Self-examination breast pad
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approved on December 22, 1995
The medical device, consisting of a silicon-filled flexible
circular plastic envelope 10 inches in diameter, is designed to
reduce friction while women examine their breasts.
Last month, the FDA received the results of a clinical study
conducted in Japan. The study found that women who were trained in
using the pad detected their own breast lumps almost as frequently
as they were found by trained nurses also using the pad.
The pad is to be distributed only by health care providers and
only to women who have received instructions in its proper use. The
FDA announcement said that women should continue bare-handed breast
self-examinations and maintain a schedule of regular breast
examinations by a physician and annual mammograms.
Monthly breast self-examination (BSE) is recommended by cancer
authorities as a routine good health habit for women 20 and older.
Upwards of 75% of breast lumps subsequently diagnosed as cancer are
first discovered by the woman herself.
Mammography is also recommended for breast cancer screening. A
"baseline" mammogram is recommended for women between 35
and 39, and this initial screening can be compared against later
mammograms as a further check. Women between 40 and 49 are advised
to have a mammogram every 1 to 2 years, and women aged 50 and over,