Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan.
Facial Plastic Surgery Associates, Houston, Texas.
JAMA Facial Plast Surg. 2018 May 1;20(3):244-248. doi: 10.1001/jamafacial.2017.2242.
Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects.
To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study reviewed complications following facial implants. The procedures reviewed were performed on patients at locations throughout the United States from January 2006 to December 2016. Data collection was completed in March 2017. The Manufacturer and User Facility Device Experience database, which contains medical device reports submitted to the US Food and Drug Administration (FDA), was searched for complications that occurred from January 2006 to December 2016 involving facial implants made by Implantech, MEDPOR, Stryker, KLS Martin, and Synthes. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation.
The complications of facial implants were analyzed in relation to the location of implant and severity of complication. Litigation was analyzed to determine which factors determine outcome.
Thirty-nine instances of adverse events reported to the FDA were identified. Sixteen (41%) involved malar implants, followed by 12 chin implants (31%). The most common complications included infection (18 [46%]), implant migration (9 [23%]), swelling (7 [18%]), and extrusion (4 [10%]). Thirty-two patients (83%) had to have their implants removed. Infection occurred at a mean (SD) of 83.3 (68.8) days following the surgery. One-third of complications involved either migration or extrusion. The mean (range) time to migration or extrusion was 381.1 (10-2400) days. In 12 malpractice cases identified in publicly available court proceedings, alleged inadequate informed consent and requiring additional surgical intervention (ie, removal) were the most commonly cited factors.
Infection and implant migration or extrusion are the most common complications of facial implants. Most of these complications necessitate removal. These considerations need to be discussed with patients preoperatively as part of the informed consent process, as allegedly inadequate informed consent was cited in a significant proportion of resultant litigation, and there were overlapping considerations among adverse events reported to the FDA and factors brought up in relevant litigation. Cases resolved with settlements and jury-awarded damages encompassed considerable award totals.
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面部植入物是提供即时和持久体积增强的重要策略，可解决衰老和创伤后缺陷。
通过检查涵盖不良事件和促进相关诉讼的考虑因素的国家资源，更好地了解面部植入物的风险。
设计、设置和参与者：一项回顾性研究分析了面部植入物后的并发症。回顾的手术是在美国各地的地点对 2006 年 1 月至 2016 年 12 月期间的患者进行的。数据收集于 2017 年 3 月完成。制造商和用户设施设备体验数据库（包含向美国食品和药物管理局（FDA）提交的医疗器械报告），用于搜索 2006 年 1 月至 2016 年 12 月期间涉及由 Implantech、MEDPOR、Stryker、KLS Martin 和 Synthes 制造的面部植入物的并发症。此外，还搜索了 Thomson Reuters Westlaw 法律数据库以查找相关诉讼。
分析了面部植入物的并发症与植入物位置和并发症严重程度的关系。分析了诉讼，以确定哪些因素决定结果。
在 FDA 报告的 39 例不良事件中，有 16 例（41%）涉及颧骨植入物，其次是 12 例颏部植入物（31%）。最常见的并发症包括感染（18 例[46%]）、植入物移位（9 例[23%]）、肿胀（7 例[18%]）和挤出（4 例[10%]）。32 名患者（83%）不得不取出植入物。感染发生在手术后的平均（标准差）83.3（68.8）天。三分之一的并发症涉及迁移或挤出。迁移或挤出的平均（范围）时间为 381.1（10-2400）天。在公开法庭程序中确定的 12 起医疗事故案件中，据称缺乏充分的知情同意和需要额外的手术干预（即取出）是最常被引用的因素。
感染和植入物移位或挤出是面部植入物最常见的并发症。大多数这些并发症都需要切除。这些考虑因素需要在术前与患者讨论，作为知情同意过程的一部分，因为据称在很大一部分由此产生的诉讼中缺乏充分的知情同意，并且在向 FDA 报告的不良事件和相关诉讼中提到的因素之间存在重叠。以和解和陪审团判给赔偿金解决的案件涵盖了相当大的赔偿金总额。
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