News | Breast Density | February 19, 2019 | Jeff Zagoudis, Associate Editor

Congress Directs FDA to Establish Federal Breast Density Inform Standard

Agency will develop reporting language for minimum amount of information to be provided about a patient’s individual fibroglandular density and associated breast cancer risk

Congress Directs FDA to Establish Federal Breast Density Inform Standard

February 19, 2019 — As part of a federal spending bill passed late Friday, Congress directed the U.S. Food and Drug Administration (FDA) to establish a national minimum standard for including fibroglandular breast density information on mammography reports. While 36 states have already enacted their own breast density inform legislation, the federal version will ensure that every state takes a minimum level of action on making patients aware of the increased breast cancer risk associated with dense breasts.

The law directs the FDA, through the regulatory process, to develop language for reports and summaries from mammography facilities to include with appropriate information about breast density for patients and their providers. According to DenseBreast-info.org, the information must include, at a minimum:

  • The effect of breast density in masking the presence of breast cancer on a mammogram;
  • The qualitative assessment of the patient’s fibroglandular breast density by the provider who interprets the mammogram according to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS); and
  • A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.

“As part of the funding bill Congress passed yesterday, the FDA must now ensure mammography reports include appropriate breast density information. Dense tissue can hide cancer on mammograms, so this information is vital to catching breast cancer early,” said Sen. Dianne Feinstein (D-Calif)., a longtime supporter of the breast density inform movement who championed the inclusion of the density standard in the current spending bill in the Senate. Rep. Rosa DeLauro (D-Conn.) led efforts in the House.

The grassroots movement to spread information about breast density began in 2009 when Connecticut became the first state to enact a breast density inform law. Those efforts were spearheaded by Nancy Cappello, Ph.D., who was diagnosed with stage 3C breast cancer in February 2004, just six weeks after her annual mammogram came up normal. Her doctor told her the cancer was missed on the mammogram because she had dense fibroglandular breast tissue, a concept that was little-known among patients at the time. Cappello passed away in November from secondary myelodyspastic syndrome (MDS), a bone marrow cancer that was a complication of her prior aggressive breast cancer treatments.

Watch the VIDEO: The Impact of Breast Density Technology and Legislation, an interview with Cappello at RSNA 2017.

Today, 10 years later, the movement has expanded to 36 states, covering an estimated 89 percent of women in the U.S. Each state law has slightly different requirements, however, for how much information is given to patients and providers. According to JoAnn Pushkin, executive director of DenseBreast-info.org, some laws only require that women are informed about breast density generally and not their own density and associated cancer risk.

“Implementation of this national law will help to address this disparity, as all imaging facilities that perform mammography screening will be required to provide at least the level of information required by the FDA’s new reporting requirement,” said Pushkin. Feinstein, DeLauro and others have previously introduced bills in Congress for a national breast density standard that ultimately stalled.

“This law is an important step forward, advanced by the efforts of many advocates, including those of the late Dr. Nancy Cappello of Are You Dense?. We are all grateful for the dedication and resolve of Sen. Dianne Feinstein and Rep. Rosa DeLauro who have championed patient notification in the several past congresses,” said Pushkin.

For more information: www.densebreast-info.org

Related Breast Density Content

Survey Shows Dense Breast Reporting Laws Increase Breast Density Awareness

Fake News: Having Dense Breast Tissue is No Big Deal

VIDEO: Breast Imaging and Risk Assessment at Northwestern Medicine Central DuPage

 

Related Content

In a demonstration on the exhibit floor of the SBI symposium, Koios software identified suspicious lesions in ultrasound images

In a demonstration on the exhibit floor of the SBI symposium, Koios software identified suspicious lesions in ultrasound images. Photo by Greg Freiherr

Feature | Artificial Intelligence | April 19, 2019 | By Greg Freiherr
Commercial efforts to develop...
Videos | Breast Imaging | April 18, 2019
In a keynote lecture at the Society of Breast Imaging (SBI)/American College of Radiology (ACR) 2019 Symposium, ...
Fatty tissue and breast density may be considered in the context of many factors that affect the occurrence and detection of breast cancer

Fatty tissue and breast density may be considered in the context of many factors that affect the occurrence and detection of breast cancer. Permission to publish provided by DenseBreast-info.org

Feature | Breast Imaging | April 18, 2019 | By Greg Freiherr
When planning a screening program to detect the early signs of breast cancer, age is a major consideration.
iCAD Appoints Stacey Stevens as President
News | Radiology Business | April 16, 2019
iCAD Inc. recently announced that Stacey Stevens has been named president. As president, Stevens will have expanded...
compressed breast during mammography.
360 Photos | 360 View Photos | April 16, 2019
A 360 view of a simulated breast compression for a...
A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images

A smart algorithm has been trained on a neural network to recognize the appearance of breast cancer in MR images. The algorithm, described at the SBI/ACR Breast Imaging Symposium, used “Deep Learning,“ a form of machine learning, which is a type of artificial intelligence. Graphic courtesy of Sarah Eskreis-Winkler, M.D.

Feature | Artificial Intelligence | April 12, 2019 | By Greg Freiherr
The use of smart algorithms has the potential to make healthcare more efficient.
This image depicts ABUS images with QVCAD results

This image depicts ABUS images with QVCAD results.

Feature | Breast Imaging | April 12, 2019
Imaging Technology News spoke with Bob Foley, vice president of sales and marketing of QView Medical, Inc.,
Uterine Fibroid Embolization Safer and as Effective as Surgical Treatment
News | Interventional Radiology | April 05, 2019
Uterine fibroid embolization (UFE) effectively treats uterine fibroids with fewer post-procedure complications compared...