Zou Chenyu, Davis Brandy, Wigle Patricia R, Hincapie Ana L, Guo Jeff Jianfei
Department of Health Outcomes Research and Policy, Harrison College of Pharmacy, Auburn University, Auburn, AL, United States.
Division of Pharmacy Practice & Administrative Sciences, The James L. Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, United States.
Front Reprod Health. 2023 Jul 13;5:1172927. doi: 10.3389/frph.2023.1172927. eCollection 2023.
There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE).
A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases.
A total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals' deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer.
These findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions.
自2002年引入用于绝育的Essure医疗器械以来，已出现大量不良事件案例。本研究分析了制造商和用户设施设备经验数据库（MAUDE）中报告的Essure安全事件报告。
一项回顾性分析研究了2018年1月1日至2018年10月31日期间的MAUDE报告，并重点关注与Essure设备相关的安全报告。安全报告按事件类型、设备问题、患者症状和伤害程度进行分类和分析。在本研究队列中，随机抽取10%的样本进行定量分析。对包括死亡病例在内的报告进行了主题分析。
共分析了4994份符合条件的报告。有10份报告与个人死亡有关，定性分析得出的安全报告主要主题为疼痛、出血、手术、偏头痛和感染。对随机抽取的500个样本进行的定量分析表明，98%的不良事件报告与手术、疼痛、出血、子宫切除和月经过多等不同伤害有关。此外，超过90%的报告由制造商提交。
这些发现表明Essure存在若干安全问题。医疗器械市场需要更有意义的上市前和上市后监测及监管，以确保安全性和有效性，包括调查投诉、及时与监管机构和用户分享相关信息以及采取纠正措施。
