Gladfelter Joanne
INAMED Corporation, Santa Barbara, California, USA.
Plast Surg Nurs. 2006 Jul-Sep;26(3):128-31. doi: 10.1097/00006527-200607000-00007.
In the early 1990s, it was reported that silicone breast implants were possibly responsible for serious damage to women's health. In January 1992, the Food and Drug Administration issued a voluntary breast implant moratorium and, in April, issued a ban on the use of silicone gel-filled implants for cosmetic breast augmentation. Since that time, silicone gel-filled breast implants have been available to women only for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast deformity. Since the ban on the use of silicone gel-filled breast implants for cosmetic breast augmentation, numerous scientific studies have been conducted. To ensure patient safety, the American Board of Plastic Surgery believes that these scientific studies and the Food and Drug Administration's scrutiny of silicone gel-filled breast implants have been appropriate and necessary.
20世纪90年代初,有报道称硅胶乳房植入物可能对女性健康造成严重损害。1992年1月,美国食品药品监督管理局发布了一项关于乳房植入物的自愿暂停令,并在4月发布了一项禁令,禁止使用硅胶填充的植入物进行隆胸手术。自那时起,硅胶填充的乳房植入物仅在特定情况下可供女性使用:寻求乳房重建或修复现有乳房植入物的女性、接受过乳腺癌手术的女性、乳房严重受伤的女性、影响乳房的先天性缺陷患者,或患有导致严重乳房畸形的疾病的女性。自禁止使用硅胶填充的乳房植入物进行隆胸手术以来,已经进行了大量的科学研究。为确保患者安全,美国整形外科委员会认为这些科学研究以及食品药品监督管理局对硅胶填充乳房植入物的审查是适当且必要的。