Global Safety & Epidemiology for Allergan, Inc, Irvine, California, USA.
Aesthet Surg J. 2013 May;33(4):529-39. doi: 10.1177/1090820X13484035. Epub 2013 Apr 4.
Clinical data concerning potential risks and benefits associated with the use of high- and extra high-profile breast implants are lacking.
The authors assess the risk of adverse events (AE) with high- and extra high-profile breast implants compared with low- to moderate-profile breast implants in patients enrolled in long-term clinical studies.
Relative risks (RR) of capsular contracture (CC), moderate to severe malposition, and secondary procedure were calculated using Cox proportional hazards regression, adjusting for patient, procedure, and device characteristics among patients enrolled in the primary augmentation cohorts of the Core (NCT00689871; round, silicone-filled implants) and 410 (NCT00690339; shaped, highly cohesive silicone-filled implants) clinical studies. Study pooling provided comparisons of implant shape and fill, as well as contributed to relative outcome. Analyses were also stratified by preoperative breast measures.
In the Core study (N = 454; 907 implants; mean follow-up 7.2 years; 3669 person-years), and the combined Core and 410 studies (N = 4412; 8811 implants; mean follow-up 3.0 years; 14 528 person-years), risk of CC, secondary procedures, and mastopexy as a secondary procedure were reduced in high-profile versus low- to moderate-profile breast implants (P < .05). The risk of moderate to severe malposition was not significantly different between high-profile and low- to moderate-profile breast implants in the Core or combined studies (RR, 0.58 [95% confidence interval (CI), 0.22-1.51] and RR, 0.72 [95% CI, 0.31-1.70], respectively). Analyses stratified by preoperative breast measures did not indicate higher risk of CC, malposition, or secondary procedure among patients with either smaller (<17 cm) or larger (≥17 cm) preoperative measures.
Among primary augmentation patients with round, silicone-filled, or shaped, highly cohesive silicone-filled implants, high- and extra high-profile implants were associated with lower risks of CC, secondary procedures, and mastopexy and were not associated with greater risks of moderate to severe malposition versus low- to moderate-profile implants.
关于使用高凸度和超高凸度乳房植入物的潜在风险和益处的临床数据尚缺乏。
作者评估了在长期临床研究中入组的患者中，与低中度凸度乳房植入物相比，高凸度和超高凸度乳房植入物发生不良事件（AE）的风险。
使用 Cox 比例风险回归计算包膜挛缩（CC）、中度至重度位置不当和二次手术的相对风险（RR），并在 Core（NCT00689871；圆形、硅胶填充植入物）和 410（NCT00690339；形状、高凝聚力硅胶填充植入物）临床试验的主要增强队列中入组的患者中，根据患者、手术和设备特征进行调整。研究汇总提供了对植入物形状和填充物的比较，并有助于相对结果。分析还按术前乳房测量进行分层。
在 Core 研究（N = 454；907 个植入物；平均随访 7.2 年；3669 人年）和 Core 与 410 研究的合并研究（N = 4412；8811 个植入物；平均随访 3.0 年；14528 人年）中，与低中度凸度乳房植入物相比，高凸度乳房植入物发生 CC、二次手术和乳房上提术作为二次手术的风险降低（P <.05）。在 Core 或合并研究中，高凸度与低中度凸度乳房植入物之间的中度至重度位置不当的风险无显著差异（RR，0.58 [95%置信区间（CI），0.22-1.51]和 RR，0.72 [95% CI，0.31-1.70]）。按术前乳房测量值分层的分析并未表明在术前测量值较小（<17 cm）或较大（≥17 cm）的患者中 CC、位置不当或二次手术的风险更高。
在使用圆形、硅胶填充或形状、高凝聚力硅胶填充植入物进行初次增强的患者中，高凸度和超高凸度植入物与较低的 CC、二次手术和乳房上提术风险相关，与低中度凸度植入物相比，其中度至重度位置不当的风险没有增加。
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