Gampper Thomas J, Khoury Habib, Gottlieb Wendy, Morgan Raymond F
Department of Plastic Surgery, Box 800376, University of Virginia Health System, Charlottesville, VA 22908, USA.
Ann Plast Surg. 2007 Nov;59(5):581-90. doi: 10.1097/01.sap.0000258970.31562.5d.
Silicone gel implants have been widely used for breast augmentation and reconstruction since the 1960s. Several alterations to both elastomer shell and filler gel have been made over the years to improve their ability to replicate the natural breast and to decrease the incidence of capsular contracture. The latter is a pathologic process involving the periprosthetic tissues formed in response to the presence of the implant. When severe, capsular contracture may cause firmness, distortion, and pain. In response to many claims of implant-related connective tissue disease, the US Food and Drug Administration placed a moratorium in 1992 on silicone gel breast implants for cosmetic purposes. Despite a preponderance of scientific data to their safety, silicone gel implants are presently available in the United States only as part of limited clinical trials. They continue to be used in Europe and other parts of the world.
自20世纪60年代以来，硅胶凝胶乳房植入物已被广泛用于隆胸和乳房重建。多年来，对弹性体外壳和填充凝胶都进行了多项改进，以提高它们复制自然乳房的能力，并降低包膜挛缩的发生率。后者是一种病理过程，涉及因植入物的存在而形成的假体周围组织。严重时，包膜挛缩可能会导致乳房变硬、变形和疼痛。针对许多与植入物相关的结缔组织疾病的说法，美国食品药品监督管理局于1992年暂停了用于美容目的的硅胶凝胶乳房植入物的使用。尽管有大量科学数据表明其安全性，但目前硅胶凝胶乳房植入物在美国仅作为有限临床试验的一部分可用。它们在欧洲和世界其他地区仍在使用。
