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    Ductal Lavage Fact Sheet           ProDuct ductal lavage logo

    Researchers have known for years that the presence of abnormal (or “atypical”) cells inside the breast milk ducts signal an increased risk of breast cancer. Ductal lavage is a new minimally invasive method of collecting milk duct fluid, which is analyzed under a microscope to search for atypical, risk-increasing cells. The technique offers high-risk women another means of surveillance, and an opportunity to uncover information about their risk status, which is both real-time and unique to them.

    Current Use of Ductal Lavage

    • Approximately 75 breast centers currently offer ductal lavage to their high-risk patients[1].
    • Ductal lavage is the only minimally invasive method of collecting large numbers of cells from the breast milk ducts, where 95% of breast cancers originate. The cells are analyzed under a microscope to determine whether they are normal or abnormal (known as “atypical”).
    • If atypical cells are found, it provides unique information about a woman’s risk of developing breast cancer. Atypical cells have been shown to increase the relative risk of breast cancer development 4-5 times, and even higher for women who also have a family history of the disease.[2] Because it is not known how often atypical cells progress to breast cancer, atypical cells are not “pre-cancerous” by definition. However, the risk implications are clear.
    • By providing real-time risk information that is unique to each woman, ductal lavage results can be used to help make decisions about risk reduction options such as closer surveillance, drug therapy and preventative mastectomy. Because ductal lavage can be repeated over time, it also offers high-risk women another way to check the status of their breast health at regular intervals.
    • Ductal lavage should be used only in conjunction with standard surveillance techniques including mammography, clinical breast examination and breast self-examination..

    Clinical Data Available on Ductal Lavage

    • A multi-center clinical study was conducted with 507 high-risk women at 19 prestigious breast centers in the United States and Europe.
    • Women were classified at high risk if they scored a minimum of 1.7 percent on the five-year Gail Index; previously had breast cancer; or were positive for BRCA1/BRCA2 mutations.
    • All study participants had negative mammograms and physical exams within the 12 months prior to their enrollment in the trial.
    • Ductal lavage determined the presence of abnormal cells in 24 percent of the women studied.

    The Procedure cross section of breast showing ductal lavage

    • A tiny tube called a microcatheter is inserted into the milk ducts. Saline is flushed through the catheter to wash (“lavage”) the ducts, and collect cells.
    • The fluid sample is sent to a laboratory to determine the presence of normal or abnormal cells.
    • Ductal lavage can be repeated at regular intervals so that cellular changes can be followed over time.

    Availability of Ductal Lavage

    • The devices used in ductal lavage have been cleared for marketing in the U.S.
    • For more information about ductal lavage or to locate a trained physician, log onto www.ductallavage.com or call 1-866-4-INDUCT.

    About Pro·Duct Health, Inc.

    • Pro·Duct Health manufactures the devices used in ductal lavage.
    • The company is dedicated to eradicating breast cancer by enabling the earliest possible detection of breast pre-cancer and cancer.
    • To learn more about Pro·Duct Health, please visit www.ductallavage.com.

    [1] Some of the risk factors cited by the National Cancer Institute include: a personal history of breast cancer, a family history of breast cancer and certain genetic changes that increase susceptibility.

    [2] Dupont W, Page D. Risk Factors for Breast Cancer in Women with Proliferative Breast Disease. N Engl J Med. 1985; 312: 146-151.
    Dupont W, et al. Breast Cancer Risk Associated with Proliferative Breast Disease and Atypical Hyperplasia. Cancer. 1993; 71: 1258-1265.
    Fabian et al., “Short-Term Breast Cancer Prediction by Random Periareolar Fine-Needle Aspiration Cytology and the Gail Risk Model,” J Natl Cancer Inst 92:1217-1227 (2000).
    Wrensch, et al., “Breast Cancer Incidence in Women with Abnormal Cytology in Nipple Aspirates of Breast Fluid,” Am. J. Epidemiology 135:130-141 (1992).

     

     

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