S Lori Brown1, Joan Ferlo Todd, Hoan-My Do Luu. 1. Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850, USA. syb@cdrh.fda.gov
Abstract
OBJECTIVE: To characterize reports of adverse events occurring during mammography to women with breast implants submitted to the Food and Drug Administration (FDA). METHODS: We searched the adverse events database for any report on silicone gel breast implants or saline breast implants that included the word "mammography" or "mammogram"in the text. We also searched adverse event reports for mammographic equipment that included the term "breast implant" in the text. RESULTS: We retrieved 714 adverse event reports using this strategy. Sixty-six of these reports detailed an adverse event that occurred during mammography or described breast implant interference with mammography. The majority of these reports, 41 of 66 (62.1%), described breast implant rupture during mammography. Other adverse events reported included mammographic compression crushing implants, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer attributed to implants. CONCLUSIONS: It is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants.
OBJECTIVE: To characterize reports of adverse events occurring during mammography to women with breast implants submitted to the Food and Drug Administration (FDA). METHODS: We searched the adverse events database for any report on silicone gel breast implants or saline breast implants that included the word "mammography" or "mammogram"in the text. We also searched adverse event reports for mammographic equipment that included the term "breast implant" in the text. RESULTS: We retrieved 714 adverse event reports using this strategy. Sixty-six of these reports detailed an adverse event that occurred during mammography or described breast implant interference with mammography. The majority of these reports, 41 of 66 (62.1%), described breast implant rupture during mammography. Other adverse events reported included mammographic compression crushing implants, pain during mammography attributed to implants, inability to perform mammography because of capsular contracture or fear of implant rupture, and delayed detection of cancer attributed to implants. CONCLUSIONS: It is important that women considering breast implants be informed of these potential risks and that clinicians, radiologists, and mammographic technicians keep them in mind when imaging women with implants.