Clinical and histopathological correlations in symptomatic patients with salpingectomy for Essure^® implant removal: a cross-sectional study

Abstract

Purpose

Many concerns have been raised about adverse effects related to Essure^® device. Several pathophysiological hypotheses have been proposed including allergic reactions, Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants, galvanic corrosion with release of heavy metals and inflammation. In the present study, we aimed to focus on inflammation process by performing a histopathological evaluation of Fallopian tubes in symptomatic patients with Essure^® removal.

Materials and methods

A cross-sectional study with identification of the type of inflammatory response and characterisation of inflammatory cells in the surrounding tubal tissue around the Essure^® (STTE) and at distance from the implant. Histopathological and clinical correlations were also investigated.

Results

In the STTE from 47 cases, acute inflammation was observed in 3/47 (6.4%) cases. Chronic inflammation with lymphocytes (42.5%, 20/47) was associated with a significant higher pre-operative pain score (p = .03). Fibrosis was noted in 43/47 (91.5%) cases. Fibrosis without lymphocytes (51.1%, 24/47) was statistically associated with significant reduced pain (p = .04). At distance from the Essure^® implant, only chronic inflammation with lymphocytes was present in 10/47 (21.7%) cases.

Conclusions

Inflammation response do not seem to be enough to explain all the Essure-related adverse outcomes, suggesting the involvement of other biological mechanisms.

ClinicalTrials.gov identifier

NCT03281564

SHORT CONDENSATION

Inflammation and fibrosis are found in the surrounding tubal tissue around the Essure^®. Inflammation process alone doesn’t seem to be enough to explain symptomatology.

摘要

目的：Essure^®设备的不良反应引起了许多关注。已经提出了几种病理生理学假说, 包括过敏反应、佐剂诱导的自身免疫/自身炎症综合征、重金属释放的电偶腐蚀和炎症。在本研究中, 我们旨在通过对有症状的Essure^®切除患者的输卵管进行组织病理学评估来关注炎症过程。

材料和方法：一项横断面研究, 鉴定Essure^®植入物周围输卵管组织中（STTE）和距离植入物较远的输卵管组织中的炎症反应类型和炎症细胞特征。还研究了组织病理学和临床相关性。

结果：47例STTE中, 急性炎症发生率为6.4%（3/47）。淋巴细胞慢性炎症（42.5%, 20/47）与术前疼痛评分显著升高有关（p=0.03）。43/47例（91.5%）出现纤维化。无淋巴细胞的纤维化（51.1%, 24/47）与疼痛显著减轻相关（p=0.04）。在距离Essure^®植入物较远的地方, 仅有10/47（21.7%）的病例中出现淋巴细胞慢性炎症。

结论：炎症反应似乎不足以解释所有Essure^®相关的不良结果, 这表明涉及其他生物学机制。

临床试验注册号：NCT03281564

简短概括

Essure^®周围的输卵管组织出现炎症和纤维化。炎症过程本身似乎不足以解释症状。

Keywords:

• Essure^® removal
• heavy metal
• inflammation
• fallopian tube
• cornuectomy

Acknowledgements

The authors thank Dea Špiljarić for her advice in medical manuscript editing.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The datasets used are available from the corresponding author on reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.