Montemurro Paolo
Aesthet Surg J. 2024 Aug 20;44(9):948-956. doi: 10.1093/asj/sjae071.
BACKGROUND: Nanotextured breast implants (classified as smooth implants by the latest ISO 14607:2018) have been described as possibly reducing major textured implant-related complications such as capsular contracture and breast implant-associated anaplastic large cell lymphoma. On the other hand, microtextured breast implants benefit from an optimal safety profile based on a much larger body of literature. OBJECTIVES: The aim of this study was to directly compare the incidence of complications between Motiva Ergonomix (Establishment Labs Holdings, Inc., Alajuela, Costa Rica) and POLYTECH MESMO (POLYTECH Health & Aesthetics GmbH, Dieburg, Germany) breast implants, especially regarding the displacement issues that might arise after breast augmentation. METHODS: Consecutive patients who previously underwent surgery by the same physician for placement of Motiva Ergonomix and POLYTECH MESMO implants were included in this study. They were divided into 2 groups according to the type of implant. The onset of complications was assessed through survival analysis. RESULTS: Data were collected from 329 patients, 185 (56.2%) with POLYTECH MESMO and 144 (43.8%) with Motiva Ergonomix implants. The median follow-up was 8 months for both groups. Of the 42 women (12.8%) who experienced at least one complication, 26 belonged to the Motiva Ergonomix subgroup (P = .013). The most represented complications during this period resulted from displacement issues, with a clear prevalence of bottoming out in the Motiva Ergonomix cohort: 15 cases vs 0 cases in the POLYTECH MESMO cohort (P < .001). For 7 patients, a reoperation was required, more frequently for patients with Motiva Ergonomix implants (4.2% vs 0.5%; P = .046). CONCLUSIONS: POLYTECH MESMO devices provided a more favorable outcome. Motiva Ergonomix devices revealed a concerning incidence of displacement issues during the first postsurgery years, with no advantage over other major complications.
背景:纳米纹理乳房植入物(根据最新的ISO 14607:2018分类为光滑植入物)被认为可能会减少与纹理植入物相关的主要并发症,如包膜挛缩和乳房植入物相关的间变性大细胞淋巴瘤。另一方面,基于更多的文献资料,微纹理乳房植入物具有最佳的安全性。 目的:本研究的目的是直接比较Motiva Ergonomix(Establishment Labs Holdings, Inc., 阿拉胡埃拉,哥斯达黎加)和POLYTECH MESMO(POLYTECH Health & Aesthetics GmbH, 迪堡,德国)乳房植入物的并发症发生率,特别是关于隆乳术后可能出现的移位问题。 方法:本研究纳入了由同一位医生先前进行Motiva Ergonomix和POLYTECH MESMO植入物手术的连续患者。根据植入物类型将他们分为两组。通过生存分析评估并发症的发生情况。 结果:收集了329例患者的数据,其中185例(56.2%)植入了POLYTECH MESMO,144例(43.8%)植入了Motiva Ergonomix。两组的中位随访时间均为8个月。在经历至少一种并发症的42名女性(12.8%)中,26名属于Motiva Ergonomix亚组(P = 0.013)。在此期间最常见的并发症是移位问题,Motiva Ergonomix队列中明显以乳房下极下垂为主:15例,而POLYTECH MESMO队列中为0例(P < 0.001)。7名患者需要再次手术,Motiva Ergonomix植入物患者更频繁(4.2%对0.5%;P = 0.046)。 结论:POLYTECH MESMO装置提供了更有利的结果。Motiva Ergonomix装置在术后头几年显示出令人担忧的移位问题发生率,在其他主要并发症方面没有优势。
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