The earliest known implant occurred in Germany in which fat from a benign tumor was removed from a woman's back and implanted in her breast. In following years the medical community experimented with implants of various materials, most commonly paraffin. The first use of silicone as breast-implant material may have been by Japanese prostitutes in the period immediately following World War II, who would directly inject silicone into their breasts.

Houston plastic surgeons Thomas Cronin and Frank Gerow developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961 and the first woman was implanted in 1962. The implant was made of a silicone rubber envelope or sac filled with a thick, viscous silicone gel.

Since then developments have focused on making the implants last longer, feel better and excite less fibrous tissue in the capsule around the device. A capsule tends to make the implant feel hard, look distorted and unnatural and may cause pain. Bacteria, leaking silicone and time are the main factors in capsule formation. Saline implants can also form capsule. Capsule rates have fallen with newer textured implants, thicker shells which leak less, and thicker 'cohesive' gels.

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