U.s. fda – Siemens SX56 User Manual

Page 131

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Two groups of 18 people were exposed to
simulated mobile phone signals under
laboratory conditions while they
performed cognitive function tests. There
were no changes in the subjects' ability to
recall words, numbers, or pictures, or in
their spatial memory, but they were able to
make choices more quickly in one visual
test when they were exposed to simulated
mobile phone signals. This was the only
change noted among more than 20
variables compared.

3

In a study of 209 brain tumor cases and
425 matched controls, there was no
increased risk of brain tumors associated
with mobile phone use. When tumors did
exist in certain locations, however, they
were more likely to be on the side of the
head where the mobile phone was used.
Because this occurred in only a small
number of cases, the increased likelihood
was too small to be statistically
significant.

4

In summary, we do not have enough
information at this point to assure the public
that there are, or are not, any low incident
health problems associated with use of mobile
phones. FDA continues to work with all
parties, including other federal agencies and
industry, to assure that research is undertaken
to provide the necessary answers to the
outstanding questions about the safety of
mobile phones.
What is known about cases of human
cancer that have been reported in users of
hand-held mobile phones?
Some people who have used mobile phones
have been diagnosed with brain cancer. But it
is important to understand that this type of
cancer also occurs among people who have

not used mobile phones. In fact, brain cancer
occurs in the U.S. population at a rate of about
6 new cases per 100,000 people each year. At
that rate, assuming 80 million users of mobile
phones (a number increasing at a rate of about
1 million per month), about 4800 cases of
brain cancer would be expected each year
among those 80 million people, whether or
not they used their phones. Thus it is not
possible to tell whether any individual's
cancer arose because of the phone, or whether
it would have happened anyway. A key
question is whether the risk of getting a
particular form of cancer is greater among
people who use mobile phones than among
the rest of the population. One way to answer
that question is to compare the usage of
mobile phones among people with brain
cancer with the use of mobile phones among
appropriately matched people without brain
cancer. This is called a case-control study.
The current case-control study of brain
cancers by the National Cancer Institute, as
well as the follow-up research to be sponsored
by industry, will begin to generate this type of
information.
What is FDA's role concerning the safety
of mobile phones?
Under the law, FDA does not review the
safety of radiation emitting consumer
products such as mobile phones before
marketing, as it does with new drugs or
medical devices. However, the agency has
authority to take action if mobile phones are
shown to emit radiation at a level that is
hazardous to the user. In such a case, FDA
could require the manufacturers of mobile
phones to notify users of the health hazard and
to repair, replace or recall the phones so that
the hazard no longer exists.

U.S. FDA

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