Aware® – Breast Self Exam

The Aware^® Pad is a medical device, which consists of two skin-safe membranes with lubricant sealed in between.

When you place your fingers on the pad and press firmly against it, your fingers will glide smoothly across your breast. The Aware^® Pad reduces friction between your fingers and your breast and may provide for an easier and more comfortable exam. The pad increases your sense of touch.

Note: Aware^® is an aid to breast self-exams. However, this product makes no explicit claim to find breast cancer, breast lumps or any other type of breast disease. Aware^® should be used in conjunction with regular medical visits and periodic ultrasound/mammography.

”Just Having the Aware® breast pad around the patient’s bedroom or bathroom is helpful because it reminds them that they are supposed to do the breast self-exam once a month.”

Josephine L. McNamara Von Herzen, M.D.

Breast cancer is the most common type of cancer in the UK.

There are around 55,900 new breast cancer cases in the UK every year, that’s more than 150 every day. About 1 in 8 women are diagnosed with breast cancer during their lifetime. Early detection is the best protection, it improves chances for successful treatment and can save lives.

About 80% of breast cancers are detected because women themselves notice changes in their breasts.

Regular Breast Self-Exams (BSE) help women to feel more comfortable, develop an awareness of their breasts and recognise changes promptly.

Performing Breast Self-Exams in conjunction with other screening methods, e.g. clinical exams by a physician and periodic mammograms, can increase the chance to detect breast cancer early.

The Aware® Pad is a medical device, which consists of two skin-safe membranes with lubricant sealed in between. When you place your fingers on the Aware® Pad and press firmly against it, your fingers will glide smoothly across your breast. The Aware® Pad reduces friction between your fingers and your breast and may provide for an easier and more comfortable exam. The pad increases your sense of touch.

 

Aware® Performance

 

Clinical Study #1

Kawasaki Medical University Hospital for Aware FDA approval (N=832 patients)

• Study concluded that Aware® is a highly effective tools for early breast cancer detection
• Regular practice of breast self exams is extremely important for early detection

 

Clinical Study #2

Millikin University, Decatur, IL for Aware FDA approval

• Breast models were used of urethane foam construction
• One lump was embedded in each model; 6 lumps of varying sizes and 7 models were used
• Models were examined with and without the use of the Aware Pad

Results

• Mean percent accuracy data and mean reaction time data support the interpretation that Aware Pad enhances lump detection
• Subjects were more accurate and took less time to find a lump when using the Aware Pad
• Lump detection was greater with the Aware Pad on lumps of size 0.18, 0.25, 0.30, 0.43 and 0.58 mm in thickness