BOCA RATON — The Christine E. Lynn Women’s Health & Wellness Institute (LWHWI) at Boca Raton Regional Hospital is one of only 10 leading clinical centers across the nation to have participated in an important new breast ultrasound study in women with dense breasts.
The study was conducted over a three and one-half year prospective multi-center trial process. Nearly 10 percent of the nation’s breast ultrasounds in the study were conducted at the Institute.
Based on the study, the U.S. Food and Drug Administration’s (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee unanimously recommended approval of U-System’s somo•v® Automated Breast Ultrasound (ABUS) System for use in women with dense breast tissue who had a normal screening mammogram.
The government panel publically recognized the limitations of mammography in women with dense breast, and that by adding whole breast ultrasound, the cancer detection rate can be doubled in this population of women.
“Recently, several scientific studies have demonstrated that supplementing mammography with ultrasound for women with dense breasts finds a statistically significant number of additional cancers,” said Kathy Schilling, MD, medical director of the institute.
“We are telling women about the breast ultrasound services being offered at our hospital and encourage patients to talk to their doctors for the need of supplemental exams. Patients are starting to realize the importance of breast ultrasounds in dense breasts and are asking questions.”
For women aged 40 and older, mammography has traditionally been the most important tool for the early detection of breast cancer. But for women who have dense breast tissue, the procedure has known limitation in detecting cancers.
Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect via mammography, according to multiple large studies.
One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks appearance of tumors. As breast density goes up, the accuracy of the mammogram goes down.
“This was a landmark decision for women’s health,” says Dr. Schilling. “We have changed the way women will be screened in the future. It makes me feel good that we, at Boca Regional, can enhance breast care for women across the world.”