FDA Enhances National Standards to Protect Breast Health : Oncology Times

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FDA Enhances National Standards to Protect Breast Health

Kumar Das, Dibash PhD

Oncology Times 45(10):p 1,12, May 20, 2023. | DOI: 10.1097/01.COT.0000936800.22152.1c
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Breast Health:
Breast Health

Breast cancer is the most common cancer among women, after skin cancer, and the second-leading cause of cancer deaths among women overall. According to estimates from the American Cancer Society (ACS), more than 297,700 women will be diagnosed with invasive breast cancer this year, with about 43,700 dying from the disease.

Furthermore, according to the Centers for Disease Control and Prevention (CDC), nearly 50 percent of women aged 40 and older have dense breasts, and the denser the breasts, the higher the risk of breast cancer. Breast density is a common condition in women, where breasts have more glandular and fibrous connective tissue and less fatty tissue.

Mammography continues to be the best tool for breast cancer screening and detection, and breast density levels are primarily assessed through mammogram screenings. Greater breast density level increases the risk of developing breast cancer and can also make cancers more difficult to detect on mammograms. This is because dense breast tissue appears white on mammograms, making it difficult for radiologists to differentiate between cancerous masses and dense tissue. In 38 states of the U.S., women are required to be informed in writing about their breast density and the risk of breast cancer that comes with it after having a mammogram. However, the wording of these notifications differs and may not always include a notification of the individual's risk.

To improve breast health strategy, the FDA has announced new regulations that require mammography facilities to notify women about the density of their breast tissue and recommend that they consult with a doctor about whether they need additional screenings to detect the disease accurately. The updates enhance the FDA's ability to communicate directly with patients and their health care providers in cases where a facility did not meet quality standards and is not adequately communicating with patients about its deficiencies. The new regulations, which amend the Mammography Quality Standards Act (MQSA) of 1992, are required to be implemented within 18 months.

To explore the effects of the recent updates, Oncology Times contacted Anne Christine Hoyt, MD, Clinical Professor of Radiology and Medical Director of both the Barbara Kort Women's Imaging Center in Santa Monica and the Santa Monica-UCLA Integrated Breast Care Clinic. She specializes in breast imaging with a particular expertise in performing image-guided biopsies of breast lesions.

Oncology Times: What were some possible factors that motivated the FDA to update the mammography regulations?

Hoyt: “In the United States, the MQSA mandates minimum standards be met by facilities and personnel to be accredited to perform mammography. In the nearly 25 years since the final regulations became effective, the accreditation process and inspection of innumerable facilities and personnel have shed light on areas where revision and additions to MQSA further enhance patient protection to assure high-quality mammography is performed and written results are uniformly reported to patients across the United States.

“As before, the safety of women remains front and center when it comes to MQSA as is evident in one of the updates which calls for faster notification of patients and their doctors (now within 7 calendar days) when a breast biopsy is needed.

“Since 2009, a growing number of states (38) enacted breast density reporting laws; however, in those states with laws, what was reported, how it was said, its significance, and recommendations, if any, varied by state. The need to equally convey to all women their breast density and its significance in uniform, easy-to-understand language is another factor addressed by this update.”

Oncology Times: What is the significance of the FDA's ability to communicate directly with patients if a facility does not meet quality standards?

Hoyt: “There are many reasons why a facility may not meet quality standards, but if a facility fails to meet quality standards such that having a mammogram at that facility poses a significant risk to human health, then the FDA agency may require that some or all patients who underwent mammography at that facility and their health care providers be notified of the deficiencies and potential harm. If the facility is not able or unwilling to perform such notification, then the updated law allows the FDA to step in and notify patients and their health care providers individually or through mass media. This important allowance serves as a safety feature designed to inform and protect women's well-being in this uncommon scenario.”

Oncology Times: How will the updated regulations empower patients when considering important decisions regarding their breast health care?

Hoyt: “All women want to understand the factors that may place them at elevated risk for developing breast cancer. Now with the updated law, all U.S. women will receive this important health information when they have their mammograms.

“How women perceive their risk for breast cancer and actions taken to improve the likelihood of finding breast cancer if present vary tremendously among women. The breast density notification requirement will educate all, inspire a fraction of women to seek supplemental breast cancer screening exams, and not change others who will elect mammography alone.”

Oncology Times: How can health care providers help patients understand their breast density and the risks associated with it?

Hoyt: “In today's age, there are many excellent resources available for both patients and health care providers, such as websites like DenseBreast-info.org and organizations like the ACS, American College of Radiology, National Cancer Institute, and the CDC.”

Dibash Kumar Das is a contributing writer.

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