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与可生物吸收鼻植入物相关的不良事件:MAUDE数据库分析

Adverse Events Associated With Bioabsorbable Nasal Implants: A MAUDE Database Analysis.

作者信息

Wilkins Sarah G, Sheth Amar H, Kayastha Darpan, Abdou Hisham, Salehi Parsa P, Citardi Martin J, Peter Manes R

机构信息

Division of Otolaryngology, Department of Surgery, Yale School of Medicine, New Haven, Connecticut, USA.

Nassif MD Plastic Surgery, Beverly Hills, California, USA.

出版信息

Otolaryngol Head Neck Surg. 2023 May;168(5):1253-1257. doi: 10.1002/ohn.227. Epub 2023 Jan 27.

Abstract

Bioabsorbable implants (eg, Latera) have recently been approved for addressing nasal valve collapse. The purpose of this study is to summarize adverse events and treatment sequelae associated with bioabsorbable nasal implants queried in the Manufacturer and User Facility Device Experience (MAUDE) database. Of the 26 device reports entered between March 2017 and April 2022, the most frequently reported complications included abscess (n = 13) and implant protrusion (n = 5). Other common symptoms reported greater than 1-year postimplantation included facial pain/discomfort (n = 3) and failure to absorb (n = 3). Management of adverse events included treatment with antibiotics (n = 9), steroid injections (n = 4), and explantation (n = 20). In 3 reports, adverse reactions required a biopsy of adjacent tissue for pathologic analysis. These findings suggest that further research is required to assess the potential long-term complications and optimize the management of bioabsorbable nasal implants. Furthermore, standardized reporting templates may improve the utility of the MAUDE database.

摘要

可生物吸收植入物(如Latera)最近已被批准用于治疗鼻瓣膜塌陷。本研究的目的是总结制造商和用户设施设备经验(MAUDE)数据库中查询到的与可生物吸收鼻植入物相关的不良事件和治疗后遗症。在2017年3月至2022年4月期间输入的26份设备报告中,最常报告的并发症包括脓肿(n = 13)和植入物突出(n = 5)。植入后1年以上报告的其他常见症状包括面部疼痛/不适(n = 3)和未吸收(n = 3)。不良事件的处理包括使用抗生素治疗(n = 9)、类固醇注射(n = 4)和取出植入物(n = 20)。在3份报告中,不良反应需要对相邻组织进行活检以进行病理分析。这些发现表明,需要进一步研究以评估潜在的长期并发症并优化可生物吸收鼻植入物的管理。此外,标准化报告模板可能会提高MAUDE数据库的实用性。

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