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确认在 Essure 植入物取出患者的输卵管或子宫角中存在锡颗粒:18 例相同病理过程的研究。

Confirmation of the systematic presence of tin particles in fallopian tubes or uterine horns of Essure implant explanted patients: A study of 18 cases with the same pathological process.

机构信息

Minapath Developpement, Insavalor CS : 52132, 69603, Villeurbanne, France.

IRCELYON UMR 5256, CNRS, Université Claude Bernard Lyon 1, 69626, Villeurbanne, France.

出版信息

J Trace Elem Med Biol. 2022 Jan;69:126891. doi: 10.1016/j.jtemb.2021.126891. Epub 2021 Nov 2.

Abstract

OBJECTIVE

To examine associations between local and systemic symptoms and the wear of the tin weld of Essure implants.

DESIGN

study of a series of cases.

SETTINGS

Two French hospitals.

PARTICIPANTS

Eighteen patients explanted by hysterectomy and salpingectomy for removal of their Essure implants between September 2019 and July 2020, have had a common anatomopathological process.

MAIN OUTCOME MEASURES

anatomopathological examination by optical microscopy and mineralogical analysis of the fallopian tube or uterine horn with scanning electron microscopy coupled with energy dispersive X-ray (SEM-EDX). Evaluation of local and systemic symptoms with a questionnaire. Examination of blood metal assays (nickel, chromium, and tin).

RESULTS

anatomopathological examination highlights foreign body granulomas, fibrosis, adenomyosis, nonspecific inflammation, cysts and myomas in the Fallopian tubes, uterine horns, or both and mentions the presence of foreign bodies in seven cases. SEM-EDX analyses showed, systematically, the presence of tin particles integrated in the wall near the weld, generally in clusters, and with a size ranging from about one micron to several dozen microns. The questionnaire shows that the most frequent local symptoms were pelvic pain, urinary disorders, bleeding, and pains during intercourse. The most common systemic symptoms were: asthenia, visual disturbances, amnesia, giddiness, dorsal pains, headaches, and joint pains. The majority of local and systemic symptoms decreased after explantation, but sometimes incompletely. Before explantation, high levels of nickel, tin and chromium were observed in 11/17, 1/7 and 2/17 patients. After explantation, tin levels were high in 3/11 patients.

CONCLUSIONS

our new anatomopathological process systematically demonstrates the presence of tin particles in tissue near the weld. These particles could be responsible for granulomatous inflammations as well as local symptoms. Many of the systemic symptoms are consistent with chronic organotin poisoning but further studies are needed to find out whether tin from the solder can be converted to organotin in the patients' bodies.

摘要

目的

研究局部和全身症状与 Essure 植入物锡焊缝磨损之间的关系。

设计

病例系列研究。

地点

法国两家医院。

参与者

18 名患者因子宫切除术和输卵管切除术而被植入物取出,他们的 Essure 植入物于 2019 年 9 月至 2020 年 7 月之间被取出,具有共同的解剖病理学过程。

主要观察指标

光学显微镜下的解剖病理学检查和扫描电子显微镜结合能谱分析(SEM-EDX)对输卵管或子宫角的矿物分析。使用问卷评估局部和全身症状。检查血液金属含量(镍、铬和锡)。

结果

解剖病理学检查突出显示了异物肉芽肿、纤维化、腺肌病、非特异性炎症、囊肿和肌瘤在输卵管、子宫角或两者中,并且在七种情况下提到了异物的存在。SEM-EDX 分析系统地显示,锡颗粒普遍存在于焊缝附近的壁内,通常呈簇状,大小从几微米到几十微米不等。问卷显示,最常见的局部症状是盆腔疼痛、排尿障碍、出血和性交疼痛。最常见的全身症状是:乏力、视力障碍、健忘、头晕、背痛、头痛和关节疼痛。大多数局部和全身症状在取出后减少,但有时并不完全。在取出前,17 例中有 11 例、7 例中有 1 例和 17 例中有 2 例观察到镍、锡和铬的高水平。取出后,11 例中有 3 例锡水平升高。

结论

我们的新解剖病理学过程系统地证明了焊缝附近组织中存在锡颗粒。这些颗粒可能导致肉芽肿性炎症以及局部症状。许多全身症状与慢性有机锡中毒一致,但需要进一步研究以确定患者体内的焊料中的锡是否可以转化为有机锡。

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