Analysis of clinical data associated with Essure® sterilization devices: An expanded case series

Abstract

Objectives: To evaluate clinical data in women who underwent Essure® hysteroscopic sterilization and to determine whether this sterilization technique plays a role in developing new-onset symptoms.

Study design: An observational, retrospective, single-center study. It was conducted in a secondary level hospital. It included 804 women who had Essure® hysteroscopic sterilization from 2009 to 2017. Charts from these women were reviewed from June 2009 to November 2019, searching for the development of gynecological symptoms (pelvic pain and bleeding disorders) and non-gynecological symptoms (bloating, joint pain, fatigue, headache, alopecia, allergy and depression). The sample was divided into two groups depending on whether they had developed gynecological symptoms (symptomatic group) or not (asymptomatic group), and a descriptive and comparative analysis was made between them. The impact of the global social alarm in 2015 regarding adverse events attributed to the devices, the development of non-gynecological symptoms, and the treatments required, including conservative and surgical options, were also described.

Results: Out of 804 women who had Essure® devices placed, 541(67.29%) remained asymptomatic, 263(32.71%) developed gynecological symptoms, and 41 of these (15.5% of the total sample) requested Essure® surgical removal. Pelvic pain was the most frequent symptom and the main reason for surgical removal. Bleeding alterations were the second most frequent symptom. Up to 55.89% described the symptoms after the social alarm. Non-gynecological symptoms were statistically significantly more frequent in the symptomatic group.

Conclusions: More than a half of the women who underwent Essure® sterilization remained asymptomatic. The new-onset symptoms attributed to the devices are the minority and causality is difficult to establish.

Implications statement: Our research provides new follow-up data about Essure® hysteroscopic sterilization. Association between gynecological symptoms and Essure® devices is difficult to demonstrate and some confounding factors may be implicated. The results we described, may guide and counsel medical-patient decisions for the treatment of symptoms related to the devices, including surgical removal.

Keywords: Abnormal uterine bleeding; Essure®; Gynecological symptoms; Hysteroscopic sterilization; Pelvic pain; Removal.