Saturday, April 8, 2023

FDA gives providers 18 months to implement new standards on mammograms and dense breasts

The Federal Drug Administration has established national mammogram standards to protect women with dense breasts.

According to the headline on a recent story by David Ovalle in The Washington Post, "almost half of women over 40 have dense breast tissue, which is tied to a higher risk of breast cancer — and also makes it harder to detect cancer."

The article notes that the new FDA standards require mammogram providers "to inform women with dense breast tissue that their cancer screenings may be difficult to interpret and suggest that they consult with their doctors about the need for additional tests" — such as MRIs or ultrasound.

Providers must implement the new regulations, which are expected to save lives by helping women detect cancer earlier, within 18 months.

The new standards are a minimum, but states can still require more severe language.

Breast cancer, Ovalle's story says, "is the most common cancer among women, after skin cancer, and the second leading cause of cancer deaths among women overall."

The American Cancer Society estimates, the piece continues, that in 2023 almost 300,000 women will be diagnosed with invasive breast cancer, and almost 44,000 will die from it.

Dr. Hilary Marston
Dr. Hilary Marston, the FDA's chief medical officer, claims in a statement that the "action represents the agency's broader commitment to support innovation to prevent, detect, and treat cancer," the Post article reports,

Currently, according to JoAnn Pushkin, executive director of the New York-based Dense Breast-info, a resource website that aims to teach patients and health-care professionals about dense breasts, some states tell women only that they have dense breasts, "really not enough to raise a red flag."

Pushkin in 2005 had a mammogram that showed no cancer, but an ultrasound shortly thereafter did. Because her breast cancer wasn't detected years earlier, she had to undergo eight surgeries, eight rounds of chemotherapy, and 30 rounds of radiation.

"Someone should have told me," the Post story quotes her saying about the greater difficulty detecting cancer in  people with dense breasts. "When I'm denied this information, I have effectively been denied an opportunity for early-stage diagnosis."

JoAnn Pushkin
The National Cancer Institute cautions that women with dense breast have a higher risk getting breast cancer.

Additional information on mammograms and dense breasts can be found in Rollercoaster: How a man can survive his partner's breast cancer, a VitalityPress book I, Woody Weingarten, aimed at male caregivers.

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