Crouzet C, Gangloff D, Chaput B, Grolleau J-L, Garrido I
Institut Claudius-Regaud, 20-25, rue Pont-Saint-Pierre, 31052 Toulouse cedex, France.
Ann Chir Plast Esthet. 2012 Feb;57(1):9-15. doi: 10.1016/j.anplas.2012.01.001. Epub 2012 Jan 27.
On March 30, 2010, AFSSAPS (sanitary French) issued a medical alert about breast implants "Poly Implant Prothese" (PIP), because it was shown that its failure rate was higher than of other manufacturers. This alert was accompanied by a suspension of sales and use of breast implants PIP. Since the announcement of this decision, the Institut Claudius Regaud (ICR) has set up a crisis unit to best meet the demands and questions concerning patients who had PIP implants. After 18 months of the beginning of the crisis, we decided to review the consequences of this decision.
This is a retrospective study of all patients who underwent breast reconstruction with a prosthesis PIP since 2006. We are interested in managing of the crisis, the fate of patients and the problems of implants.
In total 128 PIP prostheses were implanted on 116 patients. These were all cases of asymmetric anatomic implants placed in 91 cases in immediate breast reconstruction and of breast-delayed reconstruction in 25 cases. Twelve patients had a contralateral PIP prosthesis. After careful analysis of the records, we found that 18 patients (16%) had received a change of prosthesis or simple removal of the prosthesis before the beginning of the crisis. No prosthesis was broken. After the retrospective chart review we found that we reoperated 61,2% of patients and explanted 59,4% of prostheses PIP. In 31 cases (26,7%), another surgery was associated with the change of prosthesis. Of the 76 explanted prostheses, ten of them had an abnormality (13,1%). Three implants (3,9%) were ripted. Six implants (7,9%) had a phenomenon of perspiration. The average life span of these prostheses was of 21,3 months. Among patients who were reoperated, we observed three postoperative complications (3,9%).
More than 18 months after the withdrawal on the market of breast implants PIP, we reviewed almost all patients implanted at our institution. To date, 60% of patients no longer have this prosthesis in place, but 16% of patients with this specific breast implant had already been remove before March 2010. Eighteen percent of implants had an abnormality and three had a rupture. In this retrospective study we also found that the care of our patients could be improved, including the legibility of the monitoring and in the administrative field.
2010年3月30日，法国卫生安全与健康产品局（AFSSAPS）发布了关于“宝俪”（Poly Implant Prothese，PIP）乳房植入物的医疗警报，因为有证据表明其故障率高于其他制造商。该警报还伴随着PIP乳房植入物销售和使用的暂停。自宣布这一决定以来，克劳迪乌斯·雷高研究所（ICR）设立了一个危机处理小组，以更好地应对有关植入PIP植入物患者的需求和问题。在危机开始18个月后，我们决定评估这一决定的后果。
这是一项对自2006年以来接受PIP假体乳房重建的所有患者的回顾性研究。我们关注危机管理、患者的情况以及植入物的问题。
共116例患者植入了128个PIP假体。这些均为非对称解剖型植入，其中91例用于即刻乳房重建，25例用于延期乳房重建。12例患者对侧植入了PIP假体。在仔细分析记录后，我们发现18例患者（16%）在危机开始前已更换假体或单纯取出了假体。没有假体破裂。回顾病历后，我们发现61.2%的患者接受了再次手术，59.4%的PIP假体被取出。在31例（26.7%）患者中，再次手术与假体更换有关。在76个取出的假体中，10个有异常（13.1%）。3个植入物（3.9%）破裂。6个植入物（7.9%）有渗液现象。这些假体的平均使用期限为21.3个月。在接受再次手术的患者中，我们观察到3例术后并发症（3.9%）。
在PIP乳房植入物退市18个月多后，我们对本机构植入的几乎所有患者进行了评估。目前，60%的患者体内已不再有该假体，但16%植入这种特定乳房植入物的患者在2010年3月前就已取出。18%的植入物有异常，3个发生了破裂。在这项回顾性研究中，我们还发现对患者的护理可以改进，包括监测记录的清晰度和管理方面。
