Breast Implants

FDA Scientists Publish Report on Adverse Events

Published in Women's Health Weekly, November 16th, 1998

Authors of a study reported in the November/December 1998 issue of Public Health Reports have characterized adverse event reports associated with silicone gel breast implants (SGBIs) submitted to the U.S. Food and Drug Administration (FDA).

Five scientists from the Center for Devices and Radiological Health in the FDA analyzed 94,120 mandatory and 4303 voluntary SGBI-related adverse events reported to the FDA from December 13, 1984 through December 31, 1995.

The study also compared reports submitted before and after the 1991-1992 barrage of media coverage about concerns regarding breast implants. The authors concluded that the number of adverse...

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Source: Women's Health Weekly (1998-11-16)

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