False-negative mammograms. Medical, legal, and risk management implications.

From a strictly biologic perspective, delay in diagnosis of breast cancer is axiomatic. The number of cell divisions that must occur before detection is possible by either clinical or mammographic methods means that a finite time has occurred in which the outcome for any given case may have already been determined. That early detection and diagnosis of breast cancer lead to improved survival may be intuitive, but clinical trials have been necessary to validate the concept. Delay in diagnosis is unavoidable but the period of delay may be lessened in many cases, prompting earlier intervention and impacting outcomes. Mammography is an important vehicle for such earlier intervention and the issue of the false-negative mammogram is of concern to the radiology community, the lay community, and the courts. Mammographic interpretation has not yet approached a sufficiently standardized benchmark. Detection and diagnosis are dependent on a series of factors that need to be integrated to achieve the dual goals of timely intervention for bonafide purposes and reduction of unnecessary procedures and interventions. Some of the reasons for delay in diagnosis are unavoidable, beginning with the absence of clinical or imaging features of malignancy and extending to limitations of sufficiently specific features to prompt intervention. On the other hand, other reasons are avoidable and attention to many of these causes should lessen the incidence of such delay. Regardless of the reason, those women who feel that their breast cancer should have been diagnosed at an earlier time may consider subjecting their mammographic studies to independent reviews. At such a point, the precise reasons for delay may be better analyzed, all in an attempt to provide an adequate reconciliation of what has come to be known as the false-negative mammogram.