of unapproved lasers for refractive surgery as a serious
public health problem.

Second, with respect to "gray market" lasers, many of the physicians who
imported these lasers communicated their belief to the agency that their
lasers were the same as the approved Summit lasers. FDA attempted, in
the exercise of its enforcement discretion, to resolve the matter and
accommodate these physicians by providing an opportunity for them to
certify that their lasers were identical in all relevant aspects to
approved lasers.

Our experience with certification has led us to conclude that the
process described in our October 10 letter cannot be implemented
legally. Because imported Summit lasers do not meet all of the
conditions for approval of the Summit premarket approvals (PMAs), no
imported Summit lasers may be considered to be covered by those PMAs
unless the laser has been remanufactured by Summit to conform to the
specifications of the company's approved lasers. Unapproved lasers used
outside of an FDA-approved clinical trial violate the Act.

By now you are likely aware that FDA has seized "black box" lasers that
have been illegally distributed and are being used without an approved
IDE. We intend to take additional regulatory action against other
unapproved "black box" and "gray market" lasers used in refractive
surgery.

Both "black box" and "gray market" lasers for refractive surgery are
unapproved Class III medical devices that can be used on patients only
after FDA has approved an IDE for a clinical trial. Under an IDE, only a
limited number of subjects with specific conditions may be treated. The
IDE process is designed to investigate the safety and effectiveness of a
device either to obtain information for publication or to generate the
data needed to obtain marketing approval from FDA. An IDE is not an
approval for the commercial treatment of patients. Any study conducted
under an IDE is subject to all IDE regulations. You must understand,
however, that the market approval process that follows completion of IDE
studies requires more than clinical data; for example, the application
also must include detailed engineering and manufacturing specifications.

Clinicians wishing to conduct a clinical trial of a refractive surgery
laser can obtain information by visiting FDA's website at
http://www.***.com/
have further questions, contact Morris Waxler, Ph.D., at (301) 594-2018.

We know you share our concern that patients receive the safest treatment
possible when undergoing refractive surgery with lasers, and we look
forward to your cooperation in this matter. In addition, if you are
aware of any patient injuries associated with the use of lasers for
refractive surgery, we request that you report them to the FDA. You may
report adverse events to FDA's MedWatch program at telephone
1-800-FDA-1088 or fax 1-800-FDA-0178.

Sincerely yours,

Lillian J. Gill Susan Alpert, Ph.D., MD
Director Director
Office of Compliance Office of Device Evaluation
Center for Devices Center for Devices
?and Radiological Health ?and Radiological Health

(Updated July 2, 1997)

==========================
Only YOU can protect yourself.

EyeKnowWhy is the largest and most comprehensive nonprofit consumer
education web site dedicated to educating consumers worldwide regarding
the risks and benefits of refractive surgery (RK, PRK, LASIK).

http://www.***.com/



Sun, 26 Dec 1999 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning

Lasers that were shipped outside the US to be used because they couldn't
get approval here are now causing patient injuries?  Hmmm.... are we
still all e{*filter*}d about going outside the US for our surgeries?

Don't jump all over me;  it's just the first thing that came to mind
after reading the FDA letter.
--
Mark Brown
What's another word for thesaurus?



Sun, 26 Dec 1999 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning

Quote:

> Mark,

> They are not lasers
> being used in other countries because they *couldn't* be approved here
> (like you say).  These companies have fully complied by F.D.A. regulations
> and have obtained I.D.E.s to prove themselves to this rigid governmental
> body; now they are simply waiting for a slow, bureaucratic process to take
> place.

> Why should people like myself wait for this to happen when it's available
> *now* to those who have the ability to sift through all the politics and
> understand that treatment in some places outside of the U.S. (like the
> clinic I went to) can actually be *much better* than what is here?  I know
> you've read the document I recently prepared summarizing the reasons why,
> and anyone else interested can e-mail me.

> Georgia Veith

I know, I know.  Georgia, put the gun down.  I devoted an entire second
paragraph to say "please don't JUMP all over me,"  it was just a passing
thought.  I'm on your side. :o)  I understand entirely your Columbian
success and did not mean to discourage anyone from going outside.

--
Mark Brown
What's another word for thesaurus?



Mon, 27 Dec 1999 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning


ote:

Quote:
>Lasers that were shipped outside the US to be used because they couldn't
>get approval here are now causing patient injuries?  Hmmm.... are we
>still all e{*filter*}d about going outside the US for our surgeries?

>Don't jump all over me;  it's just the first thing that came to mind
>after reading the FDA letter.

        FYI, the Chiron Technolas Keracor 117 is currently undergoing U.S.=
=20
trials under an IDE (Investigational Device Exemption).  Dr. Galvis uses a=
=20
more advanced model (217).  These machines ("scanning beam" type) are *way*=
=20
ahead of the VISX Star, and at least the discussion on eyeknowwhy suggests=
=20
that machines such as this offer reduced "collateral damage" to surrounding=
=20
eye tissues because each pulse delivers less energy to the eye than the VIS=
X=20
diaphragm beam lasers do.  The resulting ascoustical shock wave generated w=
hen=20
the stromal cells struck by the laser explode should be lessened as well,=20
reducing trauma to the endothelium and (and to the retina -- the aqueous an=
d=20
vitreous humors should transmit vibration rather well, I would think).

        If my right eye's night vision problems clear up to my satisfaction=
,=20
and if my eye stays stable near 20/20, I would rather go to Dr. Galvis for =
my=20
left than to anyone in the U.S.

        Note that I have no financial stake in any company or surgeon I've=
=20
mentioned here, and in fact I've pointed out eyeknowwhy's web site to every=
one=20
who has asked me about my surgery.  If people want to have it done, I want =
to=20
make sure they make an informed decision, with full knowledge of the risks =
and=20
tradeoffs.

        And I'm not a doctor either.

Regards,

Chris BeHanna                          behannaatsyldotnjdotnecdotcom
Senior Software Engineer
NEC Systems Laboratory     No, I don't want unsolicited commercial email.
Princeton, New Jersey      See http://www.***.com/ ~behanna/nospam.html

     Check out my LASIK page:   http://www.***.com/ ~behanna/lasik.html



Tue, 28 Dec 1999 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning

--
Mark J. Lapierre Sr.



Quote:

> From the FDA's  Web site, An Important Letter to Ophthalmologists  about
> ophthalimic lasers.
> Link:   http://www.***.com/
> If the above link comes up 'not found', use
> http://www.***.com/
> Then, select New Items to get to this screen.
> FDA server has a bug.

> The entire  text is below, and regards both black box lasers (illegally
> constructed) and gray market lasers (Summit lasers sold overseas without
> keycard needed and possibly using small and nonhomogeneous beams and
> re-imported to the U.S.):
> ----------------------------------------------------

If the FDA weren't so fat, dumb, and happy basking in our tax dollars, if
they got off they're collective asses and allowed some world class
technology into the U.S. like the Chiron Technolas machines, the laws of
supply and demand would help to eliminate inferior equipment such as these
black box lasers. The trouble is, it would also help to get rid of some of
the approved equipment by rendering it obsolete. That would make the FDA
look pretty foolish.

When the government wants something for the government, like a new weapon,
or money to bail out an ally, it happens fast. When the public wants
something from the government, it takes years.

I've just returned from Canada to have LASIK done on a Chiron laser. I
could have had it done 30 minutes from home on a summit with a little {*filter*}y
6mm ablation and had my astigmatism corrected with a scalpel (yeah right,
when pigs fly).

Is the Canadian data not good enough for the folks at the FDA? They've
already got the long term case data that the FDA is "waiting" to collect.Do
we not trust the Canadians for the integrety of this data?  There's no real
pressure for the FDA to do anything about this, therefore it won't get
done.

If this post sounds like I'm just attacking the FDA because of thier
stupidity and lack of action in the interest of the people who they
supposedly serve, well... maybe I am.

Mark.



Sat, 01 Jan 2000 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning


Quote:




Quote:

> From the FDA's  Web site, An Important Letter to Ophthalmologists  about
> ophthalimic lasers.
> Link:   http://www.***.com/
> If the above link comes up 'not found', use
> http://www.***.com/
> Then, select New Items to get to this screen.
> FDA server has a bug.

> The entire  text is below, and regards both black box lasers (illegally
> constructed) and gray market lasers (Summit lasers sold overseas without
> keycard needed and possibly using small and nonhomogeneous beams and
> re-imported to the U.S.):
> ----------------------------------------------------
>>If the FDA weren't so fat, dumb, and happy basking in our tax dollars,
if
>>they got off they're collective asses and allowed some world class
>>technology into the U.S. like the Chiron Technolas machines, the laws of
>>supply and demand would help to eliminate inferior equipment such as
these
>>black box lasers. The trouble is, it would also help to get rid of some
of
>>the approved equipment by rendering it obsolete. That would make the FDA
>>look pretty foolish.
>>When the government wants something for the government, like a new
weapon,
>>or money to bail out an ally, it happens fast. When the public wants
>>something from the government, it takes years.

>>I've just returned from Canada to have LASIK done on a Chiron laser. I
>>could have had it done 30 minutes from home on a summit with a little
{*filter*}y
>>6mm ablation and had my astigmatism corrected with a scalpel (yeah
right,
>>when pigs fly).

>>Is the Canadian data not good enough for the folks at the FDA? They've
>>already got the long term case data that the FDA is "waiting" to
collect.Do
>>we not trust the Canadians for the integrety of this data?  There's no
real
>>pressure for the FDA to do anything about this, therefore it won't get
>>done.

>>If this post sounds like I'm just attacking the FDA because of thier
>>stupidity and lack of action in the interest of the people who they
>>supposedly serve, well... maybe I am.

Mark.

Mark,
It should be pointed out that these Summit 'grey box' lasers were in wide
use in other less regulated countries up until 1995, and thousands
(perhaps hundreds of thousands) of uninformed consumers had their eyes
done with experimental nomograms, nonhomogenous beams, and 4mm and 5mm
ablation zones in those countries (including Canada).  During this time,
only 2 - 3 thousand Americans were allowed the same surgery due to FDA's
trial restrictions.  If Summit and VISX had been allowed to begin
marketing their machines before developing a 6mm zone and improved optical
beam control, the US would have hundreds of thousands of people with the
severe problems these patients in these 'unregulated' countries have.

If the FDA and CDRH (Center for Device and Radiological Health) were not
in place, there would be hundreds (not 15 - 50) of  'black box' lasers on
the market blinding patients on a daily basis.

There are many owners of Summit machines eager to make money, and even if
new machines were available, they wouldn't buy them because of their
initial capital outlay that would have to be written off.  Summit's
astigmatism procedure is complex and problematic (uses a mask).  Rather
than wait for improvements or purchase a laser that integrates astig.
correction, they are selling AK as the solution.  Emory in Atlanta  is
doing this to a lot of patients.  Although astigmatism correction has been
widely touted for VISX, Chiron and others, it is still very new and has
problems, primarily with increased glare, arc, starburst and halo effects
due to the short diameter of the triangular ablation zone used for
astigmatism.

The FDA does allow the use of other countries trial data, but with limits.
 See the VISX astig. approval and the ATC Phase III approvals.  Both used
data from other countries.  The FDA does still require that there be some
domestic data during Phase III using a multicenter criteria.  You should
also be aware that the FDA now only requires 1 year of followup data for
Phase III.

To give you some perspective, you should research the history of
'thalidomide' which was widely marketed in other coutries while the FDA
held up approval for more limited trials to determine side effects and
long term complications..  It turned out many years later that almost all
the women who took thalidomide gave birth to severely deformed infants
without arms and legs.  Prior to this realization occurring, everybody
(marketers, doctors and public) were complaining publicly and bitterly
about the FDA not approving this drug.  Hundreds of thousands of Americans
today owe their health and normal appendages to the FDA's delays in
approving this dangerous drug.

It seems that everyone has a love hate with the government regulatory
agencies depending on perspective.  People accuse the FAA for interfering
with an aviation free market, but when company abuses put the flying
public at risk, everyone asks 'why don't THEY do something'.  The same
could be said for the SEC, the Federal Reserve, the NHTSA,  and many other
agencies.  It's a 'compromise' when assessing the FDA's  requirements for
determining the 'safety and effectiveness' of {*filter*}, cooking.net">food additives, and
medical devices.

Health care is a multibillion dollar business, and without some regulation
would be rife with corruption and reckless endangerment of the public.
Some would argue it is despite regulation.

 In regards to 'long term' data, there are no adequate studies of LASIK
beyond two years, and studies  based solely on the results at one center
or a small group of surgeons may be biased and misleading.  RK is an
example of reckless corruption and the power of greed when there is no
regulatory review.  Literally thousands of Americans have been  rendered
severely visually impaired or functionally blind by RK surgeons, and there
is no regulatory agency today or in the future to stop them.  It's a
caveat emptor world, and not everyone is as knowledgeable about refractive
surgery options and that suits many refractive surgeons just fine.

I find flaws in the FDA myself, but it's better than nothing.


http;//members.aol.com/eyeknowwhy/



Sat, 01 Jan 2000 03:00:00 GMT
 People, Protect Your Eyes; FDA Issues 2nd Warning

Quote:

...................

>Health care is a multibillion dollar business, and without some regulation
>would be rife with corruption and reckless endangerment of the public.
>Some would argue it is despite regulation.

Nawwwwwwww.  Never.  ;->  What regulation?  Regulation over machinery?
How about over the guys who *use* it?  They have licensure essentially
*without* regulation.  OK, so ask a burglar.  He'll surely tell you,
"Only burglars have sufficient knowledge and skills in the field of
burgling.  Only *they* should be allowed to "self-regulate" it.
Sounds familiar, doesn't it.

Quote:
> In regards to 'long term' data, there are no adequate studies of LASIK
>beyond two years, and studies  based solely on the results at one center
>or a small group of surgeons may be biased and misleading.  RK is an
>example of reckless corruption and the power of greed when there is no
>regulatory review.  Literally thousands of Americans have been  rendered
>severely visually impaired or functionally blind by RK surgeons, and there
>is no regulatory agency today or in the future to stop them.  It's a
>caveat emptor world, and not everyone is as knowledgeable about refractive
>surgery options and that suits many refractive surgeons just fine.

>I find flaws in the FDA myself, but it's better than nothing.

Very true.

Ray



Sun, 09 Jan 2000 03:00:00 GMT
 
 [ 7 post ] 

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