What is a nipple aspirate device ?
It 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.
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.
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 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.
The FDA, other public health agencies, and national medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages. These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the National Cancer Institute, and the Society for Breast Imaging. 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.
What Health Care Providers are recommended:
- Do not use a nipple aspirate test as a substitute for mammography or by itself for breast cancer screening or diagnosis.
What Patients are recommended:
- Remember that a nipple aspirate test, such as Atossa Genetics Inc.'s Mammary Aspiration Specimen Cytology Test (MASCT) and/or ForeCYTE Breast Health Test systems, or the HALO Breast Pap Test, is not a substitute for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself for breast cancer screening or diagnosis.
- If you have had a nipple aspirate test as a stand-alone evaluation tool for screening and diagnosing breast cancer, you should request a mammogram from your health care provider to get accurate results.
- Undergo regular mammograms according to screening guidelines or as recommended by your health care provider.
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