From the Department of Plastic Surgery, the Clinical Cancer Prevention Center, and the Department of Hematopathology, University of Texas M.D. Anderson Cancer Center; School of Medicine and Psychology, "Sapienza" University of Rome; and the Departments of Plastic and Reconstructive Surgery, Tel Aviv Sourasky Medical Center, affiliated with the Sackler Faculty of Medicine, Tel Aviv University.
Plast Reconstr Surg. 2021 May 1;147(5S):58S-68S. doi: 10.1097/PRS.0000000000008047.
Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.
对有症状的纹理植入物患者进行适当的管理对于识别和治疗相关的肿瘤疾病至关重要。纹理表面乳房植入物是在 50 多年前首次引入的,目的是降低第一代光滑表面乳房植入物观察到的高包膜挛缩和植入物错位发生率。在 20 世纪 90 年代末,纹理植入物在美国超过了光滑设备,但其在新一代光滑植入物中失宠,而纹理在全球范围内仍然是主导销售的植入物,直到最近。2019 年,美国食品和药物管理局(FDA)发布了 I 类设备召回,导致全球最畅销的植入物 Allergan Biocell 被移除,原因是与乳房植入物相关的间变性大细胞淋巴瘤(BIA-ALCL)的风险不成比例增加。手术策略,如在插入纹理植入物时控制细菌,尚未被可信地证明会影响或预防 BIA-ALCL 的未来发展。BIA-ALCL 患者需要完全切除其疾病,而其他无症状的纹理植入物患者不需要手术切除。对于可疑病例,在进行任何手术干预之前,应进行 CD30 免疫组织化学诊断性检测。在标准化方法中,通过 12 个战略性区域活检评估包膜。如果外科医生正在修订或更换纹理植入物,他们可能会合理地考虑进行全包膜切除术,尽管这不是食品和药物管理局或国家协会所倡导的,也没有证明可以减轻 BIA-ALCL 的未来风险。本文的目的是回顾有关纹理表面植入物的数据和结果、疾病相关风险,以及修订性手术和设备监测的管理策略。