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FDA: Nipple Aspirate No Sub For Mammogram

December 19, 2013
Written by: , Filed in: Breast Imaging, Medical Ethics, Practice Management
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Stop using the nipple aspirate test as an alternative to mammography.

That’s the message the Food and Drug Administration sent with a “safety communication” last week. The warning was unambiguous:

“A nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA is not aware of any valid scientific data to show 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.”

Why then have some companies allegedly been marketing the tests—in which fluid sucked (sometimes) from milk ducts is tested for abnormal cells—for breast cancer screening? Tarik Elsheikh, MD, told NPR the reason is simple. Sales representatives, he said, have been telling doctors that women would have the procedure every year, that it takes five minutes, that it costs $100, and that it’s not covered by insurance:

They’re convincing these docs that they can make a lot of money. They’re finding an audience, unfortunately.

Dr. Elsheikh is medical director for anatomical pathology at Cleveland Clinic in Cleveland. He has reviewed research on the nipple aspirate test. “Did they ever do studies to assess cancer risk using the nipple aspirator?” he said. “No.”

The FDA warning says some manufacturers claim a nipple aspirate test can detect precancerous abnormalities or even diagnose breast cancer itself. The warning describes those as “misleading claims.” Up to half the time, apparently, a nipple aspirate device isn’t even able to extract fluid from the breast.

Daniel Kopans, MD, director of breast imaging at Massachusetts General Hospital in Boston, told MedPage Today, “There was hope a number of years ago that you might be able to wash cells out of the milk ducts and find cancer that way. Those of us in the field were skeptical, and it turns out our skepticism was correct.”

Related CME seminar (up to 24 AMA PRA Category 1 credits™): Chicago International Breast Course and The Society for the Advancement of Women’s Imaging


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