Spear Scott L, Hedén Per
Department of Plastic Surgery, Georgetown University Hospital, 3800 Reservoir Road, N.W., 1 PHC, Washington, DC 20007, USA.
Expert Rev Med Devices. 2007 Sep;4(5):699-708. doi: 10.1586/17434440.4.5.699.
In the USA, women seeking breast implants for augmentation, revision or reconstruction can choose between saline-filled devices and round, silicone gel-filled devices. Form-stable, highly cohesive silicone gel-filled breast implants are marketed in other countries and are currently under review by the US FDA. Allergan has conducted clinical studies to investigate the safety and effectiveness of its round and anatomical (Style 410) devices for US marketing approval. The most frequently reported complications were reoperation, implant removal with replacement, implant malposition and capsular contracture. The FDA approved the round devices in 2006. The weight of the scientific literature suggests that silicone gel-filled breast implants do not increase a patient's risk of cancer, autoimmune disease, reproductive effects or suicide. As differently shaped, cohesive breast implants continue to be introduced, breast implant surgery will become more customized to the patient's biological conditions and desires.
在美国,寻求隆胸、修复或重建乳房植入物的女性可以在盐水填充型和圆形硅胶凝胶填充型植入物之间做出选择。形状稳定、高粘性硅胶凝胶填充的乳房植入物在其他国家销售,目前正在接受美国食品药品监督管理局(FDA)的审查。艾尔建公司已开展临床研究,以调查其圆形和解剖形(410型)植入物在美国上市批准的安全性和有效性。最常报告的并发症是再次手术、取出并更换植入物、植入物位置不当和包膜挛缩。FDA于2006年批准了圆形植入物。科学文献的权重表明,硅胶凝胶填充的乳房植入物不会增加患者患癌症、自身免疫性疾病、生殖影响或自杀的风险。随着不同形状、粘性的乳房植入物不断推出,乳房植入手术将根据患者的身体状况和需求变得更加个性化。