The Food and Drug Administration set forth a new rule that was implemented on March 10, 2023, requiring mammography facilities to inform women about their breast density. The purpose of this rule is to ensure that women nationwide are educated about the potential risks associated with breast density, advised on the use of other imaging tests for cancer detection, and encouraged to discuss further steps with their healthcare providers based on their unique situations.
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A team of experts in social science, health policy, radiology, and primary care and health services research were consulted by The Conversation U.S. to explain the implications of the FDA’s new regulations on health communications. This includes guidance for women on considering additional imaging tests, often referred to as supplemental screening.
Understanding Breast Density and Its Significance
Breast density is classified into four categories: fatty, scattered tissue, heterogeneously dense, and extremely dense. Dense breasts consist of more fibrous and glandular tissue, making it challenging to detect cancer as both tissues appear white on mammographic images. Approximately half of all women in America have dense breasts, which increases the risk of breast cancer.
Apart from standard mammograms, new imaging technologies like tomosynthesis have shown to be more effective in detecting cancers in women with dense breasts. Therefore, tomosynthesis screening is generally recommended for better outcomes.
Key Points of the FDA Rule
Following a mammogram, women must be informed whether they have dense or non-dense breasts, the increased risk of breast cancer due to density, the challenges of cancer detection in dense breasts, and the potential benefits of additional imaging tests for early cancer detection. They are further advised to consult with their healthcare providers on the need for additional screening based on their individual circumstances.
The Rationale Behind the FDA Regulation
Prior to this rule, various states had different breast density notification requirements, leading to inconsistencies and concerns regarding cancer detection in advanced stages. The FDA standardized the breast density information to ensure clarity and consistency, taking into account varied literacy levels among women. This standardization aims to address confusion and anxiety, particularly among women with lower literacy levels, when receiving notifications.
Evaluating the Need for Supplemental Screening
While supplemental screening beyond standard mammography may detect additional cancers, there is limited evidence supporting its ability to save more lives. Organizations and experts interpret available data differently, leading to varied recommendations. Individual risk assessment plays a crucial role in deciding the necessity of supplemental screening, with emerging evidence suggesting higher-risk women benefit the most from such screenings.
Considerations for Women Opting for Added Screening
Women are advised to assess their personal risk of breast cancer using available tools, alongside understanding that breast density is one of several risk factors. Lifestyle modifications can also impact breast cancer risk. The potential harms of supplemental screening, such as false alarms and overdiagnosis, should be weighed against the benefits when considering additional tests.
Further Information and Guidance
Conversations with healthcare providers are crucial in making informed decisions about breast cancer screening. Women can access various online resources like the American Cancer Society, Dense Breast-info, and the American College of Radiology for more information. Understanding the complexities of breast density and associated screening options will help women make informed decisions related to their breast health.
Nancy Kressin, Professor Emeritus of Medicine at Boston University; Christine M. Gunn, Assistant Professor of Health Policy and Clinical Practice at Dartmouth College; Priscilla J. Slanetz, Professor of Radiology at Boston University; and Tracy A. Battaglia, Associate Director of Cancer Care Equity at Yale Cancer Center
This article is republished from The Conversation under a Creative Commons license. Read the original article here.