FDA Panel Recommends Lifting Silicone Ban

Yes, the PS's on the panel voted themselves a lifetime annuity of
millions and millions of silicone dollars ... and thousands of women
will be harmed.

How proud you must be.

It takes away nothing from these facts:

Inamed Research Shows High Complication Rates and Autoimmune Symptoms
for Breast Implant Patients

http://biz.yahoo.com/prnews/031011/nysa004_1.html

http://www.finanznachrichten.de/nachrichten/artikel-2584674.asp

WASHINGTON, Oct. 11 /PRNewswire/ -- The following press release was
issued today by the National Center for Policy Research for Women &
Families:

In its efforts to win FDA approval for silicone gel breast implants at
hearings to be held on October 14th and 15th, implant manufacturer
Inamed submitted hundreds of pages of research information from three
studies. However, the news is not good for breast implant patients,
especially those with breast cancer. Released by the FDA October 10th,
the company''s own research indicates high complication rates for the
first three years, including the need for additional surgery for 46%
of breast cancer patients.

Inamed''s "Core" study included 221 breast cancer reconstruction
patients, 494 augmentation patients, and 225 revision (replacement)
patients. According to the FDA, their complication rates are very
high. For example, 46% of reconstruction patients underwent at least
one re-operation within 3 years, 25% had removal or replacement, 6%
had a diagnosed ruptured implant, 6% had breast pain, and 6% were
diagnosed with necrosis, a painful and disfiguring condition where the
skin or tissue dies. Complications were lower but still substantial
for augmentation patients (for example, 21% with re-operations, and 1%
diagnosed rupture) and revision patients (33% with re-operations and
4% diagnosed ruptures). The FDA assumed that the rupture rate was
higher than reported, since three out of four ruptures would not be
diagnosed unless a woman underwent an MRI.

The largest study, called the Adjunct Study, enrolled 15,465
reconstruction patients and 9,881 "revision" patients (who had
replaced their previous breast implants with new Inamed silicone gel
implants). The Adjunct Study was the compromise developed by the FDA
to enable large numbers of mastectomy patients and women with broken
gel implants to use silicone gel implants at a time when the company
had not proven that their product was safe. Although women wanting
silicone breast implants were required to participate in the Adjunct
Study, the company apparently made little effort to comply with this
requirement: barely half (54%) of the breast cancer patients who
received Inamed implants stayed in the study for one year. Even fewer
-- 27% -- stayed in the study for three years.

Women who wanted silicone gel implants to replace broken gel implants
were also required to participate in the Adjunct Study, but they were
even less likely to stay in the study than breast cancer patients.
Less than half (44%) stayed in the study for one year and only one in
five (20%) stayed for three years.

"Most women did not stay in these studies for even one year, making
the largest study useless in determining whether the implants are
safe" explains Dr. Diana Zuckerman, president of the National Center
for Policy Research for Women & Families. "Inamed was told that they
were supposed to study the safety of implants as a condition of sale.
The main concern about silicone implants is the health risks when they
break, but the company did not study women long enough to find out
what those risks are."

Inamed also gathered data about health symptoms experienced by their
patients. In the FDA review of Inamed''s data, FDA scientists noted
the following:

-- Muscle pain, joint pain, hair loss, rashes, and fatigue all
increased within two years of getting implants. -- In terms of their
quality of life, almost every measure of emotional and physical
health, including social interactions and self-esteem, declined within
two years of getting implants. The improvements were in self-reported
sexual attractiveness.

In its description of the components of the implant shell, the FDA
noted the presence of 24 potentially toxic metals, including arsenic,
lead, mercury, and platinum. (FDA Review Team Memo, p. 9)

In its review of scientific studies conducted by other researchers,
FDA scientists noted:

Cancer -- "The finding of excesses in lung (or respiratory), cervical,
vulvar, and leukemia have been reported in more than one study. These
findings are difficult to interpret, and further research is needed to
clarify this issue." (FDA Review Team Memo, p. 35) (slide #100)
Mammography -"The possibility that implants may delay cancer detection
is of concern." (Id p. 38) Silicone Migration - "Cases of distant
migration of gel to breasts, axillary lymph nodes, abdomen, groin,
arm, and fingers have been reported, some with serious consequences
and deformities..." (FDA Review Team Memo, p. 37)

Inamed also reported results from a 5-year study started in 1990, but
it included only 29 reconstruction patients. The study started with
547 augmentation patients, but most were not studied for all five
years. Since most of the patients dropped out of the study and most
had breast implants that the company is no longer selling, results
from this study were not useful.

"The findings show many areas of concerns and unanswered safety
questions, and provide worrisome evidence that women with silicone gel
implants will face numerous complications directly related to the
implants, symptoms such as pain and fatigue, and declines in health
and mental health," concludes Dr. Zuckerman. "Although the rupture
rate is low during the first two years, it is expected to increase
every year, as it has in other studies."

An FDA advisory panel will hold a public meeting on October 14-15 in
Gaithersburg, MD to decide whether to recommend Inamed''s silicone gel
breast implants for FDA approval. All silicone gel breast implants
have been available under FDA-imposed restrictions since 1992 because
the manufacturers did not provide adequate research evidence that they
were safe.

CPR for Women & Families is a nonprofit think tank that uses research
information to improve health and safety of women, children, and
families.

National Center for Policy Research for Women & Families

www.BreastImplantInfo.org

~~~~~~~~~~~~~~~~

For more information and links to the vital issue, please visit:

www.BreastImplantAwareness.org

[email hidden] (Ilsa9) wrote in message news:<[email hidden]>...

Quoted message said:

Dedicated ASBI & MHA's dear, sweet Ilena:

WASHINGTON Oct. 15 — Eleven years after most use of silicone-gel breast
implants was halted, government advisers recommended Wednesday that the ban be
lifted despite lingering questions about safety and durability.

The rest is online at:

http://abcnews.go.com/wire/Politics/ap20031015_1938.html

Quoted message said:

Subject: Re: FDA Panel Recommends Lifting Silicone Ban
From: [email hidden] (Ilena)
Date: 10/16/2003 8:37 AM Pacific Standard Time
Message-id: <[email hidden]>

Yes, the PS's on the panel voted themselves a lifetime annuity of
millions and millions of silicone dollars ... and thousands of women
will be harmed.

How proud you must be.

This is sickening and a fine example of how organized medicine works.

Follow the money and people be damned.

The poster who posted this, is a same to society.

Jan

Quoted message said:

It takes away nothing from these facts:

Inamed Research Shows High Complication Rates and Autoimmune Symptoms
for Breast Implant Patients

http://biz.yahoo.com/prnews/031011/nysa004_1.html

http://www.finanznachrichten.de/nachrichten/artikel-2584674.asp

WASHINGTON, Oct. 11 /PRNewswire/ -- The following press release was
issued today by the National Center for Policy Research for Women &
Families:

In its efforts to win FDA approval for silicone gel breast implants at
hearings to be held on October 14th and 15th, implant manufacturer
Inamed submitted hundreds of pages of research information from three
studies. However, the news is not good for breast implant patients,
especially those with breast cancer. Released by the FDA October 10th,
the company''s own research indicates high complication rates for the
first three years, including the need for additional surgery for 46%
of breast cancer patients.

Inamed''s "Core" study included 221 breast cancer reconstruction
patients, 494 augmentation patients, and 225 revision (replacement)
patients. According to the FDA, their complication rates are very
high. For example, 46% of reconstruction patients underwent at least
one re-operation within 3 years, 25% had removal or replacement, 6%
had a diagnosed ruptured implant, 6% had breast pain, and 6% were
diagnosed with necrosis, a painful and disfiguring condition where the
skin or tissue dies. Complications were lower but still substantial
for augmentation patients (for example, 21% with re-operations, and 1%
diagnosed rupture) and revision patients (33% with re-operations and
4% diagnosed ruptures). The FDA assumed that the rupture rate was
higher than reported, since three out of four ruptures would not be
diagnosed unless a woman underwent an MRI.

The largest study, called the Adjunct Study, enrolled 15,465
reconstruction patients and 9,881 "revision" patients (who had
replaced their previous breast implants with new Inamed silicone gel
implants). The Adjunct Study was the compromise developed by the FDA
to enable large numbers of mastectomy patients and women with broken
gel implants to use silicone gel implants at a time when the company
had not proven that their product was safe. Although women wanting
silicone breast implants were required to participate in the Adjunct
Study, the company apparently made little effort to comply with this
requirement: barely half (54%) of the breast cancer patients who
received Inamed implants stayed in the study for one year. Even fewer
-- 27% -- stayed in the study for three years.

Women who wanted silicone gel implants to replace broken gel implants
were also required to participate in the Adjunct Study, but they were
even less likely to stay in the study than breast cancer patients.
Less than half (44%) stayed in the study for one year and only one in
five (20%) stayed for three years.

"Most women did not stay in these studies for even one year, making
the largest study useless in determining whether the implants are
safe" explains Dr. Diana Zuckerman, president of the National Center
for Policy Research for Women & Families. "Inamed was told that they
were supposed to study the safety of implants as a condition of sale.
The main concern about silicone implants is the health risks when they
break, but the company did not study women long enough to find out
what those risks are."

Inamed also gathered data about health symptoms experienced by their
patients. In the FDA review of Inamed''s data, FDA scientists noted
the following:

-- Muscle pain, joint pain, hair loss, rashes, and fatigue all
increased within two years of getting implants. -- In terms of their
quality of life, almost every measure of emotional and physical
health, including social interactions and self-esteem, declined within
two years of getting implants. The improvements were in self-reported
sexual attractiveness.

In its description of the components of the implant shell, the FDA
noted the presence of 24 potentially toxic metals, including arsenic,
lead, mercury, and platinum. (FDA Review Team Memo, p. 9)

In its review of scientific studies conducted by other researchers,
FDA scientists noted:

Cancer -- "The finding of excesses in lung (or respiratory), cervical,
vulvar, and leukemia have been reported in more than one study. These
findings are difficult to interpret, and further research is needed to
clarify this issue." (FDA Review Team Memo, p. 35) (slide #100)
Mammography -"The possibility that implants may delay cancer detection
is of concern." (Id p. 38) Silicone Migration - "Cases of distant
migration of gel to breasts, axillary lymph nodes, abdomen, groin,
arm, and fingers have been reported, some with serious consequences
and deformities..." (FDA Review Team Memo, p. 37)

Inamed also reported results from a 5-year study started in 1990, but
it included only 29 reconstruction patients. The study started with
547 augmentation patients, but most were not studied for all five
years. Since most of the patients dropped out of the study and most
had breast implants that the company is no longer selling, results
from this study were not useful.

"The findings show many areas of concerns and unanswered safety
questions, and provide worrisome evidence that women with silicone gel
implants will face numerous complications directly related to the
implants, symptoms such as pain and fatigue, and declines in health
and mental health," concludes Dr. Zuckerman. "Although the rupture
rate is low during the first two years, it is expected to increase
every year, as it has in other studies."

An FDA advisory panel will hold a public meeting on October 14-15 in
Gaithersburg, MD to decide whether to recommend Inamed''s silicone gel
breast implants for FDA approval. All silicone gel breast implants
have been available under FDA-imposed restrictions since 1992 because
the manufacturers did not provide adequate research evidence that they
were safe.

CPR for Women & Families is a nonprofit think tank that uses research
information to improve health and safety of women, children, and
families.

National Center for Policy Research for Women & Families

www.BreastImplantInfo.org

~~~~~~~~~~~~~~~~

For more information and links to the vital issue, please visit:

www.BreastImplantAwareness.org

[email hidden] (Ilsa9) wrote in message
news:<[email hidden]>...

Quoted message said:

Dedicated ASBI & MHA's dear, sweet Ilena:

WASHINGTON Oct. 15 — Eleven years after most use of silicone-gel breast
implants was halted, government advisers recommended Wednesday that the ban

be

Quoted message said:

lifted despite lingering questions about safety and durability.

The rest is online at:

http://abcnews.go.com/wire/Politics/ap20031015_1938.html

Quoted message said:

Subject: Re: FDA Panel Recommends Lifting Silicone Ban
From: [email hidden] (Jan)
Date: 10/16/2003 9:13 PM Pacific Daylight Time
Message-id: <[email hidden]>

Quoted message said:

example of how organized medicine works.

Follow the money and people be damned.

funny...did it ever occur to you Jan that these women DO have a choice???

there are saline implants....

again..worry about YOUR health,,not that of others..or other's kids

taint none of your business

hawki