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, yearly.