Niechajev Igor, Jurell Göran, Lohjelm Lena
Lidingö Clinic, Torsvägen 30, S-181 32 Lidingö, Sweden.
Aesthetic Plast Surg. 2007 Nov-Dec;31(6):697-710. doi: 10.1007/s00266-006-0057-0.
The new generation of breast implants has an anatomic shape. These implants are made with a textured shell and filled with a cohesive silicone gel. Available since 1993 except in the United States, these implants are gaining in popularity for breast enlargement and reconstruction. This prospective, randomized, controlled, and blinded study was designed to compare mid- and long-term results with the use of cohesive gel-filled implants from two different manufacturers: Style 410 of the McGhan brand (MG) made by Allergan and Vertex made by Eurosilicone (ES).
From May 1997 to May 1999, 80 women underwent breast augmentation: 40 with Style 410 implants (MG) and 40 with Vertex implants (ES). All surgeries were performed by the same surgeon (I.N.). Another physician (G.J.) interviewed and examined 64 of these women (80%) 4 to 6 years (median, 5 years) after implantation. In addition, 10 patients responded to the same questionnaire and were interviewed by phone, bringing the follow-up rate to 92.5%.
Overall, satisfaction was high, with 98.6% of the patients evaluated after 4 to 6 years "very satisfied" or "satisfied" with the result in general. Approximately 20% of the patients who responded judged their breasts to be firmer than desirable. Breast augmentation classification (BAC) was used to grade the breast firmness of the 64 patients examined by G. J. At examination, 24% of patients had soft breasts, 53% had slightly firm breasts, and 23% had moderately firm breasts. That last category also was classified as capsular contracture. No patient was graded as having very hard breasts (BAC 4). Skin sensitivity of the breast adjacent to the incision was altered for 25% of the patients. The implant rotated in four patients (5%). Breast firmness, implant palpability, nipple sensitivity, and skin sensitivity were further analyzed by implant location (submuscular vs subglandular) and implant size (volume). Frequency of the breast asymmetries and the impact of augmentation on asymmetric breasts also was studied. All these analyses were performed with the entire pool of examined patients who answered the follow-up questionnaire. Data also were analyzed by distinguishing between results of the two each implant manufacturers. The results showed no difference between the Eurosilicone and McGhan implants except for the self-evaluation of "breast consistency" by the patient. A higher percentage of patients with the Vertex implants than with the McGhan implants reported that their breast was "firmer than desired."
Breast augmentation with anatomic, textured, cohesive silicone gel-filled implants is a reliable procedure with consistently good results. The results also show that candidates for breast enlargement should be informed that their implanted breast may feel firmer than their natural breasts. They also may experience reduced sensation of their nipple or breast skin.
新一代乳房植入物具有解剖学形状。这些植入物采用带纹理的外壳，填充有粘性硅胶凝胶。自1993年起（美国除外）可获得，这些植入物在隆乳和乳房重建方面越来越受欢迎。这项前瞻性、随机、对照和盲法研究旨在比较使用来自两个不同制造商的粘性凝胶填充植入物的中长期结果：Allergan生产的McGhan品牌（MG）的410型和Eurosilicone生产的Vertex（ES）。
从1997年5月至1999年5月，80名女性接受了隆乳手术：40名使用410型植入物（MG），40名使用Vertex植入物（ES）。所有手术均由同一位外科医生（I.N.）进行。另一位医生（G.J.）在植入后4至6年（中位数为5年）对其中64名女性（80%）进行了访谈和检查。此外，10名患者回复了相同的问卷并接受了电话访谈，使随访率达到92.5%。
总体而言，满意度较高，4至6年后接受评估的患者中有98.6%对结果“非常满意”或“满意”。约20%回复的患者认为其乳房比期望的更硬。采用乳房增大分类（BAC）对G.J.检查的64名患者的乳房硬度进行分级。检查时，24%的患者乳房柔软，53%的患者乳房稍硬，23%的患者乳房中度硬。最后一类也被归类为包膜挛缩。没有患者被分级为乳房非常硬（BAC 4）。25%的患者切口附近乳房的皮肤敏感性发生改变。4名患者（5%）的植入物发生旋转。通过植入位置（胸大肌下与乳腺下）和植入物大小（体积）进一步分析乳房硬度、植入物可触及性、乳头敏感性和皮肤敏感性。还研究了乳房不对称的频率以及增大对不对称乳房的影响。所有这些分析均在回答随访问卷的全部受检患者中进行。数据也通过区分两个植入物制造商的结果进行分析。结果显示，除了患者对“乳房质地”的自我评估外，Eurosilicone和McGhan植入物之间没有差异。使用Vertex植入物的患者中报告其乳房“比期望的更硬”的比例高于使用McGhan植入物的患者。
使用解剖学形状、带纹理、填充粘性硅胶凝胶的植入物进行隆乳是一种可靠的手术，效果始终良好。结果还表明，应告知隆乳候选人，其植入的乳房可能感觉比自然乳房更硬。他们也可能会经历乳头或乳房皮肤感觉减退。
