FDA Sets Mammogram Standards for Early Breast Cancer Detection

The FDA announced on Thursday that mammogram providers must warn women with dense breast tissue that their cancer screenings may be difficult to interpret and suggest they speak with their doctors about the need for additional tests.

The FDA's long-awaited decision has been met with praise from those who believe that the new standard will save lives by allowing women to better understand the risks associated with their breast density and, in turn, facilitate earlier cancer detection. The agency has mandated that the new rules be implemented by providers within the next 18 months.

Following skin cancer, breast cancer is the most common cancer in women and the second leading cause of cancer death in women. About 297,790 women will be diagnosed with invasive breast cancer in 2023, and about 43,700 will lose their lives to the disease, as estimated by the American Cancer Society.

Breast cancer is the second most common type of cancer in women after skin cancer (Image via Pexels @Klaus Nielsen)

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Mammogram Standards: What Does the Decision Mean?

It is already law in 38 states that patients must be warned if their breasts are denser than normal, as shown in the mammogram screening. However, the wording of these laws varies widely, and some do not even mandate that doctors advise patients to get further testing if they are concerned.

While the FDA's ruling establishes a minimum standard of reporting dense breasts for roughly 8,700 facilities across the country, states retain the authority to impose stricter language requirements.

Some states currently require mammography providers to tell women if they have dense breasts, but do not advise further consultation. This is not really enough for a woman to be concerned about the diagnosis and follow it up with additional check-ups.

In 2019, the FDA first proposed mandating the standard language for providers of mammography. Due to the agency's all-hands-on-deck efforts during the pandemic, the FDA delayed in reviewing hundreds of public comments on the proposal.

What is Mammogram?

A breast X-ray is called a mammogram. These are used by medical professionals to detect breast cancer in its earliest stages. When performed regularly, mammograms are the best test available for detecting breast cancer early, sometimes up to three years before any symptoms appear.

If mammograms detect dense breast tissue, the provider will have to inform the woman to follow up for further tests with their doctor (Image via Pexels @Klaus Nielsen)

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What does dense breast mean?

Greater amounts of glandular and fibrous connective tissue and less adipose tissue are the characteristics of dense breasts. It affects nearly half of all women over the age of 40. Radiologists may have a hard time spotting tumors in dense breasts because they may look like normal tissue on a mammogram, which is why it's important to get regular screenings.

According to the National Cancer Institute, women with dense breasts also have an increased risk of developing breast cancer.

This is why the FDA has made it mandatory for mammography providers to inform women if their breast tissue is detected to be denser than usual. Basically, the new standards will greatly pave the way for early stage breast cancer detection in women, greatly reducing the pain and suffering of lengthy treatments.

The new regulations will pave the way for early breast cancer detection (Image via Pexels @Anna Tarazevich)

The new standards specify that mammography providers must include information about having dense breasts in a summary letter given to patients. A further technical report will be provided to the concerned physician.

Women must also be informed that even though mammography is the best screening test for breast cancer, it is not foolproof and that additional screenings may be necessary.

The prescribed language must be straightforward enough that anyone can read it and understand it, according to the regulations.