FDA adverse event reports D4 silicone

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FDA Science Forum 1997

Silicone gel-filled breast implant adverse event reports

http://vm.cfsan.fda.gov/~frf/forum97/97D04.htm

Abstract

D4 Silicone gel-filled breast implant adverse event reports

S. Lori Brown, M. Parmentier, Eileen K. Woo, R. Lakshmi Vishnuvajjala, Marcia L. Headrick

Silicone gel-filled breast implants (SGBI) have been marketed in the United States since the early 1960's. Federal regulations require that the FDA be alerted when a medical device is involved in an adverse event which could be reasonably attributed to that device. This study was initiated to characterize the adverse event reports on SGBI to the FDA. Mandatory Medical Device Reports (MDR) that were filed for adverse events related to SGBI were enumerated for the years between 1984-1994. The frequency of the central event in the report was determined for the eleven year period (1984-1995), for, 1988, 1990, and 1992. Death reports were printed and analyzed for cause of death and information content. In 1990, the 729 MDR reports on SGBI accounted for 2.6% of 28,249 MDR reports. In 1992, the 20,160 SGBI reports accounted for 30% of 66,579 MDR reports that year. The most frequently coded adverse event in 1990, before widespread publicity on breast implants was implant "burst" or rupture but in 1992 the most frequently coded event was "reaction," which encompassed a broad range of symptoms and diagnoses. The quality of reports on SGBI and their public health significance is discussed.

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