Courtesy of Liane Philpotts

New Food and Drug Administration regulations went into effect on Sept. 10, requiring that mammography facilities notify patients of their breast density post-procedure.

Starting at the age of 40, women are recommended to receive annual mammograms — X-ray imaging of their breasts — to screen for breast cancer. Breast density increases the risk of breast cancer, while also making cancer detection via mammogram more difficult. Despite this, many women with dense breasts who receive mammograms are unaware of their heightened risk. The updated regulations are intended to resolve such concerns.

“Cancers are white. Dense tissue is white. So the cancers can be hidden in any amount of dense tissue,” Liane Philpotts, breast imaging section chief at the School of Medicine, told the News. “If you have a small cancer, even just a small amount of area where there’s some dense tissue can be enough to hide it, but it obviously gets increasingly harder to detect as there’s more density.” 

The FDA’s new requirements for mammography state that post-procedural reports must classify breast density into one of four categories, ranging from “almost entirely fatty” to “extremely dense” and provide a lay summary notifying the patient of the risks associated with dense breasts, whether their breasts qualify as dense and instructions to consult their healthcare providers.

A History of Advocacy in Connecticut

Connecticut was the first state to pass a law requiring mammography reports to include breast density information. The “Are You Dense?” campaign — led by breast cancer activist Nancy Cappello — sparked the movement for improved notification laws and disclosure on the limitations of mammography. 

Cappello began her activism in 2003 when she was diagnosed with Stage 3 breast cancer after two mammograms had failed to detect anything unusual, due to her having dense breast tissue. She and her husband worked with medical experts and politicians to change the protocol regarding breast cancer awareness. 

The “Act Requiring Communication of Mammographic Breast Density Information to Patients” passed into Connecticut state law in 2009. The law not only required doctors to inform patients about dense breasts, but also that medical insurance would cover the alternative ultrasounds such patients would need. 

Other states followed en suite, with 37 states individually passing versions of the breast density notification law that Cappello had advocated for. 

“I had the honor of meeting her and knowing her, and it’s an example of how someone even in a terrible part in their life can make a difference in the lives of so many,” Dr. Andrea Silber, a professor of medical oncology at the School of Medicine and associate director for clinical research at the Center for Community Engagement and Health Equity, said when asked about Cappello, who unfortunately passed away in 2018.

Increased Demand for Alternative Screening Methods

As the earliest state to pass breast density notification laws, Connecticut has insight into what effects the new national regulations may have on patients, doctors and medical facilities alike. 

“Patients will probably, if they are aware of this, start asking for ultrasounds and MRIs in high-risk cases,” Liva Andrejeva-Wright, an associate professor of radiology and biomedical imaging at Yale, told the News. “Primary doctors will be ordering it more, so I do think there could be stress on facilities that are equipped to handle them until they figure out how to implement a breast screening program. It was quite a big deal for us, back in 2009.”

Those who have been notified of having dense breasts may opt to receive alternative screening to detect breast cancer. The main concerns over the nationwide adoption of notification laws were about facilities’ ability to match the increased demand for such screening.

According to Philpotts, in 2009 the primary alternative was handheld ultrasound. Technologists had to be trained to provide handheld ultrasounds to match the growing demand as a result of the legislation.

“I think nationwide, the problem is still that we do not have a lot of trained technologists able to supply this imaging,” Philpotts told the News.

The amendments to the Mammography Quality Standards Act were passed on March 10, 2023.