Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, Texas, USA.
J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):475-82. doi: 10.1016/j.jmig.2011.04.009.
To review reported adverse events associated with suspected nickel hypersensitivity and subsequent clinical outcomes in patients with Essure implants and to evaluate the correlation of nickel allergy-related adverse events with positive results of nickel patch testing.
Case series (Canadian Task Force classification II-3).
Reports of suspected nickel hypersensitivity reported from 2001 through July 21, 2010, were collected from de-identified data obtained from the MAUDE (Manufacturer and User Facility Device Experience) database and reports to the manufacturer directly from treating physicians, and published results for the 650 patients in the Phase II and Pivotal trials. Clinical outcomes and symptom resolution, when available, were obtained from de-identified information provided by the treating physicians to the manufacturer. Patients were not directly contacted for the study, and patient files were not reviewed. Patch testing was performed at the discretion of the treating physicians. Results were reported as positive or negative, without mention of the method or brand of patch testing used.
Even considering the possibility of underreporting by several orders of magnitude, the reported incidence of adverse events suspected to be related to nickel hypersensitivity in patients with Essure micro-inserts is extremely small (0.01%). The incidence of confirmed nickel reactions is even smaller. This very low incidence of clinical reactions is consistent with data from other nickel-containing implantable devices and is reassuring, raising the question of whether nickel reactions are clinically relevant in the use of nitinol-containing micro-inserts for hysteroscopic sterilization.
回顾报道的与疑似镍超敏反应相关的不良事件，以及 Essure 植入物患者的后续临床结局，并评估镍过敏相关不良事件与镍斑贴试验阳性结果的相关性。
病例系列（加拿大任务组分类 II-3）。
从 2001 年至 2010 年 7 月 21 日，从 MAUDE（制造商和用户设施设备经验）数据库中获得的匿名数据以及直接从主治医生处收集到的 Essure 二期和关键试验中 650 名患者的贴斑试验结果中，收集到疑似镍超敏反应的报告。临床结局和症状缓解（如有）从主治医生向制造商提供的匿名信息中获得。未直接联系患者进行研究，也未查阅患者档案。斑贴试验由主治医生自行决定进行。结果报告为阳性或阴性，未提及斑贴试验使用的方法或品牌。
即使考虑到报告的不良事件数量可能低几个数量级，Essure 微植入物患者疑似与镍超敏反应相关的不良事件发生率仍然极低（0.01%）。确诊镍反应的发生率甚至更低。如此低的临床反应发生率与其他含镍植入设备的数据一致，令人放心，这引发了一个问题，即在使用含镍钛诺的微植入物进行宫腔镜绝育时，镍反应是否具有临床相关性。
