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乳房植入物评估服务临床结果的前瞻性研究

Prospective Study of Clinical Outcomes From a Breast Implant Assessment Service.

作者信息

Masoumi Elnaz, Seow Christina, Deva Anika Preeti, Cuss Amanda, Chow Oliver, Davies Matthew, Lajevardi Sepehr, Connell Tony, Magnusson Mark, Beath Kenneth, Isacson Daniel, Deva Anand K

机构信息

Department of Plastic & Reconstructive Surgery, Macquarie University, Sydney, Australia.

Integrated Specialist Healthcare Education and Research Foundation, Miranda, Australia.

出版信息

Aesthet Surg J. 2023 Feb 21;43(3):308-314. doi: 10.1093/asj/sjac266.

DOI:10.1093/asj/sjac266
PMID:36242549
Abstract

BACKGROUND

Breast augmentation remains the commonest cosmetic surgical procedure worldwide, in spite of recent regulatory action.

OBJECTIVES

The aim of this study was to evaluate women with breast implants attending a breast implant assessment clinic and to capture clinical and implant data in women presenting to the service.

METHODS

Patients were enrolled prospectively between January 2018 and December 2021. Clinical, implant, and practitioner data were recorded. Patients reported satisfaction on size, shape, and overall outcome as well as the presence or pain. Radiological evaluation, where indicated, was performed and data were included on these findings.

RESULTS

A total of 603 patients were assessed. Their mean age was 42.7 years and mean age at implantation was 29.1 years. The most common complications were capsular contracture followed by pain, waterfall deformity, and double bubble, with rupture/contracture rates increasing after the 10-year mark. The risk of double bubble was significantly lower if patients were operated on by certified practitioners (odds ratio = 0.49, P = 0.011). There was almost universally poor awareness of the risks of breast implants in patients presenting for evaluation.

CONCLUSIONS

This study has shown benefit in a breast implant assessment clinic to gather information on adverse events and patient-reported outcomes following breast implant surgery. Having appropriately trained and certified practitioners perform cosmetic augmentation significantly lowers the risk of implant malposition and deformity. Any adverse event occurring within 5 years of initial surgery should be flagged as a mandatory reportable clinical indicator and trigger further investigation.

摘要

背景

尽管最近有监管行动,但隆胸手术仍是全球最常见的整形手术。

目的

本研究旨在评估前往隆胸植入物评估诊所的隆胸女性,并收集前来该服务机构就诊女性的临床和植入物数据。

方法

前瞻性纳入2018年1月至2021年12月期间的患者。记录临床、植入物和从业者数据。患者报告对大小、形状和总体结果的满意度以及是否存在疼痛。在需要时进行放射学评估,并纳入这些检查结果的数据。

结果

共评估了603例患者。她们的平均年龄为42.7岁,植入时的平均年龄为29.1岁。最常见的并发症是包膜挛缩,其次是疼痛、瀑布状畸形和双泡畸形,10年后破裂/挛缩率增加。如果由认证从业者进行手术,双泡畸形的风险显著降低(优势比=0.49,P=0.011)。前来评估的患者对隆胸植入物风险的认知普遍较差。

结论

本研究表明,隆胸植入物评估诊所在收集隆胸手术后不良事件和患者报告结局信息方面具有益处。让经过适当培训和认证的从业者进行美容隆胸可显著降低植入物位置不当和畸形的风险。初次手术后5年内发生的任何不良事件都应标记为强制报告的临床指标,并引发进一步调查。

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