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FDA to tighten mammogram rules, following Connecticut's lead

A radiologist uses a magnifying glass to check mammograms for breast cancer
Damian Dovarganes
A radiologist uses a magnifying glass to check mammograms for breast cancer in Los Angeles, May 6, 2010. U.S. women getting mammograms will soon receive information about their breast density, which can sometimes make cancer harder to spot, under government rules finalized Thursday, March 9, 2023.

The Food and Drug Administration (FDA), following Connecticut’s lead, will require mammogram providers across the U.S. to notify women if they have dense breasts and to consult with a doctor on whether additional screening is needed.

According to the National Cancer Institute, nearly half of all women over the age of 40 have dense breast tissue. It looks white on a mammogram. Cancers are also white, making them hard to detect. Breast density is also a risk for developing cancer — the higher the density, greater the risk.

“Having a dense breast law allows us to add additional tests to mammography to find cancers that we don’t see on mammography,” said Dr. John Lewin, associate professor of radiology and biomedical imaging at the Yale School of Medicine and division chief of breast imaging at Smilow Cancer Hospital.

Connecticut was the first state in the country to make this a law. The FDA rule is effective in all states as of Sept. 10, 2024.

Doctors hope to find cancers smaller than a centimeter and a half in size before they grow into a lump, Lewin said. That's because the smaller they are, the easier they are to cure.

The most common test recommended in Connecticut after a mammogram that shows dense breast tissue is breast ultrasound, Lewin said.

“There's very strong laws that require insurance to cover the test with minimal cost,” he said.

Lewin said that in the 1,000 women who have a screening mammogram, radiologists will find four cancers with mammography. If mammography plus an ultrasound is done on women with dense breasts, that will detect about six or seven cancers.

“The first time you do breast ultrasound on a population, you find extra cancers,” Lewin said. “But then when you do it yearly, you find about two additional cancers. And some of those are cancers that wouldn’t have been found at all, and they would have shown up as lumps. So the goal of screening is to find cancers by imaging before you can feel them.”

Updated: March 24, 2023 at 3:49 PM EDT
Sujata Srinivasan is Connecticut Public Radio’s senior health reporter. Prior to that, she was a senior producer for Where We Live, a newsroom editor, and from 2010-2014, a business reporter for the station.

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