MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Chest Pain (1776); Dry Eye(s) (1814); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Headache (1880); Incontinence (1928); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Increased Sensitivity (2065); Swelling (2091); Tinnitus (2103); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vertigo (2134); Visual Impairment (2138); Tingling (2171); Dizziness (2194); Anxiety (2328); Discomfort (2330); Arthralgia (2355); Depression (2361); Numbness (2415); Sweating (2444); Sleep Dysfunction (2517); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Fibrosis (3167)

Event Date 04/27/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not menstruating") and genital haemorrhage ("heavy bleeding") , device dislocation (during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus) in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus)genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), menorrhagia ("abnormally long and heavy menses"), abdominal pain lower ("severe lower abdominal when not menstruating"), back pain ("severe back pain when not menstruating"), arthralgia ("severe hip pain when not menstruating"), abdominal pain ("severe abdominal cramping when not menstruating"), dyspareunia ("pain during intercourse"), abdominal distension ("severe bloating"), weight increased ("weight gain"), inflammation ("widespread inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), alopecia ("hair loss"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), vaginal discharge ("vaginal discharge"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photosensitivity reaction ("light sensitivity"),hypertonic bladder ("overactive bladder"), ("weight gain") -weight increased, ("headaches")- headache, ("dizziness")- dizziness, ("sinus pain")- sinus pain, ("skin rashes")- rash, ("bumps")- skin mass, ("worsening of her depression")- depression, ("anxiety")- anxiety, ("chronic inflammation")- inflammation, ("bone pain") - bone pain, ("joint pain")- arthralgia, ("inflammation of the lower extremities")- inflammation, ("osteoarthritis pain")- arthralgia, ("dyspnea")- dyspnoea, ("multiple urinary tract infections")- urinary tract infection, ("urgency incontinence")- incontinence, ("tingling")- paraesthesia, ("numbness")- hypoaesthesia, ("eye discomfort")- ocular discomfort, ("vision changes")- visual impairment, ("vertigo")- vertigo, ("dry eyes")- dry eye, ("dry mouth") - dry mouth, ("sinus pain")- sinus pain, ("tinnitus")- tinnitus, ("chest pains") - chest pain, ("her uterus had fused to her intestine")- abdominal adhesions, ("multiple uterine fibroids")- uterine leiomyoma.On (b)(6) 2016, she had ("painful procedure for essure removal") procedural pain, complication of device removal (micro-insert was not able to be removed during surgery), device difficult to use (micro-insert was not able to be removed during surgery).Essure was removed on (b)(6) 2016.The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016), the patient was treated with surgery (total hysterectomy on (b)(6) 2016).At the time of the report, the pelvic pain, genital haemorrhage, dysmenorrhoea, menorrhagia, abdominal pain lower, back pain, arthralgia, abdominal pain, dyspareunia, abdominal distension, weight increased, inflammation, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photosensitivity reaction ,hypertonic bladder, weight increased, headache, dizziness, sinus pain, rash, skin mass, depression, anxiety, inflammation, bone pain, arthralgia, inflammation, arthralgia, dyspnoea, urinary tract infection, incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, sinus pain, tinnitus, chest pain, abdominal adhesions, uterine leiomyoma, procedural pain, complication of device removal and device difficult to use was recovering.The reporter considered pelvic pain, genital haemorrhage, dysmenorrhoea, menorrhagia, abdominal pain lower, back pain, arthralgia, abdominal pain, dyspareunia, abdominal distension, weight increased, inflammation, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photosensitivity reaction ,hypertonic bladder, weight increased, headache, dizziness, sinus pain, rash, skin mass, depression, anxiety, inflammation, bone pain, arthralgia, inflammation, arthralgia, dyspnoea, urinary tract infection, incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, sinus pain, tinnitus, chest pain, abdominal adhesions, uterine leiomyoma, procedural pain, complication of device removal and device difficult to use to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.Company causality comment: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not menstruating") and genital haemorrhage ("heavy bleeding") , device dislocation (during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus)in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus) genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), menorrhagia ("abnormally long and heavy menses"), abdominal pain lower ("severe lower abdominal when not menstruating"), back pain ("severe back pain when not menstruating"), arthralgia ("severe hip pain when not menstruating"), abdominal pain ("severe abdominal cramping when not mensutarting"), dyspareunia ("pain during intercourse"), abdominal distension ("severe bloating"), weight increased ("weight gain"), inflammation ("widespread inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), alopecia ("hair loss"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), vaginal discharge ("vaginal discharge"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photosensitivity reaction ("light sensitivity"),hypertonic bladder ("overactive bladder"), (¿weight gain¿) -weight increased, (¿headaches¿)- headache, (¿dizziness¿)- dizziness, (¿sinus pain¿)- sinus pain, (¿skin rashes¿)- rash, (¿bumps¿)- skin mass, (¿worsening of her depression¿)- depression, (¿anxiety¿)- anxiety, (¿chronic inflammation¿)- inflammation, (¿bone pain¿) - bone pain, (¿joint pain¿)- arthralgia, (¿inflammation of the lower extremities¿)- inflammation, (¿osteoarthritis pain¿)- arthralgia, (¿dyspnea¿)- dyspnoea, (¿multiple urinary tract infections¿)- urinary tract infection, (¿urgency incontinence¿)- incontinence, (¿tingling¿)- paraesthesia, (¿numbness¿)- hypoaesthesia, (¿eye discomfort¿)- ocular discomfort, (¿vision changes¿)- visual impairment, (¿vertigo¿)- vertigo, (¿dry eyes¿)- dry eye, (¿dry mouth¿) - dry mouth, (¿sinus pain¿)- sinus pain, (¿tinnitus¿)- tinnitus, (¿chest pains¿) - chest pain, (¿her uterus had fused to her intestine¿)- abdominal adhesions, (¿multiple uterine fibroids¿)- uterine leiomyoma.On (b)(6) 2016, she had (¿painful procedure for essure removal¿) procedural pain, complication of device removal (micro-insert was not able to be removed during surgery), device difficult to use (micro-insert was not able to be removed during surgery) and cyst behind right knee.Essure was removed on (b)(6) 2016.The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016), the patient was treated with surgery (total hysterectomy on (b)(6) 2016).At the time of the report, the pelvic pain, genital haemorrhage, dysmenorrhoea, menorrhagia, abdominal pain lower, back pain, arthralgia, abdominal pain, dyspareunia, abdominal distension, weight increased, inflammation, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photosensitivity reaction ,hypertonic bladder, weight increased, headache, dizziness, sinus pain, rash, skin mass, depression, anxiety, inflammation, bone pain, arthralgia, inflammation, arthralgia, dyspnoea, urinary tract infection, incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, sinus pain, tinnitus, chest pain, abdominal adhesions, uterine leiomyoma, procedural pain, complication of device removal and device difficult to use was recovering.The reporter considered pelvic pain, genital haemorrhage, dysmenorrhoea, menorrhagia, abdominal pain lower, back pain, arthralgia, abdominal pain, dyspareunia, abdominal distension, weight increased, inflammation, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photosensitivity reaction ,hypertonic bladder, weight increased, headache, dizziness, sinus pain, rash, skin mass, depression, anxiety, inflammation, bone pain, arthralgia, inflammation, arthralgia, dyspnoea, urinary tract infection, incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, sinus pain, tinnitus, chest pain, abdominal adhesions, uterine leiomyoma, procedural pain, complication of device removal and device difficult to use to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.Most recent follow-up information incorporated above includes: on 22-nov-2017: event cyst behind right knee added.Reporter added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not mensturataing/ pelvic pain"), device expulsion ("during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus") and genital haemorrhage ("heavy bleeding") in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "micro-insert was not able to be removed during surgery" and device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), cesarean section in 1996, menometrorrhagia, ovarian cyst ruptured in march 2010, miscarriage in 1990 and uterine dilation and curettage in march 2011.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure) and drug allergy (eye infection).Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), weight increased ("weight gain/ weight gain / loss"), alopecia ("hair loss"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth disorder ("dental problems"), the first episode of ocular discomfort ("eye discomfort") and weight decreased ("weight gain / loss").In 2016, the patient experienced uterine leiomyoma ("multiple uterine fibroids").In june 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), the first episode of arthralgia ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), the first episode of inflammation ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue/ fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), the second episode of arthralgia ("joint pain"), the second episode of inflammation ("inflammation of the lower extremities"), the third episode of arthralgia ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), the second episode of ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), night sweats ("night sweats"), pollakiuria ("frequent urination or incontinence"), urinary incontinence ("frequent urination or incontinence") and hot flush ("hot flashes").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016) and surgery (total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photosensitivity reaction, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, the last episode of inflammation, the last episode of arthralgia, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, the last episode of ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain, complication of device removal and hot flush was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria and urinary incontinence had resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, weight decreased and uterine pain outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, insomnia, menorrhagia, migraine, nausea, night sweats, pain, paraesthesia, pelvic pain, peripheral swelling, photosensitivity reaction, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, temperature intolerance, tinnitus, tooth disorder, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of arthralgia, the first episode of inflammation, the first episode of ocular discomfort, the first episode of sinus pain, the second episode of arthralgia, the second episode of inflammation, the second episode of ocular discomfort, the second episode of sinus pain and the third episode of arthralgia to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 102.948 kgs.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping.Gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet and medical record received.Reporter information, patient¿s demographic information, relevant history and lab data updated.Essure lot number was added.Events abnormal bleeding (vaginal, menorrhagia), infection (bladder/urinary tract/vaginal), rash on right leg, migrated to uterus, dyspareunia (painful sexual intercourse), eye dryness, fatigue, weight gain / loss, back pain, lower abdomen pain, pelvic pain were clubbed with previously reported events.Events vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, ocular discomfort, weight decreased, uterine pain, peripheral swelling, night sweats, pollakiuria, urinary incontinence, hot flush, device monitoring procedure not performed were newly added.Incident: at the time of reporting, 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not mensturataing/ pelvic pain"), device expulsion ("during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus") and genital haemorrhage ("heavy bleeding") in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "micro-insert was not able to be removed during surgery" and device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), cesarean section in 1996, menometrorrhagia, ovarian cyst ruptured in (b)(6) 2010, miscarriage in 1990 and uterine dilation and curettage in (b)(6) 2011.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure) and drug allergy (eye infection).Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), weight increased ("weight gain/ weight gain / loss"), alopecia ("hair loss"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth disorder ("dental problems"), the first episode of ocular discomfort ("eye discomfort") and weight decreased ("weight gain / loss").In 2016, the patient experienced uterine leiomyoma ("multiple uterine fibroids").In (b)(6) 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), the first episode of arthralgia ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), the first episode of inflammation ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue/ fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), the second episode of arthralgia ("joint pain"), the second episode of inflammation ("inflammation of the lower extremities"), the third episode of arthralgia ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), the second episode of ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), night sweats ("night sweats"), pollakiuria ("frequent urination or incontinence"), urinary incontinence ("frequent urination or incontinence") and hot flush ("hot flashes").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016) and surgery (total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, the last episode of inflammation, the last episode of arthralgia, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, the last episode of ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain, complication of device removal and hot flush was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria and urinary incontinence had resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, weight decreased and uterine pain outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, insomnia, menorrhagia, migraine, nausea, night sweats, pain, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, temperature intolerance, tinnitus, tooth disorder, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of arthralgia, the first episode of inflammation, the first episode of ocular discomfort, the first episode of sinus pain, the second episode of arthralgia, the second episode of inflammation, the second episode of ocular discomfort, the second episode of sinus pain and the third episode of arthralgia to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 102.948 kgs.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Most recent follow-up information incorporated above includes: on 28-jun-2018: quality safety evaluation of product technical complaint.Incident at the time of reporting, 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.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not menstruating/ pelvic pain"), device expulsion ("during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus"), genital haemorrhage ("heavy bleeding") and systemic lupus erythematosus ("but i have now lupus ") in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "micro-insert was not able to be removed during surgery" and device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), cesarean section in 1996, menometrorrhagia, ovarian cyst ruptured in march 2010, miscarriage in 1990 and uterine dilation and curettage in march 2011.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure) and drug allergy (eye infection).Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)/ large clots with blood expelled from me"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), weight increased ("weight gain/ weight gain / loss"), alopecia ("hair loss"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth disorder ("dental problems"), the first episode of ocular discomfort ("eye discomfort") and weight decreased ("weight gain / loss").In 2016, the patient experienced uterine leiomyoma ("multiple uterine fibroids").In june 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not menstruating/ lower abdomen pain"), back pain ("severe back pain when not menstruating/ back pain"), the first episode of arthralgia ("severe hip pain when not menstruating"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), the first episode of inflammation ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue/ fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), the second episode of arthralgia ("joint pain"), the second episode of inflammation ("inflammation of the lower extremities"), the third episode of arthralgia ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), the second episode of ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), night sweats ("night sweats"), pollakiuria ("frequent urination or incontinence"), urinary incontinence ("frequent urination or incontinence"), hot flush ("hot flashes"), systemic lupus erythematosus (seriousness criterion medically significant) and lung disorder ("but i have now lupus that may have affected my lungs").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016) and surgery (total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, the last episode of inflammation, the last episode of arthralgia, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, the last episode of ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain and complication of device removal was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria, urinary incontinence and hot flush had resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, weight decreased, uterine pain, systemic lupus erythematosus and lung disorder outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, insomnia, lung disorder, menorrhagia, migraine, nausea, night sweats, pain, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, systemic lupus erythematosus, temperature intolerance, tinnitus, tooth disorder, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of arthralgia, the first episode of inflammation, the first episode of ocular discomfort, the first episode of sinus pain, the second episode of arthralgia, the second episode of inflammation, the second episode of ocular discomfort, the second episode of sinus pain and the third episode of arthralgia to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.5 kg/sqm.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Lupus, lung disorder most recent follow-up information incorporated above includes: on (b)(6) 2018: social media case received.Events lupus & lung disorder are added.Event outcome updated.Product, patient & reporter information updated.On (b)(6) 2018: plaintiff fact sheet received.Events outcome updated.Processed with fu 05 incident at the time of reporting, 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.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not mensturataing/ pelvic pain"), device expulsion ("during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus"), genital haemorrhage ("heavy bleeding") and systemic lupus erythematosus ("but i have now lupus") in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "micro-insert was not able to be removed during surgery" and device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), cesarean section in 1996, menometrorrhagia, ovarian cyst ruptured in march 2010, miscarriage in 1990 and uterine dilation and curettage in (b)(6) 2011.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure) and drug allergy (eye infection).Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)/ large clots with blood expelled from me"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), weight increased ("weight gain/ weight gain / loss"), alopecia ("hair loss"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth disorder ("dental problems"), the first episode of ocular discomfort ("eye discomfort") and weight decreased ("weight gain / loss").In 2016, the patient experienced uterine leiomyoma ("multiple uterine fibroids").In (b)(6) 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), the first episode of arthralgia ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), the first episode of inflammation ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue/ fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), the second episode of arthralgia ("joint pain"), the second episode of inflammation ("inflammation of the lower extremities"), the third episode of arthralgia ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), the second episode of ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), night sweats ("night sweats"), pollakiuria ("frequent urination or incontinence"), urinary incontinence ("frequent urination or incontinence"), hot flush ("hot flashes"), systemic lupus erythematosus (seriousness criterion medically significant) and lung disorder ("but i have now lupus that may have affected my lungs").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016) and surgery (total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, the last episode of inflammation, the last episode of arthralgia, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, the last episode of ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain and complication of device removal was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria, urinary incontinence and hot flush had resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, weight decreased, uterine pain, systemic lupus erythematosus and lung disorder outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, insomnia, lung disorder, menorrhagia, migraine, nausea, night sweats, pain, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, systemic lupus erythematosus, temperature intolerance, tinnitus, tooth disorder, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of arthralgia, the first episode of inflammation, the first episode of ocular discomfort, the first episode of sinus pain, the second episode of arthralgia, the second episode of inflammation, the second episode of ocular discomfort, the second episode of sinus pain and the third episode of arthralgia to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.5 kg/sqm.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Lupus, lung disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-oct-2018: quality safety evaluation of product technical complaints.Incident at the time of reporting, 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.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain when not mensturataing/ pelvic pain"), device expulsion ("during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus"), genital haemorrhage ("heavy bleeding") and systemic lupus erythematosus ("but i have now lupus") in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), cesarean section in 1996, menometrorrhagia, ovarian cyst ruptured in (b)(6) 2010, miscarriage in 1990 and uterine dilation and curettage in (b)(6) 2011.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure) and drug allergy (eye infection).Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro), multivitamin, mycophenolate mofetil, nsaid's and prednisone.On (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)/ large clots with blood expelled from me"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), weight increased ("weight gain/ weight gain / loss"), alopecia ("hair loss"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth disorder ("dental problems"), the first episode of ocular discomfort ("eye discomfort") and weight decreased ("weight gain / loss").In (b)(6) 2012, the patient experienced night sweats ("night sweats") and hot flush ("hot flashes").In (b)(6) 2013, the patient experienced urinary incontinence ("bladder or urinary problems or changes: frequent urination or incontinence").In (b)(6) 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").In 2016, the patient experienced uterine leiomyoma ("multiple uterine fibroids").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), the first episode of arthralgia ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), the first episode of inflammation ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), fatigue ("severe fatigue/ fatigue"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), the second episode of arthralgia ("joint pain"), the second episode of inflammation ("inflammation of the lower extremities"), the third episode of arthralgia ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), the second episode of ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), the first episode of complication of device removal ("micro-insert was not able to be removed during surgery"), the second episode of complication of device removal ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), pollakiuria ("frequent urination or incontinence"), systemic lupus erythematosus (seriousness criterion medically significant) and lung disorder ("but i have now lupus that may have affected my lungs").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2016) and surgery (total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, the last episode of inflammation, the last episode of arthralgia, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, the last episode of ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain and the last episode of complication of device removal was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria, urinary incontinence and hot flush had resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth disorder, weight decreased, uterine pain, systemic lupus erythematosus and lung disorder outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, insomnia, lung disorder, menorrhagia, migraine, nausea, night sweats, pain, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, systemic lupus erythematosus, temperature intolerance, tinnitus, tooth disorder, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of arthralgia, the first episode of complication of device removal, the first episode of inflammation, the first episode of ocular discomfort, the first episode of sinus pain, the second episode of arthralgia, the second episode of complication of device removal, the second episode of inflammation, the second episode of ocular discomfort, the second episode of sinus pain and the third episode of arthralgia to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.5 kg/sqm.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Lupus, lung disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: plaintiff fact sheet received.Outcome of event bladder disorder updated.Incident: at the time of reporting, 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain when not mensturataing/ pelvic pain/pain'), device expulsion ('during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus') and systemic lupus erythematosus ('but i have now lupus') in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's medical history included uterine dilation and curettage in (b)(6) 2011, ovarian cyst ruptured in (b)(6) 2010, cesarean section in 1996, miscarriage in 1990, multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), menometrorrhagia, weight gain, dysuria and lupus erythematosus.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure), drug allergy (eye infection), swelling abdomen, uterine fibroids, abdominal pain, back pain, vaginal odor, painful urination and heart disease, unspecified.Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro), mycophenolate mofetil, nsaids, prednisone and vitamins nos (multivitamin).On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)/ large clots with blood expelled from me"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), alopecia ("hair loss"), fatigue ("severe fatigue/ fatigue"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth fracture ("rigt molar on top split & ttoth has chipped since essure implant") and eye discomfort ("eye discomfort") and was found to have weight increased ("weight gain/ weight gain / loss") and weight decreased ("weight gain / loss").In (b)(6) 2012, the patient experienced night sweats ("night sweats") and hot flush ("hot flashes").In (b)(6) 2013, the patient experienced urinary incontinence ("bladder or urinary problems or changes: frequent urination or incontinence").In (b)(6) 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").In 2016, the patient was found to have uterine leiomyoma ("multiple uterine fibroids").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), pain in hip ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), inflammation nos ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), joint pain ("joint pain"), inflammation ("inflammation of the lower extremities"), arthritic-like pain ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), device removal failed ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), pollakiuria ("frequent urination or incontinence"), systemic lupus erythematosus (seriousness criterion medically significant) and lung disorder ("but i have now lupus that may have affected my lungs").The patient was treated with surgery (total hysterectomy (uterus and cervix removed) and total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, pain in hip, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, joint pain, inflammation, arthritic-like pain, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain, complication of device removal and device removal failed was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria, urinary incontinence and hot flush had resolved, the inflammation nos had not resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth fracture, eye discomfort, weight decreased, uterine pain, systemic lupus erythematosus and lung disorder outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, eye discomfort, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, inflammation nos, insomnia, lung disorder, menorrhagia, migraine, nausea, night sweats, pain, pain in hip, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, systemic lupus erythematosus, temperature intolerance, tinnitus, tooth fracture, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of sinus pain, device removal failed, inflammation, joint pain, ocular discomfort, the second episode of sinus pain and arthritic-like pain to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Discrepancy in essure removal date:(b)(6) 2016.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.5 kg/sqm.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Lupus, lung disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: content from plaintiff fact sheet received.Event tooth disorder updated to fracture tooth.Product, patient & reporter information updated.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain when not mensturataing/ pelvic pain/pain'), device expulsion ('during surgery one of the essure micro inserts had migrated from her fallopian tube into her uterus/ migrated to uterus') and systemic lupus erythematosus ('but i have now lupus') in a 46-year-old female patient who had essure (batch no.796908) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's medical history included uterine dilation and curettage in (b)(6) 2011, ovarian cyst ruptured in (b)(6) 2010, cesarean section in 1996, miscarriage in 1990, multi gravida, parity 2 (live births: (b)(6) 1990, (b)(6) 1996), menometrorrhagia, weight gain, dysuria and lupus erythematosus.Previously administered products included for birth control: depo provera from 2006 to (b)(6) 2011.Concurrent conditions included anemia, uterine fibroids, uterine leiomyoma, anesthesia, ovarian neoplasm, pain in limb, edema, sinusitis, obesity, chills, blistering, earache, dysuria, congestion nasal, eustachian tube dysfunction, cerumen impaction, weakness, breast fibrocystic, allergic reaction to analgesics, dermatofibroma, seborrheic keratosis, eczematous dermatitis, post coital bleeding, non-tobacco user, pelvic adhesions, drug allergy (anaphylaxis, tongue swelling), nickel sensitivity (lupus, problems with lungs, mild heart failure), drug allergy (eye infection), swelling abdomen, uterine fibroids, abdominal pain, back pain, vaginal odor, painful urination and heart disease, unspecified.Family history included lung cancer (father), diabetes (father), hypertension (father) and heart disease, unspecified (father).Concomitant products included iron for anemia as well as ciprofloxacin (cipro), mycophenolate mofetil, nsaids, prednisone and vitamins nos (multivitamin).On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), menorrhagia ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)/ large clots with blood expelled from me"), dyspareunia ("pain during intercourse/ dyspareunia (painful sexual intercourse)"), alopecia ("hair loss"), fatigue ("severe fatigue/ fatigue"), vaginal discharge ("vaginal discharge"), headache ("headaches"), rash ("skin rashes/ rash on right leg"), vaginal haemorrhage ("abnormally long and heavy menses/ abnormal bleeding (vaginal, menorrhagia)"), migraine ("migraines"), tooth fracture ("rigt molar on top split & ttoth has chipped since essure implant") and eye discomfort ("eye discomfort") and was found to have weight increased ("weight gain/ weight gain / loss") and weight decreased ("weight gain / loss").In (b)(6) 2012, the patient experienced night sweats ("night sweats") and hot flush ("hot flashes").In (b)(6) 2013, the patient experienced urinary incontinence ("bladder or urinary problems or changes: frequent urination or incontinence").In (b)(6) 2016, the patient experienced abdominal adhesions ("her uterus had fused to her intestine").In 2016, the patient was found to have uterine leiomyoma ("multiple uterine fibroids").On (b)(6) 2016, the patient experienced procedural pain ("painful procedure for essure removal").On an unknown date, the patient experienced genital haemorrhage ("heavy bleeding"), dysmenorrhoea ("abnormally severe pain during menstruation"), abdominal pain lower ("severe lower abdominal when not mensturataing/ lower abdomen pain"), back pain ("severe back pain when not mensturataing/ back pain"), pain in hip ("severe hip pain when not mensturataing"), abdominal pain ("severe abdominal cramping when not mansutarting"), abdominal distension ("severe bloating"), inflammation nos ("widespread inflammation/chronic inflammation"), swelling ("widespread swelling"), pain ("widespread body pain"), dental caries ("tooth decay"), dysgeusia ("metallic taste in mouth"), insomnia ("insomnia"), hyperhidrosis ("profuse sweating"), skin odour abnormal ("body odor"), temperature intolerance ("heat sensitivity"), photophobia ("light sensitivity"), hypertonic bladder ("overactive bladder"), dizziness ("dizziness"), the first episode of sinus pain ("sinus pain"), skin disorder ("bumps"), depression ("worsening of her depression"), anxiety ("anxiety"), bone pain ("bone pain"), joint pain ("joint pain"), inflammation ("inflammation of the lower extremities"), arthritic-like pain ("osteoarthritis pain"), dyspnoea ("dyspnea"), urinary tract infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), urge incontinence ("urgency incontinence"), paraesthesia ("tingling"), hypoaesthesia ("numbness"), ocular discomfort ("eye discomfort"), visual impairment ("vision changes"), vertigo ("vertigo"), dry eye ("dry eyes/ eye dryness "), dry mouth ("dry mouth"), the second episode of sinus pain ("sinus pain"), tinnitus ("tinnitus"), chest pain ("chest pains"), complication of device removal ("micro-insert was not able to be removed during surgery"), device removal failed ("micro-insert was not able to be removed during surgery"), synovial cyst ("cyst behind right knee"), cystitis ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), vaginal infection ("multiple urinary tract infections/ infection (bladder/urinary tract/vaginal)"), nausea ("nausea"), uterine pain ("uterine pain"), peripheral swelling ("swelling in right lower extremity"), pollakiuria ("frequent urination or incontinence"), systemic lupus erythematosus (seriousness criterion medically significant), lung disorder ("but i have now lupus that may have affected my lungs") and menopause ("menopause").The patient was treated with surgery (total hysterectomy (uterus and cervix removed) and total hysterectomy (uterus and cervix removed) on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, device expulsion, genital haemorrhage, dysmenorrhoea, menorrhagia, back pain, pain in hip, abdominal pain, dyspareunia, abdominal distension, weight increased, swelling, pain, alopecia, dental caries, dysgeusia, fatigue, insomnia, hyperhidrosis, vaginal discharge, skin odour abnormal, temperature intolerance, photophobia, hypertonic bladder, headache, dizziness, rash, skin disorder, depression, anxiety, bone pain, joint pain, inflammation, arthritic-like pain, dyspnoea, urinary tract infection, urge incontinence, paraesthesia, hypoaesthesia, ocular discomfort, visual impairment, vertigo, dry eye, dry mouth, the last episode of sinus pain, tinnitus, chest pain, abdominal adhesions, procedural pain, complication of device removal and device removal failed was resolving, the abdominal pain lower, peripheral swelling, night sweats, pollakiuria, urinary incontinence and hot flush had resolved, the inflammation nos had not resolved and the synovial cyst, vaginal haemorrhage, cystitis, vaginal infection, migraine, nausea, tooth fracture, eye discomfort, weight decreased, uterine pain, systemic lupus erythematosus, lung disorder and menopause outcome was unknown.The reporter provided no causality assessment for synovial cyst with essure.The reporter considered abdominal adhesions, abdominal distension, abdominal pain, abdominal pain lower, alopecia, anxiety, back pain, bone pain, chest pain, complication of device removal, cystitis, dental caries, depression, device expulsion, dizziness, dry eye, dry mouth, dysgeusia, dysmenorrhoea, dyspareunia, dyspnoea, eye discomfort, fatigue, genital haemorrhage, headache, hot flush, hyperhidrosis, hypertonic bladder, hypoaesthesia, inflammation nos, insomnia, lung disorder, menopause, menorrhagia, migraine, nausea, night sweats, pain, pain in hip, paraesthesia, pelvic pain, peripheral swelling, photophobia, pollakiuria, procedural pain, rash, skin disorder, skin odour abnormal, swelling, systemic lupus erythematosus, temperature intolerance, tinnitus, tooth fracture, urge incontinence, urinary incontinence, urinary tract infection, uterine leiomyoma, uterine pain, vaginal discharge, vaginal haemorrhage, vaginal infection, vertigo, visual impairment, weight decreased, weight increased, the first episode of sinus pain, device removal failed, inflammation, joint pain, ocular discomfort, the second episode of sinus pain and arthritic-like pain to be related to essure.The reporter commented: on (b)(6) 2016, she underwent a bilateral salpingectomy, during which both of her fallopian tubes were removed.It was noted during surgery that one of the essure micro-inserts had migrated from her fallopian tube into her uterus and consequently that micro-insert was not able to be removed during surgery.On (b)(6) 2016, she underwent a total hysterectomy, during which her cervix and uterus were both removed.Her uterus had fused to her intestine, and that she had multiple uterine fibroids.Essure did not worsened a previously existing injury/condition.She had no complications or problems that occurred at the time of essure placement procedure and essure removal procedure.She did retain the essure device or any portion of it after essure removed.Essure did not caused birth defects.Discrepancy in essure removal date:(b)(6) 2016.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34.5 kg/sqm.On (b)(6) 2011, essure placement: right ostia started and placed essure under normal technique to 4 rings, left ostia visualized and placed essure under normal procedure to 4 rings, microinserts successfully placed.Transvaginal sonogram on (b)(6) 2011, impression: 3 intramural fibroids.Us pelvic w transvaginal on (b)(6) 2012, impression: leiomyomatous was uterus.Non-visualization of the right ovary.Hysterosonogram pelvic sonogram, hsg or hss injection, transvaginal pelvic sonogram on (b)(6) 2013, impression: normal-appearing endometrium measuring 3.9 mm in single layer thickness in the region of the lower uterine segment/proximal endometrium.Secondary to positioning of the uterus, there was limited evaluation of the distal portion of the endometrium.Ultrasound pelvis on (b)(6) 2015, impression: leiomyomatous uterus.Addendum: bilateral essure devices are partially seen and appear grossly normally sited.Us pelvic with transvaginal on (b)(6) 2015, leiomyomatous was uterus.Surgical pathology report on (b)(6) 2016, pre and postoperative diagnosis: pain in female pelvis, bilateral lower abdominal cramping gross description: right fallopian tube: the lumen contains a metal device consistent with an essure device.Left fallopian tube: the lumen contains a metal device consistent with an essure device.Mri knee right on (b)(6) 2016, impression: complex tear in the middle and posterior thirds of the medial meniscus, fraying and mild horizontal free margin tearing in the middle third of the lateral meniscus, degenerathjfglaries of the knee, small knee joint effusion with a small bakers cyst.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hot flush, weight increased, vaginal haemorrhage, fatigue, urinary tract infection, back pain, dizziness, abdominal distension, menorrhagia, abdominal pain, vaginal discharge, abdominal pain lower, dyspareunia.Lupus, lung disorder.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: content from social media received: new event menopause was added.Reporter added.We received a lot number in this case.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 6721101
• MDR Text Key: 80383565
• Report Number: 2951250-2017-02521
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Model Number: ESS305
• Device Lot Number: 796908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CIPRO; CIPRO; CIPRO; CIPRO; CIPRO; CIPRO [CIPROFLOXACIN]; CIPRO [CIPROFLOXACIN]; IRON; IRON; IRON; IRON; IRON; IRON; IRON; MULTIVITAMIN; MULTIVITAMIN; MULTIVITAMIN; MULTIVITAMIN; MULTIVITAMIN; MULTIVITAMIN [VITAMINS NOS]; MULTIVITAMIN [VITAMINS NOS]; MYCOPHENOLATE MOFETIL; MYCOPHENOLATE MOFETIL; MYCOPHENOLATE MOFETIL; NSAID'S; NSAIDS; NSAIDS; PREDNISONE; PREDNISONE; PREDNISONE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 103