Silicone gel implants in breast augmentation and reconstruction.

Area of Science:

• Plastic Surgery
• Biomaterials Science
• Medical Device Technology

Background:

• Silicone gel implants have been utilized for breast augmentation and reconstruction since the 1960s.
• Modifications to elastomer shells and filler gels aim to enhance natural appearance and reduce capsular contracture.
• Capsular contracture, a pathological response to implants, can lead to firmness, distortion, and pain.

Purpose of the Study:

• To review the history and evolution of silicone gel breast implants.
• To address concerns regarding implant safety and their association with connective tissue disease.
• To discuss the regulatory status and global availability of silicone gel implants.

Main Methods:

• Literature review of studies on silicone gel implant safety and efficacy.
• Analysis of historical data on implant modifications and patient outcomes.
• Examination of regulatory actions and their impact on implant availability.

Main Results:

• Numerous scientific studies indicate the safety of silicone gel implants.
• Despite safety data, a US moratorium was placed on cosmetic silicone gel implants in 1992.
• Silicone gel implants are currently available in the US only within limited clinical trials.

Conclusions:

• Silicone gel breast implants have undergone significant development to improve outcomes.
• Regulatory actions, particularly in the US, have restricted access despite scientific evidence supporting safety.
• Global usage patterns for silicone gel implants vary, with continued use in Europe and elsewhere.