Lavage Fact Sheet
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.
Use of Ductal Lavage
75 breast centers currently offer ductal lavage to their high-risk
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”).
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. 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
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.
lavage should be used only in conjunction with standard surveillance
techniques including mammography, clinical breast examination
and breast self-examination..
Data Available on Ductal Lavage
multi-center clinical study was conducted with 507 high-risk
women at 19 prestigious breast centers in the United States
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.
study participants had negative mammograms and physical exams
within the 12 months prior to their enrollment in the trial.
lavage determined the presence of abnormal cells in 24 percent
of the women studied.
A tiny tube called a microcatheter is inserted into the milk
is flushed through the catheter to wash (“lavage”) the ducts,
and collect cells.
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.
of Ductal Lavage
Pro·Duct Health, Inc.
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.
Dupont W, Page D. Risk Factors for Breast Cancer in Women with
Proliferative Breast Disease. N Engl J Med. 1985; 312:
Dupont W, et al. Breast Cancer Risk Associated with Proliferative
Breast Disease and Atypical Hyperplasia. Cancer. 1993;
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