"en-US"> Are You Dense :: Nancy’s Chalkboard: Could the Breast Density Fog be Lifting? Breast Cancer Screening in Women with Dense Breasts: ACR and FDA weigh in

Nancy’s Chalkboard: Could the Breast Density Fog be Lifting? Breast Cancer Screening in Women with Dense Breasts: ACR and FDA weigh in

Originally Posted Jan 28th, 2018

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Nancy M. Cappello, Ph.D. Founder & Director,
Are You Dense, Inc. &
Are You Dense Advocacy, Inc.
See Bio

It was a cold, dark and dreary afternoon on February 3, 2004, with an icy and snowy mix when I rushed from my workplace in Hartford for the one-hour commute to receive the results of my breast biopsy.  A few weeks earlier, my OB/GYN felt a ridge in my right breast during a routine yearly exam. This was the first time, since my eleven yearly mammograms, that any of my health care providers raised concerns about my breast health. My husband Joe wanted to join me at my appointment but I refused his loving offer since my mammography results five weeks earlier, just like the past 10 reports, stated that the results of my mammogram are ‘normal.’

It wasn’t my breast surgeon’s first sentence that stunned and frightened me – it was what came next, “And, it appears to be at a later stage.” Everything she said to me after that was garbled.

My mind was racing with inside chatter. “I just had a normal mammogram, how could this be? Later stage? What the heck does that mean?  I don’t have any family history? Maybe this is a mistake.”

It was no mistake. The pathology report, after my single latissimus flap mastectomy reported that my cancer was at Stage 3C, with metastases to 13 lymph nodes. After nearly arm-wrestling my team of doctors for a response as to why my cancer was diagnosed so late when I never missed a mammogram appointment, I was told that I had dense breast tissue.  Each of my five doctors reported to me that mammograms often miss cancer in dense breasts.  

“Shouldn’t I have known this health-care team? If you believe that early detection, through screening reduces mortality, where is your outrage that 40% of women with dense breast tissue are at a greater risk for missed cancer and a later stage diagnosis?” Their lock-step group think response haunted me. “No, we don’t tell women this, as it is not the standard protocol.” 

Their lack of concern about an unequal access to an early diagnosis for women with dense breast tissue offended me, the one with the late stage disease, and led my husband Joe and me to seek a legislative solution which we have relentless pursued for the past fourteen years.

With not much fanfare and quite astonishing very little media coverage, the American College of Radiology (ACR) published recommendations last week for breast cancer screening in women with higher-than-average risk, including dense breasts as one of the population subgroups. Setting aside the masking risk of cancer in dense breasts by mammography, the authors report “that there is an increased risk for developing breast cancer among women with dense breasts, usually defined as heterogeneous dense and extremely dense." The authors recommend annual surveillance with breast MRI for women with personal histories of breast cancer and dense breast tissue or those diagnosed before age 50. For women with elevated risk, limited to increased breast density, ultrasound can be considered for adjunctive screening, after weighing the benefits and risks. 

The benefits of this non-ionizing radiation technology include detection of cancers, invisible by mammogram. These cancers tend to be invasive, small and node negative – the poster for an early diagnosis. The false positive finding (having a biopsy that is negative for cancer) is the most mentioned risk of ultrasound screening. However, studies have shown that practice and training significantly reduces false positives.

On the U.S. Food and Drug Administration (FDA) front, Dr. Scott Gottlieb, Commissioner of the FDA, listed recognizing advances in technology to ensure women get the most relevant, up-to-date information about their breast density as one of the FDA's major policy goals in 2018.  For a decade, Are You Dense Advocacy Inc. and Are You Dense Inc. have advocated for a change to the Mammography Quality Standards Act (MQSA) to include a patient's breast tissue composition as part of the mammography reporting results. 

In 2011, the MQSA committee of the FDA came to consensus to propose regulations to the MQSA to incorporate these changes.  At the time of the meeting, two states had density reporting laws (Connecticut and Texas).  In more than 6 years since that declaration, which has not resulted in any published proposed regulations, another 29 states have followed Connecticut and Texas in protecting women from missed, delayed and advanced stage breast cancer.  

Being diagnosed with an advanced stage breast cancer diagnosis, despite never missing my mammogram appointment, I have relentlessly pursued survival, with the odds for life stacked against me. The ACR recommendations for the large subgroup of women with increased breast density as a higher-than-average risk factor and Dr. Gottlieb’s leadership at the FDA to “modernize mammography standards” to include a patient’s breast tissue composition for informed screening decisions, give me hope that the persistent fog of breast density may be lifting.

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  • Are You Dense? Fact #1:

    Breast density is one of the strongest predictors of the failure of mammography screening to detect cancer.

     
  • Are You Dense? Fact #2:

    Two-thirds of pre-menopausal women and 1/4 of post menopausal women have dense breast tissue. 

     
  • Are You Dense? Fact #3:

    Adding more sensitive tests to mammography significantly increase detection of invasive cancers that are small and node negative.

     
  • Are You Dense? Fact #4:

    American College of Radiology describes women with "Dense Breast Tissue" as having a higher than average risk of Breast Cancer.

     
  • Are You Dense? Fact #5:

    While a mammogram detects 98% of cancers in women with fatty breasts, it finds only 48% in women with the densest breasts.

     
  • Are You Dense? Fact #6:

    A woman at average risk and a woman at high risk have an EQUAL chance of having their cancer masked by mammogram.

     
  • Are You Dense? Fact #7:

    Women with dense breasts who had breast cancer have a four times higher risk of recurrence than women with less-dense breasts.

     
  • Are You Dense? Fact #8:

    A substantial proportion of Breast Cancer can be attributed to high breast density alone.

     
  • Are You Dense? Fact #9:

    Cancer turns up five times more often in women with extremely dense breasts than those with the most fatty tissue.

     
  • Are You Dense? Fact #10

    There are too many women who are unaware of their breast density, believe their “Happy Gram” when it reports no significant findings and are at risk of receiving a later stage cancer diagnosis.

     
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