title: Infections related to breast implants reported to the Food and Drug Administration, 1977-1997.
abstract: 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.
authors.affiliation: Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA.
authors.forename: S L
authors.initials: SL
authors.lastname: Brown
authors.forename: B
authors.initials: B
authors.lastname: Hefflin
authors.forename: E K
authors.initials: EK
authors.lastname: Woo
authors.forename: C M
authors.initials: CM
authors.lastname: Parmentier
mesh_terms: D001424:Bacterial Infections / Q000453:epidemiology / Q000209:etiology*; D018427:Breast Implants / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D012772:Shock, Septic / Q000209:etiology; D020034:Silicone Gels; D012965:Sodium Chloride; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D020034:Silicone Gels; D012965:Sodium Chloride