The saline breast implant—filled with saline solution (biological-concentration salt water 0.90% w/v of NaCl, ca. 300 mOsm/L.)—was first manufactured by the Laboratoires Arion company, in France, and was introduced for use as a prosthetic medical device in 1964. The contemporary models of saline breast implant are manufactured with thicker, room-temperature vulcanized (RTV) shells made of a silicone elastomer. The study In vitro Deflation of Pre-filled Saline Breast Implants (2006) reported that the rates of deflation (filler leakage) of the pre-filled saline breast implant made it a second-choice prosthesis for corrective breast surgery. Nonetheless, in the 1990s, the saline breast implant was the prosthesis most common device used for breast augmentation surgery in the United States, because of the U.S. FDA's restriction against the implantation of silicone-filled breast implants outside of clinical studies. Saline breast implants have enjoyed little popularity in the rest of the world, possessing negligible market share.
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