FDA approves the Breast self-examination device.

Click link to see the FDA Approval pdf file

For the first time, the Food and Drug Administration has approved a non-prescription breast self-examination (BSE) pad for at-home use. "The BSE Pad" is composed of two plastic sheets (eight inches in diameter) with a small amount of liquid lubricant sealed inside. When used properly by a woman during her monthly BSE, the pad reduces the friction between her fingers and breast and enhances her sense of touch during the exam.

"BSE is a simple test women can do to maintain breast health and statistics show women still don't do it on a routine basis," says Katherine Alley, MD, and Director of The Breast Center at Suburban Hospital in Bethesda, Maryland. "The "BSE Pad" aid can help women feel more confident in their ability to conduct exams by making it easier and more comfortable for them." The ultra-thin, soft-polyurethane breast pad may be reused each month. The pad is latex-free, and comes with a step-by-step reference guide designed by a General Surgeon and Breast Cancer Surgery Specialist.

A clinical trial conducted with seventy-two breast cancer patients revealed that patients who used "The BSE Pad" were able to use the product as effectively as nurses familiar with the proper breast examination technique. A similar study showed that women who used" The BSE Pad" had higher tactile awareness than with a bare hand or with soapy water (simulating BSE in the shower).

Routine breast self-examination helps women become familiar with how their breasts normally feel, making it easier to detect any changes that may occur. According to the American Cancer Society, when breast cancer is discovered early and confined to the breast, the five-year survival rate is over ninety-six percent. Early detection of breast cancer increases the possibility that you may only need minimal surgery on the breast and axilla, which will reduce pain and suffering. The very small tumors (less than 1.0 cm) may not need to be treated with chemotherapy. Some studies estimate breast cancer mortality can be reduced by as much as eighteen percent through increased use of BSE.

The American Cancer Society recommends that all women 18 years of age and older should perform monthly breast self exams.