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01607.txt
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1994-01-17
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$Unique_ID{BRK01607}
$Pretitle{}
$Title{Breast Implants and Breast Cancer}
$Subject{breast breasts implant implants cancer Neoplasms neoplasm special
procedure procedures polyurethane foam silicone Surgitek Bristol-Myers Squibb
cancers operation operations}
$Volume{B-19, P-19}
$Log{}
Copyright (c) 1991-92,1993 Tribune Media Services, Inc.
Breast Implants and Breast Cancer
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QUESTION: I am very concerned about my sister, who had breast surgery several
years ago using breast implants. She is now almost crazy about the reports
that this could cause breast cancer to develop and wants the implants removed
at once. What information can you give me that will help me to talk with her
and help her make the right decisions?
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ANSWER: The recent flood of reports in newspapers and on television about
these breast implants has caused many women the same distress your sister is
now suffering, and to my thinking is a shame. I am certainly for giving you
all the information you need to make correct choices in medical care, but also
believe that this advice must be based on substantial scientific evidence
that helps bring us as close to the truth as possible. That is not the
situation in this case. To start with, the reports were based on preliminary
data in a Food and Drug Administration (FDA) study that was "leaked" to the
press before even the FDA had a chance to examine the data completely. Just
who leaked the data or why is unknown, but even the FDA believes that some of
the reports in the media "may have overstated the risk of cancer to woman who
have these implants". The source of the discussion is the polyurethane foam
that is used as a coating for certain kinds of silicone gel-filled implants.
It is possible that this material might break down into another substance that
has been shown to cause cancer in laboratory animals. The key word here is
"might", as well as the fact that there is no evidence of cancer ever having
been linked to the implants in humans.
Despite this, the manufacturer of the implants, Surgitek, a subsidiary of
Bristol-Myers Squibb, voluntarily stopped shipment of the implants and advised
doctors to delay any surgery using these devices. This responsible action
will allow the FDA to complete its evaluation of the results of the study, and
should publish its results in but a few weeks. In a statement released by
Bristol-Myers Squibb, it said that "it is confident in the safety of the
product and that it deplored the uncertainty created by the anonymous reports
of research results".
The FDA, in a TALK PAPER issued about this question, stated "While still
assessing the data, FDA believes that the statistical values expressed in some
media accounts may have overstated the risk of cancer to woman who have these
implants". It also said, "It is unfortunate that preliminary FDA laboratory
results reached the public before FDA's analysis of the data was complete.
This has created an unnecessary climate of fear in patients who have been
implanted with these products."
In speaking with a spokesperson for the American Cancer Society, she too
agreed that the sensationalism of press reports had been a disservice to the
public and suggested the following advice. Patients with these breast
implants in place should not seek surgery to remove them. This is not always
a simple procedure and the risk of removal could outweigh the risk of keeping
the implant. In fact there may be no risk for cancer at all, or possibly one
that is very small. Women considering implant surgery should delay the
operation until final analysis of the results of the FDA study.
And that is my advice to you and your sister, as well as anyone else now
facing this situation. Once again, it is clear that you must carefully
analyze anything you learn from the media, and I am here to help you.
----------------
The material contained here is "FOR INFORMATION ONLY" and should not replace
the counsel and advice of your personal physician. Promptly consulting your
doctor is the best path to a quick and successful resolution of any medical
problem.