Ductal lavage has been touted as a possible screening tool for patients with a high risk for the development of breast cancer. This article examines the fundamental concepts underlying the procedure and critically evaluates its possible utility in light of the known molecular and surgical pathologic data. It highlights the fact that risk assessment in breast cancer is far from an exact science, since most women who develop breast cancers are not identified as high-risk by the Gail model. The utility of ductal lavage has as yet not been proven, and even if it were useful, it is likely to benefit only a subset of all breast cancer patients. Further studies, preferably controlled clinical trials, are necessary before routine use of the procedure can be recommended. Diagn. Cytopathol. 2004;30:166–171. © 2004 Wiley-Liss, Inc.