[188720402]
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 pelvic pain ('pelvic pain') in a (b)(6) year old female patient who had essure (batch no. 948837) inserted. The occurrence of additional non-serious events is detailed below. Medical conditions: tests for allergy to nickel, tin, heavy metals were performed. On (b)(6) 2012, the patient had essure inserted. On (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("chronic fatigue"), menstruation irregular ("periods/bleeding with irregular cycles"), ovarian cyst ("inflammatory flare-ups of follicles during periods"), vaginal cyst ("vaginal cysts"), vaginal discharge ("odorous vaginal discharge"), musculoskeletal pain ("muscle and joint pain"), arthritis ("arthritis"), tendonitis ("tendinitis"), limb discomfort ("heavy legs with fluid retention"), oedema peripheral ("heavy legs with fluid retention"), gait disturbance ("difficulty walking"), migraine ("migraine"), alopecia ("hair loss"), loss of libido ("loss of libido"), memory impairment ("memory loss/forgetting words"), cough ("dry cough"), hot flush ("hot flushes"), adenomyosis ("adenomyosis") and asthenia ("asthenia") and was found to have weight increased ("weight gain"). The patient was treated with surgery (ovary-sparing total hysterectomy with bilateral salpingectomy). Essure was removed on (b)(6) 2020. At the time of the report, the pelvic pain, fatigue, menstruation irregular, ovarian cyst, vaginal cyst, vaginal discharge, musculoskeletal pain, arthritis, tendonitis, limb discomfort, oedema peripheral, gait disturbance, weight increased, migraine, alopecia, loss of libido, memory impairment, cough, hot flush and adenomyosis was resolving and the asthenia had not resolved. The reporter provided no causality assessment for adenomyosis, alopecia, arthritis, asthenia, cough, fatigue, gait disturbance, hot flush, limb discomfort, loss of libido, memory impairment, menstruation irregular, migraine, musculoskeletal pain, oedema peripheral, ovarian cyst, pelvic pain, tendonitis, vaginal cyst, vaginal discharge and weight increased with essure. The reporter commented: the reporter informed that the patient had adenomyosis despite a novasure procedure performed on (b)(6) 2013 (endometrial removal). Since device removal the consequences were asthenia and physical and mental sequelae following the many symptoms that she suffered for just over 7 years. It was also reported an improvement in the symptoms since removal of essure, however a persistence of asthenia. A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5