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New NJ Breast Density Law-- Information for Clinicians

What is the New Jersey breast density legislation?
A new law, effective May 1st 2014, that mandates that radiologists include the follow comment in all letters mailed to patients and reports to providers after their screening mammogram:
“Your mammogram may show that you have dense breast tissue as determined by the Breast Imaging Reporting and Data System established by the American College of Radiology. Dense breast tissue is very common and is not abnormal. However, in some cases, dense breast tissue can make it harder to find cancer on a mammogram and may also be associated with a risk factor for breast cancer. Discuss this and other risks for breast cancer that pertain to your personal medical history with your healthcare provider. A report of your results was sent to your healthcare provider. You may also find more information about breast density at the website for the American College of Radiology,”
My patient received her screening mammogram lay letter. Now she is concerned about her breast density. Her first question is “Should I continue to have mammograms?”
Yes. All patients should continue to have annual screening mammograms. Mammograms have been shown to be effective in decreasing breast cancer mortality for all breast densities.
My patient is concerned that her breast density places her at increased risk for breast cancer.
Reassure your patient that breast density alone has a small impact on the risk for breast cancer. More importantly, they are not at increased risk of dying from breast cancer when compared to women with fatty breasts.
My patient asks “How dense are my breasts?”
Refer to the mammogram report (different from the lay letter). There are four classifications of breast density (A,B,C,D). This is determined subjectively by the interpreting radiologist.
A. Almost entirely fatty
B. Scattered areas of fibroglandular densities
C. Heterogeneously dense
Minimal increased risk above average (RR=1.2 compared to average breast density)
D. Extremely dense
Doubles the risk of breast cancer compared to average density. This increase in risk is similar to the risk associated with a family history of unilateral, postmenopausal breast cancer in a mother, sister or daughter.
My patient does NOT have dense breasts but she still wants additional breast screening studies.
Assure the patient that she is not at increased risk for breast cancer and that annual screening mammography is the current best screening method for breast cancer for women of all breast densities.
Other supplemental screening studies exist (MRI, ultrasound, tomosynthesis) but will likely not be covered by insurance for patients that do not have dense breasts.
My patient has dense breasts. Should she be screened with something different than mammography?
Explain that at this point, there is no other method recommended to replace mammography. There are certain signs of cancer (for example, calcifications) that are best seen on a mammogram. Other “screening” options are not meant to replace mammography. These studies are done as a supplement.
What role does tomosynthesis play in breast cancer screening?
Tomosynthesis is an emerging imaging modality that has shown promise in early clinical trials. Its role in breast cancer screening is currently being evaluated.

  Breast Density Diagram                                                                               

My patient is in a high risk category. She has at least one of the following:
• Calculated >20% lifetime risk (as based upon a risk model)
• Calculated >5% 10 year risk of breast cancer (as based upon a risk model)
• BRCA mutation (or untested with BRCA mutation in first-degree relative)
• History of mantle radiation at 30 years of age or younger
Regardless of breast density, recommend annual screening mammogram and annual screening breast MRI. Screening MRI is typically covered by insurance for high risk women. If a woman is being screening annually with a mammogram and MRI, no other screening tests (such as ultrasound) are needed.

My patient meets criteria of a high risk patient. I recommended continuing annual screening mammography and adding annual screening MRI. However, my patient is unable to have an MRI (claustrophobia, pacemaker, contrast allergy, or other reasons).
Recommend an annual screening mammogram and annual screening ultrasound, as the second best supplementary screening test for high risk women. Studies have shown some utility for ultrasound in high risk women if screening MRI is not performed.
My patient has dense breasts without high-risk factors.  What are considerations about supplemental screening with ultrasound and MRI?

The American College of Radiology Imaging Network (ACRIN) 6666 Study is the largest prospective trial studying additional cancer detection performance with the addition of ultrasound and MRI to mammography.  All patients were intermediate to high risk, with 54% having a personal cancer history.  Statistics may differ for a general community population.
Increased cancer detection rates were shown for added ultrasound and added MRI compared to mammography alone.  Mammography detected 7.6 cancers/1000 patients.  Ultrasound found an additional 4.3 cancers/1000, while MRI found an additional 14.7 cancers/1000.
i) For patients screened by mammography alone, 2% required biopsy--38% were cancer.
ii) For patients screened by ultrasound, 5% had additional ultrasound findings requiring biopsy for diagnosis—7.4% were cancer. Also in the ultrasound group, 12.2% of patients had probably benign findings requiring serial follow-up to assess stability.
iii) For patients screened by MRI, 13.2% had additional MRI findings requiring biopsy for diagnosis—19% were cancer.

Thank you. We hope that this clarifies your concerns about breast density.


Information from the Radiological Society of New Jersey, the California Breast Density Information Group (CBDIG) Scenarios for clinicians, March 2013, and American College of Radiology Imaging Network Study 6666, 2008.

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