假体隆乳召回事件之后发生了什么？假体破裂对假体置换术后并发症预测价值的前瞻性队列研究：808 例植入物。
What Happened after the Poly Implant Prothèse Recall? A Prospective Cohort Study of 808 Implants into the Predictive Value of Implant Rupture on Postexchange Complications.
机构信息
From Quaba Plastic Surgery, Spire Murrayfield Hospital; the Department of Plastic, Reconstructive, Aesthetic, and Hand Surgery, University Hospital Basel; and Fitzgerald Plastic Surgery, Beacon Clinic.
出版信息
Plast Reconstr Surg. 2019 Jul;144(1):35e-42e. doi: 10.1097/PRS.0000000000005706.
BACKGROUND
Problems with a variety of breast implants have emerged with consequences for patients' health and safety. The authors' goal was to follow up on their Poly Implant Prothèse patients after their implant exchange.
METHODS
This single-center, single-surgeon, prospective cohort study lasted from 2012 until 2017. Implant size, implantation interval, surgical details, and complications were registered. The Clavien-Dindo classification was used to grade postoperative complications. Logistic regression was used to investigate whether rupture, interval between implantation and explantation, and new implant size were predictors of postexchange complications.
RESULTS
The authors explanted 808 implants in 404 patients. The rupture rate was 30.9 percent per patient and 20.2 percent per implant. The capsular contracture rate at the time of exchange was low, with 1.86 percent of implants and 2.7 percent of patients; 97.8 percent of patients elected implant exchange and only 2.2 percent just wanted their implants removed. The mean follow-up after implant exchange was 5.2 years, with the last mandatory outpatient appointment usually being scheduled 6 to 12 months after implant exchange. The authors found that 74 patients (18.3 percent) and 124 implants (15.3 percent) had postexchange complications, the majority of them minor (83 percent Clavien-Dindo grade I). Patients with a ruptured implant at the time of exchange were significantly more likely to develop postexchange complications than were patients without rupture.
CONCLUSIONS
This is the first study providing such a complete long-term postexchange follow-up of a single surgeon's Poly Implant Prothèse implant cohort. Implant rupture at the time of exchange had a high predictive value for postexchange complications in the authors' series of 808 implants and 404 Poly Implant Prothèse recall patients.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
背景
各种乳房植入物出现了问题，对患者的健康和安全造成了影响。作者的目的是对他们的 Poly Implant Prothèse 患者进行植入物更换后的随访。
方法
这是一项单中心、单外科医生、前瞻性队列研究，持续时间为 2012 年至 2017 年。记录了植入物大小、植入间隔、手术细节和并发症。使用 Clavien-Dindo 分类对术后并发症进行分级。使用逻辑回归分析破裂、植入和取出间隔以及新植入物大小是否是交换后并发症的预测因素。
结果
作者共取出 404 名患者的 808 个植入物。每个患者的破裂率为 30.9%，每个植入物的破裂率为 20.2%。在更换时包膜挛缩的发生率较低，植入物为 1.86%，患者为 2.7%；97.8%的患者选择更换植入物，只有 2.2%的患者只想取出植入物。植入物更换后的平均随访时间为 5.2 年，最后一次强制性门诊预约通常在植入物更换后 6 至 12 个月进行。作者发现 74 名患者（18.3%）和 124 个植入物（15.3%）出现了更换后的并发症，其中大多数为轻微并发症（Clavien-Dindo 分级 I 级，83%）。在更换时发生破裂的患者发生更换后并发症的可能性明显高于未破裂的患者。
结论
这是第一项对单个外科医生的 Poly Implant Prothèse 植入物队列进行完整的长期更换后随访的研究。在作者的 808 个植入物和 404 个 Poly Implant Prothèse 召回患者系列中，更换时的植入物破裂对更换后的并发症具有很高的预测价值。
临床问题/证据水平：治疗，IV。
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