Thomas W O, Harper L L, Wong S W, Michalski J P, Harris C N, Moore J T, Rodning C B
Department of Surgery, College of Medicine/Medical Center, University of South Alabama, Mobile, USA.
Am Surg. 1997 May;63(5):421-9.
Silicone gel-filled breast implants have been employed clinically for decades for aesthetic augmentation or postmastectomy reconstruction. Most patients and surgeons attest to the efficacy and safety of these devices. However, more recently in the medical literature and popular media, silicone gel-filled breast implants have been claimed to incite an array of clinical sequelae such as capsular formation, granulomatous disease, arthritis, arthralgia, fibromyalgia, autoimmune collagen vascular disease, human adjuvant disease, siliconosis, silicone-related disease, and silicone implant-associated syndrome. During a recent 24-month period, 25 referred patients underwent explantation of bilateral silicone gel-filled prostheses at the University of South Alabama. Patient-reported symptoms and signs included mastodynia, arthralgia, fibromyalgia, xerophthalmia, xerostomia, hypesthesia, and amblyopia. Clinical examination and mammography were reliable in diagnosing implant rupture, but only re-exploration reliably detected implant leakage. Most patients underwent concurrent replacement with saline-filled devices. Histopathologic analyses of all tissue samples revealed chronic inflammation. Subjective improvement of patient-reported symptoms and signs occurred over the course of months postoperatively. There was no mortality associated with explantation, with or without replacement, but an overall morbidity incidence of 20 per cent (5 of 25) was observed. Predicated upon review of the available scientific literature and analysis of this modest number of patients, the following perspectives are germane. 1) A small cohort of patients of status postimplantation of silicone gel-filled devices will manifest chronic morbidity. Identifying such patients prospectively remains problematic. 2) Whether or not silicone gel incites adverse systemic phenomena is unproven, although it has been implicated. 3) Symptomatic patients with silicone gel-filled implants in place should be considered for removal, with full knowledge of the morbidity associated with revisional procedures. 4) Patients currently undergoing breast augmentation or reconstruction employing prosthetics are perhaps best served by insertion of saline-filled devices. 5) Patient-physician dialogue regarding the risk-benefit analysis of prosthetic implantation is imperative. Patients consenting to such procedures must be willing to assume risks.
几十年来，硅胶填充乳房植入物一直被临床用于美容隆胸或乳房切除术后重建。大多数患者和外科医生都证明了这些装置的有效性和安全性。然而，最近在医学文献和大众媒体中，有人声称硅胶填充乳房植入物会引发一系列临床后遗症，如包膜形成、肉芽肿病、关节炎、关节痛、纤维肌痛、自身免疫性胶原血管病、人类辅助疾病、矽肺、硅相关疾病和硅胶植入物相关综合征。在最近的24个月期间，25名转诊患者在南阿拉巴马大学接受了双侧硅胶填充假体的取出手术。患者报告的症状和体征包括乳房疼痛、关节痛、纤维肌痛、干眼症、口干、感觉减退和弱视。临床检查和乳房X线摄影在诊断植入物破裂方面是可靠的，但只有再次手术才能可靠地检测到植入物渗漏。大多数患者同时更换为盐水填充装置。对所有组织样本的组织病理学分析显示有慢性炎症。患者报告的症状和体征在术后数月内出现主观改善。取出植入物（无论是否更换）均无死亡病例，但总体发病率为20%（25例中有5例）。基于对现有科学文献的回顾和对这一小部分患者的分析，以下观点是相关的。1）一小部分硅胶填充装置植入后的患者会出现慢性疾病。前瞻性地识别这类患者仍然存在问题。2）尽管有人认为硅胶会引发不良全身现象，但尚未得到证实。3）对于有症状的硅胶填充植入物患者，应考虑取出，同时充分了解翻修手术相关的发病率。4）目前正在使用假体进行隆胸或重建的患者，也许最好使用盐水填充装置。5）患者与医生就假体植入的风险效益分析进行对话至关重要。同意进行此类手术的患者必须愿意承担风险。
