Silicone Gel Breast Implants : Science and Testing COSMETIC

47S Before 1963, implants of any type were rarely used to augment the breast. Cronin and Gerow introduced a first-generation breast implant, and since these were brought to market, many iterations of the original product have been developed.1 From January 1992 to November 2006, the use of silicone implants was highly restricted and not available to first-time and nonreconstructive patients.2 Major design innovations have addressed clinical challenges from previous generations—natural feel and softness of the gel, palpability and thickness of the shell, barrier materials in the shell reducing gel diffusion, and creation of textured surfaces, to name a few. The current “shaped” devices, commonly deemed fifth generation, have increased structural stability and cohesion of the gel to retain a teardrop shape in vivo.3 Two design features, silicone gel filler and a silicone elastomer shell, have survived generational variations and remain the core components of current Food and Drug Administration–approved implants. Thus, the material testing of these devices has remained consistent, with slow evolution of specifications in concert with adjustments in materials. Biocompatibility, validated designs, and mechanical integrity are required under current Food and Drug Administration and