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Raising Health Awareness Through Examining Benign Brain Tumor Cancer, Alpha One and Breast Implant Issues.
Subcommittee on Health
Dr. Diana Zuckerman
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? 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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