Tropet Yves, Oulharj Sarah, Pauchot Julien
Bull Acad Natl Med. 2013 Jan;197(1):123-30; discussion 130-1.
On 29 march 2010, the French authorities (Afssaps) issued a health alert concerning breast implants manufactured by the company Poly Implant Prothèse, because of a high rupture rate. Marketing authorization was suspended and the use of PIP breast implants was prohibited. In our hospital department, 630 patients had received these prostheses since 2001. We conducted a retrospective study of all patients who underwent explantation between May 2010 and January 2012, corresponding to 434 explanted prostheses and 217 patients, all operated on by the same surgeon. Median age was 42 years and the prostheses had been implanted an average of 4 years 7 months earlier. We found that 38 implants (8.7%) had ruptured, in 33 patients (15.2%). Five patients had bilateral rupture. Preoperative ultrasonography, performed in 166 patients, detected 30 ruptures that were confirmed at surgery, but missed a further 9 cases (8%). Biopsy samples of capsular tissue were obtained in 103 cases, revealing granulation tissue possibly due to silicone exposure in 33 cases, 22 of which were associated with intact implants. Surgical complications included three hematomas, with no infections. Despite the low false-negative rate of ultrasonography, we recommend systematic preventive explantation, owing to the risk of silicone impregnation of capsular tissue even in the absence of rupture.
2010年3月29日，法国当局（法国卫生安全和健康产品局）发布了一项关于Poly Implant Prothèse公司生产的乳房植入物的健康警报，原因是其破裂率很高。市场授权被暂停，PIP乳房植入物的使用被禁止。在我们医院科室，自2001年以来有630名患者接受了这些假体。我们对2010年5月至2012年1月期间所有接受取出手术的患者进行了回顾性研究，共有434个取出的假体和217名患者，所有手术均由同一位外科医生进行。中位年龄为42岁，假体平均植入时间为4年7个月前。我们发现38个植入物（8.7%）破裂，涉及33名患者（15.2%）。5名患者为双侧破裂。166名患者术前进行了超声检查，检测到30例破裂并在手术中得到证实，但另有9例（8%）漏诊。103例获取了包膜组织活检样本，其中33例显示可能因硅胶暴露导致肉芽组织形成，其中22例与完整的植入物有关。手术并发症包括3例血肿，无感染病例。尽管超声检查的假阴性率较低，但由于即使在植入物未破裂的情况下也存在包膜组织被硅胶浸润的风险，我们建议进行系统性预防性取出。
