Laboratory of Human Physiology, Phystech BioMed School, Faculty of Biological & Medical Physics, Moscow Institute of Physics and Technology (State University), Dolgoprudny, Moscow Region, Russian Federation.
New European Surgical Academy (NESA), Berlin, Germany.
Curr Pharm Des. 2020;26(3):318-325. doi: 10.2174/1381612826666200204093737.
Following the FDA safety communication of 2014 increasing attention has been to the treatment of uterine fibroids, due to the suspicion of a potential leiomyosarcoma (ULM). FDA banned the use of power morcellation in the US, since this technique is likely to spread malignant cells from an unsuspected ULM. We criticized the medical legal consequences of this banning among gynecologists and patients, focusing on the drawbacks of biology and surgery. The authors analyzed literature data on one side, on the incidence, diagnosis and treatment of leiomyoma and ULM, and the other side, on the power morcellations and related critical issues, trying to highlight their main controversial aspects and to outline the possible impact on patients and on medical responsibility. The alternative methods to power morcellation are more invasive surgical solutions (as mini laparotomy or culdotomy), which inevitably involve associated risks with the surgical procedure as such and always request the containing bags. Although the in-bag morcellation is a promising technique, currently the used devices are largely off-label. This highlights the surgical risk, in case of complications, of suffering for malpractice claims both for not having used a containment system, favoring the spread of the neoplasm, and for its off-label use. Since the diagnosis of ULM is by histology after surgery, the fear of legal consequences or medical malpractice for unknown ULM power morcellation, should be targeted to analyze, in terms of cost/benefit ratio, the surgical priority. It should focus on the prevention of the risk of having a rare and statistically limited ULM or on the surgical-related complications, often linked to a slowdown minimally invasive surgery, or on the use of the authorized in-bag morcellations.
自 2014 年美国食品药品监督管理局（FDA）发布安全通讯以来，人们越来越关注子宫肌瘤的治疗，因为怀疑存在潜在的平滑肌肉瘤（ULM）。由于这种技术可能会使未被怀疑的 ULM 中的恶性细胞扩散，因此 FDA 禁止在美国使用电动组织粉碎术。我们批评了这种禁令对妇科医生和患者产生的医疗法律后果，重点关注生物学和手术方面的缺点。作者分析了文献数据，一方面是关于平滑肌瘤和 ULM 的发病率、诊断和治疗，另一方面是关于电动组织粉碎术和相关关键问题，试图突出其主要争议方面，并概述对患者和医疗责任的可能影响。除了电动组织粉碎术，还有更具侵入性的手术解决方案（如小剖腹术或经阴道子宫切除术），但这不可避免地会涉及与手术本身相关的风险，而且总是需要使用包含袋。尽管在袋内粉碎术是一种有前途的技术，但目前使用的设备大多是超适应证的。这突出了手术风险，如果发生并发症，无论是因为没有使用包含系统而导致肿瘤扩散，还是因为超适应证使用而遭受医疗事故索赔的风险都会增加。由于 ULM 的诊断是在手术后进行组织学检查，因此应该针对因未知 ULM 电动组织粉碎术而产生的法律后果或医疗事故的恐惧进行分析，根据成本/效益比，确定手术的优先级。这应该侧重于预防罕见且统计学上有限的 ULM 的风险，或者侧重于与手术相关的并发症，这些并发症通常与微创手术的减缓有关，或者与授权的在袋内粉碎术的使用有关。
