Bachour Y, Heinze Z C M, Dormaar T S, van Selms W G, Ritt M J P F, Niessen F B
1Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Center, De Boelelaan 1117, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
Department of Plastic, Reconstructive and Hand Surgery, OLVG location West, 1061 AE Amsterdam, The Netherlands.
Eur J Plast Surg. 2018;41(5):563-570. doi: 10.1007/s00238-018-1427-y. Epub 2018 Jun 1.
The Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants.
Eighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon.
The implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase ( ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase ( ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture ( ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture ( ≤ 0.05).
We managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture.Level of evidence: Level III, risk / prognostic study.
聚植入假体（PIP）因使用劣质硅胶于2010年退出市场，这会导致假体破裂的高风险。本研究的目的是调查PIP乳房植入物的植入动态，以及确定PIP植入物中凝胶渗漏、破裂和包膜挛缩的发生率及预测因素。
2012年，80名共植入152个PIP植入物且接受再次手术的女性纳入本研究。体格检查包括评估贝克评分，人口统计学信息通过病历进行回顾性追踪。计算植入物术前和术后的体积，并由外科医生在术中确定其状态。
平均植入时间为11±2.1年后取出植入物。分别有42%和25%的植入物发生凝胶渗漏和破裂。完整的植入物术后体积有增加也有减少。凝胶渗漏与术后植入物体积增加更多之间存在相关性（≤0.05）。包膜挛缩对术后植入物体积增加有保护作用（≤0.05），而术后植入物体积增加对包膜挛缩的发生有保护作用（≤0.05）。此外，植入物破裂导致包膜挛缩的风险更高（≤0.05）。
我们成功表明PIP植入物外壳渗透性过高，且凝胶渗漏与术后植入物体积增加之间存在相关性。植入物破裂导致发生包膜挛缩的风险更高。证据水平：III级，风险/预后研究。
