Answers
09/01/1994

<TITLE>PANEL RECOMMENDS STUDIES FOR BREAST SELF EXAM DEVICES </TITLE>
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T94-40                                             Sharon Snider
Sept. 1, 1994                                      (301) 443-3285

      PANEL RECOMMENDS STUDIES FOR BREAST SELF EXAM DEVICES 

     We are receiving inquiries about today's advisory committee
meeting on devices to aid in breast self examination.  The
following can be used to answer questions.
     FDA's Obstetrics and Gynecology Devices Advisory Panel
recommended that such devices be tested before they are allowed on
the market.  The panel, a group of outside experts, recommended
that laboratory and clinical studies be performed to address the
following questions:
     *  Does the device add benefit to a conventional breast self
examination?
     *  After using the device routinely for a long time, will a
woman be more likely or less likely to seek help if she finds an
abnormality?
     *  Could the device "mask"  breast lumps, making them more
difficult to detect?  If this were the case, it could delay a
woman's seeking medical attention.
     *  Could the device lead a woman to believe she has a breast
lump when in fact none exists?  If this were the case, it could
cause needless anxiety and lead to unnecessary testing, including
biopsies.
                             -MORE-

                       Page 2, T94-40, Breast Self Exam Devices
     The panel also stressed the need for clear labeling of the
device to be sure that women understand its proper use and
limitations.  They also recommended that groups of women be
involved in developing the labeling.     
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