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Effectiveness in Disease and Injury Prevention Inappropriate Use of Transillumination for Breast Cancer Screening -- Wisconsin, 1990
The overall effectiveness of early breast cancer detection efforts requires the appropriate use and maintenance of dedicated radiographic mammography systems. However, the effectiveness of early detection efforts can be compromised if proven technology is improperly used and/or maintained or if ineffective technology is successfully marketed as an equivalent or superior alternative to mammography. This report summarizes state and federal responses to the inappropriate use of a nonradiographic imaging technique in a breast cancer screening service advertised and used in Wisconsin in 1990.
In June 1990, the Radiation Protection Section, Division of Health (DOH), Wisconsin Department of Health and Social Services, was contacted by a local public health department inquiring about the efficacy of breast examination using a transillumination light scanning (also known as diaphanography) device. The inquiry was prompted when the local health department learned that such a device was being used in communities to screen women for breast cancer. In response, the Radiation Protection Section obtained information about the equipment and procedure from the manufacturer.
In July, the DOH Cancer Control Program learned that a Wisconsin company had placed a newspaper advertisement promoting a mobile van-based breast cancer screening service. The advertisement, which promoted "mammography screening" in large block letters, described a "non x-ray, painless and rapid breast screening technique." Subsequently, the DOH located the van parked outside a shopping mall in a small town in south-central Wisconsin; "mammography screening" appeared on large signs across the van. Company staff explained that their breast screening procedure entailed shining visible and infrared light through the breast to visualize internal tissues and that the results were recorded on videotape for interpretation by a physician in another state.
The DOH contacted the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and CDC to inquire about the efficacy and uses of transillumination. Both NCI and CDC emphasized that the efficacy of transillumination of the breast as a screening test for early breast cancer detection had not been demonstrated and that the technique could not be legitimately labeled as "mammography." The FDA confirmed that, although marketing of the device was allowed through the grandfather provisions of the federal Food, Drug, and Cosmetic Act,* FDA had not approved the device or its labeling or allowed the device to be marketed as being comparable to or as a substitute for mammography. Based on the promotional materials provided by the Wisconsin DOH, FDA began an investigation.
The Wisconsin-based company had been marketing the device and services to employers in the state. As part of its marketing strategy, the company had used the "Worksite Breast Health Programs" planning packet that had been developed by the DOH and distributed in April to Wisconsin employers of more than 500 persons. At least one employer had planned to offer the mobile clinic's "radiation-free" screening to its employees that fall.
On September 6, Wisconsin state officials alerted the U.S. Department of Health and Human Services of the inappropriate marketing of the device in Wisconsin. In late September, the NCI's Office of Cancer Communications reported on the limitations of transillumination for early breast cancer screening (1).
The DOH continued to work with local, state, and federal health officials to monitor breast cancer screening activities (2). As a result of these efforts and the FDA's investigation, federal marshals seized the device in Markesan, Wisconsin, on December 6, based on charges that the device violated the federal Food, Drug, and Cosmetic Act. The government's complaint specifically objected to the device's labeling, which included statements that represented or suggested that the device was adequate and effective as 1) a screening method for the early detection of breast cancer, 2) an alternative to radiographic mammography for the detection of breast cancer, and 3) a means to accurately and reliably differentiate benign breast conditions from breast cancer. Reported by: SK Latton, PL Remington, MD, M Bunge, N Kaufman, PM Lantz, JA Zvara, DE Anderson, HA Anderson, MD, Div of Health, Wisconsin Dept of Health and Social Svcs. Public Health Applications and Research Br, Cancer Control Special Programs, Div of Cancer Prevention and Control, National Cancer Institute. Center for Devices and Radiological Health, Food and Drug Administration. Cancer Prevention and Control Br, Div of Chronic Disease Control and Community Intervention, Center for Chronic Disease Prevention and Health Promotion, CDC.
In many states, breast cancer-control programs promote screening and attempt to monitor and improve the quality of mammography. However, efforts to increase the use of mammography create an opportunity for promotion and inappropriate use of less effective imaging techniques as breast screening methods. In Wisconsin, the advertising strategy used by the company not only promoted transillumination as superior to mammography but also exploited some women's fears of radiation and the potential discomfort from the breast compression required in mammography.
In transillumination, light is shone through the breast to illuminate its interior structure (3). By using beams of light in the red and near-infrared spectrum, transillumination produces an image of breast tissue on film, usually through video systems that permit simultaneous recording and viewing on a monitor. This technique is based on the principle that different types of tissues (i.e., cancerous and normal tissues) will manifest different patterns of light scatter and absorption; therefore, the transmission of light through the breast will vary in identifiable ways. Within the breast, adipose breast tissue typically absorbs less light and thus allows greater light transmission. Both glandular breast tissue and cancerous tissue absorb more light and allow comparably less light transmission; however, the increased vascularity of carcinoma yields comparably lower light transmission than normal glandular breast tissue.
Transillumination has at least four important limitations as a method for breast cancer screening. First, transillumination is not sufficiently sensitive or specific to be an acceptable screening technique for breast cancer (4). Second, transillumination is especially ineffective in detecting small ( less than 1 cm) tumors. Third, the sensitivity of transillumination is substantially diminished for tumors near the chest wall and for women with dense breast tissue, because dense breast tissue produces greater light scatter. Fourth, transillumination cannot distinguish clearly between the increased vascularity associated with cancer and the increased vascularity associated with different areas of normal breast structure, some benign breast conditions, and internal hemorrhage associated with recent biopsy.
The only recognized imaging techniques for the early detection of breast cancer are radiographic examinations with screen-film mammography and xeromammography. Although other breast imaging techniques (e.g., sonography, thermography, magnetic resonance imaging, and transillumination) have been investigated for their screening potential, such techniques have not yet achieved the levels of sensitivity and specificity of conventional approaches (5). Both sonography and ultrasound may be used as diagnostic adjuncts to mammography; however, the adjunctive benefits of thermography and transillumination have not been established. The FDA's Obstetrics and Gynecology Devices Advisory Panel recently considered the clinical utility of breast transilluminators and concluded that, except in investigational settings, the devices do not provide meaningful clinical information and should not be used in the clinical evaluation of breast tissue, neither alone nor in conjunction with other techniques (6).
Emphasis on improving the quality of mammography is increasing. The American College of Radiology's Mammography Accreditation Program has increased the general awareness and practice of procedures that improve the quality of mammography (7). In addition, some states (8) and the FDA, CDC, and NCI are supporting activities that focus on improving the quality of mammography, and as of January 1, 1991, Medicare coverage for screening mammography is contingent on the supplier's meeting quality assurance requirements (9). This report underscores the importance of collaboration among state-based cancer-control programs, radiation-control programs, and state agencies to ensure that ongoing breast cancer screening programs meet existing quality standards.
9. Health Care Financing Administration. Medicare Program: Medicare coverage of screening mammography. Federal Register 1990;55(251):53510. (42 CFR 405, 410, 411, 413, and 494).
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