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羧甲基纤维素水凝胶填充乳房植入物——一种理想的替代品?关于该装置五年使用经验的报告。

Carboxy-methyl-cellulose hydrogel-filled breast implants - an ideal alternative? A report of five years' experience with this device.

作者信息

Brunner Christina A, Gröner Reinhard W

机构信息

Clinic for Plastic and Aesthetic Surgery, Neuer Wall, Germany.

出版信息

Can J Plast Surg. 2006 Fall;14(3):151-4. doi: 10.1177/229255030601400302.

Abstract

The controversy over the potential health risks from exposure to silicone gel from breast implants has led to extensive research to improve the safety of silicone gel-filled implants. In addition, there has been simultaneous research directed toward the development of alternative filling materials, with the goal of a breast implant that would minimize health risks and maximize cosmetic attributes. In the present study, experience with a filler material that has textural characteristics similar to that of silicone gel, but which is biodegradable and can therefore be eliminated by the body in case of implant failure, is reported.Since February 2000, the authors have been monitoring carboxy-methyl-cellulose (CMC) hydrogel breast implants as participants in a prospective clinical trial. CMC hydrogel is a biodegradable, nontoxic, nonmutagenic and viscoelastic gel, which has been in clinical use since 1984 and has been available as the Monobloc breast implant since 1994. For the present study, 122 patients who underwent surgery between February 2000 and February 2005 were evaluated. It was determined that CMC hydrogel implants have a higher radiotranslucency than silicone gel, and the integrity of this device was easy to prove by clinical examination. In case of rupture, the implant can be replaced immediately; it is easily inserted and can be placed through a small incision because of its highly elastic shell. The complication rate was very low, and the patients were highly satisfied. In terms of safety, the implant is comparable with saline, and its consistency is comparable with that of silicone gel.

摘要

乳房植入物中硅胶凝胶可能带来的健康风险引发了诸多争议,这促使人们进行广泛研究以提高填充硅胶凝胶的植入物的安全性。此外,同时也有针对开发替代填充材料的研究,目标是研发出一种能将健康风险降至最低且能最大化美容效果的乳房植入物。在本研究中,报告了一种填充材料的使用经验,该材料具有与硅胶凝胶相似的质地特性,但可生物降解,因此在植入物出现故障时可被身体清除。自2000年2月以来,作者作为一项前瞻性临床试验的参与者,一直在监测羧甲基纤维素(CMC)水凝胶乳房植入物。CMC水凝胶是一种可生物降解、无毒、无致突变性且具有粘弹性的凝胶,自1984年起已用于临床,自1994年起作为Monobloc乳房植入物上市。在本研究中,对2000年2月至2005年2月期间接受手术的122名患者进行了评估。结果确定,CMC水凝胶植入物的射线透过性高于硅胶凝胶,并且通过临床检查很容易证明该装置的完整性。在破裂的情况下,植入物可立即更换;由于其外壳具有高弹性,它易于插入且可通过小切口放置。并发症发生率非常低,患者满意度很高。在安全性方面,该植入物与生理盐水相当,其稠度与硅胶凝胶相当。

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