Silicone Gel Breast Implant Adverse Event Reports To The Food And Drug Administration, 1984-1995

Brown, S L; Parmentier, C M; Woo, E K; Vishnuvajjala, R L; Headrick, M L

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Silicone Gel Breast Implant Adverse Event Reports To The Food And Drug Administration, 1984-1995

11/01/1998
By Brown, S L ; Parmentier, C M ; Woo, E K ; ...
Source: Public Health Rep. 113(6):535-543

[PDF-3.26 MB]

English

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Details:

Alternative Title:

Public Health Rep
Personal Author:

Brown, S L ; Parmentier, C M ; Woo, E K ; Vishnuvajjala, R L ; Headrick, M L

Brown, S L ; Parmentier, C M ; Woo, E K ; Vishnuvajjala, R L ; Headrick, M L Less -
Description:

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

[+]

Breast Implants Equipment Failure Female Humans Product Surveillance, Postmarketing Silicone Gels
Source:

Public Health Rep. 113(6):535-543
Pubmed ID:

9847926
Pubmed Central ID:

PMCnull
Document Type:

Journal Article
Name as Subject:

U.S. Food and Drug Administration ; U.S. Food and Drug Administration

U.S. Food and Drug Administration ; U.S. Food and Drug Administration Less -
Place as Subject:

North America
Collection(s):

Public Health Reports
Main Document Checksum:

[+]

urn:sha256:a830d924be6e647dede93ab9a4763c11b51511f90de31994e446fd13ae0b9127
Download URL:

https://stacks.cdc.gov/view/cdc/64697/cdc_64697_DS1.pdf
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Silicone Gel Breast Implant Adverse Event Reports To The Food And Drug Administration, 1984-1995

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