Rotterdam and Amsterdam, The Netherlands From the Department of Surgical Oncology, Erasmus Medical Center/Daniel den Hoed Cancer Center; the Department of Plastic and Reconstructive Surgery, VU University Medical Center; and the Medical Center Jan van Goyen.
Plast Reconstr Surg. 2013 Mar;131(3):394e-402e. doi: 10.1097/PRS.0b013e31827c70aa.
Recently, Poly Implant Prothèse silicone breast implants were recalled from the European market. The authors studied 112 women and previously published data on rupture prevalence. Women are presenting with symptoms they feel may be a result of ruptured implants. The authors' aim was to study the clinical consequences of Poly Implant Prothèse implants.
One hundred twelve women with 224 proven Poly Implant Prothèse implants after 10 years of implantation were enrolled in this study. All women underwent physical examination and magnetic resonance imaging and were interviewed regarding symptoms. Details of the explantations of 35 women with at least one ruptured implant were documented. Tissue from 10 women was sent for pathologic investigation.
Of 112 women, 34 (30.4 percent) had symptoms attributable to their implants. Physical examination showed that 12 of the 121 women (10.7 percent) had findings suggestive of rupture, most commonly pain. Three had lymphadenopathy that seemed to correlate with implant rupture or excessive "gel bleed." Pathologic findings showed no malignancies. Eight women who underwent explantation had no implant rupture. Excessive gel bleed was documented in half of them.
Clinical consequences of women with Poly Implant Prothèse implants are comparable to those reported in the literature of other manufacturers. Neither complaints nor findings at physical examination had a significant correlation with implant rupture at explantation. Magnetic resonance imaging is still the preferred method compared with physical examination for diagnosing rupture. The low specificity was probably caused by the difficulty in differentiating between rupture and excessive gel bleed in these implants.
最近，聚植入修复体（Poly Implant Prothèse）硅胶乳房植入物从欧洲市场召回。作者研究了 112 名女性和先前发表的破裂流行率数据。女性出现了她们认为可能是植入物破裂引起的症状。作者的目的是研究 Poly Implant Prothèse 植入物的临床后果。
这项研究纳入了 112 名女性，她们在植入 10 年后均证实有 224 个聚植入修复体（Poly Implant Prothèse）植入物。所有女性均接受了体格检查和磁共振成像检查，并接受了关于症状的访谈。记录了 35 名至少有一个破裂植入物的女性的手术取出细节。将 10 名女性的组织送去进行病理检查。
在 112 名女性中，有 34 名（30.4%）有与植入物相关的症状。体格检查显示，在 121 名女性中有 12 名（10.7%）出现了提示破裂的发现，最常见的是疼痛。有 3 名出现了淋巴结病，似乎与植入物破裂或“凝胶渗出过多”有关。病理检查未发现恶性肿瘤。接受取出手术的 8 名女性没有植入物破裂。其中一半有过多的凝胶渗出。
Poly Implant Prothèse 植入物女性的临床后果与其他制造商文献报道的相似。体格检查的发现既与磁共振成像检查的结果没有显著相关性，也与手术取出时的植入物破裂没有显著相关性。磁共振成像仍然是诊断破裂的首选方法，优于体格检查。这种低特异性可能是由于在这些植入物中，区分破裂和过多凝胶渗出比较困难。
