A federal bill mandating national notification regarding breast density could save the lives of countless women.

Nancy M. Cappello, PhD

We are pleased to inform you that the results of your mammogram are “normal.” Within 6 weeks of my “Happy Gram,” after a palpable ridge, an ultrasound revealed a quarter-size lesion not seen by mammogram. Pathology confirmed a stage 3C breast cancer with 13 metastasized lymph nodes. During this terrifying time, I learned that “extremely” dense tissue was why my mammograms did not detect my cancer. Puzzled and afraid, I searched the medical journals for answers.

Yearly, 45,000 US women receive “normal” mammography reports yet have a hidden “invasive” cancer, which, most likely once detected, will be at a later stage.1-3 That’s a sold out “Wrigley Field” filled with moms, sisters, daughters, and grandmothers.

Armed with science and compelled to action, my husband and I began working with the Connecticut legislature. It resulted in the landmark breast density notification bill in 2009. Currently, there are 11 states following Connecticut’s lead. Women, sharing their personal tragedies of missed cancers, are educating state officials about this public health hazard. Interestingly, three of these state bills were initiated by radiologists—those on the front line of screening challenges created by dense tissue.

After signing Connecticut’s bill in 2009, Governor Jodi Rell remarked, “This law is a no brainer.” Her words ring in my ears daily as we face opposition to legislation from medical organizations like the ACR, AMA, and ACOG.

So, what’s the opposition saying?

There is not enough science: Although the challenge of cancer detection in dense tissue and limitations of mammography would seem reason enough to include “inform” language in reports to patients, the number of peer-reviewed published studies on the masking and causal risk of dense breast tissue have been around for decades and continue to grow.4-9

Measurement of density is subjective: Variability for breast density is not different from other BI-RADS features in mammographic interpretation.10 There is substantiation that training of radiologists dramatically reduces density assessment variability.11 Additionally, there are currently two FDA-cleared volumetric density assessment tools that are commercially available.12

False positives, resulting from adjuvant screening, will scare women: A recent national survey found that 90% of women would return for screening the following year, even after experiencing a false positive.13 Women are more concerned with a MISSED positive than a false one.

We don’t want government to mandate practice as technology is constantly changing: Enacted and proposed legislation does not mandate any technology. It does ensure ALL women receive critical information about their breast composition so they are informed participants in their health care. Right now, women have to rely upon luck for an early breast cancer diagnosis as less than one in 10 women learn about their dense breast tissue from their physician.14

In addition to 11 state bills, Federal Bill HR3102 has been introduced. While the process of enacting a federal bill moves forward, access to early detection becomes state dependent as a woman’s zip code determines whether she receives critical information about her density, which may affect her destiny. What is needed is a single, national notification. The ACR, whose mission statement includes improving the quality of patient care, should take the lead. A revision in ACR’s mammography accreditation standards to include patient breast density in the “lay” letter is the most expeditious way forward.15 It accomplishes in one fell swoop what would otherwise take years. This simple change would result in density notification to nearly 90% of US women.

Each year, we have a stadium filled with women who already have two strikes against them—cancer missed by mammogram and cancer that will most likely be detected when palpable, thus at a later stage. These women, faithful in their screening regimen, yet denied equal access to early detection, have fewer treatment options and worse survival outcomes.16 One more strike left. How much longer can we wait to inform women of the risks and challenges of their dense tissue? This is a no brainer.

References
  1. US Food & Drug Administration: MQSA National Statistics
  2. Steenbergen S, & Weigert, J, “The Connecticut Experiment: The Role of Ultrasound in the Screening of Dense Breasts,” Radiological Society of North America 2011 Scientific Assembly and Annual Meeting.
  3. Berg WA, Blume JD, Cormack JB, et al. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA 2008; 299(18):2151-63.
  4. Boyd NF, Guo H, Martin LJ, et al. Mammographic density and the risk and detection of breast cancer. N Engl J Med. 2007; 356(3):227-36.
  5. Yaghjyan L, Colditz GA, Collins, LC et al. Mammographic breast density and subsequent risk of breast cancer in postmenopausal women according to tumor characteristics. J Natl Cancer Institute 2011; 103:1-11.
  6. Chui SY, Duffy S, Yen AM, Tabar L, et al. The effect of baseline breast density on breast cancer incidence, Stage mortality and screening parameters: 25-year follow-up of a Swedish mammographic screening. Cancer Epidemiol Biomarkers Prev. 2010; 19(5):1219-28.
  7. Stomper, P, D’Souza, D, DiNitto, P, & Arrendondo, M. Analysis of parenchymal density on mammograms in 1353 women 25-79 years old. American Roentgen Ray Society, 1996; 167:1261-1265
  8. Mandelson, M.T., Oestreicher, N, Porter PL., et al. “Breast Density as a predictor of mammographic detection: Comparison of interval and screen-detected cancers,” Journal of the National Cancer Institute 92:13 (2000): 1081-1087.
  9. Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology 2002; 225(1):165-75.
  10. Berg WA, Campassi C, Langenberg P, Sexton MJ. Breast Imaging Reporting and Data System: inter- and AJR Am J Roentgenol 2000; 174:1769-1777.
  11. Martin K, Helvie M, Chou Z, et al: Mammographic density measured with quantitative computer-aided method: Comparison with radiologists’ estimates and BI-RADS categories. Radiology 2006; 240(3): 656-65.
  12. Quantra Volumetric Assessment by Hologic & Volpara Breast Imaging Software
  13. National Survey by Research Now commissioned by Are You Dense, Inc. Woodbury, CT: Sept., 2011
  14. National Survey by Harris Interactive commissioned by U-Systems, Inc. New York: May, 2010
  15. ACR: Practice Guidelines For Screening & Digital Mammography Page VIII (c) (1)(2008) (retrieved online)
  16. ACS: Breast Cancer Survival Rates by Stage 1/6/2012 (retrieved online)