Current status of silicone breast implants.

Area of Science:

• Plastic Surgery
• Biomaterials Science
• Regulatory Affairs

Background:

• Silicone breast implants, initially "grandfathered" by the FDA in 1976, are now subject to rigorous safety and effectiveness reviews.
• Recent FDA scrutiny and negative media coverage have raised public concern regarding these devices.
• Polyurethane-covered implants were voluntarily withdrawn due to concerns over diaminotoluene (TDA) and potential liver cancer in animal studies.

Purpose of the Study:

• To review the current status and safety profile of silicone breast implants.
• To address concerns regarding potential health risks associated with silicone gel-filled implants.
• To present the prevailing professional opinion on the safety of silicone breast implants.

Main Methods:

• Literature review of existing studies and regulatory information.
• Analysis of reported adverse events and scientific evidence.
• Evaluation of data concerning both silicone gel-filled and polyurethane-covered implants.

Main Results:

• Potential risks include capsular contracture, mammography interference, and theoretical sarcoma development in animals.
• Silicone gel leakage and connective tissue disease are also noted potential risks.
• Diaminotoluene (TDA) from polyurethane implants showed carcinogenicity in animal models, leading to market withdrawal.

Conclusions:

• The American Society of Plastic Surgery, after reviewing available evidence, maintains that silicone breast implants are reliable and safe.
• Ongoing scientific evidence is crucial for addressing public and regulatory concerns.
• The removal of polyurethane implants highlights the importance of material safety in medical devices.