For the first time, the Food and Drug Administration has approved a non-prescription FDA approves Sensability breast self-examination pad (dateline October 11, 1999) | Breast Health News | Imaginis - The Women's Health & Wellness Resource Network

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FDA approves Sensability breast self-examination pad (dateline October 11, 1999)


For the first time, the Food and Drug Administration has approved a non-prescription breast self-examination (BSE) pad for at-home use. The Sensability breast pad is distributed by B-D, Inc. (Becton Dickinson) and is composed of two plastic sheets (ten 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, Director of The Breast Center at Suburban Hospital in Bethesda, Maryland. "The Sensability 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-plastic breast pad may be reused each month. The pad is latex-free, comes with a step-by-step reference guide and easy to understand video. Sensability may be ordered online at http://www.drugstore.com/products/40420.asp?pid=40420&catid=10265. Sensability is also available at stores such as K-Mart, Walgreens, and Wal-Mart.

A clinical trial conducted with seventy-two breast cancer patients revealed that patients who used the Sensability pad (then known as Sensor 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 Sensability 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 helps reduce the need for therapeutic treatment and minimizes pain and suffering. 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 20 years of age and older should perform breast self-examination (BSE) every month (click here for more guidelines women should follow for early detection of breast cancer).

Presently, seventy one million American women do not perform BSE for a variety of reasons including lack of confidence, not knowing what to look for, limited tactile sensitivity with a bare hand, fear of finding an abnormality, and discomfort in touching their own breasts. Although ninety-six percent of women are aware of the importance of BSE, only twenty-nine percent perform self-exams on a regular basis.

"When I first brought home the Sensability pad, I didn’t use it for six months because I didn’t feel confident that I would be able to detect a lump on my own," said Mary Gorman of Chevy Chase, Maryland. "Once I started using it, I was amazed at how the pad was able to enhance my sense of touch. The Sensability pad helped me find a lump that both a mammogram and my doctor had missed."

To use the Sensability pad correctly, women should examine their breasts standing up, lying down, and before a mirror. Many women who conduct monthly BSE only do so in the shower and therefore do not complete a thorough examination. An instructional video on how to conduct a BSE using the Sensability pad is available for online viewing at: http://www.bd.com/sensability/prod_demo.asp.

Women with breast implants or other reconstructive surgery should consult their physician before using the B-D Sensability Breast Self-Examination Aid.

The American Cancer Society recommends that in addition to monthly BSE, women should receive routine clinical breast exams by a healthcare professional. Women over forty should also have a yearly mammogram.

This article references the September 14, 1999 B-D press release available at http://www.prnewswire.com/. Additional information about the Sensability Breast Examination Pad is available from B-D at http://www.bd.com/sensability/ and from Drugstore.com at http://www.drugstore.com/products/40420.asp?pid=40420&catid=10265.

For more information about breast self-examination (BSE), please visit http://www.imaginis.com/breasthealth/bse.asp.