FDA gives approval for breast self-exam pad
FDA gives approval for breast self-exam pad
Pad boosts accuracy of self-tests
Becton Dickinson in Franklin Lakes, NJ, recently received approval from the Rockville, MD-based U.S. Food and Drug Administration to sell its B-D Sensability Breast Self-Examination Aid in drug stores and major chain stores nationwide. A study using Sensability, which is a latex-free pad, found that the pad provided a higher level of tactile awareness than a bare hand.
A clinical trial of 72 breast cancer patients found that patients who use the Sensability pad were able to use the product as effectively as nurses familiar with proper breast examination technique. A separate clinical study showed that the Sensa bility pad provided better tactile awareness than either a dry palpation using a bare hand or palpation with soapy water, such as women might experience when performing self-exams in the shower.
The B-D Sensability Breast Self Examination Aid consists of two thin, round plastic sheets that are 10 inches in diameter with a liquid lubricant sealed between them. The design makes it easy for the woman’s fingers to glide smoothly across her breast during a self-exam. An educational video, an instruction guide, and a storage case are included with each Sensability pad.
[For more information, visit www.bd.com or call toll-free (877) 232-7324.]
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