For decades, the American College of Radiology (ACR) has been a vigorous advocate of quality breast imaging. Before there was a federal mandate for breast imaging accreditation, the College established a voluntary mammography accreditation program promoting standards for quality assurance and quality control. The ACR supported the enactment and subsequent reauthorizations of the Mammography Quality Standards Act (MQSA) – including the requirement for patient notification through summary letters. The ACR has developed voluntary accreditation programs for other breast imaging modalities that are not covered by the MQSA. The ACR supports the breast cancer screening guidelines promulgated by the American Cancer Society, and has invested considerable effort to encourage women and their health care providers to utilize screening to save lives.

The ACR recognizes that breast density has an impact on mammographic screening. The ACR’s BI-RADS lexicon describes four categories of breast parenchymal density and instructs radiologists to include this density information in the medical report. It is well known that greater breast density results in lower sensitivity for mammography. By including this information in the medical report, the referring health care provider is given a general idea of the likelihood that cancer will be detected or missed based on the parenchymal pattern. The ACR would support an FDA mandate that information on breast parenchymal density be included in the mammography report.

While the ACR supports and promotes the practice of patient education and encourages Americans to take charge of their own care, it is less clear how patients may interpret the same information if included in a patient summary. While the ACR is not opposed to including breast parenchymal information in the lay summary, we urge strong consideration of the benefits, possible harms and unintended consequences of doing so. In particular, we would urge consideration of the following:

• The assessment of breast density is not reliably reproducible. When the same mammogram is interpreted by a different physician or by the same physician on different occasions, differing density can be reported. If these variations are reported to each woman screened on each occasion, it might result in confusion or an impression of the lack of reliability of mammography.
• For women with fatty breasts, the reporting of this information may convey a false sense of security about negative mammography results. Even women with fatty breasts may have breast cancer undetected by mammography and may present with a palpable finding. High-risk women should not be complacent and forego recommended Screening MRI because they have fatty breasts.
• The significance of breast density as a risk factor for breast cancer is highly controversial. Moreover, there is no consensus that density per se confers sufficient risk to warrant supplemental screening. For women with dense breasts, receipt of breast density information may create undue anxiety about their risk and worry that mammography may have missed a breast cancer.
• The inclusion of breast density information in the lay summary could result in demands for additional non-mammographic screening. Both ultrasound and magnetic resonance imaging (MRI) have been studied as supplemental screening techniques, primarily in higher risk women, and both can detect malignancies undetected via mammography. Breast MRI is more sensitive than either mammography or ultrasound and can detect malignancies not found when both screening mammography and screening ultrasound are combined. Importantly, both additional techniques result in additional false positive examinations and increase the number of benign breast biopsies. Also, it needs to be remembered that there is no randomized trial data that shows that adding either ultrasound or MRI to mammography screening saves lives.
• Unless supplemental screening were reimbursed by insurers, there may be an unfortunate disparity between women who can afford to pay for the additional screening exam and those who cannot.

The ACR recommends that all stakeholders proceed with caution in considering a statutory or legislative mandate to include breast parenchymal density information in the patient summary or to require that patients receive copies of their imaging reports sent to their ordering physician. It might be valuable to review the experience in the state of Connecticut, where a law requiring this communication has been in place long enough to gather and evaluate outcomes and effects. As always, the ACR is happy to work with legislators, regulatory agencies and patient groups to arrive at evidenced based imaging policies which save and extend lives.