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

Purpose: Many concerns have been raised about adverse effects related to Essure((R)) 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((R)) 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((R)) (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((R)) 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.