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This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ("lower abdominal pain") in a (b)(6) -year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida, liver disorder (in the first pregnancy) and gestational diabetes (in three previous pregnancies).Concomitant products included omeprazole (omeprazole) for gastric protection.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2017, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced the first episode of sinusitis (¿sinusitis¿).On (b)(6) 2017, the patient experienced palpitations (¿palpitation/ irregular heartbeats¿), heart rate irregular (¿palpitation/ irregular heartbeats¿), blood pressure increased (¿momentary increase in blood pressure at 162/102¿) (seriousness criteria medically significant), malaise (¿feeling ill¿) and hypoaesthesia (¿numbness in the hand¿).On (b)(6) 2017, the patient experienced menopausal symptoms (¿premenopausal symptoms worsened¿).On (b)(6) 2017, the patient experienced the second episode of sinusitis (¿sinusitis¿).On (b)(6) 2017, the patient experienced chills (¿chills with self-measured temperature 35¿).On (b)(6) 2017, the patient experienced pruritus and pain mucosal (¿stinging and itching of mucous membranes¿) and dyspareunia (¿pain during sexual intercourse¿).On (b)(6) 2017, the patient experienced neck pain (¿pain in neck/shoulder¿).On (b)(6) 2017, the patient experienced the first episode bursitis (¿trochanteric bursitis of the left side¿).On an unknown date, the patient experienced amenorrhoea (¿no periods for three months¿), dysmenorrhoea (¿pain during menstrual bleedings¿), menorrhagia (¿heavy menstrual bleedings, uncontrollable / lasting 7 days / blood clots during menstruations¿), vaginal haemorrhage (¿spotting¿), blood glucose increased (¿blood sugar levels increased¿), fatigue (¿fatigue, feeling tired after sleeping at night¿), menstruation irregular (¿menstrual cycle abnormal / cycle was messed up, at first 20 days and thereafter every month lengthening to 35 days¿), , headache (¿headache¿), abdominal distension (¿abdominal bloating¿), loss of libido (¿loss of sexual appetite¿), abdominal pain (¿sharp twinges in the lower abdomen while bending over and while walking¿), ovulation pain (¿pain during ovulation¿), sleep disorder (¿disturbing sleep¿), dyschezia (¿difficulty in passing stools¿), diarrhoea (¿diarrhea¿), constipation (¿constipation¿), hot flush (¿hot flushes¿), night sweats (¿sweating at night¿), skin odour abnormal (¿change in sweat odor¿), the second episode of bursitis (¿bursitis in hip¿), pain in extremity (¿muscle aches in legs and hands¿), polyuria (¿polyuria, no infection¿), bladder discomfort (¿sensation of pressure in the bladder¿), visual impairment (¿visual disturbances¿), dry eye (¿dry eyes¿), pruritus (¿itching spots in the head with varying frequency¿), pruritus generalised (¿itching of the skin randomly across the body¿), pain of skin (¿skin sensitive to touch¿), influenza (¿prolonged flu¿), and musculoskeletal pain (¿pain in neck/shoulder¿).The patient was treated with analgesics, antibiotics, fluanxol, primolut n, avamys, norflex, cortisone, panadol, burana and voltaren.Essure treatment was not changed.On an unspecified date, amenorrhoea had resolved.In (b)(6) 2017, neck pain had resolved.At the time of the report, the fatigue, menstrual disorder, and pruritus had not resolved.The reporter provided no causality assessment for abdominal pain lower, amenorrhoea, dysmenorrhoea, menorrhagia, menstrual disorder, vaginal haemorrhage, blood glucose increased, fatigue, menstruation irregular, menopausal symptoms, headache, abdominal distension, pruritus, dyspareunia, loss of libido, abdominal pain, ovulation pain, sleep disorder, dyschezia, diarrhoea, constipation, palpitations, heart rate irregular, blood pressure increased, malaise, hypoaesthesia, hot flush, night sweats, skin odour abnormal, bursitis, pain in extremity, first episode of sinusitis, polyuria , bladder discomfort, visual impairment, dry eye, pruritus, pruritus generalised, pain of skin, influenza, neck pain, musculoskeletal pain, bursitis, second episode of sinusitis, and chills with essure.Reporter causality comment: insertion went well; on the left 1 spiral and on the right 3 spirals remained visible.She had no periods for three months, but when they started again, they were really painful and heavy and uncontrollable, lasting 7 days, cycle 28 days.This kind of periods continued until (b)(6) 2017.After this, pain diminished but painkillers were still needed and the cycle was messed up, at first 20 days and thereafter every month lengthening to 35 days, at the beginning 2 days of uncontrollable bleeding and blood clots and then slight spotting for about 5 days.The latest cycle was 24 days with duration of bleeding 8 days.She was treated with nasal irrigation pot for sinusitis on (b)(6) 2017 and obgyn cream for stinging and itching of mucous membranes.The cream helped, stinging and itching diminished but did not disappear completely.It occurs about a week before periods.She is on a queue for essure removal and hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): unspecified date: blood glucose 6.0 ¿ 6.8.(b)(6) 2016: blood glucose - 6.0.(b)(6) 2017: blood glucose - 5.1; glycosylated haemoglobin - 31.(b)(6) 2017: blood phosphorus (normal); blood pressure measurement - 108/69 mmhg.(normal); blood sodium (normal); blood thyroid stimulating hormone (normal); c-reactive protein (normal); electrocardiogram - ok; full blood count (normal); glomerular filtration rate (normal); t4v (as reported) - normal; blood creatinine (normal).(b)(6) 2016: glycosylated haemoglobin - 33.(b)(6) 2017: haemoglobin - 143; vitamin b12 - 731 (elevated).(b)(6) 2017: serum ferritin - 59; blood follicle stimulating hormone - 6.2.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term (pt).In this particular case a search in the global safety database was performed on (b)(6) 2017 for the following meddra pt: abdominal pain lower: n° 821 cases (excluding this case).Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Incident: no lot number or sample was available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available, it will be provided in a supplemental report.
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