Groups Oppose Allowing Silicone Breast Implants

Groups Oppose Allowing Silicone Breast Implants

By Lisa Richwine

WASHINGTON (Reuters) - Too little is known about the long-term health
risks of silicone breast implants for U.S. regulators to consider
allowing them back on the market, health and consumer groups said on Monday.

The United States banned silicone implants for most women in 1992 amid a
controversy over whether they caused chronic diseases, but at least one
company has applied to sell them again.

The National Organization for Women (news - web sites), consumer group
Public Citizen and others want the Food and Drug Administration (news -
web sites) to delay its review of any applications until longer studies
are completed.

[My comment: Collecting more information from long term studies for this
is an excellent idea.]

Arguing that many problems do not appear for years after implantation,
the groups want the FDA to require clinical trials following women for
at least seven to 10 years, NOW President Kim Gandy said in an
interview. The agency currently is reviewing about two years' worth of
data, she said.

"Two years of data is not going to give you any valid information so
that women will know what's going into their bodies," Gandy said.

In the early 1990s, many women alleged silicone implants led to serious
health problems. But a 1999 Institute of Medicine (news - web sites)
study found silicone implants did not cause cancer, lupus or other
chronic disorders, although they can rupture and present other problems.

Since 1992, silicone implants have been available only through clinical
trials. Saline-filled implants remained on the market, but are not as
popular.

More than 300,000 U.S. women got breast implants last year, according to
the American Society of Plastic Surgeons.

Inamed Corp. last December applied for FDA permission to sell silicone
implants and said many women in clinical trials had benefited from them.

NOW convened a panel of scientists to evaluate the latest implant data.
The panel concluded silicone implants' long-term safety had not been
sufficiently studied.

One major concern is the effect of silicone gel that leaks from an
implant to surrounding tissues and lymph nodes.

"We're still very unsure of the long-term effects on the body," said
Paul Wooley, one of NOW's panelists and a professor of orthopedic
surgery, immunology, microbiology and biomedical engineering at Wayne
State University School of Medicine.

Mark,
Thanks for posting this. . .It is important to remember that the 1999
Institute of Medicine "study" finding silicone implants did not cause
cancer, lupus or other chronic disorders, really wasn't anything more
than a regurgitation of old studies performed by the manufacturers
themselves.

After having access to the documents on the Discovery CDs to breast
implant litigation, it's quite clear that manufacturer studies were
clearly biased for making profit, rather than worrying about the
health issues of women who were to receive them. In some instances
studies were falsified, stopped when results were showing to be
disasterous, and out right fraudulent.

Found among the "discovery" internal manufacturer documents from
Bristol-Myers Squibb was a 1978 document describing beagle studies
indicating such adverse reactions as hemorrhage, possible pneumonia of
the lung, and hyperplasia of lymphoid tissue in the large intestines.
The president¹s response was "sacrifice dogs ASAP" and "no organs of
dogs in freezer". One year later, the president responded to a letter
regarding animal maintenance cost with the note, "I thought we wiped
out all dogs and had parts send to W.L. [a company vice president]. My
rec[commendation] - kill dogs; forget organs; just dispose of them."

Implant history is a long one, beginning well over 40 years ago. Most
women receiving implants never knew, they had not been approved by the
FDA, and have continued to receive them under the guise of studies,
that never seem to end. . .Days, weeks, months, years, decades, semi
centennials. . .what does it take to run a good study with integrity?

Myrl

Mark Probert <[email hidden]> wrote in message news:<[email hidden]>...

Quoted message said:

Groups Oppose Allowing Silicone Breast Implants

By Lisa Richwine

WASHINGTON (Reuters) - Too little is known about the long-term health
risks of silicone breast implants for U.S. regulators to consider
allowing them back on the market, health and consumer groups said on Monday.

The United States banned silicone implants for most women in 1992 amid a
controversy over whether they caused chronic diseases, but at least one
company has applied to sell them again.

The National Organization for Women (news - web sites), consumer group
Public Citizen and others want the Food and Drug Administration (news -
web sites) to delay its review of any applications until longer studies
are completed.

[My comment: Collecting more information from long term studies for this
is an excellent idea.]

Arguing that many problems do not appear for years after implantation,
the groups want the FDA to require clinical trials following women for
at least seven to 10 years, NOW President Kim Gandy said in an
interview. The agency currently is reviewing about two years' worth of
data, she said.

"Two years of data is not going to give you any valid information so
that women will know what's going into their bodies," Gandy said.

In the early 1990s, many women alleged silicone implants led to serious
health problems. But a 1999 Institute of Medicine (news - web sites)
study found silicone implants did not cause cancer, lupus or other
chronic disorders, although they can rupture and present other problems.

Since 1992, silicone implants have been available only through clinical
trials. Saline-filled implants remained on the market, but are not as
popular.

More than 300,000 U.S. women got breast implants last year, according to
the American Society of Plastic Surgeons.

Inamed Corp. last December applied for FDA permission to sell silicone
implants and said many women in clinical trials had benefited from them.

NOW convened a panel of scientists to evaluate the latest implant data.
The panel concluded silicone implants' long-term safety had not been
sufficiently studied.

One major concern is the effect of silicone gel that leaks from an
implant to surrounding tissues and lymph nodes.

"We're still very unsure of the long-term effects on the body," said
Paul Wooley, one of NOW's panelists and a professor of orthopedic
surgery, immunology, microbiology and biomedical engineering at Wayne
State University School of Medicine.

Peter Bowditch <[email hidden]>

Quoted message said:

Then again, Ilena is somewhat of a fan of Patrick Timothy Bolen,

I am a fan of medical freedom ... and a foe to those like you and
Probert and the others in the HealthFraud / Quack Team headed by
Barrett who harass, sue and maintain character / Life assassination
campaigns against those who speak out against the funders of ACSH /
junkscience.com.

www.BreastImplantAwareness.org

D. C. Sessions said:

In said:

D. C. Sessions wrote:

Quoted message said:

Quoted message said:

Dang it, Mark, do you *have* to keep yanking her chain?

Quoted message said:

Whose?

Oh, no, you aren't tricking me /that/ easily!

Aw shucks.

In said:

OK, so she's nuts, and so is Jan Drew. I really don't understand why
you people haven't all killfiled Jan. Doing so has improved my life a
great deal -- I don't get my daily dose of her ever-increasing
irrationality, her hypocrisy, and her outright craziness.

Jan actually makes my senior management look rational,
and unlike them she has no power over me or the people
I love.

Think of it as comic relief.

--
| Microsoft: "A reputation for releasing inferior software will make |
| it more difficult for a software vendor to induce customers to pay |
| for new products or new versions of existing products." |
end

In article <[email hidden]>,

Ilena said:

Peter Bowditch <[email hidden]>

Quoted message said:

Then again, Ilena is somewhat of a fan of Patrick Timothy Bolen,

I am a fan of medical freedom ... and a foe to those like you and
Probert and the others in the HealthFraud / Quack Team headed by
Barrett who harass, sue and maintain character / Life assassination
campaigns against those who speak out against the funders of ACSH /
junkscience.com.

Not to mention a foe to anyone who dares to disagree with you about
anything. At least you're consistent.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)

Quoted message said:

Subject: Re: Groups Oppose Allowing Silicone Breast Implants
From: [email hidden] (David Wright)
Date: 7/22/2003 9:49 PM Pacific Standard Time
Message-id: <[email hidden]>

In article <[email hidden]>,

Ilena said:

Peter Bowditch <[email hidden]>

Quoted message said:

Then again, Ilena is somewhat of a fan of Patrick Timothy Bolen,

I am a fan of medical freedom ... and a foe to those like you and
Probert and the others in the HealthFraud / Quack Team headed by
Barrett who harass, sue and maintain character / Life assassination
campaigns against those who speak out against the funders of ACSH /
junkscience.com.

Not to mention a foe to anyone who dares to disagree with you about
anything. At least you're consistent.

Where as David is oh so friendly, sweet and nice to all who diagree with him.

LOL!!

Jan

Mark Probert <[email hidden]> posting from yet another of
his failed law career aliases

http://www.humanticsfoundation.com/PropagandistProbert.html

In article <[email hidden]>,

D. C. Sessions said:

In said:

Not to mention a foe to anyone who dares to disagree with you about
anything. At least you're consistent.

Old New England comment about the evenest-tempered man in town?

Ayup.

(For those unfamiliar with this one, it goes something like "He
was the evenest-tempered man in town -- mad all the time."😉

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)

[email hidden] (David Wright)

Boo hoo, poor Davey whining yet again ... as always ... he is Wronger
Than Wright ...

http://www.humanticsfoundation.com/DisinfoAgentsFAQ.htm

In article <[email hidden]>,

Ilena said:

[email hidden] (David Wright)

Boo hoo, poor Davey whining yet again ... as always ... he is Wronger
Than Wright ...

Go ahead, Iloonie -- give an example of anything in my posting that
was erroneous. I won't hold my breath waiting for you.

-- David Wright :: alphabeta at prodigy.net
These are my opinions only, but they're almost always correct.
"If I have not seen as far as others, it is because giants
were standing on my shoulders." (Hal Abelson, MIT)