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McLaren Bay Diagnostic Center Now Offering FDA-Approved Automated Breast Ultrasound System for Screening Women with Dense Breasts

Published on Thursday, January 28, 2016

McLaren Bay Diagnostic Center announced that they are on the leading edge of breast care by now offering the InveniaTM ABUS (Automated Breast Ultrasound System), approved by the FDA for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue and no prior interventions. McLaren Bay Diagnostic is located in the Health Pavilion on McLaren Bay Region’s West Campus, 3175 W. Professional Dr., Bay City.

“We are excited to add the Automated Breast Ultrasound system from GE Healthcare to our comprehensive breast cancer screening program. By offering ABUS in addition to mammography for our patients with dense breast tissue, we anticipate improving detection for small cancers that cannot be seen on a mammogram alone in these women. We believe ABUS will become an integral part of our practice for the detection of breast cancer,” said Tari Stull, MD, FACS, Breast Surgeon at McLaren Bay Region, Bay City, MI.

Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect using mammography, according to multiple large studies. One study, published in the New England Journal of Medicine, showed mammography sensitivity is reduced by 36 to 38 percent in women with dense breasts, as density masks the appearance of tumors (Boyd, et al, NEJM 2007:356:227-36M). As breast density goes up, the accuracy of mammograms goes down (Kolb et al Radiology, October 2002).

As a result, several states, including Michigan, have passed laws mandating that women be notified if their breasts are dense, and may offer supplemental imaging as appropriate.

“Mammography is an effective tool for the detection of breast cancer; however, it doesn’t work equally well in all women, particularly those with dense breast tissue,” added Dr. Stull. “Designed and built specifically for screening, research shows that ABUS technology as an adjunct to mammography has the potential to find 35.7 percent additional cancers that would not have been found with mammography alone.”

The Invenia ABUS system is FDA-approved for breast cancer screening in the United States as an adjunct to mammography for asymptomatic women with dense breast tissue and no prior interventions. The Invenia ABUS system is designed to enhance the consistency, reproducibility, and sensitivity of whole breast ultrasound, demonstrating a 35.7 percent improvement in cancer detection (sensitivity) in women with dense breasts without prior breast intervention. (FDA PMA Approval P110006, Sept. 18, 2012.)

The unique challenges of breast cancer screening led to important technology innovations that result high resolution images that can be acquired rapidly. Clinically, this offers an efficient option that provides enhanced resolution and contrast, making the Invenia ABUS system well positioned to address the workflow challenges of breast cancer screening and improve the detection of breast cancer, in women with dense breasts.

Dr. Stull recommends that women get regular mammograms as suggested by their doctor, and if they have been informed that they have dense breast tissue, they should talk to their doctor about their specific risk and additional screening tests that might be appropriate.

For more information or to schedule an ABUS Whole Breast Ultrasound at McLaren Bay Diagnostic, call (989) 667-6350. For further information about Invenia ABUS, visit www.gehealthcare.com.

Brief Statement

The Invenia ABUS is indicated as an adjunct to mammography or breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign (BI-RADS® Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/Density 3 or 4), and have not had previous clinical breast intervention. The device is intended to increase breast cancer detection in the described patient population. The Invenia ABUS may also be used for diagnostic ultrasound imaging of the breast in symptomatic women. See the device manual for detailed information, contraindications, warnings, precautions, potential adverse events.

About McLaren Health Care

McLaren Health Care, headquartered in Flint, Michigan, is a fully integrated health network committed to quality evidence-based patient care and cost efficiency. The McLaren system includes 12 hospitals, ambulatory surgery centers, imaging centers, the state’s only proton therapy center, an employed primary care physician network, commercial and Medicaid HMOs covering more than 260,000 lives, home health and hospice providers, retail medical equipment showrooms, pharmacy services, and a wholly owned medical malpractice insurance company. McLaren operates Michigan’s largest network of cancer centers and providers, anchored by the Barbara Ann Karmanos Cancer Institute, one of only 45 National Cancer Institute-designated comprehensive centers in the U.S. McLaren has 21,000 employees and more than 25,000 network providers. Its operations are housed in more than 300 facilities serving a 54-county market and 75 percent of Michigan’s population. Learn more at mclaren.org.,