Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.
OBJECTIVE
To characterize the adverse event reports on silicone gel breast implants (SGBIs), including death reports, submitted to the Food and Drug Administration (FDA) from 1984 through 1995 and to analyze changes in the type and complexity of reports following extensive media coverage of breast implants.


METHODS
The authors analyzed mandatory and voluntary reports from the adverse events reporting system for medical devices at the FDA.


RESULTS
In 1988, adverse event reports related to SGBIs accounted for 2.4% of the 14,473 mandatory reports entered into the FDA database on medical devices. In 1992, SGBI-related reports accounted for 30.3% of the total 66,476 mandatory reports of adverse events. The most frequently reported adverse event in 1988, before the widespread publicity on breast implants, was implant burst or rupture. In contrast, in 1992 the most frequently reported event was reaction, a term used to describe a range of adverse effects.


CONCLUSIONS
The numbers of mandatory and voluntary reports of SGBI-related adverse events increased exponentially, as did the complexity of the reports, following publicity over the lack of safety data on breast implants and a short voluntary moratorium on their sale. A significant proportion of reports lacked information on specific medical symptoms or diagnoses.
Brown
S L
SL
Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. syb@cdrh.fda.gov
Parmentier
C M
CM
Woo
E K
EK
Vishnuvajjala
R L
RL
Headrick
M L
ML
D018427:Breast Implants / Q000009:adverse effects*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D020034:Silicone Gels / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
D020034:Silicone Gels