RESUMO
BACKGROUND: Most of the clinical adverse events associated with the Essure® sterilization device have been attributed to incidents during and immediately after device placement (perforation, infection, expulsion). The aim of this study was to prospectively evaluate the prevalence and severity of non-gynecological clinical symptoms (e.g. memory disorders, muscle pain, and impaired vision) in patients before device placement and after device removal. METHODS: Women who presented at least four non-gynecological clinical symptoms with the Essure® filled out a questionnaire before surgical removal of the device and then 1, 3 and 6 months afterwards. Patients with bleeding (metrorrhagia and menorrhagia) or tube perforation were excluded. RESULTS: Fifty-two symptomatic women were included in the study and followed up for 6 months. The median (range) time interval between Essure® placement and the first clinical symptom was 13 months (1-60), and the median time interval between Essure® placement and removal was 38 months (12-72). The prevalence of clinical symptoms prior to device removal ranged from 26% (for urinary tract disorders) to 96% (for weakness). The mean±standard deviation intensity (on a 0-to-10 scale) of the symptoms before removal of the Essure® was 8.4±0.4; at 1 month, 3 months and 6 months post-removal, the values had fallen significantly to 4.2±0.6, 4±0.8, and 4.1±1, respectively (P<0.0001 for all the symptoms). CONCLUSIONS: The observed decrease in symptom frequency and severity following Essure® removal and the persistence of this effect at 6 months suggest that the device should be removed in all symptomatic women.