Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography

[Posted 12/12/2013]

AUDIENCE: Radiology, Pathology, Internal Medicine, Obstetrics/Gynecology, Oncology

ISSUE: The FDA is alerting the public, including women and health care providers, that 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.

Certain manufactures are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells. 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 adverse health consequences.

Possible health consequences include false negative test results, indicating the absence of breast cancer when cancer exists, and false positive test results, indicating the presence of breast cancer when none exists.  False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of serious illness or death.  False positive results may lead to needless patient anxiety, along with unnecessary additional testing and treatment. 

The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.

BACKGROUND: A nipple aspirate device is a type of pump used to collect fluid from a woman's breast. A nipple aspirate test can determine whether the fluid collected from the breast contains any abnormal cells.

RECOMMENDATION: Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[12/12/2013 -Safety Communication - FDA]