Eur J Contracept Reprod Health Care. 2023 Jun 27:1-7. doi: 10.1080/13625187.2023.2218953. Online ahead of print.
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.
PMID:37365993 | DOI:10.1080/13625187.2023.2218953
