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Breast Pump Adverse Events: Reports to the Food and Drug Administration

Roselie A. Bright, ScD

medical device epidemiologists in the Center for Devices and Radiological Health at the Food and Drug Administration, Rockville, Maryland

Diane E. Dwyer, BSN, RN

Food and Drug Administration and reviews postmarket adverse event reports for breast pumps and medical devices associated with obstetrics and gynecology

Betsy Foxman, PhD

Center for Molecular and Clinical Epidemiology of Infectious Diseases at the University of Michigan, Ann Arbor

Breast pumps are medical devices used to express milk and maintain the milk supply. The purpose of this study was to characterize adverse events reported to the United States Food and Drug Administration (FDA) on breast pumps. Thirty-seven adverse event reports on breast pumps were identified from the Manufacturer and User Facility Device Experience database between 1992 and 2003. Four additional reports were found in the Device Experience Network database from 1992 to 1996. The most commonly reported adverse events for electric breast pumps were pain, soreness, or discomfort; the need for medical intervention; and breast tissue damage. Most frequently reported problems for manual breast pumps were breast tissue damage and infection. Contamination of breast milk during pumping was also reported. Breast pump adverse events are likely underreported to the FDA. Reporting adverse events is important for improving the design and manufacture of breast pumps and subsequently decreasing adverse events. Journal of Human Lactation. 21(2):169-174.

Key Words: breast pump • adverse events • surveillance • breastfeeding

Journal of Human Lactation, Vol. 21, No. 2, 169-174 (2005)
DOI: 10.1177/0890334405275445


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