Hedström Karin, Falk-Delgado Alberto, Sackey Helena
Department of Surgery, South General Hospital, Stockholm, Sweden.
Department of Plastic and Craniofacial Surgery, Karolinska University Hospital, Stockholm, Sweden.
JPRAS Open. 2024 Jan 23;40:19-31. doi: 10.1016/j.jpra.2024.01.009. eCollection 2024 Jun.
Dermal fillers containing copolyamide are used for breast augmentation and are marketed under different labels, such as Aquafilling, Los Deline, Aqualift, and Activegel. In recent years, the number of publications reporting complications after use of these fillers has increased.
Through a computerized search following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of published studies on complications, treatment options, and radiological findings related to breast augmentation with dermal fillers containing copolyamide was performed. Publications between January 1, 2007, and January 23, 2023, were included. Retrieved studies were screened for inclusion and quality assessment. The Joanna Briggs checklist for case reports and the Strengthening the Reporting of Observational Studies in Epidemiology checklist for cross-sectional studies were used.
Sixteen studies met the inclusion criteria: 14 case reports and 2 retrospective cohort studies, including 196 women and 333 complications. Long-term complications (≥30 days after surgery) were described in 15 studies. The most commonly reported complications were nodules in the breast (130 patients), pain (92 patients), inflammation and/or infection (43 patients), breast deformities (35 patients), and migration of the filler to the pectoralis muscle, abdominal wall, thoracic wall, pubic area, back, or upper extremity (27 patients). The median time between injection of the dermal filler and any complication was 18 months, and the majority of patients with complications required surgical intervention.
Given the reports of severe complications months to years after injection of dermal fillers containing copolyamide and the lack of studies evaluating long-term safety, our interpretation is that dermal fillers containing copolyamide should not be used for breast augmentation.
含共聚酰胺的真皮填充剂用于隆乳,有不同的品牌,如Aquafilling、Los Deline、Aqualift和Activegel。近年来,报道使用这些填充剂后出现并发症的文献数量有所增加。
按照系统评价和Meta分析的首选报告项目指南进行计算机检索,对已发表的关于含共聚酰胺真皮填充剂隆乳的并发症、治疗选择和影像学表现的研究进行系统评价。纳入2007年1月1日至2023年1月23日期间发表的文献。对检索到的研究进行纳入筛选和质量评估。使用乔安娜·布里格斯病例报告清单和加强流行病学观察性研究报告清单对横断面研究进行评估。
16项研究符合纳入标准:14项病例报告和2项回顾性队列研究,包括196名女性和333例并发症。15项研究描述了长期并发症(术后≥30天)。最常报告的并发症是乳房结节(130例患者)、疼痛(92例患者)、炎症和/或感染(43例患者)、乳房畸形(35例患者)以及填充剂迁移至胸肌、腹壁、胸壁、耻骨区、背部或上肢(27例患者)。注射真皮填充剂至出现任何并发症的中位时间为18个月,大多数有并发症的患者需要手术干预。
鉴于有报告称注射含共聚酰胺真皮填充剂数月至数年后出现严重并发症,且缺乏评估长期安全性的研究,我们的解读是含共聚酰胺真皮填充剂不应再用于隆乳。