Q&A: New FDA mammogram guidelines stand to improve breast density awareness, patient care

Key takeaways:

• FDA guidelines help patients understand their breast density, fostering better conversations with their HCPs.
• Supplemental screening should be based on an individual risk assessment, not breast density alone.

In September, the FDA implemented new mammogram rules mandating that providers inform patients about their breast density.

Despite the known risks associated with dense breast tissue, Myriad Genetics’ Cancer Risk Survey: Breast Cancer Edition found that 63% of women are unaware of its link to breast cancer, highlighting the need for improved patient education and communication, according to a press release.

Healio spoke with Ifeyinwa Stitt, MD, FACOG, senior partner and medical director for Luminis Health Annapolis OB/GYN, to learn more about the implications of these guidelines for physicians and how they can better support their patients in understanding breast health.

Healio: The FDA’s new mammogram guidelines require providers to notify patients about their breast density. How do you think this will impact physicians’ clinical practice, particularly in terms of patient communication and follow-up care?

Stitt: As providers, we are often stretched very thin and often have many results to follow-up on in a given day. With the updated FDA guidelines, patients are now also aware of their breast density and have an opportunity to engage in discussions with a health care professional (HCP) in the event that their HCP doesn’t bring it up themselves. Personally, I have appreciated when a patient brings this up with me, as it gives me an opportunity to either reassure my patient if they are of low or average risk and, conversely, arrange closer follow-up if they are high risk. These guidelines help to build a true partnership between women and their HCPs in appropriately addressing risk factors for breast cancer and mitigation strategies.

Healio: Dense breasts are associated with an increased risk for breast cancer. How do you explain this risk to patients in a way that is both informative and reassuring?

Stitt: First, I explain that almost 50% of women have dense breasts — this is not something that a woman can change. Dense breasts are often inherited. Younger, premenopausal women and women with leaner BMIs also tend to have more dense breasts. Women with dense breasts have more fibrous and glandular tissue as opposed to fatty tissue. Breast cancers often arise in the fibrous and glandular areas of the breasts. Further, on mammograms, tumors and calcifications (which are associated with cancer) appear white. Fatty tissue appears dark on mammograms; conversely, dense breast tissue appears white, thus making tumors difficult to visualize on imaging. Breast cancer risk is multifactorial — there are often multiple causes including family history, genetics, menopausal status, previous pregnancies, prior exposures and lifestyle. Dense breasts alone do not mean that a patient will get cancer; however, this information allows for proper risk stratification to help decrease a woman’s potential risk for developing breast cancer. Lastly, I explain that increased breast density is not associated with increased chance of dying of breast cancer.

Healio: What are your thoughts on the different testing options available, such as supplemental screening with ultrasound or MRI, and how do you advise patients about these options?

Stitt: The new FDA guidelines actually do not encourage further testing for women with dense breasts; instead, the guidelines recommend that patients with dense breasts talk to their HCP about their breast density and their individualized risk for breast cancer. This is in agreement with current medical evidence and expert consensus from the leading authorities as supplemental ultrasound and MRI can result in false-positive findings, which can potentially lead to additional biopsies with resultant patient anxiety and possible overdiagnosis. These supplemental studies have not been definitively shown to demonstrate a reduction in overall breast cancer mortality.

It is important to individualize a patient’s risk. High-risk patients (who have a > 20% lifetime chance of developing breast cancer) can benefit from additional screening; however, for low-risk patients with dense breasts (< 15% lifetime chance of developing breast cancer), there is no consensus for recommending supplemental screening.

Healio: What are the most important steps woman can take to advocate for their own breast health and ensure they receive appropriate screening and care?

Stitt: Every woman aged 25 to 39 years should discuss their breast cancer risk with their HCP. This will allow for the patient to determine when she should initiate breast cancer screening and adjust/correct modifiable risk factors prior to age 40 years when average-risk women typically start annual breast cancer surveillance. Discussion should include review of family history (maternal and paternal sides), prior radiation exposure, lifestyle exposures, previous breast biopsies, etc. There are several breast cancer risk calculators that are available online to aid in this assessment. Personally, I tell all my patients that an awareness of their family history is paramount. As we approach the holiday season, this is a perfect opportunity to update your family history during family gatherings.

Healio: What advice should HCPs give to patients who are concerned about their risk for breast cancer?

Stitt: HCPs should recommend that patients who are concerned about their risk for breast cancer bring up their questions and concerns at a visit specifically to address their concerns. Other recommendations include getting routine mammograms annually (3D mammograms, preferably); be aware of any concerning breast changes and report them immediately; maintain a healthy weight; exercise regularly; limit alcohol and tobacco consumption; and follow proper eating habits.

Healio: Beyond the new FDA guidelines, what are some of the broader challenges and opportunities you see in the field of breast cancer screening and risk assessment?

Stitt: I think one of the biggest challenges we face for health care in general is providing access to adequate medical care for underserved and minority populations. I am heartened when I see mobile mammography in areas where patients do not always have access to the most current modalities of breast cancer screening. I feel that the medical community must ensure that every woman has the opportunity to have current and accurate breast cancer screening regardless of where she lives or what her ethnic background is. Additionally, in the field of breast cancer, we know that Black women are more likely to develop more aggressive breast cancers at younger ages despite being less likely to have dense breasts. I think that there is an opportunity to investigate why these tumors often go undetected in black women despite the lack of socioeconomic differences with their white counterparts. I suspect that current-state mammography needs to be modified to better detect these seemingly more obscure lesions.

References:

• FDA. Important information: Final rule to amend the Mammography Quality Standards Act (MQSA). https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program/important-information-final-rule-amend-mammography-quality-standards-act-mqsa#:~:text=On%20March%2010%2C%202023%2C%20the,later%20than%20September%2010%2C%202024. Published Sept. 10, 2024. Accessed Dec. 16, 2024.
• What we don’t know can hurt: New cancer risk survey from Myriad Genetics reveals serious knowledge gaps about breast density and cancer risk. https://investor.myriad.com/news-releases/news-release-detail/25351/. Published July 17, 2024. Accessed Dec. 16, 2024.