Brought to you by Health Lover, Ilena Rosenthal:
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Prepared Witness Testimony
The Committee on Energy and Commerce
W.J. "Billy" Tauzin, Chairman
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http://energycommerce.house.gov/107/hearings/11152001Hearing428/Zuckerman728print.htm

Raising Health Awareness Through Examining Benign Brain Tumor Cancer,
Alpha One and Breast Implant Issues.
Subcommittee on Health
November 15, 2001
2:00 PM
2123 Rayburn House Office Building

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Dr. Diana Zuckerman
Executive Director
National Center for Policy Research for Women and Families
1444 I Street, N.W., Suite 900
Washington, DC, 20005

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My name is Dr. Diana Zuckerman and I am president of the National
Center for Policy Research for Women & Families.   Our organization is
a nonprofit think tank dedicated to improving the lives of women and
families by explaining and disseminating medical and scientific
research information.

I am honored to be on this panel with Congressman Roy Blunt and these
courageous women, to talk about the need for H.R. 1961, a bill that
will help to ensure and protect women’s health and well-being.  

The Breast Implant Research and Information Act calls for more
research on breast implants.  I am here to tell you why this bill is
so essential.  

Breast implants have been sold in this country for almost 40 years,
but we still know very little about their long-term health risks.  In
fact, almost a million women had breast implants before the first
epidemiological study was published about health risks.  Before then,
there were just a few studies of rats and dogs, but no published
studies of human beings.  

In 1990, as a scientist working on what is now the House Reform and
Oversight Committee, I started an investigation of the FDA’s
regulation of breast implants.  We found that the FDA had ignored the
concerns of its own scientists by allowing the sale of breast implants
without requiring that the manufacturers prove that implants were
safe.  As a result of our hearing, the FDA finally required the
manufacturers to submit studies of silicone gel implants.
Unfortunately, those studies were so badly designed that they could
not prove whether or not implants were safe.  

In response to pressure on both sides, the FDA did something they
almost never do – they refused to approve implants but allowed them to
stay on the market as a “public health need.”  I think the last two
months have shown us what a true public health need is – and breast
augmentation does not qualify.  But, at the time, Congress went along
with the FDA decision, but required the NIH to conduct long-term
research.  

There were no studies of women with implants in 1990, but quite a few
epidemiological studies have been conducted since then.  I have read
all of them.  Despite what you may have heard in the media, the
research and the report by the Institute of Medicine does not conclude
that implants are safe -- to the contrary, they show many serious
problems related to implants.  

In fact, just a few months ago, three major new studies reported that
women who have breast implants are at significant risk for several
debilitating and fatal diseases.    

One study, conducted by researchers at the National Cancer Institute
(NCI) reported that women with implants were more likely to die from
brain cancer, lung cancer, other respiratory diseases, and suicide
compared to other plastic surgery patients.  

A second study, also by NCI, reported that women with breast implants
are more likely to develop cancer compared to other women their age.
Both of these studies were of women who had either silicone or saline
breast implants for at least 8 years.   In contrast, the studies
showing no increase in disease for women with implants included many
women who had implants for short periods of time – even as short as
one month.  Obviously, cancer and autoimmune diseases do not develop
that quickly.

A third study, conducted by scientists at the FDA, found that women
with leaking silicone gel breast implants are more likely to have
several painful and potentially fatal autoimmune diseases.  Implants
were found to be increasingly likely to break as they got older, and
most implants were broken by the time they were 10-15 years old.  This
study may provide an important clue:  it is possible that illnesses
reported by women with implants are a result of leaking implants –
which would explain why most women do not have systemic health
problems until after they have had implants for several years.

At the same time that these new studies were released, the plastic
surgery organizations announced that almost 300,000 American women got
breast implants last year, most of them for augmentation.  Although
they don’t boast about it, their statistics also show that the number
of teenage girls getting implants has more than doubled in the last 3
years.  

These three new studies remind us that, although relatively few women
become ill after having implants for a year or two, we need to be
concerned about the long-term dangers.  And women who are considering
implants deserve to be accurately informed about the risks -- what is
known, and what is not known.  And yet, hundreds of thousands of women
are deciding to get implants because they mistakenly believe that
implants are proven safe for long-term use.  

The two studies conducted by NCI were mandated by Congress.  They were
designed to answer two essential questions:

1) do breast implants increase health risks and

2) do women with implants die at a younger age than other women?
These are still the essential questions and that is the purpose of
H.R. 1961.  I am especially pleased that this legislation requires
studies of women with implants after mastectomies.  It is
unfortunately true that not one single breast cancer patient was
included in the studies that the federal government has conducted thus
far.   I want you to know that Congress requested that mastectomy
patients be included in those studies, but the head of NIH at the
time, Dr. Bernadine Healy, refused.  It’s too late to fix those
studies, but it is absolutely essential that studies of reconstruction
patients be conducted as soon as possible.  At this point, most of
what we know is based on the manufacturers’ own studies, which show
that one in four reconstruction patients need to have at least one
additional surgery within the first three years after getting saline
implants, and that other complication rates are also extremely high.
We need to know what happens after three years, and we need to tell
breast cancer patients about these complications so that they can make
an informed decision about what would be best for them.  

In addition to new studies, it would be very cost-effective for the
NIH to continue to study the breast augmentation patients in the NCI
and FDA studies that I described a few minutes ago.  At the time the
NCI studied the women’s medical records, they had implants for at
least 8 years.  They have now had implants for at least 11 years, so
it is important to study what has happened – whether the cancer rates,
autoimmune diseases, and death rates of women with implants have
increased or decreased in the last three years.  

Although  I am especially concerned about the lack of information
about the long-term safety of reconstruction, I m also concerned about
the thousands of teenage girls that are getting breast implants every
year.  We don’t know what will happen to those girls, but
unfortunately neither they nor their parents realize how little is
known about long-term risks.  It is time we answered that question.
And H.R. 1961 would help ensure that patients -- and teenage patients’
parents -- know what the risks are well before they decide whether or
not to get implants.  

In conclusion, I want to thank the Committee for holding this hearing,
and especially thank Congressman Blunt and Congressman Gene Green for
their essential work on this legislation.   And, I thank the Committee
members who have supported this legislation and shown respect and
support for their constituents who have courageously shared their
experiences with implants.  We need your continued help.  If Congress
doesn’t require that these important studies be conducted by NIH, it
is unlikely that they ever will be.  And so, we’re counting on this
Committee to make sure that NIH moves forward as quickly as possible.

I hope the Committee will also undertake a careful review of the role
of the FDA regarding the lack of long-term safety data on breast
implants.  Breast implants have been sold for almost 40 years, and yet
the FDA has never required long-term safety data.  They have not
required that patients be informed of the risks of implants.
Meanwhile, more than 127,000 adverse reactions have been reported
regarding silicone gel implants and more than 65,000 for saline-filled
implants – and yet the FDA has not even bothered to examine them.  As
this Committee considers legislation to reform the FDA in the coming
year, I urge you to include a provision requiring long-term safety
data for implanted medical devices that are already on the market.
This is not like a new medical product:  women who have had implants
for many years are available to be studied, and the FDA should be
mandated to do so.  

I would be glad to answer any questions, and I invite staff to go to
our website, www.center4policy.org, to read some of the medical and
lay articles that we have written on the topic, and to link to FDA’s
consumer materials about breast implants.

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The Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515
(202) 225-2927
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