Jin Rui, Luo Xusong, Wang Xiaoke, Ma Jie, Liu Fei, Yang Qun, Yang Jun, Wang Xi
Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, 639 Zhizaoju Road, Shanghai, 200011, People's Republic of China.
Department of Medical Aesthetic Surgery, Weihai Central Hospital, Weihai, People's Republic of China.
Aesthetic Plast Surg. 2018 Apr;42(2):402-409. doi: 10.1007/s00266-017-1006-9. Epub 2017 Nov 9.
From 1997 to 2006, polyacrylamide hydrogel (PAAG) was approved for use in China as a permanent filler for breast augmentation, and it is estimated that 200,000 women have undergone PAAG injection since then. After injection, complications such as pain, mass, hematoma, asymmetry, migration, infection, and even cancer continue to emerge. Because of the potential toxicity and unstable nature of the material and the nonstandardized injection layers, complications after PAAG injection breast augmentation are often complex and difficult to treat. The only treatment for these complications is debridement surgery, which includes PAAG evacuation, capsule remove, lesion excision, and mastectomy. Currently, although there are a variety of surgical methods for complications after PAAG injection, there is a lack of consensus regarding the diagnosis and treatment. We systematically review the literature and summarize our experience of diagnosis and treatment of complications after PAAG injection in our hospital over the past 10 years. To date, this is the first attempt to propose a diagnostic classification for PAAG injection breast augmentation and to set out a treatment strategy based on this classification. Although the China Food and Drug Administration withdrew its approval in 2006, PAAG is still being used illegally in some areas, and the patient population is widespread. This study aims to provide a more comprehensive understanding of PAAG complications to drive the standard diagnosis and treatment based on clinical classification, and to provide references for the future development of safer injectable products. Level of Evidence IV This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
1997年至2006年期间,聚丙烯酰胺水凝胶(PAAG)在中国被批准用作隆乳的永久性填充材料,据估计自那时起已有20万名女性接受了PAAG注射。注射后,疼痛、肿块、血肿、不对称、移位、感染甚至癌症等并发症不断出现。由于该材料具有潜在毒性且性质不稳定,以及注射层次不规范,PAAG注射隆乳后的并发症往往复杂且难以治疗。这些并发症的唯一治疗方法是清创手术,包括PAAG清除、包膜切除、病灶切除和乳房切除术。目前,尽管针对PAAG注射后的并发症有多种手术方法,但在诊断和治疗方面缺乏共识。我们系统回顾了文献,并总结了我院过去10年中对PAAG注射后并发症的诊断和治疗经验。迄今为止,这是首次尝试对PAAG注射隆乳提出诊断分类,并基于该分类制定治疗策略。尽管中国食品药品监督管理总局于2006年撤销了其批准,但PAAG在一些地区仍被非法使用,且患者群体广泛。本研究旨在更全面地了解PAAG并发症,以推动基于临床分类的规范诊断和治疗,并为更安全的注射产品的未来发展提供参考。证据级别IV 本刊要求作者为每篇文章指定证据级别。有关这些循证医学评级的完整描述,请参阅目录或作者在线指南www.springer.com/00266 。