ANSWERS
12/22/1995

<TITLE> FDA APPROVES SENSORPAD AS AID IN SELF-EXAMINATION OF
BREASTS </TITLE>
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T95-68                                Don McLearn
Dec. 22, 1995                         (301) 827-6242

  FDA APPROVES SENSORPAD AS AID IN SELF-EXAMINATION OF BREASTS 
     The Food and Drug Administration today cleared for marketing
a plastic pad that can be used as an aid to self-examination for
breast lumps by women who are trained in the pad's use.
     The product, Sensor Pad, made by Inventive Products Inc. of
Decatur, Ill., will be available through health care providers,
clinics and other institutions where women can receive the
necessary instructions in its proper use. The pad is to be used
in addition to bare hand breast self-examination, and women are
urged to ensure early detection of breast cancer by continuing to
have regular breast exams by a physician and yearly mammograms.
     FDA's decision to approve the device was based on two
clinical studies submitted by the manufacturer on November 15.
One of the studies, conducted in the United States, examined the
impact of different educational strategies on the skill and
frequency of breast self-examinations. The other study was
performed as part of a breast self-exam screening program in
Japan.
     The Japanese study of 832 women showed that women who had
been properly instructed in the pad's use detected their own
breast lumps almost as frequently as they were found by trained 
                             -More-                                       Page 2, T95-68, SensorPad
nurses also using the pad. Nurses were able to detect lumps in
each of the 72 women identified with breast cancer; of the women
who took part in the study, only one missed her own breast lumps
when self-examining with the pad.
     The studies were submitted to FDA on the recommendation of
the Obstetrics and Gynecology Panel of FDA's Medical Devices
Advisory Committee, which met in September 1994 to discuss the
type of scientific data needed to approve such a product.
     The advisory panel expressed concern that using the pad
might decrease a woman's ability to detect changes in breast
tissue, perhaps masking a lump.  The panel recommended that
clinical studies be required to show that the pad could be used
appropriately by women on their own breasts.
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