硅凝胶乳房植入物相关疾病的研究进展

doi:10.3969/j.issn.1004-616x.2024.05.013

摘要/Abstract

摘要： 乳房假体植入相关疾病一直受到社会密切关注，经系统分析发现硅凝胶乳房植入产品的表面形貌、渗透性均可能成为这类并发症的诱因。毛面乳房植入物能够抑制炎症和异物反应，却增加了乳腺植入物相关的间变性大细胞淋巴瘤(BIA-ALCL)的发生率。未破裂的硅凝胶植入物有凝胶渗漏现象，渗出的硅胶碎片迁移到周围组织，介导不同免疫细胞反应，最终导致疾病的产生。本文综述了现阶段硅凝胶乳房植入物与疾病关系研究进展，重点阐述了硅凝胶乳房植入物表面形貌、凝胶渗漏和硅酮毒性对炎症、包膜挛缩和BIA-ALCL三种疾病的影响，以期为探索硅凝胶乳房植入产品所导致的乳房植入物相关疾病产生的原因提供全新的视角和研究方向，对进一步完善乳房植入物医疗器械产品质量评价体系具有重要意义。

关键词: 硅凝胶乳房植入物, 炎症, 包膜挛缩, 间变性大细胞淋巴瘤

中图分类号:

TH778

郭采妮, 刘璟, 张玉龙, 丁黎, 付步芳. 硅凝胶乳房植入物相关疾病的研究进展[J]. 癌变·畸变·突变, 2024, 36(5): 412-416.

参考文献

[1] 谢胜芬, 刘珍珍, 王云英. 取出乳房植入体的化学性能分析[J]. 中国医疗器械信息, 2022, 28(9): 22-25.
[2] 方玉, 冯晓明, 奚廷斐, 等. 乳房植入物行业标准的研究[J]. 中国药事, 2008, 22(7): 613-615.
[3] BUINEWICZ B R, VALORAS D, TOWT R. Understanding breast implant illness[J]. Adv Cosmet Surg, 2023, 6(1): 125-135.
[4] MAXWELL G P, GABRIEL A. The evolution of breast implants[J]. Plast Reconstr Surg, 2014, 134(1 Suppl): 12S-17S.
[5] SPOOR J, MUREAU M A M, HOMMES J, et al. The Areola study: design and rationale of a cohort study on long-term health outcomes in women with implant-based breast reconstructions[J]. Ann Epidemiol, 2023, 82: 16-25.
[6] TAVAZZANI F, XING S, WADDELL J E, et al. In vitro interaction between silicone gel and human monocyte-macrophages[J]. J Biomed Mater Res A, 2005, 72(2): 161-167.
[7] VIJAYA BHASKAR T B, MA N, LENDLEIN A, et al. The interaction of human macrophage subsets with silicone as a biomaterial[J]. Clin Hemorheol Microcirc, 2015, 61(2): 119-133.
[8] 燕荣帅, 兰雨洁, 石小花, 等. 包膜挛缩——从异物反应到纤维化的研究进展[J]. 中国美容整形外科杂志, 2024, 35(2): 124-127.
[9] BRODY G S, DEAPEN D, TAYLOR C R, et al. Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases[J]. Plast Reconstr Surg, 2015, 135(3): 695-705.
[10] MEMPIN M, HU H H, CHOWDHURY D, et al. The A, B and C’s of silicone breast implants: anaplastic large cell lymphoma, biofilm and capsular contracture[J]. Materials, 2018, 11(12): 2393.
[11] DOREN E L, MIRANDA R N, SELBER J C, et al. U.S. epidemiology of breast implant-associated anaplastic large cell lymphoma[J]. Plast Reconstr Surg, 2017, 139(5): 1042-1050.
[12] TEVIS S E, HUNT K K, MIRANDA R N, et al. Breast implant-associated anaplastic large cell lymphoma: a prospective series of 52 patients[J]. Ann Surg, 2022, 275(1): e245-e249.
[13] BARR S, HILL E W, BAYAT A. Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness[J]. J Mech Behav Biomed Mater, 2017, 75: 75-81.
[14] YE X, SHOKROLLAHI K, ROZEN W M, et al. Anaplastic large cell lymphoma (ALCL) and breast implants: breaking down the evidence[J]. Mutat Res Rev Mutat Res, 2014, 762: 123-132.
[15] 国家药品监督管理局. YY/T 0647—2021无源外科植入物乳房植入物的专用要求[S]. 北京: 中国标准出版社, 2021: 22-25.
[16] HEADON H, KASEM A, MOKBEL K. Capsular contracture after breast augmentation: an update for clinical practice[J]. Arch Plast Surg, 2015, 42(5): 532-543.
[17] BARNSLEY G P, SIGURDSON L J, BARNSLEY S E. Textured surface breast implants in the prevention of capsular contracture among breast augmentation patients: a meta-analysis of randomized controlled trials[J]. Plast Reconstr Surg, 2006, 117(7): 2182-2190.
[18] WONG C H, SAMUEL M, TAN B K, et al. Capsular contracture in subglandular breast augmentation with textured versus smooth breast implants: a systematic review[J]. Plast Reconstr Surg, 2006, 118(5): 1224-1236.
[19] DOLOFF J C, VEISEH O, MEZERVILLE R D, et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans[J]. Nat Biomed Eng, 2021, 5(10): 1115-1130.
[20] SEYHAN H, KOPP J, BEIER J P, et al. Smooth and textured silicone surfaces of modified gel mammary prostheses cause a different impact on fibroproliferative properties of dermal fibroblasts[J]. J Plast Reconstr Aesthet Surg, 2011, 64(3): e60-e66.
[21] LYKISSA E D, KALA S V, HURLEY J B, et al. Release of low molecular weight silicones and platinum from silicone breast implants[J]. Anal Chem, 1997, 69(23): 4912-4916.
[22] FLASSBECK D, PFLEIDERER B, KLEMENS P, et al. Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants[J]. Anal Bioanal Chem, 2003, 375(3): 356-362.
[23] 李莉, 王春仁, 付步芳. GC-MS法测定硅凝胶乳房假体中低分子量物质[J]. 药物分析杂志, 2010, 30(7): 1361-1363.
[24] YU L T, LATORRE G, MAROTTA J, et al. In vitro measurement of silicone bleed from breast implants[J]. Plast Reconstr Surg, 1996, 97(4): 756-764.
[25] DIJKMAN H B P M, SLAATS I, BULT P. Assessment of silicone particle migration among women undergoing removal or revision of silicone breast implants in the Netherlands[J]. JAMA Netw Open, 2021, 4(9): e2125381.
[26] MUSTAFá J C R, FLEURY E F C, DIJKMAN H B P M. Case report: evidence of migratory silicone particles arising from cohesive silicone breast implants[J]. Front Glob Womens Health, 2022, 3: 730276.
[27] NESHER G, SORIANO A, SHLOMAI G, et al. Severe ASIA syndrome associated with lymph node, thoracic, and pulmonary silicone infiltration following breast implant rupture: experience with four cases[J]. Lupus, 2015, 24(4/5): 463-468.
[28] 吴建军, 薛民杰, 朱力敏. 顶空-气相色谱-质谱法测定整形用有机硅制品中两种硅氧烷[J]. 上海计量测试, 2017, 44(3): 17-19.
[29] 付步芳, 冯晓明, 奚廷斐. 人工乳房硅凝胶填充物中小分子物质的检测[J]. 生物医学工程与临床, 2010, 14(5): 387-389.
[30] 郝玉红, 吴建军. 气相色谱-质谱法测定硅凝胶中两种硅氧烷[J]. 理化检验: 化学分册, 2015, 51(6): 818-820.
[31] DZIUBEK M, LAURENT R, BONAPACE-POTVIN M, et al. Silicone particles in capsules around breast implants: establishment of a new pathological methodology to assess the number of particles around breast implants[J]. Ann Chir Plast Esthet, 2023, 68(1): 19-25.
[32] PARK A J, BLACK R J, SARHADI N S, et al. Silicone gel-filled breast implants and connective tissue diseases[J]. Plast Reconstr Surg, 1998, 101(2): 261-268.
[33] ONNEKINK C, KAPPEL R M, BOELENS W C, et al. Low molecular weight silicones induce cell death in cultured cells[J]. Sci Rep, 2020, 10(1): 9558.
[34] COLARIS M J L, RUHL T, BEIER J P. Effects of silicone breast implants on human cell types in vitro: a closer look on host and implant[J]. Aesthetic Plast Surg, 2022, 46(5): 2208-2217.