Aesthet Surg J. 2018 May 15;38(6):623-626. doi: 10.1093/asj/sjy044.
In the fourth quarter of 2017, the US FDA reviewed and approved a request by one of the breast implant manufacturers for a change in the Directions for Use (DFU) that removed warnings regarding the use of Betadine (povidone-iodine [PI] 10% solution, 1% available iodine [Purdue Frederick Company, Stamford, CT], also available in generic formulations [Aplicare, Inc., Meriden, CT]). Previously, in 2000, there were concerns by the FDA that PI would degrade the silicone elastomer shell. This change in the DFU represents an important advance that will benefit patients through the permitted use of PI to reduce the risk of bacterial contamination of implant surfaces. What was formerly an off-label practice can be openly practiced by plastic surgeons as an anti-infective and biofilm-mitigation strategy. PI has an ideal spectrum effect for gram-positive and gram-negative organisms. Gram-positive organisms have been linked to capsular contracture and gram-negative Ralstonia picketti to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). R picketti is resistant to aminoglycoside antibiotics, but it is susceptible to at least a 50% solution of PI. We believe that the strategy of antisepsis and biofilm mitigation is an integral part of a contemporary approach for breast augmentation. This is beneficial regarding reduction of the risk of surgical infection, capsular contracture, and BIA-ALCL. Outcome data so far indicate that antibiotics/anti-infectives seem to reduce the incidence of these adverse events that lead to reoperation and increased costs. It behooves plastic surgeons to take all actionable steps that enhance the quality of breast implant outcomes and reduce the rate of reoperation.
2017 年第四季度，美国食品药品监督管理局审查并批准了一家乳房植入物制造商的请求，修改了使用说明（DFU），删除了关于使用聚维酮碘（Povidone-iodine [PI] 10%溶液，1%有效碘[Purdue Frederick Company，Stamford，CT]，也有通用制剂[Aplicare，Inc.，Meriden，CT]）的警告。此前，在 2000 年，FDA 担心 PI 会降解硅酮弹性体外壳。DFU 的这一变化代表了一个重要的进展，将通过允许使用 PI 来降低植入物表面细菌污染的风险，使患者受益。以前是一种未经批准的做法，现在可以由整形外科医生公开作为一种抗感染和生物膜缓解策略。PI 对革兰氏阳性和革兰氏阴性菌具有理想的广谱作用。革兰氏阳性菌与包膜挛缩有关，革兰氏阴性菌罗尔斯顿氏菌与乳房植入物相关间变性大细胞淋巴瘤（BIA-ALCL）有关。R picketti 对氨基糖苷类抗生素有耐药性，但至少对 50%的 PI 溶液敏感。我们认为，消毒和生物膜缓解策略是乳房隆乳当代方法的一个组成部分。这对于降低手术感染、包膜挛缩和 BIA-ALCL 的风险是有益的。到目前为止的结果数据表明，抗生素/抗感染药物似乎可以降低导致再次手术和增加成本的这些不良事件的发生率。整形外科医生应该采取所有可行的措施，提高乳房植入物的质量并降低再次手术的比率。
