FDA Says Ductal Lavage Shouldn’t Be Used in Place of Mammograms

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The U.S. Food and Drug Administration (FDA) issued a safety alert warning women and doctors that ductal lavage, also known as a nipple aspirate test, isn’t a replacement for mammograms, other breast imaging tests, or breast biopsy and shouldn’t be used by itself to screen for or diagnose breast cancer.

The FDA issued the statement on Dec. 12, 2013 on its website. Read "FDA Safety Communication: Breast Cancer Screening – Nipple Aspirate Test Is Not An Alternative To Mammography.”

In ductal lavage, a doctor applies suction to your nipple to bring out fluid from the many little milk ducts that end in the nipple. A tiny tube is placed into the milk duct and then fluid is washed into the duct to rinse out cells. This fluid is then pulled back out of the nipple and sent to a lab for evaluation under a microscope. While there is fairly intense suction applied on the nipple, the small tube placed in the milk duct doesn’t hurt. It just feels like a very small poke.

In the safety alert, the FDA said it’s not aware of any valid scientific information that shows that a nipple aspirate test by itself is an effective screening tool for any medical condition including the early detection of breast cancer or other breast disease.

The FDA issued the safety alert because some test makers have promoted certain ductal lavage tests as stand-alone tests to screen for and diagnose breast cancer, claiming they are an alternative to mammography or biopsy. The test makers also have said that ductal lavage can detect precancerous abnormalities and diagnose breast cancer before mammography with a sample of just a few cells.

The safety alert says, “The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious health consequences.”

It’s important to know that ductal lavage doesn’t tell us where any abnormal or cancerous cells may have originated in the breast. By washing out the milk duct, it may be possible to know the general area of the breast that has abnormal cells, but not the exact spot. It’s most accurate to think of ductal lavage as a test for changes that may suggest a higher risk of breast cancer, rather than a breast cancer screening test.

The FDA, along with the Centers for Disease Control, the National Cancer Institute, the American Cancer Society, Breastcancer.org, and other organizations, all agree that mammography is the most effective way to detect breast cancer in its earliest, most treatable stage.

For more information on ductal lavage, mammograms, and other tests related to breast cancer, visit the Breastcancer.org Screening and Testing pages.

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