FDA proposes changes to mammography services, more breast density reporting

KANSAS CITY, Mo. --  The FDA has proposed amendments to current mammography service regulation.

The amendments largely have to do with providing patients with information about dense breast tissue, to empower and help them make better decisions regarding their breast health and to learn how dense breast tissue can affect mammogram results.

Breast density is the amount of glandular tissue compared to the amount of fatty tissue present in a breast. A higher amount of glandular tissue can make it harder to read a mammogram's results and can increase the risk for breast cancer.

The newly proposed regulations would require patients to receive information about their breast density.

This is the first time the FDA is requesting changes since the  the Mammography Quality Standards Act of 1992.

Currently, around 30 states require some type of reporting on breast density, according to the American College of Radiology. The FDA's amendments would set a uniform standard of care.

"Everybody throughout the country will get the same info reported to their doctors and to themselves in ways the patients can use it," said Dr. Linda Harrison, a radiologist and head of mammography at Diagnostic Imaging Centers in Overland Park.

The amendments would require breast density information be added to the mammography summary provided to patients and their referring doctor.

Additionally, it would require specific language that explains how breast density can influence the accuracy of a mammogram and would require patients with dense breast tissue to talk to doctor about that and how it relates to risks.

It would also require three more categories for the assessment of mammograms, including adding "known biopsy proven malignancy."

Three years ago, Char Wallace went in for her annual 3-D mammogram. It didn't show anything, but as a nurse who works in breast imaging, she recognized other symptoms of breast cancer. Doctors continued doing tests.

"I had some nipple discharge, and so I had an ultrasound that really didn't show anything. And then I had an MRI, and that's what showed my breast cancer," Wallace said.

She had a bilateral mastectomy and is now cancer free.

Her breast cancer was hard to detect because of her dense breasts, a factor she knew could obscure a mammogram's results.

"If I had waited another year or so or when I had my next mammogram, it could have been a lot different story," Wallace said.

Harrison said the FDA's proposed changes are for the best.

"What we are trying to do is personalize breast screening. Breast screening is a combo of your physical exam and also imaging," Harrison said. "Mammography works, but it doesn't work for everybody."

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