Silicone breast implants and long-term health effects: when are data adequate?

Area of Science:

• Epidemiology
• Medical device safety
• Rheumatology

Background:

• The U.S. Food and Drug Administration (FDA) initially found insufficient data on silicone breast implant safety in 1992.
• A substantial body of epidemiological literature now exists regarding silicone breast implants and associated health conditions.
• This literature allows for better risk assessment and uncertainty reduction for diseases linked to breast implantation.

Purpose of the Study:

• To evaluate the current epidemiological literature on silicone breast implants.
• To assess the adequacy of existing data for determining risks of cancer and rheumatological diseases.
• To identify future research needs concerning implant safety.

Main Methods:

• Comprehensive review of epidemiological studies on silicone breast implants.
• Analysis of existing data to estimate disease risks.
• Identification of research gaps and future directions.

Main Results:

• The existing body of research is substantial and provides a basis for risk assessment.
• Current data are likely sufficient to accurately define cancer risks associated with breast implants.
• The risks of developing scleroderma are reasonably well-established by the available studies.

Conclusions:

• The epidemiological literature adequately addresses cancer risks and scleroderma risk associated with silicone breast implants.
• Further research may be beneficial for other specific connective tissue diseases.
• The overall database is significantly improved, allowing for more informed safety assessments.