[188664487]
This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 24-mar-2020. This spontaneous case was reported by a consumer and describes the occurrence of back pain ('back pain') and eye haemorrhage ('problem with blood in left eye') in an adult female patient who had essure inserted. The occurrence of additional non-serious events is detailed below. On (b)(6) 2013, the patient had essure inserted. On (b)(6) 2013, the patient experienced back pain (seriousness criterion medically significant), eye haemorrhage (seriousness criterion medically significant), vision blurred ("problem with blurred left eye"), anosmia ("loss of smell"), anxiety ("anxiety attack at night"), insomnia ("insomnia"), vaginal discharge ("malodorous discharge"), depressed mood ("sadness"), haemorrhoids ("frequent haemorrhoids"), paraesthesia ("tingling in legs"), cardiovascular disorder ("circulation problem"), limb discomfort ("streaky legs"), nasal obstruction ("continuously blocked nose"), neck pain ("neck pain"), burning sensation ("burning sensations"), abdominal distension ("continuous abdominal swelling"), diarrhoea ("diarrhoea at night"), arthralgia ("ankle and joint pain") and headache ("headaches"). At the time of the report, the back pain, eye haemorrhage, vision blurred, anosmia, anxiety, insomnia, vaginal discharge, depressed mood, haemorrhoids, paraesthesia, cardiovascular disorder, limb discomfort, nasal obstruction, neck pain, burning sensation, abdominal distension, diarrhoea, arthralgia and headache outcome was unknown. The reporter considered abdominal distension, anosmia, anxiety, arthralgia, back pain, burning sensation, cardiovascular disorder, depressed mood, diarrhoea, eye haemorrhage, haemorrhoids, headache, insomnia, limb discomfort, nasal obstruction, neck pain, paraesthesia, vaginal discharge and vision blurred to be related to essure. The reporter commented: i have discovered that all my symptoms are due to my essure thanks to the resist website. I had never made the connection that my daily suffering was due to this horror. Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5