Department of Plastic Surgery, Level 5, Ninewells Hospital, Dundee DD1 9SY, UK.
J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1182-7. doi: 10.1016/j.bjps.2013.05.003. Epub 2013 May 30.
To determine the true rupture rates of PIP implants from a large single surgeon cohort and to assess whether rupture rates varied depending on time of implant insertion. In addition, the efficacy of ultra sound scanning (USS) in determining rupture is examined.
Predominantly prospectively based analysis of patient records, investigations and surgical findings.
338 patients (676 implants) were included in the study and they all had removal of their implants. The senior author operated on all patients at some stage of their treatment. 160 patients were imaged pre-operatively with USS. Patients had implants inserted between 1999 and 2007 for cosmetic breast augmentation.
A total of 144 ruptured implants were removed from 119 patients, giving a rupture rate of 35.2% per patient and 21.3% per implant over a mean implantation period of 7.8 years. A statistical difference (P < 0.001) in rupture rates between implants inserted prior to 2003 and those inserted from 2003 was demonstrated, with higher failure rates in the latter group. There was a significant difference in rupture rates depending on pocket placement of the implants. The sensitivity and specificity of USS at detecting rupture was 90.6% and 98.3% respectively. A proportion of patients (29.4%) demonstrated loco-regional spread of silicone to the axilla on scanning.
Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women.
本研究旨在通过对大量单外科医生队列的调查，确定 PIP 植入物的真实破裂率，并评估其破裂率是否随植入时间的不同而变化。此外，还评估了超声扫描（USS）在确定破裂方面的效果。
主要基于患者记录、检查和手术结果的前瞻性分析。
共纳入 338 名患者（676 个植入物），他们均接受了植入物取出手术。所有患者均由资深作者进行手术治疗。160 名患者在术前接受了 USS 成像。患者于 1999 年至 2007 年期间因美容隆胸植入了这些植入物。
119 名患者共取出 144 个破裂的植入物，每个患者的破裂率为 35.2%，每个植入物的破裂率为 21.3%，平均植入时间为 7.8 年。植入物插入时间早于 2003 年和插入时间晚于 2003 年的两组患者的破裂率存在统计学差异（P<0.001），后者的失败率更高。植入物的破裂率与植入物的口袋位置有关。USS 检测破裂的灵敏度和特异性分别为 90.6%和 98.3%。在扫描时，一部分患者（29.4%）的腋窝部位显示出硅胶的局部扩散。
本研究证实了迄今为止发表的最大系列 PIP 植入物失败率较高。植入物插入时间早于 2003 年和插入时间晚于 2003 年的两组患者的破裂率存在显著差异，这支持了 2003 年后工业硅胶被用于该设备的观点。与植入于胸肌下平面的植入物相比，植入于胸肌上平面的植入物更容易破裂。USS 对 PIP 植入物破裂的检测非常有效，与其他设备相比，局部扩散率较高。我们认为，本研究提供了有力的数据，使患者、临床医生和提供者在这一仍在活跃、影响数千名女性的问题上做出更明智的决策。
