Silicone breast implants: implications for society and surgeons

Area of Science:

• Medical device safety
• Plastic surgery
• Toxicology

Background:

• Recent scientific studies confirm no significant increase in risks like breast cancer or connective-tissue disease for women with silicone gel-filled breast implants.
• Despite scientific consensus, a long-standing moratorium on silicone breast implants persists in the United States due to litigation.
• Australian authorities have also imposed restrictions on silicone breast implant availability.

Purpose of the Study:

• To highlight the consequences of not relying on scientific data in legal assessments of medical devices.
• To discuss the impact of litigation-driven moratoria on the availability of silicone breast implants.

Main Methods:

• Review of scientific literature on silicone gel-filled breast implants.
• Analysis of legal and regulatory actions concerning breast implants in the US and Australia.

Main Results:

• Evidence indicates no significant health risks associated with silicone gel-filled breast implants.
• Litigation and resulting moratoria have severely limited the availability of these medical devices.
• Dow Corning, a major manufacturer, filed for bankruptcy, halting the supply of implantable silicone.

Conclusions:

• The withdrawal of implantable silicone represents a significant loss for surgical procedures and patient care.
• Failure to prioritize scientific evidence in legal proceedings can have detrimental effects on medical advancements and public health.
• Australian courts must consider scientific data when adjudicating claims related to medical devices to ensure informed decisions.