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(http://www.natrelle.com/breast_augmentation.aspx)上发表的内容。



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Approved Uses
Breast Augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.



使用许可



隆胸最少要到22岁才可以做。这里隆胸术指的是为扩大乳房所做的第一次手术，还包括为矫正第一次手术结果所做的或以改善目的所做的修复手术。



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C​ontraindications
Breast implant surgery should NOT be performed in:



•Women with active infection anywhere in their body


•Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions


•Women who are currently pregnant or nursing​




不能做隆胸术的情况



•身体某个部位感染有没有治愈好的时候


•乳房上有没有得当的治疗癌或癌前期的有疾病的时候


•怀孕中或授乳中的时候






Warnings



•There are many factors that can affect the outcome and appropriate timing of a breast reconstruction


•Many of the changes to breasts following implantation cannot be undone, and if the implants are removed without replacement, dimpling, wrinkling, or puckering may be experienced


•Breast implants are not lifetime devices, and additional unplanned surgeries will likely be necessary


•In order to screen for silent rupture, regular MRI screenings are recommended




必须需要知道的信息



•​手术结果有过多的影响要素，为了确定结果需要等待时间。


•在假体填入时组织有无法挽回的大变化，所以在取出假体后部分会凹进去或有褶皱感。


•乳房假体不能终身维持的很好，所以需要再手术的情况。


•有时察觉不到假体的破裂，所以推荐定期做 MRI 检查。








​Precautions
Safety and effectiveness have not been established in patients with the following:



•Autoimmune diseases (for example, lupus and scleroderma)


•A weakened immune system (for example, currently taking drugs that weaken the body’s natural resistance to disease)


•Planned chemotherapy following breast implant placement


•Planned radiation therapy to the breast following breast implant placement


•Conditions that interfere with wound healing and blood clotting


•Reduced blood supply to breast tissue


•Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders with your surgeon prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait for resolution or stabilization of these conditions prior to undergoing breast implantation surgery




​事前要注意信息



在以下情况下无法确认安全性及效果。



•自身免疫疾病(狼疮, 硬皮症等)


•免疫体质差的情况(近期服用药物使身体免疫低下的药物等)


•假体填入后有做化学疗法或放射线治疗计划的情况


•伤口治愈以及止血方面有障碍的情况


•乳房组织的血液循环不好的情况


•例如抑郁症一样患有精神疾病，或过去有过疾病史的需要与主刀医生商讨并等稳定后接受手术。








​Adverse events
The most commonly reported adverse events for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), implant rupture, and Baker grade III/IV capsular contracture.



水珠状假体手术后最常见的副作用是修复手术，假体破裂，包膜痉挛现象。



Other potential complications for Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants include: swelling, implant malposition, pain, ptosis, infection, changes in breast sensation, nipple complications, seroma, delayed wound healing, hematoma, scarring, asymmetry, wrinkling/rippling, extrusion, implant palpability/visibility, and upper pole fullness. 之外有浮肿，移位（位置移动），疼痛，伤处恢复延迟，血肿（血液淤积），疤痕，不对称，被折叠，凸出来，假体能触摸到或能看到，上方凸出等等。



The most commonly reported adverse events for Natrelle® Silicone-Filled Breast Implants are: reoperation, implant removal (with or without replacement), Baker grade III/IV capsular contracture, implant malposition, and asymmetry. 使用圆形假体做手术最常见的副作用是修复手术，假体取出，包膜痉挛，假体移位，不对称。



Other potential complications for Natrelle Silicone-Filled Breast Implants include: unsatisfactory results, pain, changes in nipple and breast sensation, infection, hematoma/seroma, difficulties breastfeeding, calcium deposits in the tissue around the implant, extrusion, necrosis, delayed wound healing, breast tissue atrophy / chest wall deformity, and lymphadenopathy. 之外还有结果不满，疼痛，乳头以及乳房感觉变化，感染，血肿/血清积液，授乳障碍，石灰化，凸出，组织怪异，伤处恢复延迟，乳房组织萎缩，胸壁变形，淋巴结病等。