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外科医生会成为替罪羊吗?切口疝修补术与腹腔内不可吸收补片植入并发症

Are Surgeons Going to Be Left Holding the Bag? Incisional Hernia Repair and Intra-Peritoneal Non-Absorbable Mesh Implant Complications.

作者信息

Kirkpatrick Andrew W, Coccolini Federico, Tolonen Matti, Minor Samual, Catena Fausto, Celotti Andrea, Gois Emanuel, Perrone Gennaro, Novelli Giuseppe, Garulli Gianluca, Ioannidis Orestis, Sugrue Michael, De Simone Belinda, Tartaglia Dario, Lampella Hanna, Ferreira Fernando, Ansaloni Luca, Parry Neil G, Colak Elif, Podda Mauro, Noceroni Luigi, Vallicelli Carlo, Rezende-Netos Joao, Ball Chad G, McKee Jessica, Moore Ernest E, Mather Jack

机构信息

Regional Trauma Services, Department of Surgery, Critical Care Medicine, University of Calgary, Calgary, AB T2N 2T9, Canada.

TeleMentored Ultrasound Supported Medical Interventions (TMUSMI) Research Group, University of Calgary, Calgary, AB T3H 3W8, Canada.

出版信息

J Clin Med. 2024 Feb 9;13(4):1005. doi: 10.3390/jcm13041005.

Abstract

Ventral incisional hernias are common indications for elective repair and frequently complicated by recurrence. Surgical meshes, which may be synthetic, bio-synthetic, or biological, decrease recurrence and, resultingly, their use has become standard. While most patients are greatly benefited, mesh represents a permanently implanted foreign body. Mesh may be implanted within the intra-peritoneal, preperitoneal, retrorectus, inlay, or onlay anatomic positions. Meshes may be associated with complications that may be early or late and range from minor to severe. Long-term complications with intra-peritoneal synthetic mesh (IPSM) in apposition to the viscera are particularly at risk for adhesions and potential enteric fistula formation. The overall rate of such complications is difficult to appreciate due to poor long-term follow-up data, although it behooves surgeons to understand these risks as they are the ones who implant these devices. All surgeons need to be aware that meshes are commercial devices that are delivered into their operating room without scientific evidence of efficacy or even safety due to the unique regulatory practices that distinguish medical devices from medications. Thus, surgeons must continue to advocate for more stringent oversight and improved scientific evaluation to serve our patients properly and protect the patient-surgeon relationship as the only rationale long-term strategy to avoid ongoing complications.

摘要

腹直肌切口疝是择期修复的常见指征,且常并发复发。手术补片可分为合成补片、生物合成补片或生物补片,能降低复发率,因此其使用已成为标准做法。虽然大多数患者受益匪浅,但补片是一种永久性植入的异物。补片可植入腹膜内、腹膜前、腹直肌后、嵌入或覆盖等解剖位置。补片可能会引发早期或晚期并发症,严重程度不一。与内脏相邻的腹膜内合成补片(IPSM)尤其有发生粘连和潜在肠瘘形成的风险。由于长期随访数据不佳,此类并发症的总体发生率难以确切评估,不过外科医生理应了解这些风险,因为是他们植入这些装置。所有外科医生都应意识到,补片是商业器械,由于医疗器械与药物在监管方面的独特做法,这些器械在进入手术室时并无疗效甚至安全性的科学证据。因此,外科医生必须继续倡导更严格的监管和改进科学评估,以便恰当地为患者服务,并保护医患关系,这是避免持续出现并发症的唯一合理长期策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc6f/10889414/3265c7797724/jcm-13-01005-g001.jpg

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