Klein Doron, Hadad Eran, Wiser Itay, Wolf Omer, Itzhaki Shapira Ortal, Fucks Shir, Heller Lior
From the Department of Plastic Surgery, Assaf Harofeh Medical Center, Tel Aviv, Israel.
Ann Plast Surg. 2018 Jan;80(1):5-9. doi: 10.1097/SAP.0000000000001294.
Silicone breast implants from the French manufacturer Poly Implants Prosthèse (PIP) were recalled from the European market after the French regulator has revealed the implants contain non-medical-grade silicone filler. In December 2011, following a large increase in reported rupture rate and a possible cancer risk, the French Ministry of Health recommended consideration of the PIP explantation, regardless of their condition. In 2012, the Israel Ministry of Health recommended to replace the implants only upon suspected implant rupture.
The aims of this study were to characterize breast-augmented Israeli patients with PIP implants, compare their outcomes with those of breast-augmented patients with different implant types, and review the current PIP literature.
Breast-augmented patients who underwent an elective breast implant exchange in Israel between January 2011 and January 2017 were included in the study. Data were collected from electronic and physical medical files.
There were 73 breast-augmented female patients with 146 PIP breast implants included in this study. Average implant age was 6.7 ± 2.79 years. Mean implant size was 342.8 ± 52.9 mL. Fourteen women (19 implants [16%]) had a high-grade capsular contracture (Baker grade 3-4). During exchange, 28 implants were found to be ruptured (19.2%).
Less than 10 years following breast augmentation, PIP implants demonstrated higher rupture rate compared with other implants. Our data are comparable to overall available rupture rate. Among patients with definitive rupture diagnosis, an elective implant removal should be recommended. In cases of undamaged implants, plastic surgeons should also seriously consider PIP implant explantation. When the patient does not desire to remove the implant, an annual physical examination and breast ultrasound are recommended, beginning a year after augmentation.
法国制造商聚植入物假体公司（PIP）生产的硅胶乳房植入物在法国监管机构披露这些植入物含有非医用级硅胶填充物后，从欧洲市场召回。2011年12月，在报告的破裂率大幅上升以及可能存在癌症风险之后，法国卫生部建议考虑取出PIP植入物，无论其状况如何。2012年，以色列卫生部建议仅在怀疑植入物破裂时更换植入物。
本研究的目的是对植入PIP植入物的以色列隆胸患者进行特征描述，将其结果与不同植入物类型的隆胸患者的结果进行比较，并回顾当前关于PIP的文献。
纳入2011年1月至2017年1月在以色列接受择期乳房植入物置换的隆胸患者。数据从电子和纸质医疗档案中收集。
本研究纳入了73名接受隆胸的女性患者，共146个PIP乳房植入物。植入物的平均使用年限为6.7±2.79年。植入物的平均大小为342.8±52.9毫升。14名女性（19个植入物[16%]）发生了严重的包膜挛缩（贝克3 - 4级）。在置换过程中，发现28个植入物破裂（19.2%）。
隆胸后不到10年，PIP植入物的破裂率高于其他植入物。我们的数据与总体可用破裂率相当。对于确诊破裂的患者，应建议择期取出植入物。在植入物未受损的情况下，整形外科医生也应认真考虑取出PIP植入物。当患者不希望取出植入物时，建议在隆胸一年后开始每年进行一次体格检查和乳房超声检查。
