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Medical Forum / Diseases and Disorders / Breast Cancer / March 2007

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Silicone gel breast implants most defective medical device ever approved by the FDA (corrected)

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Ilena Rose - 26 Dec 2006 17:23 GMT
The coward Skeptic could not be more wrong. Dr. Wolfe accurately
described the problems with this industry forced approval of a
dangerous product. More than a quarter of a million women have
reported serious adverse affects from their defective implants.

Have a lovely holdiay.

http://www.elfyourself.com/?userid=c7592398da519e7b70e47d3G06121616

www.BreastImplantAwareness.org/Holidays2006.htm

On this holiday cheer time ... there are untold thousands of us who
feel that the FDA caved in to the silicone industry, by granting
questionable 'safety approval' for an unproven product. We believe
this will endanger the lives of millions of women, who oft are denied
health insurance because of their implants.

The Humantics Foundation message mirrors that of Dr. Sidney Wolfe's of
Public Citizen. Bravo to his strong stance on the dangers of breast
implants. 

http://www.citizen.org/hot_issues/issue.cfm?ID=1477

Nov. 17 - Silicone gel breast implants most defective medical device
ever approved by the FDA

Statement of Dr. Sidney Wolfe, Director of Public Citizen’s Health
Research Group

Public Citizen has opposed the use of silicone gel breast implants
since the fall of 1988, when we petitioned the Food and Drug
Administration (FDA) to ban them after receiving numerous documents
from FDA scientists concerned about their safety.

In terms of adverse safety and health information known at the time of
approval – such as high rates of rupture, the need for repeat surgery
and clear evidence of lymph node infiltration and damage by leaked
silicone – silicone gel breast implants are the most defective medical
device ever approved by the FDA. The approval makes a mockery of the
legal standard that requires “reasonable assurance of safety.”

It is a terrible reminder of the double standard for women versus men
that the FDA has not approved silicone gel testicular implants because
of the inadequacy of clinical trials on these devices. (Saline breast
implants and testicular implants have been approved by the FDA.)

This approval of such a defective medical device raises again the
larger issue of the poor leadership and dangerously poor performance
of the FDA’s Center for Devices and Radiological Health (CDRH). Recent
examples of this include the large number of defibrillator and
pacemaker recalls, primarily the fault of manufacturers such as
Guidant but abetted by the lack of FDA promptness, and the approval of
the vagus nerve stimulator for depression despite the opposition of
dozens of FDA staffers because it lacked evidence of effectiveness.

We will certainly be urging thorough congressional investigations and
hearings on this lack of assertion of regulatory authority by the
FDA’s CDRH.

###
George Conklin - 26 Dec 2006 19:19 GMT
> The coward Skeptic could not be more wrong.

  I actually knew the people the courts hired to examine this, and saw
their presentation of the statistics they used.  There is no reason for a
ban.  Skeptic is right on that one.
Skeptic - 27 Dec 2006 03:19 GMT
>> The coward Skeptic could not be more wrong.
>
>   I actually knew the people the courts hired to examine this, and saw
> their presentation of the statistics they used.  There is no reason for a
> ban.  Skeptic is right on that one.

And he doesn't say *that* very often.
Ilena Rose - 26 Dec 2006 20:04 GMT
O George ... that's just silly.

Dr. Zuckerman is right on in her quote here:

EXCERPT:

“Getting silicone breast implants (without the MRIs to detect
ruptures) has greater risks than sky diving,” says Diana Zuckerman,
president of the nonprofit research and education organization.

“The thing that's so dangerous about silicone breast implants is that
things can seem absolutely fine. But in time, they can break inside
the body and might leak,” she says. “We don't actually know what those
(leakage) risks are. But, we do know that two-thirds of the time, you
can't detect a rupture (without an MRI).”

Because there's no way to enforce FDA recommendations, she believes
most women won't follow through, either because they can't afford it
or because they don't think there's anything wrong.

“Right now, I think the biggest issue for women making a decision
about silicone breast implants is 'Can I afford an additional $10,000
to $20,000 (for MRIs and possible replacement surgeries) over the next
few years?' ” Zuckerman says.

The FDA will continue its review of the silicone implants, requiring
the manufacturers to study their effects on 43,000 women for 10 years
after surgery.

http://www.signonsandiego.com/news/health/20061226-9999-1c26saline1.html
Ilena Rose - 27 Dec 2006 02:51 GMT
O George ... that's just silly.

Dr. Zuckerman is right on in her quote here:

EXCERPT:

“Getting silicone breast implants (without the MRIs to detect
ruptures) has greater risks than sky diving,” says Diana Zuckerman,
president of the nonprofit research and education organization.

“The thing that's so dangerous about silicone breast implants is that
things can seem absolutely fine. But in time, they can break inside
the body and might leak,” she says. “We don't actually know what those
(leakage) risks are. But, we do know that two-thirds of the time, you
can't detect a rupture (without an MRI).”

Because there's no way to enforce FDA recommendations, she believes
most women won't follow through, either because they can't afford it
or because they don't think there's anything wrong.

“Right now, I think the biggest issue for women making a decision
about silicone breast implants is 'Can I afford an additional $10,000
to $20,000 (for MRIs and possible replacement surgeries) over the next
few years?' ” Zuckerman says.

The FDA will continue its review of the silicone implants, requiring
the manufacturers to study their effects on 43,000 women for 10 years
after surgery.

http://www.signonsandiego.com/news/health/20061226-9999-1c26saline1.html
Skeptic - 27 Dec 2006 03:21 GMT
>O George ... that's just silly.
>
[quoted text clipped - 4 lines]
> "Getting silicone breast implants (without the MRIs to detect
> ruptures) has greater risks than sky diving," says Diana Zuckerman,

greater risk for.. for what??  For death?  No.  For rupture of an implant?
I'd hope so.  Kind of a stupid analogy, don't ya think?  Oh wait, you don't.
Ilena Rose - 27 Dec 2006 05:31 GMT
NOW President, Kim Gandy shows well the fallacy in Skeptics's (for
want of a better term) thinking ...

http://www.now.org/press/11-06/11-17.html
FDA Approval of Dangerous Implants During Lame Duck Session
Follows FDA Pattern of Favoring Money and Politics Over Science

November 17, 2006

Today the Food and Drug Administration (FDA) issued final approval to
manufacturers Allergen Corporation (formerly Inamed) and Mentor Corp.
for general marketing of silicone gel-filled breast implants to women
of all ages for reconstruction purposes and women 22 and older for
augmentation purposes.

"Women should be outraged by this reckless decision. Bush-appointed
FDA leaders are once again endangering the public health, this time to
enrich manufacturers and cosmetic surgeons," said NOW President Kim
Gandy. "Sadly, we are not shocked that this agency is swayed more by
money and politics than science and medicine. And I doubt it's a
coincidence the FDA issued approval during the 'lame duck session'
just before Congress is set to change leadership. The new Congress
would likely have exercised more oversight, in order to limit
political influence over decisions at the FDA. Without George W.
Bush's cronies in charge, it's much more probable that the next
Congress will take a close look at the FDA's highly suspect review and
approval process. But many more women will suffer until that happens."

In recent months, more and more evidence has accumulated that
manufacturers withheld critical information clearly demonstrating that
silicone implants are not safe. The FDA has shown little interest in
examining concerns expressed by their own scientists or the
allegations of industry whistleblowers.

A recently published peer-reviewed study showed that women with
implants, and their children, who are ill with autoimmune diseases and
other health problems, have high levels of a toxic form of platinum,
which was found in samples of their blood, tissue, hair, nail, urine
and breast milk. Rather than attempting to replicate the study, FDA
officials responded by dismissing it, following the lead of scientists
who are paid consultants to implant makers.

Unfortunately, the FDA has not required manufacturers to study the
impact of silicone implants on breast milk, breastfeeding, or the
health of offspring born to women with implants. At NOW, we have heard
from many women who believe that their silicone breast implants have
adversely affected their children's health. In the coming weeks, NOW
will be reviewing more than 1,000 questionnaires filled out by mothers
with implants who detail the deformities and illnesses found in their
children.

"It is impossible for women to give informed consent for implants if
the information they are receiving is inaccurate or incomplete," said
Gandy. "The very real possibility that women and their children will
be exposed to grave health risks is a serious matter. The FDA made an
unconscionable move today."

Gandy concluded: "The FDA has never rescinded approval for a medical
device after it has been approved, but that's not going to stop NOW
from trying. When the new Congress takes office we will petition our
representatives to initiate an immediate review of the FDA and this
dreadful, dangerous decision."

~~~~~~~~~~

www.BreastImplantAwareness.org/
Skeptic - 29 Dec 2006 02:33 GMT
More aimless babbling and politicizing without a shred of science.

> NOW President, Kim Gandy shows well the fallacy in Skeptics's (for
> want of a better term) thinking ...
[quoted text clipped - 62 lines]
>
> www.BreastImplantAwareness.org/
Ilena Rose - 29 Dec 2006 03:28 GMT
Skeptic, in utter confusion as to the mighty harm done to hundreds of
thousands of women with failed breast implants, blurted :

>Adverse events, such as rupture, migration, infection, etc. are known possibilities going into surgery.  That is not the issue at hand.

Nice try at minimizing these problems. I just got off the phone with a
women who lost her breasts to necrosis after her implants infected.

It was definitely "the issue at hand" with her.

www.BreastImplantAwareness.org/blog.htm
Skeptic - 29 Dec 2006 23:09 GMT
> Skeptic, in utter confusion as to the mighty harm done to hundreds of
> thousands of women with failed breast implants, blurted :
[quoted text clipped - 4 lines]
> Nice try at minimizing these problems. I just got off the phone with a
> women who lost her breasts to necrosis after her implants infected.

Well, I hope she finds them.  If she's a good girl, maybe Santa will bring
her a new pair next Christmas.
George Conklin - 30 Dec 2006 01:02 GMT
> > Skeptic, in utter confusion as to the mighty harm done to hundreds of
> > thousands of women with failed breast implants, blurted :
[quoted text clipped - 7 lines]
> Well, I hope she finds them.  If she's a good girl, maybe Santa will bring
> her a new pair next Christmas.

That is crude Skeptic.  I am sure there are many surgical screwups.  Making
fun of a victim does not cut it.  But that also does NOT mean that such
implants are so bad they need to be banned, nor do they cause arthritis and
the other diseases attributed to them.
Skeptic - 30 Dec 2006 15:33 GMT
>> > Skeptic, in utter confusion as to the mighty harm done to hundreds of
>> > thousands of women with failed breast implants, blurted :
[quoted text clipped - 10 lines]
>>
> That is crude Skeptic.

Well, intelligent arguments seem to bounce of the armor of idiocy
surrounding Ilena, so might as well have some fun with her lies.

> I am sure there are many surgical screwups.

I can guarantee you there are.

> Making
> fun of a victim does not cut it.

I didn't.  I poked fun a fake conversation posted by Ilena.

> But that also does NOT mean that such
> implants are so bad they need to be banned, nor do they cause arthritis
> and
> the other diseases attributed to them.

Agreed.
George Conklin - 30 Dec 2006 15:59 GMT
> >> > Skeptic, in utter confusion as to the mighty harm done to hundreds of
> >> > thousands of women with failed breast implants, blurted :
[quoted text clipped - 29 lines]
>
> Agreed.

 What I don't understand is why normal women want to undergo surgery to
change their breasts.  I can see such surgery for reconstruction after
cancer or something like that.  But small breasts are just as attractive as
larger ones, and probably more attractive than some pushed up with implants.
John Richards - 30 Dec 2006 17:12 GMT
>  What I don't understand is why normal women want to undergo surgery to
> change their breasts.  I can see such surgery for reconstruction after
> cancer or something like that.  But small breasts are just as attractive as
> larger ones, and probably more attractive than some pushed up with implants.

From another male's viewpoint, I totally agree. The bigger they are,
the quicker they sag.

Signature

John Richards

George Conklin - 30 Dec 2006 17:34 GMT
> >  What I don't understand is why normal women want to undergo surgery to
> > change their breasts.  I can see such surgery for reconstruction after
[quoted text clipped - 6 lines]
> --
> John Richards

   Even if they sag, there is nothing ugly about that either.
John Richards - 30 Dec 2006 20:54 GMT
>> "George Conklin" <georgeconklin1@earthlink.net> wrote in message
> news:j1wlh.4528$pQ3.2322@newsread4.news.pas.earthlink.net...
[quoted text clipped - 13 lines]
>
>    Even if they sag, there is nothing ugly about that either.

'Ugly' is in the eye of the beholder. I happen to prefer perkiness,
but thank goodness men's preferences for what they find
physically attractive about a female vary widely.

Signature

John Richards

Skeptic - 30 Dec 2006 21:10 GMT
>> >> > Skeptic, in utter confusion as to the mighty harm done to hundreds
>> >> > of
[quoted text clipped - 39 lines]
> larger ones, and probably more attractive than some pushed up with
> implants.

Mainstream America disagrees with that sentiment.  Me personally - I'd never
want myself or my spouse or my kids to undergo a vanity surgery.  Let me
clear that not all implant surgeries fall into this category, however.
George Conklin - 30 Dec 2006 22:32 GMT
> >> >> > Skeptic, in utter confusion as to the mighty harm done to hundreds
> >> >> > of
[quoted text clipped - 43 lines]
> want myself or my spouse or my kids to undergo a vanity surgery.  Let me
> clear that not all implant surgeries fall into this category, however.

A 60-year-old woman (or man) with a face life looks like a 60-year-old with
a face lift.
Ilena Rose - 30 Dec 2006 18:21 GMT
George Conklin wrote:
>That is crude Skeptic.  I am sure there are many surgical screwups.  Makingfun of a victim does not cut it.  But that also does NOT mean that suchimplants are so bad they need to be banned, nor do they cause arthritis and the other diseases attributed to them.

Thanks for your comments. I'm going to address a few issues regarding
this thread:

What did I name it?

>Re: Silicone gel breast implants most defective medical device ever approved by the FDA (corrected)

It is about the hundreds of thousands of implants that fail ... and
when they do, cause serious harm and complications.

Look at the way, the coward who calls himself "Skeptic" highjacks the
conversation with this distraction:

>>Adverse events, such as rupture, migration, infection, etc. are known possibilities going into surgery.  That is not the issue at hand.

Indeed, these adverse events (such as women's nipples rotting away
from infection from the implants) are an issue. For this coward to try
to minimize the harm that has been done because of breast implant is
typical of the propaganda put out by the Junk Science / ACSH.org /
Quackwatch / NCAHF disinformation teams.

George adds:

> But that also does NOT mean that suchimplants are so bad they need to be banned, nor do they cause arthritis and the other diseases attributed to them.

They were never really banned. Women got them for a variety of reasons
... including having  a ruptured saline implant. PS's did so called
"studies" with little follow-up and less motivation. Women were tossed
out of the studies if they removed their implants for any reason ...
how skewed is that?

The silicone sellers backed by the PR teams mentioned above .. have
invaded every medium:  blogs, Wikipedia, usenet to minimize the harms
and claim safety.

After studying this issue for 11 years, reading every study (the vast
majority funded by the industry).... communicating with thousands of
women who got seriously ill with implant related complications ... I
do believe there is an immune system related diseases that can be
exacerbated or perhaps reveal themselves sooner than after implants.

I believe with all the toxic componets ... many women have allergic
and otherwise immune reactions to various ones.

I believe the toxic soup of chemicals brings on various reactions ...
and that Multiple Chemical Sensitivities are something that more
should be studying.

This brings me to my disgust with Stephen Barrett ... who could not
even pass the Psychiatric Boards to protect patients.

He has been widely distributed by the group named above, leading a
Witchhunt against what he calls "medical ecologists" ... trying to
discredit and waste the time & resources of scientists searching for
the sources and ways to heal from chemical poisonings.

Barrett is never honest enough to admit that the chemical industry
funds ACSH who funded these pieces on MCS ...

So George ... keep an open mind ... breast implants are far more
dangerous than you realize ... over a quarter of a million women have
written the FDA with their implant related illnesses and injuries.

Best from Ilena Rosenthal

www.BreastImplantAwareness.org/Holidays2006.htm

www.BreastImplantAwareness.org/QuackWatchWatch.htm
Ilena Rose - 15 Mar 2007 21:25 GMT
George Conklin wrote:
>That is crude Skeptic.  I am sure there are many surgical screwups.  Makingfun of a victim does not cut it.  But that also does NOT mean that suchimplants are so bad they need to be banned, nor do they cause arthritis and the other diseases attributed to them.

Thanks for your comments. I'm going to address a few issues regarding
this thread:

What did I name it?

>Re: Silicone gel breast implants most defective medical device ever approved by the FDA (corrected)

It is about the hundreds of thousands of implants that fail ... and
when they do, cause serious harm and complications.

Look at the way, the coward who calls himself "Skeptic" highjacks the
conversation with this distraction:

>>Adverse events, such as rupture, migration, infection, etc. are known possibilities going into surgery.  That is not the issue at hand.

Indeed, these adverse events (such as women's nipples rotting away
from infection from the implants) are an issue. For this coward to try
to minimize the harm that has been done because of breast implant is
typical of the propaganda put out by the Junk Science / ACSH.org /
Quackwatch / NCAHF disinformation teams.

George adds:

> But that also does NOT mean that suchimplants are so bad they need to be banned, nor do they cause arthritis and the other diseases attributed to them.

They were never really banned. Women got them for a variety of reasons
... including having  a ruptured saline implant. PS's did so called
"studies" with little follow-up and less motivation. Women were tossed
out of the studies if they removed their implants for any reason ...
how skewed is that?

The silicone sellers backed by the PR teams mentioned above .. have
invaded every medium:  blogs, Wikipedia, usenet to minimize the harms
and claim safety.

After studying this issue for 11 years, reading every study (the vast
majority funded by the industry).... communicating with thousands of
women who got seriously ill with implant related complications ... I
do believe there is an immune system related diseases that can be
exacerbated or perhaps reveal themselves sooner than after implants.

I believe with all the toxic componets ... many women have allergic
and otherwise immune reactions to various ones.

I believe the toxic soup of chemicals brings on various reactions ...
and that Multiple Chemical Sensitivities are something that more
should be studying.

This brings me to my disgust with Stephen Barrett ... who could not
even pass the Psychiatric Boards to protect patients.

He has been widely distributed by the group named above, leading a
Witchhunt against what he calls "medical ecologists" ... trying to
discredit and waste the time & resources of scientists searching for
the sources and ways to heal from chemical poisonings.

Barrett is never honest enough to admit that the chemical industry
funds ACSH who funded these pieces on MCS ...

So George ... keep an open mind ... breast implants are far more
dangerous than you realize ... over a quarter of a million women have
written the FDA with their implant related illnesses and injuries.

Best from Ilena Rosenthal

www.BreastImplantAwareness.org/Holidays2006.htm

www.BreastImplantAwareness.org/QuackWatchWatch.htm
Skeptic - 27 Dec 2006 03:18 GMT
> The coward Skeptic could not be more wrong. Dr. Wolfe accurately
> described the problems with this industry forced approval of a
> dangerous product. More than a quarter of a million women have
> reported serious adverse affects from their defective implants.

Adverse events, such as rupture, migration, infection, etc. are known
possibilities going into surgery.  That is not the issue at hand.  The issue
is whether they lead to things like autoimmune diseases.   That has been
debated at length, there are two pretty clear sides.  The side with the
preponderance of the medical data is the one that shows there is no
cause/effect relationship.  That was the impetus for their being
re-introduced to the market.  You're just so f*cking blinded by your own
DESIRE for there to be a connection you can't see the forest through the
trees.
 
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