Welcome to CDC stacks | Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995. - 64697 | Public Health Reports
Stacks Logo
Advanced Search
Select up to three search categories and corresponding keywords using the fields to the right. Refer to the Help section for more detailed instructions.
 
 
Help
Clear All Simple Search
Advanced Search
Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.
  • Published Date:
    1998 Nov-Dec
  • Source:
    Public Health Rep. 113(6):535-543
  • Language:
    English
Filetype[PDF-3.26 MB]


Details:
  • Pubmed ID:
    9847926
  • Pubmed Central ID:
    PMCnull
  • 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.

  • Document Type:
  • Main Document Checksum:
  • Supporting Files:
    No Additional Files
You May Also Like: