The FDA’s new mammogram guidelines require dense breast disclosure. What does that mean in Pennsylvania?

Mammography clinics must notify patients if their screening indicates dense breast tissue, a potential cancer risk, the Food and Drug Administration announced Thursday.

That’s been a requirement in Pennsylvania since 2014, but the new FDA guidelines could make it easier for patients to find personalized information about themselves.

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Mammography is the standard for breast cancer screening but has limitations. One of them is that tumors and breast gland tissue both appear white and opaque, unlike fatty tissue that appears black and transparent. In dense breasts, where a majority of the tissue is white, tumors can be harder to see. Breast cancer providers and researchers often compare it to searching for a snowball in a snowstorm.

What’s more, people with dense breasts are at greater risk for cancer.

“It’s a double whammy,” said Emily Conant, chief of breast imaging at Penn Medicine.

Breast density is measured on a scale from A, “the breasts are almost entirely fatty,” to D, “the breasts are extremely dense.”

Health-care providers may recommend patients with dense breasts get supplemental screening tests, such as an MRI or ultrasound, Conant said. She and her colleagues often find cancer missed by a mammogram when they scan with an MRI, she said.

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The new requirement directs mammography facilities to clearly state in a notice to the patients “your breast tissue is not dense” or “your breast tissue is dense,” along with a recommendation for patients to consult their health-care provider about their risk of developing cancer.

A similar requirement has been in place in Pennsylvania since 2014, under a law that requires mammogram providers to report breast density as part of the screening results. They must also explain in the screening results that breast density is a risk factor.

But the law does not require a direct notification, in lay terms, to the patient about their own breast density, as is required under the new FDA rules, Conant said. The change will create a better way of communication that is standardized across the United States.

“It is going to spark discussions between providers and their patients, and that’s great,” she said.

The FDA update also aims to get mammography reports to health-care providers more quickly.

“Delays in communication of screening results can lead to delays in diagnosis and result in worse outcomes,” Karen Knudsen, CEO of the American Cancer Society, wrote in an email.

New Jersey and Delaware are also among 38 states with breast density laws, according DenseBreast-info, a nonprofit that tracks information on breast density. In states that passed dense breast legislation, the number of supplemental tests, such as an ultrasound or MRI, has increased, research shows.

In 2020, former Pa. Gov. Tom Wolf signed a law requiring insurance coverage of supplemental testing for women who are at a higher risk for breast cancer. Among those risk factors are extreme breast density or genetic predisposition. The risk of breast cancer for women who have a BRCA mutation can be up to 70% higher throughout their lifetime.

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This week, the Pennsylvania state Senate unanimously passed a bill that removes co-pays, deductibles, or other costs associated with supplemental screening or genetic testing for women at greatest risk. It must now pass the House before heading to governor’s desk to be signed into law.

“It allows the consumer to make informed decisions a lot earlier than the words ‘you have cancer,’” said Sen. Tracy Pennycuick, a Montgomery County Republican and a cosponsor of the bill. Her family has a long history of breast cancer, and she said that removing financial barriers to screening can give women peace of mind.

Pat Halpin-Murphy, the founder and president of the Pennsylvania Breast Cancer Coalition, said that the FDA recommendation shows that Pennsylvania is ahead of the curve.

“We were ahead of the curve 10 years ago with dense breast notification requirements,” said Halpin-Murphy, herself a breast cancer survivor. “We hope to soon be ahead of the curve to allow women at high risk to get access to the additional screenings they need to save their lives.”