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This spontaneous case was reported by a consumer and describes the occurrence of back pain ("lower back pain") and arrhythmia ("arrhythmia worsen") in a (b)(6) 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 an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), arrhythmia (seriousness criterion medically significant), fatigue ("chronic tiredness, classified as fatigue syndrome"), food allergy ("corn allergy"), vaginal infection ("chronic vaginal infection"), bacterial vaginosis ("bacterial vaginosis"), diarrhoea ("diarrhea attacks daily after eating, also during nights"), rectal polyp ("polyps in rectum"), rheumatic disorder ("rheumatic symptoms"), pain in extremity ("pain in soles of the feet"), menstrual disorder ("menstrual disorder"), peripheral vascular disorder ("peripheral blood flow disorder"), urticaria ("urticaria") and lichen planus ("lichen ruber").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the back pain, arrhythmia, fatigue, food allergy, vaginal infection, bacterial vaginosis, diarrhoea, rectal polyp, rheumatic disorder, pain in extremity, menstrual disorder, peripheral vascular disorder, urticaria and lichen planus had resolved.The reporter provided no causality assessment for arrhythmia, back pain, bacterial vaginosis, diarrhoea, fatigue, food allergy, lichen planus, menstrual disorder, pain in extremity, peripheral vascular disorder, rectal polyp, rheumatic disorder, urticaria and vaginal infection with essure.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 15-jan-2018 for the following meddra preferred term: back pain ¿ analysis in the global safety database revealed (b)(4) cases.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 these meddra pt.Incident no lot number or sample 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 on a supplemental report.
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This spontaneous case was reported by a consumer and describes the occurrence of the first episode of pain ("at times the pain is so severe that i black out"), back pain ("lower back pain"), arrhythmia ("arrhythmia worsen"), hypertension ("arrhythmias increase and attack like increases in blood pressure result in a very high pressure/ upper blood pressure about 200 and the lower blood pressure could be well over 100"), atrial fibrillation ("attacks of atrial fibrillation"), loss of consciousness ("fell unconscious on the floor at the entrance to my home/ fell asleep even while cycling uphill/ black out"), feeling abnormal ("really strong murderous feeling and an urge to kill people") and rectal polyp ("polyps in rectum") in a (b)(6) year-old 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.In 2014, the patient experienced hypertension (seriousness criterion medically significant).In (b)(6) 2016, the patient experienced feeling abnormal (seriousness criterion medically significant), hypomenorrhoea ("the amount of bleeding period is between a teaspoon and tablespoon") and premenstrual syndrome ("pms symptoms become more difficult").In 2016, the patient experienced vomiting ("vomit occasionally"), swelling ("ovulation is coupled with a rapid and strong swelling invariably") and abdominal distension ("stomach bloating in the area of fallopian tubes resembling a shoe").In 2017, the patient experienced atrial fibrillation (seriousness criterion medically significant).On an unknown date, the patient experienced the first episode of pain (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), arrhythmia (seriousness criterion medically significant), loss of consciousness (seriousness criterion medically significant), rectal polyp (seriousness criterion medically significant), fatigue ("chronic tiredness, classified as fatigue syndrome/ complete exhaustion"), food allergy ("corn allergy"), vaginal infection ("chronic vaginal infection"), bacterial vaginosis ("bacterial vaginosis chronic until the operation") with vulvovaginal pain and vulvovaginal burning sensation, diarrhoea ("diarrhea attacks daily after eating, also during nights/ stomach problems had worsened (watery diarrhea) in (b)(6) 2017"), rheumatic disorder ("rheumatic symptoms"), menstrual disorder ("menstrual disorder"), peripheral vascular disorder ("peripheral blood flow disorder"), urticaria ("urticaria"), lichen planus ("lichen ruber/ lichen ruben appears on my buttocks"), vaginal haemorrhage ("bloody discharge lasted 2¿7 days"), the first episode of genital discharge ("mucus dripping and strong fishy smell /unpleasant smell in the genital region/ metalic smell in my genital region"), the second episode of genital discharge ("mucus dripping and strong fishy smell /unpleasant smell in the genital region/ metallic smell in my genital region"), muscle spasms ("a persistent muscle cramp in leg"), weight increased ("weight increased without reason 7 kg in one week"), hypersomnia ("during the next 4 months i slept 22 hours a day"), migraine ("migraines become more common"), the second episode of pain ("pain in the soles of feet, back pain, a stuffy body"), decreased appetite ("become ill with anorexia"), ill-defined disorder ("become ill with anorexia") and abdominal pain upper ("unbearable stomach cramps become daily").The patient was treated with antibiotics, clindamycin hydrochloride (dalacin), beta blocking agents, surgery (essure removal), surgery (essure removal) and surgery (the first removal in (b)(6) 2017 and the second removal in (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the back pain, arrhythmia, hypertension, atrial fibrillation, loss of consciousness, feeling abnormal, rectal polyp, fatigue, food allergy, vaginal infection, bacterial vaginosis, diarrhoea, rheumatic disorder, menstrual disorder, peripheral vascular disorder, urticaria, lichen planus, vaginal haemorrhage, the last episode of genital discharge, muscle spasms, weight increased, hypersomnia, the last episode of pain, decreased appetite, ill-defined disorder, hypomenorrhoea, abdominal pain upper, vomiting, swelling and abdominal distension had resolved, the psoriasis outcome was unknown and the migraine and premenstrual syndrome had not resolved.The reporter considered abdominal distension, abdominal pain upper, arrhythmia, atrial fibrillation, back pain, bacterial vaginosis, decreased appetite, diarrhoea, fatigue, feeling abnormal, hypersomnia, hypertension, hypomenorrhoea, ill-defined disorder, lichen planus, loss of consciousness, migraine, muscle spasms, premenstrual syndrome, rectal polyp, swelling, vaginal haemorrhage, vaginal infection, vomiting, weight increased, the first episode of genital discharge, the first episode of pain, the second episode of genital discharge and the second episode of pain to be related to essure.The reporter provided no causality assessment for food allergy, menstrual disorder, peripheral vascular disorder, rheumatic disorder and urticaria with essure.The reporter commented: the essure insertion was easy.For the persistent muscle cramp in her leg, she took pain killers and muscle relaxants for a couple of weeks which did not help much but she was just able to move.She also reported complete exhaustion so that she had to give up her work as nursing assistant because she was no longer able to stay awake.In 2014, her spouse complaints about her continuous tiredness, and this causes many arguments.Finally she manage to lose 20 kg with an insane diet and become ill with anorexia.Lichen ruben appears on her buttocks and it is erroneously diagnosed as fungal rash and she treated it wrongly for a couple years until she google the matter herself and treated it successfully with strong cortisones that are meant for her own psoriasis.In 2016 tiredness becomes worse than before even though she exercise 5 days a week.Exercise is the only thing she can manage daily anymore.The rest of the time she lie on the bed or couch.A course of dalacin caused a total infection of mucous membranes and blue lesions were detected in the uterine cervix in a visit to a gynecologist.Neither are gels from the pharmacy for bacterial vaginosis of any help because using them makes me feel like i have acid in the vagina.All these ailments came to a sudden end after the operation, except migraine and pms symptoms.Nowadays she can eat even wheat and rye without getting symptoms, there have been no stomach problems, and since the morning after surgery, bowel movements have been normal like they were before essure.She tested for bacterial vaginosis and got the first clean test swab for ages.She can get up and move without pain.Her heart has calmed down and she doesn't live constantly on a razor's edge.She no longer go blind, which was typical when she had essure.Pms has included normal tearfulness and a need for intimacy without the insane murderous urge.Diagnostic results: more blood tests are taken but no cause is found.A course of dalacin caused a total infection of mucous membranes and blue lesions were detected in the uterine cervix in a visit to a gynecologist.Neither are gels from the pharmacy for bacterial vaginosis of any help because using them makes her feel like she has acid in the vagina.All stds, including herpes, were tested several times in 2017, all the results were negative and blood count excellent.Thus there is no medical reason for her symptoms.Operation details on (b)(6) 2017: on the right side, first the mesosalpinx of the tube is cauterized by bilateral burning and severed.After this the tube is cauterized by bilateral burning along the cornu and scraped with scissors in so that only the intact implant remains and the implant it is removed whole even from inside the cornu.Removed via 10 mm ancillary trocar.Thereafter on the left side, the mesosalpinx of the tube is cauterized and severed and the tube cauterized along the cornu and again scraped so that only the implant keeps the tube attached to the uterus, and pulling from this the tube and the implant are successfully removed even from inside the cornu.The implant is removed whole also from this side.The tube and the implant are removed through a larger ancillary trocar in the lower abdomen.Most recent follow-up information incorporated above includes: on 16-jan-2018: additional events received: consumer provided the case description of events during essure.The serious events included: "at times the pain is so severe that i black out", "arrhythmias increase and attack like increases in blood pressure result in a very high pressure/ upper blood pressure about 200 and the lower blood pressure could be well over 100", "attacks of atrial fibrillation", "fell unconscious on the floor at the entrance to my home/ fell asleep even while cycling uphill/ black out", "psoriasis", "really strong murderous feeling and an urge to kill people" and "polyps in rectum".The non-serious events are detailed in the narrative.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 19-jan-2018 for the following meddra preferred term: back pain ¿ analysis in the global safety database revealed 477 cases.Pain ¿ analysis in the global safety database revealed 414 cases.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 these meddra pt.Incident no lot number or sample 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 on a supplemental report.
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