New FDA Ruling on Breast Density Hits Home for Sylvester Writer
Article Summary
- Dense breasts signal higher risk of developing breast cancer.
- A new ruling by the U.S. Food and Drug Administration mandates standard nationwide breast-density information reporting to all patients receiving mammograms.
- Sylvester’s breast health experts use a variety of imaging tools and strategies to provide personalized, tailored screening options for all breast cancer patients, including those with dense breasts.
Transition from uncertainty to heightened clarity is now obtainable for millions of women as the result of a recent ruling by the U.S. Food and Drug Administration. The directive requires that all mammography reports and results letters sent to patients inform the recipients if they have dense breasts. Dense breasts are linked to higher rates of breast cancer, which will affect one in eight women in the U.S.
An appraisal of the magnitude of a patient’s breast density must also be sent to the referring physician.
This information is crucial for developing personalized imaging strategies for each patient. Almost half of all women 40 and older who have mammograms have dense breast tissue. For younger women and those with a lower body mass index (BMI), the rates are even higher.
Radiologists at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, have been providing patients with the newly required information for years, as have doctors in 39 other states. The FDA directive makes the practice mandatory for all states and directs a standard format for reporting the information.
For breast cancer survivor Rochelle Broder-Singer, the news is decidedly welcome.
Broder-Singer, an independent writer in Florida for a number of organizations, including Sylvester, said, “My breast cancer wouldn’t have been uncovered as soon if I hadn’t been in a dense breast screening protocol. Being in that protocol meant that my annual screening included an ultrasound, in addition to a 3D tomosynthesis mammogram. My small, early-stage cancer wouldn’t have been picked up without both types of imaging. I’m thrilled that more women will now have access to the same information that I received.”
Dense Breast Tissue
Both tumors and dense breast tissue appear as white areas on a patient’s mammogram, which makes it challenging to differentiate between the two. In contrast, fatty tissue is dark in the mammogram. Three-dimensional mammography—digital breast tomosynthesis—can sometimes pick up cancer in women with dense breasts that is not visible in standard, 2D mammograms, but not always.
“Breast density is a nebulous concept and people won’t necessarily understand the implications the first time they hear about it,” said Monica Yepes, M.D., a Sylvester radiologist and professor of radiology in the Miller School’s Division of Women’s Imaging. “Therefore, it’s extremely important that patients receive the information they need to make informed decisions in conjunction with their physicians. The new FDA directive is a significant step in that direction.”
Breast self-exams and clinical breast exams by a doctor can’t detect dense breasts. Radiologist-read screenings are the only way to do so.
Breast Imaging at Sylvester
Every Sylvester breast patient undergoes a risk assessment on an annual basis based on responses to questionnaires. This identifies patients at higher risk for breast cancer as well as those who might not be at high risk but whose family histories suggest otherwise.
Each of these patients receives a high-risk clinic referral and undergoes a comprehensive health review, fully tailored to each person’s risk factors for breast and other cancers. Optimal screening strategies for each patient are then developed. The clinic also offers personalized risk-reduction strategies, including lifestyle modifications such as diet and exercise, and proactive endocrine therapy.
Until recently, interpreting mammograms and medical images in general was accomplished by radiologist visual inspection. Occasionally, physicians disagreed about the image’s implications. Now, image-processing algorithms can be employed to help assess the visualizations, providing additional confidence in the accuracy of readings.
Sylvester employs advanced technology in several areas, including calculating a patient’s volumetric breast density. Radiologists integrate this information with results from the patient’s Tyrer-Cuzick assessment—a questionnaire incorporating family history, childbirth status and other variables. The approach is superior to using each tool separately.
Other technology includes a platform that gives technologists direct feedback for improving their mammogram technique. This includes positioning and compression and allows technologists to see how they stand in accuracy in relation to national peers.
Sylvester’s approach uses a fully dedicated breast-imaging team, including breast technologists in mammography and ultrasound supported by radiologists exclusively practicing breast imaging.
“Our team comprises 16 board-certified, fellowship-trained, dedicated breast imagers,” said Jose Net, M.D., director of breast imaging services at Sylvester and associate professor of clinical radiology in the Miller School’s Division of Women’s Imaging. “When you add our state-of-the-art technology, including the latest, 3D mammography capability and contrast-enhanced mammography, you have the potential for the highest read-quality possible.”
On the Near Horizon
Sylvester continues to look for opportunities to incorporate validated technology for identifying breast cancer at its earliest stage. This includes the impending introduction of artificial intelligence to complement human interpretation of breast mammograms, ultrasounds and MRI scans as well as assess patient prognosis.
“We are in the process of evaluating various AI platforms before we make our choice,” Dr. Net said. “Everything we do at Sylvester is evidence-based, including adopting new technology.”
Broder-Singer is joining Sylvester to galvanize attention for heightened patient awareness.
“Patients need to empower themselves with as much information about their breast health as possible,” she said. “Many people are afraid to know their risk factors, including breast density. I understand that. But it’s crucial because it can save lives.”
Tags: breast cancer, cancer research, cancer screening, mammography, Sylverster Comprehensive Cancer Center