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Home > Archive > Lasik Eyes Surgery > November 2004 > JewelEye: Ophthalmologists Express Concerns
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JewelEye: Ophthalmologists Express Concerns
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| http://abcnews.go.com/Health/story?id=118200&page=1
August 10, 2004 Ridiculous. Weird. Strange. These are the adjectives
some ophthalmologists are using to describe eyeball jewelry — a new
kind of body adornment imported from Europe and now being showcased on
American shores.
That's right. If you want to add glitz to your gaze, you can have a
thin platinum jewel implanted in the mucus membrane of the eye. And to
do it, you don't have to go all the way to Europe, where the procedure
originated. You just have to go to L.A.
Robert K. Maloney, director of Maloney Vision Institute in Los
Angeles, is the first ophthalmologist in America to perform the
procedure.
Unlike many of his colleagues, Maloney thinks that eyeball jewelry is
fun — and safe.
"We believe it's as safe as wearing contact lenses. It's certainly as
safe as the colored contact lenses you see all the time — it may be
safer — and it's really a lot of fun," says Maloney. "It's a really
neat way to make yourself unique if that's something you want to do."
But many ophthalmologists are wary of eyeball jewelry, and are issuing
strong cautions about the fashion trend.
"I am not in favor of this type of surgery because there may be risks
such as chronic eye redness, irritation, and even infection," says
Allan Rutzen, associate professor of ophthalmology at the University
of Maryland School of Medicine in Baltimore. "The general population
needs to know that this has not been thoroughly tested and that the
risks are not fully known."
Warns Jim McCulley, professor and chairman, Department of
Ophthalmology at the university of Texas Southwestern Medical Center
at Dallas, "They are taking unknown risks that might be vision
threatening."
The Procedure
To give his customers a twinkle in their eye, Maloney implants a
0.13-inch wide piece of jewelry into the conjunctiva — the mucus
membrane lining the front of the eyeball.
"The eye is covered by a thin layer of skin and we make a small
incision in that skin and slip the jewel underneath," says Maloney.
"It sits on top of the eyeball itself."
The 15-minute procedure costs $3,900 and is performed under local
anesthetic.
The procedure was developed and patented by The Rotterdam Institute in
the Netherlands. There have been no reported side effects or
complications in the approximately 50 people around the world who have
opted for eyeball jewels.
And according to Maloney, the procedure is painless.
"As you recover, there's some mild irritation for a couple of weeks
and there's some redness around the jewel and all the redness goes
away and the discomfort goes away and you've got a little twinkle in
your eye."
Maloney's first customer chose a heart as her eyeball jewel. And the
21-year-old woman is delighted with the new twinkle in her eye.
"One of the really neat things about it — it's not obvious from the
picture — it's much more subtle than it looks," says Maloney. "When
you're looking at people straight ahead you don't see it. It's when
they look to the side that you can suddenly see the jewel.
Maloney predicts that this is what many of his future customers will
find appealing about eyeball jewelry.
"There's this sense of it being a secret. Something that's uncovered,
something to be revealed," says Maloney.
Is It Really Safe?
But the American Academy of Ophthalmology released a statement in
April expressing concern and cautions about the procedure. And eyeball
jewelry or "JewelEye" has not yet been approved by the U.S. Food and
Drug Administration, or FDA.
After briefly reviewing Maloney's press release on eye jewelry, the
FDA released a statement saying although it needs more information to
proceed, the agency would not regulate the eye jewelry as a medical
device, but perhaps as a cosmetic.
Maloney, after talking with a lawyer, doesn't believe eye jewelry
needs to be regulated by the FDA at all.
"I don't believe the FDA has regulatory authority — they may claim
regulatory authority, in which case we can do an FDA trial."
But Maloney notes that eyeball jewelry can ultimately be removed, if
the wearer wants.
Yet even Maloney cautions the procedure has to be performed by a
licensed ophthalmic surgeon.
"We've been putting implants under the eye for a very long time, for
maybe 30 to 40 years," says Maloney. "Even though this is brand new,
the general concept of an implant is something that is tried and
true."
‘ Way Out of Mainstream Medicine'
But other ophthalmologists maintain eyeball jewelry procedures are
unnecessary and unsafe.
"I think this is something way out of mainstream medicine," says Yaron
S. Rabinowitz, a clinical professor of ophthalmology at U.C.L.A.
School of Medicine. "I just don't think the average ophthalmologist is
going to offer something like this in their medical practices."
Rabinowitz further cautions, "While I have no experience with this, it
would appear to me that the main potential risks are infection,
allergy, erosion of the jewelry and possible loss of the jewelry if
you rubbed the eye on a regular basis."
Susan Taub, M.D., assistant professor of ophthalmology at Northwestern
University in Chicago, says the three risks of implanting jewels in
the mucus membrane of the eye are rejection, infection, and
inflammation.
"For anything foreign that is planted in the body you have to worry
about these three things," says Taub. "And people doing it for a
cosmetic reason should definitely know what the potential
complications may be."
Yet with only 50 eyeball jewelry procedures conducted in the world, no
one knows what, if any, the long-term risks might be.
Randall Olson, director of the John A. Moran Eye Center at the
University of Utah in Salt Lake City, thinks it is too soon to know if
the procedure is safe.
"If sterile, [the procedure] will work short term, but dislocation [of
the jewel] with exposure and infection is a real possibility," warns
Olson. "This all begs the question of why put an eye at risk?"
"The reality is that if you do get bored with it, unlike a tattoo, you
can take it out and throw it away — it can be surgically removed,"
says Maloney. "If you like the idea of a tattoo but you are little
concerned about its permanency, you may want to think about an eye
jewel."
For the fashonistas who want JewelEye, H. Dwight Cavanagh, professor
and vice chairman, Department of Ophthalmology, university of Texas
Southwestern Medical Center at Dallas has this advice: "Go only to
licensed surgeon-ophthalmologist and understand that follow-up is
required."
But remember, as one ophthalmologist said, we only have two eyes.
"When it comes to a cosmetic surgery, I think personally that the
benefits do not outweigh the risks," says Rutzen.
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| Ragnar Suomi 2004-11-08, 7:12 pm |
| On 7 Nov 2004 01:05:11 -0800, sandy@savvysneaks.com (Sandy) wrote:
I have 3 comments to add about this right now. I did post a lengthy
post on this weeks ago.
First, the eye is an organ - in fact an extension of the brain. It's
not merely a bit of flesh like a belly button or earlobe or nostril
that someone might have jewelry implanted into.
Second, $3900 for this eye jewelry operation? That is ridiculous.
The cost of the jewelry and equipment involved is certainly under
$100.
Third, Dr. Maloney seems to have an obsession with being the first
surgeon to do everything. Maybe he's a test surgeon? I hope he isn't
seriously considering including this procedure as part of his normal
practice.
BTW, as I recall, Dr. M is one of the surgeons you picked out well
after you declared yourself to be an expert.
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| Glenn - USAEyes.org 2004-11-08, 7:13 pm |
| >BTW, as I recall, Dr. M is one of the surgeons you picked out well
>after you declared yourself to be an expert.
Not only did Keller do extensive research to select Dr. Maloney to
perform multiple procedures to restore her sight after her bad LASIK
outcome, but she repeatedly praised him in multiple forums. That is,
she praised him until he had to audacity to suggest that there may
have been mitigating circumstances and her optometrist may not have
been totally wrong in the process by which she was determined to be an
appropriate candidate for LASIK.
The mere suggestion that her optometrist may not have wronged Keller
threw her into tirades against Dr. Maloney on this newsgroup.
The ranks of those who Keller attacks is ever growing. It now
includes her original doctors, her own lawyers that got her a quarter
of a million dollar settlement, and Dr. Maloney who helped restore her
vision. Come to think of it, I guess I'm among those ranks too.
As is often said, no good deed goes unpunished.
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.
| |
| Ragnar Suomi 2004-11-08, 7:13 pm |
| On Mon, 08 Nov 2004 20:28:37 GMT, Glenn - USAEyes.org
<glenn.hageleSTOPSPAM@USAEyes.org> wrote:
>
>Not only did Keller do extensive research to select Dr. Maloney to
>perform multiple procedures to restore her sight after her bad LASIK
>outcome, but she repeatedly praised him in multiple forums. That is,
>she praised him until he had to audacity to suggest that there may
>have been mitigating circumstances and her optometrist may not have
>been totally wrong in the process by which she was determined to be an
>appropriate candidate for LASIK.
>
>The mere suggestion that her optometrist may not have wronged Keller
>threw her into tirades against Dr. Maloney on this newsgroup.
>
>The ranks of those who Keller attacks is ever growing. It now
>includes her original doctors, her own lawyers that got her a quarter
>of a million dollar settlement, and Dr. Maloney who helped restore her
>vision. Come to think of it, I guess I'm among those ranks too.
>
>As is often said, no good deed goes unpunished.
>
>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.
I think the worst thing I ever heard of Dr. Maloney doing was letting
her into the operating room without a mask or booties to stand behind
him and watch a LASIK procedure. He had no business doing that. He
could have been successfully sued for that if the story is true. Can
you imagine someone sneezing without a mask on from the venting of the
gases during ablation?
| |
| Glenn - USAEyes.org 2004-11-08, 7:13 pm |
| As much as this may surprise you, a significant portion of surgeons do
not use masks while performing refractive surgery, and a sizeable
portion do not wear gloves. The really surprising part is the lack of
problems related to no gloves and no masks.
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.
| |
| serebel 2004-11-08, 10:08 pm |
| Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<mevvo09nrfsesimn24u34fgnqc02484eej@4ax.com>...
> As much as this may surprise you, a significant portion of surgeons do
> not use masks while performing refractive surgery, and a sizeable
> portion do not wear gloves. The really surprising part is the lack of
> problems related to no gloves and no masks.
>
> 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.
Possibly because RS is bloodless and minimumly invasive?
SErebel
| |
| Glenn - USAEyes.org 2004-11-08, 10:08 pm |
| The Centers for Disease Control was asked by the California Medical
Board to comment on the issue of cross contamination and the lack of
mask/glove, etc. Their response was that the probability of
contamination causing infection or disease in LASIK was so small as to
almost be nonexistent.
LASIK, PRK, LASEK, and Epi-LASIK are not performed in a sterile
environment, but in an antiseptic environment. If a patient is going
to have RLE or P-IOLs, then a sterile environment is required because
these procedures are significantly more invasive and prone to
infection than LASIK, PRK, LASEK, and Epi-LASIK. Even Intacs are less
invasive than RLE or P-IOLs.
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.
| |
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| Ragnar Suomi <ragnarsuomi@yahoo.com> wrote in message news:<f8ovo0l7vbjav2kgqjtig1ipv5rtucpc23@4ax.com>...
>
> I think the worst thing I ever heard of Dr. Maloney doing was letting
> her into the operating room without a mask or booties to stand behind
> him and watch a LASIK procedure. He had no business doing that. He
> could have been successfully sued for that if the story is true. Can
> you imagine someone sneezing without a mask on from the venting of the
> gases during ablation?
Christopher, you can't just sue someone for damages where there are
none. I have not been called by that patient's attorney to testify
that I was standing a couple of feet behind his head, so there was
probably no harm done. As I recall, he knew that someone was
observing--someone who didn't really belong there--because as I walked
up behind him (he was already under the laser) I told Dr. Maloney that
I had never watched a lasik surgery before, and he said that he had
guessed that I hadn't. I didn't sneeze, but who knows...I may have
spit while I was talking, or even Dr. Maloney could have. Heck,
flakes of dead skin could have fallen from his face as he put his mask
on. I wonder if the flap had been lifted yet? LOL!!!! I wonder if
any lasik patients have dandruff under the flap? Hey, I think I have
identified a new lasik syndrome. DDK--Diffuse Dandruff Keratitis!!
AKA "crap under the flap" or "surgeon snow". ROFL!!!
| |
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| Glenn - USAEyes.org <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message news:<28lvo0td0g8vclpslo6tq7ppv2ucphg359@4ax.com>...
I have never declared myself to be an expert. Let's see...I demand an
immediate retraction of that untrue statement, Glenn Hagele, in this
forum. What was that verbage you barraged this group with recently?
[vbcol=seagreen]
>
> Not only did Keller do extensive research to select Dr. Maloney to
> perform multiple procedures to restore her sight after her bad LASIK
> outcome, but she repeatedly praised him in multiple forums. That is,
> she praised him until he had to audacity to suggest that there may
> have been mitigating circumstances and her optometrist may not have
> been totally wrong in the process by which she was determined to be an
> appropriate candidate for LASIK.
Thanks for the history lesson, Glenn.
Mitigating circumstances? I had dry eyes, mild blepharitis,
warped/irregular corneas and huge pupils, yet I was declared a great
candidate for lasik. Ah, yes! The mitigating circumstances were that
I was there, and I could afford the $4400 fee.
When I first saw Dr. Maloney, one of my questions for him was, "Should
my surgeon have known my pupil size when he chose the ablation zone?"
and Dr. Maloney's answer was, "Not necessarily". I already knew the
answer to that question, and thus sadly realized that although Dr.
Maloney might be willing to help me surgically, I may or may not get
honest answers to my questions. I know that I would have fared much
better with a 6.5 mm ablation zone than I have with the smaller 6.0 mm
zone I got. I had plenty of cornea, being only a -3.5. In fact, I
had enough cornea for a fully corrected 8 mm zone.
I recall that his optometrist measured my pupils at 7 mm and that Dr.
Maloney suggested that he try some minus correction lenses to see if
that cleared up the starbursts, but it did not. Then the OD tried the
flashlight test, and sure enough, they immediately shrank to nothing.
Years later, I would find that Alphagan did the same for me. Hmmm,
does anything here lead you to believe that my pupil size is a
problem, given my small ablation zones??
I know for a fact that pupils are measured in Maloney's office as part
of the first round of exams when a patient wants refractive surgery,
so for him to tell me that it was okay that Hawley didn't measure my
pupils...sheesh.
I recall having a discussion with Dr. Maloney about enlarging my
ablation zones out to 8 mm, to match my 8 mm pupils. Why would he
tell me that I needed to wait until a future generation of Visx
software was available, because the fully corrected zone on his laser
was only 6.5mm at the time and he couldn't do an 8 mm zone? You know
what's funny? Even the rookie Weinman knew that my pupils were too
big. For him, 8 mm was the "no go size".
I will never in my lifetime forget the look on Maloney's face after my
lawsuit ended and I showed him the photo I had taken of my pupils, nor
what he said. "Those are YOUR pupils??" A couple of years later, he
says it doesn't matter. Hawley's insurance company said it mattered
when they wrote me a check for $125,000. I think Weinman's insurer
did too, when they wrote theirs.
> The mere suggestion that her optometrist may not have wronged
Keller
> threw her into tirades against Dr. Maloney on this newsgroup.
I recall that YOU had the tirades, Glenn, because you initially
responded that you would be very concerned about any surgeon who would
say those things to me. Then, when you found out that it was Dr.
Maloney who had said them, you found yourself in the position of doing
everything you could to defend him, or distract attention away from
the fact that you disagreed with what he'd said...whatever you were
trying to do. Then you finally admitted that Dr. Maloney had admitted
that what he said was "less than artfully worded", which I guess is as
close as we'll ever get to a retraction of those words.
and Dr. Maloney who helped restore her
> vision.
Glenn, I have many times over the years expressed my appreciation that
Dr. Maloney tried to improve my vision. I thanked him for trying and
he has thanked me for in the past referring patients to him---"the guy
who couldn't help you" is how he put it.
The fact that I may be grateful that he attempted to repair my cornea
doesn't mean that he can tell me that it is okay that Dr. Hawley
failed to measure my pupils, which was and is the standard of care
even in Dr. Maloney's own office.
> As is often said, no good deed goes unpunished.
Good deeds.....hmmmm, Glenn, when you do a good deed, do you charge a
fee? Let's define "good deed". You first.
>
> 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.
| |
| Glenn - USAEyes.org 2004-11-09, 11:09 am |
| >> >BTW, as I recall, Dr. M is one of the surgeons you picked out well
>
>I have never declared myself to be an expert.
Get a grip, Keller. You are attributing Ragnar's quote to me.
Of course, Keller claims she has never said she is an expert, but she
feels she can publicly berate a Harvard graduated surgeon because she
knows better than him about refractive surgery issues.
If anybody is interested in the long and protracted attempt by Keller
to:
1) Decry Dr. Maloney's knowledge because he disagreed with her.
2) Attempt to put words in Dr. Maloney's mouth.
3) Selectively edit Dr. Maloney's statement to make it appear to be
something other than it was.
4) Attempt to make it appear that I disagree with Dr. Maloney, when in
fact I disagreed with what Keller manipulated and misquoted.
5) Attempt to create the appearance of a conflict when no conflict
actually exists.
6) Demonstrate that she will turn against anyone no matter how much
that person has helped her if that person ever has the audacity to
disagree with her.
If you want to see all this and more, then just do a search on this
newsgroup with the words "pupil size", "Schallhorn", and/or "Maloney".
Or, if you don't want to waste your time but would like to know the
important issues underlying Keller's tirade and attempt at character
assassination, visit
http://www.usaeyes.org/faq/subjects..._pupil_size.htm for a
detailed and plain language article on pupil size and its relevance to
refractive surgery.
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.
| |
| Ragnar Suomi 2004-11-09, 7:12 pm |
| There's another thing to add to your CRSQA recommendations. Watch
your surgeon perform a surgery. If he doesn't wear a mask, go to
another surgeon. I wouldn't disqualify a LASIK surgeon for not
wearing gloves though... although it's a good idea.
A mask is a must.
A looney standing behing the surgeon is a definite no-no.
On Mon, 08 Nov 2004 23:16:06 GMT, Glenn - USAEyes.org
<glenn.hageleSTOPSPAM@USAEyes.org> wrote:
>As much as this may surprise you, a significant portion of surgeons do
>not use masks while performing refractive surgery, and a sizeable
>portion do not wear gloves. The really surprising part is the lack of
>problems related to no gloves and no masks.
>
>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.
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