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一种抗纤维化乳房植入物表面涂层可显著减少假体周围包膜形成。

An Antifibrotic Breast Implant Surface Coating Significantly Reduces Periprosthetic Capsule Formation.

作者信息

Karinja Sarah J, Bernstein Jaime L, Mukherjee Sudip, Jin Julia, Lin Alexandra, Abadeer Andrew, Kaymakcalan Omer, Veiseh Omid, Spector Jason A

机构信息

From the Laboratory of Bioregenerative Medicine & Surgery, Weill Cornell Medical College.

Department of Surgery, Division of Plastic Surgery.

出版信息

Plast Reconstr Surg. 2023 Oct 1;152(4):775-785. doi: 10.1097/PRS.0000000000010323. Epub 2023 Feb 28.

DOI:10.1097/PRS.0000000000010323
PMID:36847657
Abstract

BACKGROUND

The body responds to prosthetic materials with an inflammatory foreign body response and deposition of a fibrous capsule, which may be deleterious to the function of the device and cause significant discomfort for the patient. Capsular contracture (CC) is the most common complication of aesthetic and reconstructive breast surgery. The source of significant patient morbidity, it can result in pain, suboptimal aesthetic outcomes, implant failure, and increased costs. The underlying mechanism remains unknown. Treatment is limited to reoperation and capsule excision, but recurrence rates remain high. In this study, the authors altered the surface chemistry of silicone implants with a proprietary anti-inflammatory coating to reduce capsule formation.

METHODS

Silicone implants were coated with Met-Z2-Y12, a biocompatible, anti-inflammatory surface modification. Uncoated and Met-Z2-Y12-coated implants were implanted in C57BL/6 mice. After 21, 90, or 180 days, periprosthetic tissue was removed for histologic analysis.

RESULTS

The authors compared mean capsule thickness at three time points. At 21, 90, and 180 days, there was a statistically significant reduction in capsule thickness of Met-Z2-Y12-coated implants compared with uncoated implants ( P < 0.05).

CONCLUSIONS

Coating the surface of silicone implants with Met-Z2-Y12 significantly reduced acute and chronic capsule formation in a mouse model for implant-based breast augmentation and reconstruction. As capsule formation obligatorily precedes CC, these results suggest contracture itself may be significantly attenuated. Furthermore, as periprosthetic capsule formation is a complication without anatomical boundaries, this chemistry may have additional applications beyond breast implants, to a myriad of other implantable medical devices.

CLINICAL RELEVANCE STATEMENT

Coating of the silicone implant surface with Met-Z2-Y12 alters the periprosthetic capsule architecture and significantly reduces capsule thickness for at least 6 months postoperatively in a murine model. This is a promising step forward in the development of a therapy to prevent capsular contracture.

摘要

背景

机体对假体材料会产生炎症性异物反应并形成纤维包膜,这可能对假体功能有害,并给患者带来极大不适。包膜挛缩(CC)是美容和重建性乳房手术最常见的并发症。它是导致患者出现严重发病情况的根源,可引起疼痛、美学效果欠佳、植入物失效以及成本增加。其潜在机制尚不清楚。治疗方法仅限于再次手术和包膜切除,但复发率仍然很高。在本研究中,作者使用一种专利抗炎涂层改变了硅胶植入物的表面化学性质,以减少包膜形成。

方法

硅胶植入物用Met-Z2-Y12进行涂层处理,这是一种生物相容性抗炎表面改性处理。将未涂层和Met-Z2-Y12涂层的植入物植入C57BL/6小鼠体内。在21天、90天或180天后,取出假体周围组织进行组织学分析。

结果

作者比较了三个时间点的平均包膜厚度。在21天、90天和180天时,与未涂层植入物相比,Met-Z2-Y12涂层植入物的包膜厚度有统计学意义的显著降低(P < 0.05)。

结论

在基于植入物的隆乳和乳房重建小鼠模型中,用Met-Z2-Y12涂覆硅胶植入物表面可显著减少急性和慢性包膜形成。由于包膜形成必然先于CC,这些结果表明挛缩本身可能会显著减轻。此外,由于假体周围包膜形成是一种无解剖边界的并发症,这种化学性质可能在乳房植入物之外还有其他应用,可应用于无数其他可植入医疗设备。

临床相关性声明

在小鼠模型中,用Met-Z2-Y12涂覆硅胶植入物表面可改变假体周围包膜结构,并在术后至少6个月显著降低包膜厚度。这是在开发预防包膜挛缩疗法方面向前迈出的有希望的一步。

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