Silicone Breast Implant Safety
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Breast enlargement or augmentation began about 1959. Since then about
two million women in the United States have undergone breast
augmentation. The majority of those augmentations have been performed
with silicone filled implants.
Not long after a Connie Chung presented a piece on television about
silicone breast implants, the FDA called for a moratorium on the use of
silicone-filled breast implants for cosmetic breast augmentation.
"Silicon is a naturally occurring element which is found in sand, quartz and most rocks."
However, silicone implants could continue to be used for breast
reconstruction. Concern was raised from some women with multiple
medical problems about the safety of the silicone used in breast
implants. Once their lawyers became involved, the situation rapidly
escalated to class action law suits and courtroom proceedings. This was
all done without the benefit of true scientific data to either support
or refute the safety of these implants.
Many women became scared and worried about their own health and the
effects that silicone could have on it. But what is silicone and is it
safe?
Silicon is a naturally occurring element which is found in sand, quartz
and most rocks. Next to oxygen, silicon is the most common element near
the surface of the earth. When silicon is combined with oxygen, carbon
and hydrogen it becomes silicone. Silicone comes in a variety of forms
including liquids and solids.
"Our contact with silicone is extensive throughout all of our lives and it is widely used in medicine."
Silicone has been a part of manufacturing for many years and is a part
of many consumer products. Silicone appears in most hair-sprays, suntan
lotions and moisturizing creams. Our contact with silicone is extensive
throughout all of our lives and it is widely used in medicine. Silicone
is used in artificial joints, pacemakers, heart valves and catheters
among others.
Safety issues about silicone have been primarily focused on their use
in breast implants and the possible link with breast cancer and
autoimmune diseases such as arthritis. Silicone materials have been
studied with great interest over the past years. Since so many women
already have silicone implants, it has been possible to gather much
information about them.
A study published in the New England Journal of Medicine in 1992
studied the potential for breast cancer in over 11,000 women who had
received silicone breast implants. This study "did not find an
increased risk of cancer among women who had received breast implants,
although the length of follow-up, the completeness of follow-up, and
the size [of the study group] would have allowed the detection of such
a risk."
"There also seems to be no link between arthritis or other connective tissue diseases and silicone."
There are many similar studies which have been performed by scientists throughout the world.
In fact, most studies using standard mammography have shown no
difference in the time to detect breast cancer between women with and
without breast implants. There also seems to be no link between
arthritis or other connective tissue diseases and silicone.
In an official statement by the American College of Rheumatology, based
on several research studies involving over 87,000 women, it was
concluded that there is "no reason to discourage women from considering
breast [implant surgery] on the basis of acquiring or [worsening] a
connective tissue disorder."
But what about those women who have such terrible medical conditions and have silicone implants?
There is no question that there are women who have connective tissue
disorders. Some of these problems can range from mild arthralgias and
myalgias (joint and muscle pains) to severely debilitating arthritis,
Lupus or other connective tissue disorders. Some of these women may
also have silicone breast implants.
"At the moment it seems that the research show that silicone implants are safe."
Based on research performed, it is not likely that any of these
problems are related to silicone. The women who have these problems and
who also have silicone breast implants have these problems with the
same frequency as other women in the population who have no implants.
Further, the overwhelming majority of women with breast implants have
no medical problems at all.
According to the FDA, even women who have tested positive for silicone
in their body fluids "does not indicate whether a person is sensitive
to these substances or is at any risk for any specific disease…"
Four scientific experts in the fields of immunology, epidemiology,
toxicology, and rheumatology were appointed by the Honorable Sam C.
Pointer, Jr., Coordinating Judge for the Federal Breast Implant
Multi-District Litigation, to serve on a National Science Panel. The
panel was instructed to review and critique the scientific literature
pertaining to the possibility of a causal association between silicone
breast implants and connective tissue diseases, related signs and
symptoms, and immune system dysfunction. Judge Pointer was recently
presented with the final report by this panel. That report can be
viewed at http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm. A condensed
version containing the table of contents and the summary is available
here at Silicone Breast Implants in Relation to Connective Tissue
Diseases and Immunologic Dysfunction.
"… there is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation."
The conclusions from the science panel were that "The preponderance of
data from these studies indicate that silicone implants do not alter
incidence or severity of autoimmune disease." "… there is no evidence
that silicone breast implants precipitate novel immune responses or
induce systemic inflammation." "… there are no consistent data to
suggest systemic inflammation or systemic induction of anti-silicone or
autoreactive responses in women with silicone breast implants." "… when
appropriate comparisons were made, (ill women with implants compared to
healthy women with implants, or healthy women with implants compared to
healthy women without implants), neither immune system activation nor
autoreactivity could be reproducibly demonstrated in women with
silicone breast implants." "The main conclusion that can be drawn from
existing studies is that women with silicone breast implants do not
display a silicone-induced systemic abnormality in the types or
functions of cells of the immune system."
"No association was evident between breast implants and any of the
individual connective tissue diseases, all definite connective diseases
combined, or the other autoimmune/rheumatic conditions." "There was no
association between silicone gel-filled implants and any of the
definite connective tissue diseases (including Sjögren's syndrome) or
the other autoimmune/rheumatic conditions." "The one study that
specifically addressed undifferentiated connective tissue disease found
no association with silicone breast implants." "Breast implant patients
have reported a diversity of symptoms and signs that are also
associated with rheumatic or autoimmune diseases.
Furthermore, many of the rheumatologic complaints reported are common
in the general population and as presenting complaints in physicians'
offices. No distinctive features relating to silicone breast implants
could be identified."
At the moment it seems that there is no conclusive scientific evidence
that silicone materials in breast implants increases the risk of
developing breast cancer or connective tissue diseases.
Further information about breast implants can be obtained from the FDA.
A simple phone call to the toll free number (800-532-4440), and the FDA
will send you a free copy of their "Breast Implant Information Package"
The FDA Information for Women Considering Saline-Filled Breast Implants
is also available here.
References
1. Tanne J. Everything You Need to Know About Breast Cancer…But Were
Afraid to Ask. New York. October 11, 1993:53-62.
2. Berkel H, Birdsell DC, et al. Breast Augmentation: A Risk Factor for
Breast Cancer? New England Journal of Medicine. 1992;326(25):1649-1653.
3. Gabriel SE, O'Fallon WM, et al. Risk of Connective-Tissue Diseases
and Symptoms. New England Journal of Medicine. 1995;332(25):1666-1670.
About the Author
Located in Nashville and serving the Murphysboro and other Tennessee areas, Board Certified Plastic Surgeon, Dr. Alexander Nein, utilizes the latest surgical techniques in his practice of Breast Augmentation, Breast Implants, and Breast Enhancement surgery!
Visit Breast Implants 411 for more information about Breast Implants.
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