Adams William P, Culbertson Eric J, Deva Anand K, R Magnusson Mark, Layt Craig, Jewell Mark L, Mallucci Patrick, Hedén Per
Dallas, Texas; Sydney, Toowoomba, and Gold Coast, Australia; Portland, Ore.; London, United Kingdom; and Stockholm, Sweden.
From the Department of Plastic Surgery, University of Texas Southwestern Medical Center; Macquarie University and Integrated Specialist Healthcare; private practice; Oregon Health Science University; and Royal Free Hospital.
Plast Reconstr Surg. 2017 Sep;140(3):427-431. doi: 10.1097/PRS.0000000000003575.
Bacteria/biofilm on breast implant surfaces has been implicated in capsular contracture and breast implant-associated anaplastic large-cell lymphoma (ALCL). Macrotextured breast implants have been shown to harbor more bacteria than smooth or microtextured implants. Recent reports also suggest that macrotextured implants are associated with a significantly higher incidence of breast implant-associated ALCL. Using techniques to reduce the number of bacteria around implants, specifically, the 14-point plan, has successfully minimized the occurrence of capsular contracture. The authors hypothesize that a similar effect may be seen in reducing the risk of breast implant-associated ALCL.
Pooled data from eight plastic surgeons assessed the use of macrotextured breast implants (Biocell and polyurethane) and known cases of breast implant-associated ALCL. Surgeon adherence to the 14-point plan was also analyzed.
A total of 42,035 Biocell implants were placed in 21,650 patients; mean follow-up was 11.7 years (range, 1 to 14 years). A total of 704 polyurethane implants were used, with a mean follow-up of 8.0 years (range, 1 to 20 years). The overall capsular contracture rate was 2.2 percent. There were no cases of implant-associated ALCL. All surgeons routinely performed all 13 perioperative components of the 14-point plan; two surgeons do not routinely prescribe prophylaxis for subsequent unrelated procedures.
Mounting evidence implicates the role of a sustained T-cell response to implant bacteria/biofilm in the development of breast implant-associated ALCL. Using the principles of the 14-point plan to minimize bacterial load at the time of surgery, the development and subsequent sequelae of capsular contracture and breast implant-associated ALCL may be reduced, especially with higher-risk macrotextured implants.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
乳房植入物表面的细菌/生物膜与包膜挛缩及乳房植入物相关间变性大细胞淋巴瘤（ALCL）有关。已表明，大纹理乳房植入物比光滑或微纹理植入物含有更多细菌。近期报告还表明，大纹理植入物与乳房植入物相关ALCL的发病率显著更高有关。采用减少植入物周围细菌数量的技术，特别是“14点计划”，已成功将包膜挛缩的发生率降至最低。作者推测，在降低乳房植入物相关ALCL风险方面可能会看到类似效果。
汇总来自八位整形外科医生的数据，评估大纹理乳房植入物（Biocell和聚氨酯）的使用情况以及已知的乳房植入物相关ALCL病例。还分析了外科医生对“14点计划”的遵守情况。
共为21650例患者植入了42035个Biocell植入物；平均随访时间为11.7年（范围1至14年）。共使用了704个聚氨酯植入物，平均随访时间为8.0年（范围1至20年）。总体包膜挛缩率为2.2%。没有植入物相关ALCL的病例。所有外科医生都常规执行了“14点计划”的所有13个围手术期组成部分；两位外科医生没有常规为后续无关手术开预防性药物。
越来越多的证据表明，对植入物细菌/生物膜的持续T细胞反应在乳房植入物相关ALCL的发生中起作用。采用“14点计划”的原则在手术时尽量减少细菌负荷，可能会降低包膜挛缩和乳房植入物相关ALCL的发生及后续后遗症，特别是对于风险较高的大纹理植入物。
临床问题/证据水平：治疗性，IV级。
