Duxbury Paula J, Harvey James R
University of Manchester, Manchester Academic Health Science Centre, 46 Grafton Street, Manchester M13 9NT, UK; Nightingale Centre, University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road, Manchester M23 9LT, UK.
University of Manchester, Manchester Academic Health Science Centre, 46 Grafton Street, Manchester M13 9NT, UK; Nightingale Centre, University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road, Manchester M23 9LT, UK.
J Plast Reconstr Aesthet Surg. 2016 Apr;69(4):452-60. doi: 10.1016/j.bjps.2016.01.013. Epub 2016 Jan 19.
Silicone gel implants are used worldwide for breast augmentation and breast reconstruction. Textured silicone implants are the most commonly placed implant, but polyurethane-coated implants are increasingly being used in an attempt to ameliorate the long-term complications associated with implant insertion.
This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Electronic searches of MEDLINE, EMBASE, the Cochrane Library and www.ClinicalTrials.gov were undertaken in March 2014 using keywords.
Following data extraction, 18 studies were included in the review, including four core studies of textured silicone implants and five studies reporting outcomes for polyurethane-coated silicone implants. There are no clear data reporting revision rates in patients treated with polyurethane implants. In the primary reconstructive setting, capsular contracture rates with silicone implants are 10-15% at 6 years, whilst studies of polyurethane implants report rates of 1.8-3.4%. In the primary augmentation setting, core studies show a capsular contracture rate of 2-15% at 6 years compared with 0.4-1% in polyurethane-coated implants; however, the polyurethane studies are limited by their design and poor follow-up.
The use of polyurethane implants should be considered a safe alternative to textured silicone implants. It is likely that an implant surface does influence short- and long-term outcomes; however, the extent of any benefit cannot be determined from the available evidence base. Future implant studies should target the short- and long-term benefits of implant surfacing by procedure with defined outcome measures; a head-to-head comparison would help clarify outcomes.
硅胶植入物在全球范围内用于隆胸和乳房重建。有纹理的硅胶植入物是最常用的植入物,但聚氨酯涂层植入物的使用越来越多,试图改善与植入物插入相关的长期并发症。
本系统评价按照系统评价和Meta分析的首选报告项目指南进行。2014年3月使用关键词对MEDLINE、EMBASE、Cochrane图书馆和www.ClinicalTrials.gov进行了电子检索。
数据提取后,18项研究纳入评价,包括4项有纹理硅胶植入物的核心研究和5项报告聚氨酯涂层硅胶植入物结果的研究。没有关于接受聚氨酯植入物治疗患者翻修率的明确数据报告。在初次重建手术中,硅胶植入物6年时包膜挛缩率为10% - 15%,而聚氨酯植入物的研究报告率为1.8% - 3.4%。在初次隆胸手术中,核心研究显示6年时包膜挛缩率为2% - 15%,而聚氨酯涂层植入物为0.4% - 1%;然而,聚氨酯研究受其设计和随访不佳的限制。
聚氨酯植入物的使用应被视为有纹理硅胶植入物的安全替代方案。植入物表面可能确实会影响短期和长期结果;然而,从现有证据基础无法确定任何益处的程度。未来植入物研究应以明确的结果指标针对不同手术方式下植入物表面处理的短期和长期益处;直接比较将有助于明确结果。