美国食品药品管理局（FDA）日前批准了由Sientra 公司（Sientra Inc）生产的新一代硅胶丰胸产品，以用于年龄达到或大于22岁的女性丰胸或任何年龄段之女性的乳房重建。FDA同时还强调“尽管批准了该产品应用于临床，但生产厂家仍应收集植入该类产品后之效果与风险，及不良反应等， 和提醒女士们“植入该类产品后仍应定期随访，以有效预防不良反应的发生”。更多资讯，有兴趣者请参阅原文（http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm295437）。

FDA approves new silicone gel-filled breast implant

Approval conditioned on post-approval safety studies

Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.

As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

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