The Southeast Permanent Medical Group, Atlanta, GA, USA.
Aesthet Surg J. 2021 Aug 13;41(9):1029-1037. doi: 10.1093/asj/sjab198.
Protective funnel devices are commonly used to deliver implants in primary breast augmentation (BA) yet there is a paucity of evidence-based data describing their safety in the literature.
The purpose of this study was to assess the safety of protective funnels in primary BA within the first 30 days postoperatively.
This multicenter, Level 3 study retrospectively reviewed the surgical records of 380 consecutive patients (760 breasts) who underwent primary BA by 9 board-certified plastic surgeons using the iNPLANT Funnel (Proximate Concepts LLC, Allendale, NJ) for implant delivery between November 2019 and December 2020. Data were collected pertaining to demographics, implant information, surgery details, and postoperative complications.
The mean patient age was 33 years and 76% of patients had a BMI <25 kg/m2. Of this cohort, 11.4% were smokers, 0.8% had diabetes, and 83% were ASA Class 1. All patients received smooth implants with a median volume of 375 cc. A total of 8 (2.1%) complications were reported, including 3 hematomas (0.79%), 1 seroma (0.26%), and 1 superficial infection (0.26%). No patient required explantation. We identified ASA class, BMI, surgery duration, and implant size as potential risk factors.
The data suggest that the use of protective funnels, such as the iNPLANT Funnel, in primary BA is a safe option when these are utilized according to the manufacturer's Instructions for Use. The use of this device led to a low infection rate (0.26%) and a complication rate of (2.1%) consistent with the average reported in the literature (2%-2.5%).1 Implications for clinical practice are encouraging and future research will include a prospective analysis with a larger case series and potentially a control group.
在原发性乳房增大（BA）中，通常使用保护漏斗装置来输送植入物，但文献中缺乏描述其安全性的循证数据。
本研究的目的是评估在原发性 BA 术后 30 天内使用保护漏斗的安全性。
这项多中心、3 级研究回顾性分析了 2019 年 11 月至 2020 年 12 月期间，9 位经过董事会认证的整形外科医生使用 iNPLANT 漏斗（Proximate Concepts LLC，Allendale，NJ）为 380 例连续患者（760 只乳房）进行原发性 BA 手术的手术记录。收集了人口统计学、植入物信息、手术细节和术后并发症等数据。
患者的平均年龄为 33 岁，76%的患者 BMI<25kg/m2。该队列中，11.4%的患者吸烟，0.8%的患者患有糖尿病，83%的患者 ASA 分级为 1 级。所有患者均接受了光滑植入物，中位数体积为 375cc。共报告了 8 例（2.1%）并发症，包括 3 例血肿（0.79%）、1 例血清肿（0.26%）和 1 例浅表感染（0.26%）。没有患者需要取出植入物。我们确定了 ASA 分级、BMI、手术时间和植入物大小是潜在的危险因素。
数据表明，当按照制造商的使用说明使用保护漏斗（如 iNPLANT 漏斗）进行原发性 BA 时，这是一种安全的选择。该装置的使用导致感染率（0.26%）和并发症率（2.1%）与文献中报告的平均水平（2%-2.5%）一致。1 对临床实践的影响是令人鼓舞的，未来的研究将包括更大的病例系列和潜在的对照组的前瞻性分析。
