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

Area of Science:

• Medical device safety
• Infectious disease epidemiology
• Plastic surgery complications

Background:

• The U.S. Food and Drug Administration (FDA) maintains a surveillance system for monitoring adverse events associated with medical devices.
• Breast implants, as medical devices, are subject to this monitoring, with infection being a significant reported adverse event.

Purpose of the Study:

• To characterize infection reports submitted to the FDA concerning breast implants between 1977 and 1997.
• To analyze trends in infection reporting, common causative organisms, and timing of infection relative to implant type.

Main Methods:

• Analysis of FDA adverse event reports related to breast implants, specifically focusing on infection events from 1977 to 1997.
• Categorization of reports by adverse event type, causative organism (when identified), and timing of infection onset or explantation.

Main Results:

• A total of 1,971 infection reports were identified within the study period.
• A notable increase in infection reports occurred between 1992 and 1995, coinciding with heightened publicity and litigation surrounding breast implants.
• Staphylococcus species were the most frequently identified organisms. Reports indicated earlier infection onset for saline breast implants compared to silicone gel implants when timing data was available.

Conclusions:

• Infections are a significant adverse event associated with breast implants, with reporting influenced by external factors.
• Understanding the timing differences between saline and silicone implants can inform clinical practice and patient counseling.
• The FDA's surveillance system provides valuable data for monitoring medical device safety and identifying potential risks.