Breast Cancer Action Challenges the FDA’s Proposal Requiring Women Get Breast Density Information After Mammograms

 

 

 


For immediate release
March 28, 2019

Contact: Kira Jones
Communications Manager
415.243.9301×15
ksjones@bcaction.org

SAN FRANCISCO, CALIFORNIA (March 28, 2019) – Breast Cancer Action today challenged the proposed update to the U.S. Food and Drug Administration’s (FDA) regulation of mammography screening, the first change in more than two decades, to require specific wording about breast density detected through mammograms.

 

“Any attempt by policy makers to dictate what health providers must or must not say to their patients is misguided and ill-informed,” said Breast Cancer Action’s Executive Director, Karuna Jaggar.

 

“Breast Cancer Action has long argued that people living with and at risk of breast cancer need unbiased, evidence-based information in order to make deeply personal and life-changing decisions related to breast cancer,” said Jaggar. “This proposed regulation is likely to do the opposite of what’s intended. It will interfere in patient-provider communication by singling out just one of the limitations of mammography screening, instead of encouraging a full discussion of the range of possible harms and potential benefits.”

 

Patient and consumer watchdog groups have spoken out against similar legislative efforts to mandate what health providers can and cannot say to their patients on a range of health and safety issues, from requiring providers to say that abortion increases the risk of breast cancer (despite no evidence of this link) to preventing pediatricians from asking about guns in the home.

 

“Despite the growing focus on breast density, including legislation in more than 35 states that requires notification for dense breasts, women with dense breasts are not more likely to die of breast cancer than women without dense breasts,” said Jaggar. “Research has shown that many women with dense breasts may actually be at low or average risk, which calls into question the utility and wisdom of singling out breast density when discussing risk.”

 

“It’s often suggested that dense breasts are a problem, when the reality is that dense breasts are perfectly normal and healthy,” cautioned Jaggar. “In fact, the very concept of breast density emerged as a result of mammography screening. There is nothing uncommon or abnormal about having dense breasts.”

 

Rather than proposing adding only information about breast density to the revised mammography summary letter that patients receive, Breast Cancer Action encourages the FDA to instead focus on ensuring balanced information about the limitations and potential harms of mammography screening, including overdiagnosis. “The false negatives that result from breast density are just one of the limitations associated with mammography screening,” said Jaggar. “When an estimated 50,000 or more women are overtreated for breast cancer, that’s of at least equal concern.”

 

Experts estimate that around one in five breast cancers that are detected through routine mammograms are overdiagnosed, resulting in overtreatment. “Given that around 20 percent of women are overdiagnosed through routine mammography, improvements to screening should be focused on including how to do the least amount of harm,” said Jaggar. “There is currently no evidence of benefit from supplemental screening for women with dense breasts. Only with balanced, evidence-based information can people make truly informed decisions,” said Jaggar.

 

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Breast Cancer Action (www.bcaction.org) is a national education and activist nonprofit organization whose mission is to achieve health justice for all women at risk of and living with breast cancer. BCAction has a strict conflict of interest policy and refuses to accept corporate funding from companies or organizations that profit from or contribute to the breast cancer epidemic.

This entry was posted in Press Releases.

3 Responses to Breast Cancer Action Challenges the FDA’s Proposal Requiring Women Get Breast Density Information After Mammograms

  1. Ashlie Lopez says:

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  2. Caroline says:

    1) There is quite a bit of persuasive evidence that denser breast tissue actually does increase the risk of breast cancer. 2) Unfortunately, many of us don’t live in an “ideal world” and our physicians do not chose to have discussions with us about breast cancer risk. So some imperfect language on our mammogram is the only “heads up” we get. Opposing this language does women a disservice.
    “From the fattiest breast, up to the most dense breast, there’s about a five-fold difference in risk. So, from looking at density alone, your lifetime risk could go from 1 in 20 for the least dense breast to around 1 in 4 for the most dense.”
    https://www.news-medical.net/news/20180201/Exploring-the-Future-of-Breast-Cancer-Risk-Assessment.aspx
    “Women with dense breasts have a higher rate of recall, higher rates of screen-detected and interval breast cancers, and more lymph node-positive disease, according to a study published in Radiology.”
    https://doi.org/10.1148/radiol.2018172972
    The benefits of adjunct imaging should be considered alongside the risks.
    DOI: https://doi.org/10.1016/j.ejca.2018.08.029
    AMA Urges Coverage for Added Breast Cancer Screening Resolution aimed at women with dense breasts
    https://www.medpagetoday.com/meetingcoverage/ama/76307?xid=nl_mpt_SRObgyn_2018-11-17&eun=g1278169d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=ObGynScope_111718&utm_term=Breaking%20News%20-%20Obgyn
    Patients with or without dense breasts benefit from lower recall rates with 3D mammography and there is no trade off with cancer detection according to a study published in Radiology.
    https://doi.org/10.1148/radiol.2019182305

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