[188720860]
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 abdominal distension ('abdominal swelling') in a (b)(6) year old female patient who had essure (ess205) (batch no. 620725) inserted. The occurrence of additional non-serious events is detailed below. On (b)(6) 2006, the patient had essure (ess205) inserted. In 2007, the patient experienced pain in extremity ("roaming pain in the foot"), tooth disorder ("dental problems"), tinnitus ("tinnitus"), ear discomfort ("left ear discomfort"), ear pruritus ("ear itching"), burning sensation ("burning"), blepharophimosis ("blepharophimosis"), pruritus ("itching"), cognitive disorder ("cognitive disorders"), memory impairment ("memory problem"), balance disorder ("balance disturbances"), depression ("depressive tendency") and mental impairment ("disorders including organization of thought"). In 2014, the patient experienced abdominal distension (seriousness criterion medically significant), palpitations ("heart palpitations at night"), fatigue ("persistent fatigue"), neck pain ("cervical pain"), coccydynia ("coccyx pain") and dyspepsia ("digestive disorders") and was found to have weight increased ("significant weight gain"). At the time of the report, the abdominal distension, pain in extremity, tooth disorder, tinnitus, ear discomfort, ear pruritus, burning sensation, blepharophimosis, pruritus, cognitive disorder, memory impairment, balance disorder, depression, palpitations, fatigue, neck pain, coccydynia, weight increased, dyspepsia and mental impairment outcome was unknown. The reporter provided no causality assessment for abdominal distension, balance disorder, blepharophimosis, burning sensation, coccydynia, cognitive disorder, depression, dyspepsia, ear discomfort, ear pruritus, fatigue, memory impairment, mental impairment, neck pain, pain in extremity, palpitations, pruritus, tinnitus, tooth disorder and weight increased with essure (ess205). The reporter commented: she was trying to contact a surgeon-gynaecologist in this first quarter of 2020, to schedule an explantation 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