Adverse events/FDA. reports

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1: J Long Term Eff Med Implants. 2001;11(1-2):1-12.Links

Infections related to breast implants reported to the Food and Drug Administration, 1977-1997.

Brown SL, Hefflin B, Woo EK, Parmentier CM.

Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.

The FDA has a surveillance system for monitoring adverse events related to medical devices. Infection reports submitted to the FDA by breast implant manufacturers between 1977 and 1997 are characterized. Two cases of death caused by toxic shock syndrome after mammoplasty reported to the FDA are presented. Overall, 1,971 reports with a principal adverse event of infection were reported in this time frame. There was a large increase in the number of reports on infections related to breast implants between 1992 and 1995 due to the publicity and litigation surrounding breast implants. When an organism was identified in the report, the most common organism reported was Staphylococcus sp. Information on the time between the implantation and the onset of the infection or the explantation of the implant was not always reported. However, in reports that did contain this information, there were differences between the length of time to infection onset reported for saline breast implants (earlier) compared to silicone gel breast implants (later). More than half of the reports (56.6%) asserted only that there was an infection and that breast implants were explanted as a result; the remaining reports asserted that infection and other signs, symptoms, or diagnoses had afflicted the patient.

PMID: 11495100 [PubMed - indexed for MEDLINE]

Infections related to breast implants reported to ...[J Long Term Eff Med Implants. 2001] - PubMed Result

1: Public Health Rep. 1998 Nov-Dec;113(6):535-43. Links

Silicone gel breast implant adverse event reports to the Food and Drug Administration, 1984-1995.

Brown SL, Parmentier CM, Woo EK, Vishnuvajjala RL, Headrick ML.

Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA. syb@...

OBJECTIVES: 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.

PMID: 9847926 [PubMed - indexed for MEDLINE]

Silicone gel breast implant adverse event reports ...[Public Health Rep. 1998 Nov-Dec] - PubMed Result

So, what is the real number of adverse event reports ??????

I find it rather odd that they are making a big point that more reports were made to the FDA after legal things hit the fan and it became a more public issue..........well of course, few people know to report to the FDA..........if there is any adverse events, and many that DO know about are to fatigued to do so........

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