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

Model Number ESS205

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Syncope (1610); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Occlusion (1984); Pain (1994); Respiratory Distress (2045); Hot Flashes/Flushes (2153); Dizziness (2194); Arthralgia (2355); Tooth Fracture (2428); Palpitations (2467); Prolapse (2475); Sleep Dysfunction (2517); Abdominal Distention (2601); Constipation (3274)

Event Date 12/21/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("strong allergy to nickel"), tooth abscess ("dental abscesses"), intestinal obstruction ("the small intestine is occluded"), cholelithiasis ("gallstones"), sinusitis aspergillus ("superinfection of the sinuses / very marked aspergillosis"), hydronephrosis ("left ureterohydronephrosis on lithiasis") and nephrolithiasis ("left ureterohydronephrosis on lithiasis") in a (b)(6) female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2, diarrhoea in 1999, weight loss in 1999, crohn's disease in 1999, obstruction intestinal and abdominal pain in 1999.Concomitant products included prazepam (lysanxia) on (b)(6) 2016 for anxiety and delirium tremens, smectite (smecta) on (b)(6) 2016 for chronic diarrhoea, yeast dried (ultra levura) on (b)(6) 2016 for diarrhoea, amoxicillin on 20(b)(6) 2016 for infectious disease nos carrier, pivalone (pivalone neomycin) on (b)(6) 2016 for inflammatory reaction and allergic reaction, metopimazine (vogalene) on (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) on (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) on (b)(6) 2016 for rhinitis, zolpidem (stilnox) on (b)(6) 2016 and zolpidem (stilnox) on (b)(6)2016 for sleep disturbance, cefpodoxime on (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as cholecalciferol (uvedose) on (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and tooth disorder ("fragility of her teeth ").On (b)(6) 2011, 3 years 11 months after insertion of essure (ess205), the patient experienced the first episode of abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and the first episode of arthralgia ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the second episode of abdominal pain ("abdominal pain"), the first episode of abdominal distension ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced abdominal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced sensitivity of teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced the second episode of fatigue ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and the first episode of diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in (b)(6)").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced the third episode of back pain ("back pain"), dyspnoea ("shortness of breath") and the third episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain with intermittent bloating") and the second episode of abdominal distension ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced adhesion ("numerous adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").On (b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound") and amenorrhoea ("absence of menstrual periods for more than one year").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and uterine leiomyoma ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6)2016, the patient experienced chest pain ("chest pain"), palpitations ("palpitations"), haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On(b)(6) 2016, the patient experienced the fourth episode of abdominal pain ("abdominal pain") and the second episode of diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced ventilation/perfusion scan abnormal ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness") and syncope ("faint").On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness") and syncope ("faint").The patient was hospitalized from (b)(6) 2015.The patient was treated with surgery (hysterectomy with removal of uterine tubes on (b)(6)2017), surgery (the gallbladder was resected.), surgery (bilateral meatotomy) and surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, tooth disorder, tooth fracture, tooth abscess, gingival disorder, cyst, sensitivity of teeth, abdominal pain lower, nausea, intestinal dilatation, intestinal obstruction, abdominal adhesions, decreased appetite, cholelithiasis, hepatic steatosis, the last episode of abdominal distension, adhesion, the last episode of abdominal pain, the last episode of diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, urinary incontinence, the last episode of polymenorrhoea, amenorrhoea, ovarian cyst, uterine leiomyoma, crying, constipation, muscle spasms, the last episode of back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, the last episode of arthralgia, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, haemoglobin increased, eosinophil count decreased, c-reactive protein increased, ventilation/perfusion scan abnormal, myopia, dizziness, syncope, premature menopause and fibromyalgia outcome was unknown.The reporter considered abdominal adhesions, abdominal pain lower, adhesion, allergy to metals, amenorrhoea, c-reactive protein increased, chest pain, cholelithiasis, constipation, crying, cyst, decreased appetite, dizziness, dyspnoea, eosinophil count decreased, fibromyalgia, gingival disorder, haematuria, haemoglobin increased, hepatic steatosis, hot flush, hydronephrosis, hypoacusis, intestinal dilatation, intestinal obstruction, leukocyturia, muscle spasms, musculoskeletal pain, myopia, nausea, nephrolithiasis, ovarian cyst, palpitations, pelvic pain, premature menopause, prolapse, respiratory disorder, sciatica, sensitivity of teeth, sinusitis aspergillus, sleep disorder, spinal pain, syncope, synovial cyst, tooth abscess, tooth disorder, tooth fracture, toothache, urinary incontinence, uterine leiomyoma, ventilation/perfusion scan abnormal, the first episode of abdominal distension, the first episode of abdominal pain, the first episode of arthralgia, the first episode of back pain, the first episode of diarrhoea, the first episode of fatigue, the first episode of polymenorrhoea, the fourth episode of abdominal pain, the second episode of abdominal distension, the second episode of abdominal pain, the second episode of arthralgia, the second episode of back pain, the second episode of diarrhoea, the second episode of fatigue, the second episode of polymenorrhoea, the third episode of abdominal pain, the third episode of back pain and the third episode of fatigue to be related to essure (ess205).The reporter commented: she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Diagnostic results: (b)(6) 2011: ct scan showed no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling.On (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.On (b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.On (b)(6) 2016: blood tests found no abnormalities.On (b)(6) 2016: ct scan found no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn's disease and of adhesions was therefore ruled out/ (b)(6).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 20_sep_2017 for the following meddra preferred terms: 1.Allergy to metals: the analysis in the global safety database revealed 302 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("strong allergy to nickel"), tooth abscess ("dental abscesses"), small intestinal obstruction ("the small intestine is occluded"), cholelithiasis ("gallstones"), sinusitis aspergillus ("superinfection of the sinuses / very marked aspergillosis"), hydronephrosis ("left ureterohydronephrosis on lithiasis") and nephrolithiasis ("left ureterohydronephrosis on lithiasis") in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "left essure insert placement was a little more difficult" on (b)(6) 2007.The patient's medical history included parity 2, chronic diarrhea in 1999, abdominal pain in 1999, weight loss in 1999, crohn's disease in 1999, partial bowel obstruction, endometritis and synechiae posterior.The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Concomitant products included prazepam (lysanxia) since (b)(6) 2016 for anxiety and delirium tremens, diosmectite (smecta) since (b)(6) 2016 for chronic diarrhoea, alimentary tract and metabolism since (b)(6) 2016 for diarrhoea, amoxicillin since (b)(6) 2016 for infectious disease carrier, neomycin sulfate;tixocortol pivalate (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6) 2016 for rhinitis, zolpidem tartrate (stilnox) since (b)(6) 2016 for sleep disturbance, cefpodoxime since (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth").On (b)(6) 2011, the patient experienced the first episode of abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and the first episode of arthralgia ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the second episode of abdominal pain ("abdominal pain"), the first episode of abdominal distension ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced sensitivity of teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced the second episode of fatigue ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and the first episode of diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in december").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced the third episode of back pain ("back pain"), dyspnoea ("shortness of breath") and the third episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").In 2015, the patient experienced amenorrhoea ("absence of menstrual periods for more than one year / amenorrhea starting 18 months earlier").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain with intermittent bloating") and the second episode of abdominal distension ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").On 23-(b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound").In (b)(6) 2016, the patient experienced rash erythematous ("erythematous skin eruption").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and was found to have the first episode of uterine leiomyoma ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6) 2016, the patient experienced chest pain ("chest pain") and palpitations ("palpitations") and was found to have mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6) 2016, the patient experienced the fourth episode of abdominal pain ("abdominal pain") and the second episode of diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced obstructive airways disorder ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope ("faint"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), emphysema ("emphysema") and rhinitis ("rhinitis") and was found to have the second episode of uterine leiomyoma ("small subserosal fibroma measuring 16 mm").The patient was hospitalized from (b)(6) 2015.The patient was treated with surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided, the gallbladder was resected., bilateral meatotomy and hysterectomy with removal of uterine tubes on(b)(6) 2017).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, sensitivity of teeth, abdominal pain lower, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, the last episode of abdominal distension, the last episode of peritoneal adhesions, the last episode of abdominal pain, the last episode of diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, amenorrhoea, ovarian cyst, crying, constipation, muscle spasms, the last episode of back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, the last episode of arthralgia, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, obstructive airways disorder, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder, general physical health deterioration, the last episode of uterine leiomyoma, emphysema, rhinitis and rash erythematous outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, amenorrhoea, c-reactive protein increased, chest pain, cholelithiasis, constipation, crying, cyst, decreased appetite, dizziness, dyspnoea, ear disorder, emphysema, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, obstructive airways disorder, ovarian cyst, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, rash erythematous, respiratory disorder, rheumatic disorder, rhinitis, sciatica, sensitivity of teeth, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, the first episode of abdominal distension, the first episode of abdominal pain, the first episode of arthralgia, the first episode of back pain, the first episode of diarrhoea, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, the first episode of uterine leiomyoma, the second episode of abdominal distension, the second episode of abdominal pain, the second episode of arthralgia, the second episode of back pain, the second episode of diarrhoea, the second episode of fatigue, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, the second episode of uterine leiomyoma, the third episode of abdominal pain, the third episode of back pain, the third episode of fatigue and the fourth episode of abdominal pain to be related to essure (ess205).The reporter commented: hysteroscopy performed on (b)(6) 2007 for placement of essure.Right essure insert placement was done with no difficulty, 3 trailing coils.On (b)(6) 2016 she underwent spirometry and lung plethysmography.It was also reported that she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Diagnostic results (normal ranges are provided in parenthesis if available): blood test: on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities.Computerised tomogram: on (b)(6) 2011: results: no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling; on (b)(6) 2016: results: no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.Laparoscopy: on (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.; on (b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.Nuclear magnetic resonance imaging: on (b)(6) 2016: results: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.Smear cervix: on (b)(6) 2016: results: no abnormalities.Ultrasound kidney: on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.Ultrasound pelvis: on (b)(6) 2015: results: double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.; on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.; on (b)(6) 2016: results: no abnormalities.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2019: quality-safety evaluation of ptc.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 allergy to metals ("strong allergy to nickel"), tooth abscess ("dental abscesses"), small intestinal obstruction ("the small intestine is occluded"), cholelithiasis ("gallstones"), sinusitis aspergillus ("superinfection of the sinuses / very marked aspergillosis"), hydronephrosis ("left ureterohydronephrosis on lithiasis") and nephrolithiasis ("left ureterohydronephrosis on lithiasis") in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2, chronic diarrhea in 1999, weight loss in 1999, crohn's disease in 1999, partial bowel obstruction and abdominal pain in 1999.The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Concomitant products included prazepam (lysanxia) since (b)(6)2016 for anxiety and delirium tremens, smectite (smecta) since (b)(6)2016 for chronic diarrhoea, yeast dried (ultra levura) since (b)(6)2016 for diarrhoea, amoxicillin since (b)(6)2016 for infectious disease carrier, pivalone (pivalone neomycine) since (b)(6)2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6)2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6)2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6)2016 for rhinitis, zolpidem (stilnox) since (b)(6)2016 and zolpidem (stilnox) since (b)(6)2016 for sleep disturbance, cefpodoxime since (b)(6)2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6)2016.On (b)(6)2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth ").On (b)(6)2011, 3 years 11 months after insertion of essure (ess205), the patient experienced the first episode of abdominal pain ("persistent abdominal pain").On (b)(6)2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and the first episode of arthralgia ("tenderness is present in the sacroiliac region").On (b)(6)2011, the patient experienced the second episode of abdominal pain ("abdominal pain"), the first episode of abdominal distension ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6)2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6)2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced sensitivity of teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In july 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6)2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6)2014, the patient experienced the second episode of fatigue ("excessive fatigue") and crying ("crying").On (b)(6)2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and the first episode of diarrhoea ("phase of constipation and chronic diarrhoea").In december 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in december").On (b)(6)2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6)2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6)2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6)2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6)2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On(b)(6)2015, the patient experienced the third episode of back pain ("back pain"), dyspnoea ("shortness of breath") and the third episode of fatigue ("general fatigue").In may 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6)2015, the patient experienced musculoskeletal pain ("scapular pain").On (b)(6)2016, the patient experienced sciatica ("sciatica").On(b)(6)2016, the patient experienced the third episode of abdominal pain ("abdominal pain with intermittent bloating") and the second episode of abdominal distension ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous adhesions").On (b)(6)2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").On (b)(6)2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound") and amenorrhoea ("absence of menstrual periods for more than one year").On (b)(6)2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6)2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6)2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and uterine leiomyoma ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6)2016, the patient experienced chest pain ("chest pain"), palpitations ("palpitations"), mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6)2016, the patient experienced the fourth episode of abdominal pain ("abdominal pain") and the second episode of diarrhoea ("persistent diarrhoea").On (b)(6)2016, the patient experienced ventilation/perfusion scan abnormal ("probably obstructive ventilatory defect").On (b)(6)2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope ("faint"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders") and general physical health deterioration ("health status progressively deteriorated").The patient was hospitalized from (b)(6)2015 to (b)(6)2015.The patient was treated with surgery (hysterectomy with removal of uterine tubes on (b)(6)2017), surgery (the gallbladder was resected.), surgery (bilateral meatotomy) and surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, sensitivity of teeth, abdominal pain lower, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, the last episode of abdominal distension, the last episode of peritoneal adhesions, the last episode of abdominal pain, the last episode of diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, amenorrhoea, ovarian cyst, uterine leiomyoma, crying, constipation, muscle spasms, the last episode of back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, the last episode of arthralgia, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, ventilation/perfusion scan abnormal, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder and general physical health deterioration outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, amenorrhoea, c-reactive protein increased, chest pain, cholelithiasis, constipation, crying, cyst, decreased appetite, dizziness, dyspnoea, ear disorder, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, ovarian cyst, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, respiratory disorder, rheumatic disorder, sciatica, sensitivity of teeth, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, uterine leiomyoma, ventilation/perfusion scan abnormal, the first episode of abdominal distension, the first episode of abdominal pain, the first episode of arthralgia, the first episode of back pain, the first episode of diarrhoea, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, the second episode of abdominal distension, the second episode of abdominal pain, the second episode of arthralgia, the second episode of back pain, the second episode of diarrhoea, the second episode of fatigue, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, the third episode of abdominal pain, the third episode of back pain, the third episode of fatigue and the fourth episode of abdominal pain to be related to essure (ess205).The reporter commented: she was put on disability leave from(b)(6)2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Diagnostic results: (b)(6)2011: ct scan showed no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling (b)(6)2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.(b)(6)2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.(b)(6)2016: blood tests found no abnormalities (b)(6)2016: ctscan found no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out (b)(6)2016: blood tests found no abnormalities (b)(6)2016: pelvic ultrasound showed no abnormalities (b)(6)2016: blood tests found no abnormalities (b)(6)2016:blood tests found no abnormalities (b)(6)2016: pap smear was performed and found no abnormalities (b)(6)2016: renal and pelvic ultrasound showed no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm (b)(6)2016: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess (b)(6)2015: abdominal pelvic ct-scan showed the double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day (b)(6)2016: she underwent spirometry and lung plethysmography the list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6)2018 for the following meddra preferred terms: 1.Allergy to metals: the analysis in the global safety database revealed 403 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on (b)(6)2018: case 2018-046926 was identified as duplicate of this case.All of its information has been transferred.Events added: rheumatologic disorders, ent disorders, health status progressively deteriorated.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 allergy to metals ("strong allergy to nickel"), tooth abscess ("dental abscesses"), small intestinal obstruction ("the small intestine is occluded"), cholelithiasis ("gallstones"), sinusitis aspergillus ("superinfection of the sinuses / very marked aspergillosis"), hydronephrosis ("left ureterohydronephrosis on lithiasis") and nephrolithiasis ("left ureterohydronephrosis on lithiasis") in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 2, chronic diarrhea in 1999, weight loss in 1999, crohn's disease in 1999, partial bowel obstruction and abdominal pain in 1999.The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Concomitant products included prazepam (lysanxia) since (b)(6) 2016 for anxiety and delirium tremens, smectite (smecta) since (b)(6) 2016 for chronic diarrhoea, yeast dried (ultra levura) since (b)(6) 2016 for diarrhoea, amoxicillin since (b)(6) 2016 for infectious disease carrier, pivalone (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6) 2016 for rhinitis, zolpidem (stilnox) since (b)(6) 2016 and zolpidem (stilnox) since (b)(6) 2016 for sleep disturbance, cefpodoxime since (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth ").On (b)(6) 2011, 3 years 11 months after insertion of essure (ess205), the patient experienced the first episode of abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and the first episode of arthralgia ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the second episode of abdominal pain ("abdominal pain"), the first episode of abdominal distension ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced sensitivity of teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced the second episode of fatigue ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and the first episode of diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in december").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced the third episode of back pain ("back pain"), dyspnoea ("shortness of breath") and the third episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain with intermittent bloating") and the second episode of abdominal distension ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").On (b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound") and amenorrhoea ("absence of menstrual periods for more than one year").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and uterine leiomyoma ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6) 2016, the patient experienced chest pain ("chest pain"), palpitations ("palpitations"), mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6) 2016, the patient experienced the fourth episode of abdominal pain ("abdominal pain") and the second episode of diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced ventilation/perfusion scan abnormal ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope ("faint"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders") and general physical health deterioration ("health status progressively deteriorated").The patient was hospitalized from (b)(6) 2015 to (b)(6) 2015.The patient was treated with surgery (hysterectomy with removal of uterine tubes on (b)(6) 2017), surgery (the gallbladder was resected.), surgery (bilateral meatotomy) and surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, sensitivity of teeth, abdominal pain lower, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, the last episode of abdominal distension, the last episode of peritoneal adhesions, the last episode of abdominal pain, the last episode of diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, amenorrhoea, ovarian cyst, uterine leiomyoma, crying, constipation, muscle spasms, the last episode of back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, the last episode of arthralgia, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, ventilation/perfusion scan abnormal, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder and general physical health deterioration outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, amenorrhoea, c-reactive protein increased, chest pain, cholelithiasis, constipation, crying, cyst, decreased appetite, dizziness, dyspnoea, ear disorder, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, ovarian cyst, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, respiratory disorder, rheumatic disorder, sciatica, sensitivity of teeth, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, uterine leiomyoma, ventilation/perfusion scan abnormal, the first episode of abdominal distension, the first episode of abdominal pain, the first episode of arthralgia, the first episode of back pain, the first episode of diarrhoea, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, the second episode of abdominal distension, the second episode of abdominal pain, the second episode of arthralgia, the second episode of back pain, the second episode of diarrhoea, the second episode of fatigue, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, the third episode of abdominal pain, the third episode of back pain, the third episode of fatigue and the fourth episode of abdominal pain to be related to essure (ess205).The reporter commented: she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Diagnostic results: (b)(6) 2011: ct scan showed no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.(b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.(b)(6) 2016: blood tests found no abnormalities (b)(6) 2016: ctscan found no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.(b)(6) 2016: blood tests found no abnormalities (b)(6) 2016: pelvic ultrasound showed no abnormalities (b)(6) 2016: blood tests found no abnormalities (b)(6) 2016:blood tests found no abnormalities (b)(6) 2016: pap smear was performed and found no abnormalities (b)(6) 2016: renal and pelvic ultrasound showed no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.(b)(6) 2016: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.(b)(6) 2015: abdominal pelvic ct-scan showed the double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.(b)(6) 2016: she underwent spirometry and lung plethysmography.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred terms: 1.Allergy to metals: the analysis in the global safety database revealed 403 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on 12-apr-2018: case (b)(4) was identified as duplicate of this case.All of its information has been transferred.Events added: rheumatologic disorders, ent disorders, health status progressively deteriorated.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 allergy to metals ("strong allergy to nickel"), tooth abscess ("dental abscesses"), small intestinal obstruction ("the small intestine is occluded"), cholelithiasis ("gallstones"), sinusitis aspergillus ("superinfection of the sinuses / very marked aspergillosis"), hydronephrosis ("left ureterohydronephrosis on lithiasis") and nephrolithiasis ("left ureterohydronephrosis on lithiasis") in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "left essure insert placement was a little more difficult" on (b)(6)2007.The patient's medical history included parity 2, chronic diarrhea in (b)(6), abdominal pain in (b)(6), weight loss in (b)(6), crohn's disease in (b)(6), partial bowel obstruction, endometritis and synechiae posterior.The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Concomitant products included prazepam (lysanxia) since (b)(6)2016 for anxiety and delirium tremens, smectite (smecta) since (b)(6)2016 for chronic diarrhoea, yeast dried (ultra levura) since (b)(6)2016 for diarrhoea, amoxicillin since (b)(6)2016 for infectious disease carrier, neomycin sulfate;tixocortol pivalate (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6)2016 for nausea and vomiting, paracetamol (paracetamol al) since(b)(6)2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6)2016 for rhinitis, zolpidem tartrate (stilnox) since (b)(6)2016 for sleep disturbance, cefpodoxime since (b)(6)2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6)2016.On (b)(6)2007, the patient had essure (ess205) inserted.In (b)(6), the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth ").On (b)(6)2011, the patient experienced the first episode of abdominal pain ("persistent abdominal pain").On (b)(6)2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and the first episode of arthralgia ("tenderness is present in the sacroiliac region").On (b)(6)2011, the patient experienced the second episode of abdominal pain ("abdominal pain"), the first episode of abdominal distension ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6)2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6)2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6)2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced sensitivity of teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6)2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6)2014, the patient experienced the second episode of fatigue ("excessive fatigue") and crying ("crying").On (b)(6)2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and the first episode of diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in december").On (b)(6)2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6)2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6)2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6)2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6)2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6)2015, the patient experienced the third episode of back pain ("back pain"), dyspnoea ("shortness of breath") and the third episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6)2015, the patient experienced musculoskeletal pain ("scapular pain").In 2015, the patient experienced amenorrhoea ("absence of menstrual periods for more than one year / amenorrhea starting 18 months earlier").On (b)(6)2016, the patient experienced sciatica ("sciatica").On (b)(6)2016, the patient experienced the third episode of abdominal pain ("abdominal pain with intermittent bloating") and the second episode of abdominal distension ("abdominal pain with intermittent bloating").On (b)(6)2016, the patient experienced the second episode of peritoneal adhesions ("numerous adhesions").On (b)(6)2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").On (b)(6)2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound").In july 2016, the patient experienced rash erythematous ("erythematous skin eruption").On (b)(6)2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6)2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6)2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and was found to have the first episode of uterine leiomyoma ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6)2016, the patient experienced chest pain ("chest pain") and palpitations ("palpitations") and was found to have mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6)2016, the patient experienced the fourth episode of abdominal pain ("abdominal pain") and the second episode of diarrhoea ("persistent diarrhoea").On (b)(6)2016, the patient was found to have ventilation/perfusion scan abnormal ("probably obstructive ventilatory defect").On (b)(6)2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), the second episode of arthralgia ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope ("faint"), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), emphysema ("emphysema") and rhinitis ("rhinitis") and was found to have the second episode of uterine leiomyoma ("small subserosal fibroma measuring 16 mm").The patient was hospitalized from (b)(6) 2015 to (b)(6)2015.The patient was treated with surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided, the gallbladder was resected., bilateral meatotomy and hysterectomy with removal of uterine tubes on (b)(6)2017).Essure (ess205) was removed on (b)(6)2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, sensitivity of teeth, abdominal pain lower, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, the last episode of abdominal distension, the last episode of peritoneal adhesions, the last episode of abdominal pain, the last episode of diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, amenorrhoea, ovarian cyst, crying, constipation, muscle spasms, the last episode of back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, the last episode of arthralgia, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, ventilation/perfusion scan abnormal, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder, general physical health deterioration, the last episode of uterine leiomyoma, emphysema, rhinitis and rash erythematous outcome was unknown.The reporter considered abdominal pain lower, allergy to metals, amenorrhoea, c-reactive protein increased, chest pain, cholelithiasis, constipation, crying, cyst, decreased appetite, dizziness, dyspnoea, ear disorder, emphysema, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, ovarian cyst, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, rash erythematous, respiratory disorder, rheumatic disorder, rhinitis, sciatica, sensitivity of teeth, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, ventilation/perfusion scan abnormal, the first episode of abdominal distension, the first episode of abdominal pain, the first episode of arthralgia, the first episode of back pain, the first episode of diarrhoea, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, the first episode of uterine leiomyoma, the second episode of abdominal distension, the second episode of abdominal pain, the second episode of arthralgia, the second episode of back pain, the second episode of diarrhoea, the second episode of fatigue, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, the second episode of uterine leiomyoma, the third episode of abdominal pain, the third episode of back pain, the third episode of fatigue and the fourth episode of abdominal pain to be related to essure (ess205).The reporter commented: hysteroscopy performed on (b)(6)2007 for placement of essure.Right essure insert placement was done with no difficulty, 3 trailing coils.On (b)(6)2016 she underwent spirometry and lung plethysmography.It was also reported that she was put on disability leave from (b)(6)2016 to (b)(6)2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on (b)(6)2016: results: no abnormalities; on (b)(6)2016: results: no abnormalities; on (b)(6)2016: results: no abnormalities; on (b)(6)2016: results: no abnormalities.Computerised tomogram - on (b)(6)2011: results: no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling; on (b)(6)2016: results: no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.Laparoscopy - on (b)(6)2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.; on (b)(6)2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.Nuclear magnetic resonance imaging - on (b)(6)2016: results: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.Smear cervix - on (b)(6)2016: results: no abnormalities.Ultrasound kidney - on (b)(6)2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.Ultrasound pelvis - on (b)(6)2015: results: double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.; on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.; on (b)(6)2016: results: no abnormalities.Most recent follow-up information incorporated above includes: on(b)(6)2019: patient¿s information was updated, and the events uterine fibroma, device insertion difficult, emphysema, rhinitis and erythematous eruption were added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 allergy to metals ('strong allergy to nickel'), tooth abscess ('dental abscesses'), small intestinal obstruction ('the small intestine is occluded'), cholelithiasis ('gallstones'), sinusitis aspergillus ('superinfection of the sinuses / very marked aspergillosis'), hydronephrosis ('left ureterohydronephrosis on lithiasis'), nephrolithiasis ('left ureterohydronephrosis on lithiasis'), syncope ('faint') and pyelonephritis ('pyelonephritis') in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "left essure insert placement was a little more difficult" on (b)(6) 2007.The patient's medical history included tobacco user (10 cigarettes a day) from 2007 to 2017, chronic diarrhoea (accompanied by major abdominal pain) in 1999, abdominal pain in 1999, weight loss in 1999, crohn's disease in 1999, early miscarriage in 1994, parity 2, partial bowel obstruction (hospitalisation due to sub-occlusion of the terminal small intestine in a context of crohn¿s disease), endometritis, vaginal delivery (1990 and 1994) and alcohol use (occasional).The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Previously administered products included for an unreported indication: remicade in 2000, remicade in 2000 and acupan.Past adverse reactions to the above products included anaphylactic shock with remicade; drug hypersensitivity with acupan; and paralysis with remicade.Concomitant products included prazepam (lysanxia) since (b)(6) 2016 for anxiety and delirium tremens, diosmectite (smecta) since (b)(6) 2016 for chronic diarrhoea, alimentary tract and metabolism since (b)(6) 2016 for diarrhoea, amoxicillin since (b)(6) 2016 for infectious disease carrier, neomycin sulfate;tixocortol pivalate (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6) 2016 for rhinitis, zolpidem tartrate (stilnox) since (b)(6) 2016 for sleep disturbance, cefpodoxime since (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth").On (b)(6) 2011, the patient experienced chronic abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and pain sacroiliac ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the first episode of abdominal pain ("abdominal pain"), bloating ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced hyperaesthesia teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in (b)(6)") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced fatigue extreme ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in (b)(6)").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced back pain ("back pain"), dyspnoea ("shortness of breath") and the second episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").In 2015, the patient experienced amenorrhoea ("absence of menstrual periods for more than one year / amenorrhea starting 18 months earlier").In 2015, the patient experienced dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia"), menstruation irregular ("cycle irregularity") and acne ("acne").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the second episode of abdominal pain ("abdominal pain with intermittent bloating") and abdominal bloating ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous omentum adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").In 2016, the patient experienced depression ("depression").On (b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound").In (b)(6) 2016, the patient experienced rash erythematous ("erythematous skin eruption").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and was found to have uterine fibroid ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6) 2016, the patient experienced chest pain ("chest pain") and palpitations ("palpitations") and was found to have mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain") and chronic diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced obstructive airways disorder ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), arthralgia multiple ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope (seriousness criterion medically significant), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), emphysema ("emphysema"), rhinitis ("rhinitis"), anxiety ("anxiety"), renal colic ("renal colic"), pyelonephritis (seriousness criterion medically significant), biliary colic ("hepatic colic") and malaise ("malaise") and was found to have subserous leiomyoma of uterus ("small subserosal fibroma measuring 16 mm").The patient was hospitalized from (b)(6) 2015 to (b)(6) 2015.The patient was treated with surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided, the gallbladder was resected., bilateral meatotomy and hysterectomy with removal of uterine tubes on (b)(6) 2017).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, hyperaesthesia teeth, chronic abdominal pain, abdominal pain lower, pain sacroiliac, bloating, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, abdominal bloating, the last episode of peritoneal adhesions, the last episode of abdominal pain, chronic diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, dysmenorrhoea, amenorrhoea, ovarian cyst, uterine fibroid, fatigue extreme, crying, constipation, diarrhoea, the last episode of back pain, muscle spasms, back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, arthralgia multiple, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, obstructive airways disorder, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder, general physical health deterioration, subserous leiomyoma of uterus, emphysema, rhinitis, rash erythematous, menorrhagia, menstruation irregular, acne, anxiety, depression, renal colic, pyelonephritis, biliary colic and malaise outcome was unknown.The reporter provided no causality assessment for anxiety, biliary colic, depression, malaise, pyelonephritis and renal colic with essure (ess205).The reporter considered abdominal pain lower, acne, allergy to metals, amenorrhoea, bloating, c-reactive protein increased, chest pain, cholelithiasis, chronic abdominal pain, constipation, crying, cyst, decreased appetite, diarrhoea, dizziness, dysmenorrhoea, dyspnoea, ear disorder, emphysema, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hyperaesthesia teeth, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, menorrhagia, menstruation irregular, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, obstructive airways disorder, ovarian cyst, pain sacroiliac, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, rash erythematous, respiratory disorder, rheumatic disorder, rhinitis, sciatica, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, uterine fibroid, the first episode of back pain, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, abdominal bloating, arthralgia multiple, chronic diarrhoea, fatigue extreme, subserous leiomyoma of uterus, the first episode of abdominal pain, the second episode of back pain, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, back pain, the second episode of abdominal pain, the second episode of fatigue and the third episode of abdominal pain to be related to essure (ess205).The reporter commented: hysteroscopy performed on (b)(6) 2007 for placement of essure.Right essure insert placement was done with no difficulty, 3 trailing coils.On (b)(6) 2016 she underwent spirometry and lung plethysmography.It was also reported that she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Medical expert assessment: the anxiety and depression are not caused by the essure implants, as well as the renal colic complicated by pyelonephritis and the hepatic colic.The patient indicates having been transformed after essure removal, but this coincides with menopause, which put an end to perimenopause - a period during which the alleged gynecological problems are likely.There is no organic pathology to explain the malaise and sensations that she feels.The malaise should be attirbuted to her reported excessive anxiety.A late diagnosis of depression is mentioned in 2016, but the patient describes symptoms of untreated severe anxiety.The gynecological symptoms are directly related to the patient's pre-menopausal hormonal state; the symptoms began 5 years prior to menopause in (b)(6) 2015.The urological and digestive pathologies have no relationship to the essure implants.Finally, the positivity of the nickel allergy tests are not representative of an allergy in this case, but rather a simple hypersensitivity.The general symptoms do not in any way correspond to a delayed nickel allergy.These tests do not constitute a medical indication for the removal of the essure implants.The essure implants are not the cause of the problems occurring between 2010 and 2017.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities.Computerised tomogram - on (b)(6) 2011: results: no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling; on (b)(6) 2016: results: no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.Laparoscopy - on (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.; on (b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.Magnetic resonance imaging - on (b)(6) 2016: results: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.Smear cervix - on (b)(6) 2016: results: no abnormalities.Ultrasound kidney - on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.Ultrasound pelvis - on (b)(6) 2015: results: double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.; on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.; on (b)(6) 2016: results: no abnormalities.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-nov-2019: information added: historical drug and condition, events dysmenorrhea, menorrhagia, cycle irregularity, acne, anxiety, depression, renal colic, pyelonephritis, hepatic colic, malaise.Medical expert assessment provided.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We conducted a review of our complaint records and other non-conformances 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 allergy to metals ('strong allergy to nickel'), tooth abscess ('dental abscesses'), small intestinal obstruction ('the small intestine is occluded'), cholelithiasis ('gallstones'), sinusitis aspergillus ('superinfection of the sinuses / very marked aspergillosis'), hydronephrosis ('left ureterohydronephrosis on lithiasis'), nephrolithiasis ('left ureterohydronephrosis on lithiasis'), syncope ('faint') and pyelonephritis ('pyelonephritis') in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "left essure insert placement was a little more difficult" on (b)(6) 2007.The patient's medical history included tobacco user (10 cigarettes a day) from 2007 to 2017, chronic diarrhoea (accompanied by major abdominal pain) in 1999, abdominal pain in 1999, weight loss in 1999, crohn's disease in 1999, early miscarriage in 1994, parity 2, partial bowel obstruction (hospitalisation due to sub-occlusion of the terminal small intestine in a context of crohn¿s disease), endometritis, multigravida (1990 and 1994) and alcohol use (occasional).The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Previously administered products included for an unreported indication: remicade in 2000, remicade in 2000 and acupan.Past adverse reactions to the above products included anaphylactic shock with remicade; drug hypersensitivity with acupan; and paralysis with remicade.Concomitant products included prazepam (lysanxia) since (b)(6) 2016 for anxiety and delirium tremens, diosmectite (smecta) since (b)(6) 2016 for chronic diarrhoea, alimentary tract and metabolism since (b)(6) 2016 for diarrhoea, amoxicillin since (b)(6) 2016 for infectious disease carrier, neomycin sulfate;tixocortol pivalate (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6) 2016 for rhinitis, zolpidem tartrate (stilnox) since (b)(6) 2016 for sleep disturbance, cefpodoxime since (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as colecalciferol (uvedose) since (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth").On (b)(6) 2011, the patient experienced chronic abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and pain sacroiliac ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the first episode of abdominal pain ("abdominal pain"), bloating ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced hyperaesthesia teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in july") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced fatigue extreme ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in december").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced back pain ("back pain"), dyspnoea ("shortness of breath") and the second episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").In 2015, the patient experienced amenorrhoea ("absence of menstrual periods for more than one year / amenorrhea starting 18 months earlier").In 2015, the patient experienced dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia"), menstruation irregular ("cycle irregularity") and acne ("acne").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the second episode of abdominal pain ("abdominal pain with intermittent bloating") and abdominal bloating ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous omentum adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").In 2016, the patient experienced depression ("depression").On (b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound").In (b)(6) 2016, the patient experienced rash erythematous ("erythematous skin eruption").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and was found to have uterine fibroid ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6) 2016, the patient experienced chest pain ("chest pain") and palpitations ("palpitations") and was found to have mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain") and chronic diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced obstructive airways disorder ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), arthralgia multiple ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope (seriousness criterion medically significant), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), emphysema ("emphysema"), rhinitis ("rhinitis"), anxiety ("anxiety"), renal colic ("renal colic"), pyelonephritis (seriousness criterion medically significant), biliary colic ("hepatic colic"), malaise ("malaise") and hypersensitivity ("nickel hypersensitivity") and was found to have subserous leiomyoma of uterus ("small subserosal fibroma measuring 16 mm").The patient was hospitalized from (b)(6) 2015.The patient was treated with surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided, the gallbladder was resected., bilateral meatotomy and hysterectomy with removal of uterine tubes on (b)(6) 2017).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the allergy to metals, pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, hyperaesthesia teeth, chronic abdominal pain, abdominal pain lower, pain sacroiliac, bloating, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, abdominal bloating, the last episode of peritoneal adhesions, the last episode of abdominal pain, chronic diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, dysmenorrhoea, amenorrhoea, ovarian cyst, uterine fibroid, fatigue extreme, crying, constipation, diarrhoea, the last episode of back pain, muscle spasms, back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, arthralgia multiple, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, obstructive airways disorder, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder, general physical health deterioration, subserous leiomyoma of uterus, emphysema, rhinitis, rash erythematous, menorrhagia, menstruation irregular, acne, anxiety, depression, renal colic, pyelonephritis, biliary colic, malaise and hypersensitivity outcome was unknown.The reporter provided no causality assessment for anxiety, biliary colic, depression, malaise, pyelonephritis and renal colic with essure (ess205).The reporter considered abdominal pain lower, acne, allergy to metals, amenorrhoea, bloating, c-reactive protein increased, chest pain, cholelithiasis, chronic abdominal pain, constipation, crying, cyst, decreased appetite, diarrhoea, dizziness, dysmenorrhoea, dyspnoea, ear disorder, emphysema, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hyperaesthesia teeth, hypersensitivity, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, menorrhagia, menstruation irregular, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, obstructive airways disorder, ovarian cyst, pain sacroiliac, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, rash erythematous, respiratory disorder, rheumatic disorder, rhinitis, sciatica, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, uterine fibroid, the first episode of back pain, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, abdominal bloating, arthralgia multiple, chronic diarrhoea, fatigue extreme, subserous leiomyoma of uterus, the first episode of abdominal pain, the second episode of back pain, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, back pain, the second episode of abdominal pain, the second episode of fatigue and the third episode of abdominal pain to be related to essure (ess205).The reporter commented: right essure insert placement was done with no difficulty, 3 trailing coils.On (b)(6) 2016 she underwent spirometry and lung plethysmography.It was also reported that she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Medical expert assessment: the anxiety and depression are not caused by the essure implants, as well as the renal colic complicated by pyelonephritis and the hepatic colic.The patient indicates having been transformed after essure removal, but this coincides with menopause, which put an end to perimenopause - a period during which the alleged gynecological problems are likely.There is no organic pathology to explain the malaise and sensations that she feels.The malaise should be attributed to her reported excessive anxiety.A late diagnosis of depression is mentioned in 2016, but the patient describes symptoms of untreated severe anxiety.The gynecological symptoms are directly related to the patient's pre-menopausal hormonal state; the symptoms began 5 years prior to menopause in (b)(6) 2015.The urological and digestive pathologies have no relationship to the essure implants.Finally, the positivity of the nickel allergy tests are not representative of an allergy in this case, but rather a simple hypersensitivity.The general symptoms do not in any way correspond to a delayed nickel allergy.These tests do not constitute a medical indication for the removal of the essure implants.The essure implants are not the cause of the problems occurring between 2010 and 2017.Medical records: general symptoms do not match delayed nickel allergy, it reflects nickel hypersensitivity, not allergy.Conclusion : essure implants are not the cause of the effects reported between 2010 and 2017.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities.Computerised tomogram - on (b)(6) 2011: results: no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling; on (b)(6) 2016: results: no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.Laparoscopy - on (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.; on (b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.Magnetic resonance imaging - on (b)(6) 2016: results: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.Smear cervix - on (b)(6) 2016: results: no abnormalities.Ultrasound kidney - on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.Ultrasound pelvis - on (b)(6) 2015: results: double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.; on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.; on (b)(6) 2016: results: no abnormalities.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-mar-2020: reporter (hcp), event ¿nickel hypersensitivity¿ added.Essure date was amended from (b)(6) 2007.On 5-mar-2020: no new information.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of tooth abscess ('dental abscesses'), small intestinal obstruction ('the small intestine is occluded'), cholelithiasis ('gallstones'), sinusitis aspergillus ('superinfection of the sinuses / very marked aspergillosis'), hydronephrosis ('left ureterohydronephrosis on lithiasis'), nephrolithiasis ('left ureterohydronephrosis on lithiasis'), syncope ('faint'), pyelonephritis ('pyelonephritis') and multiple episodes of allergy to metals ('nickel hypersensitivity', 'strong allergy to nickel') in a 45-year-old female patient who had essure (ess205) inserted for sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "left essure insert placement was a little more difficult" on (b)(6) 2007.The patient's medical history included tobacco user (10 cigarettes a day) from 2007 to 2017, chronic diarrhoea (accompanied by major abdominal pain) in 1999, abdominal pain in 1999, weight loss in 1999, crohn's disease in 1999, early miscarriage in 1994, parity 2, partial bowel obstruction (hospitalisation due to sub-occlusion of the terminal small intestine in a context of crohn¿s disease), endometritis, multigravida (1990 and 1994) and alcohol use (occasional).The patient had regular gynecological follow ups and no remarkable medical history that could foresee such a deterioration of health status.Previously administered products included for an unreported indication: remicade in 2000, remicade in 2000 and acupan.Past adverse reactions to the above products included anaphylactic shock with remicade; drug hypersensitivity with acupan; and paralysis with remicade.Concomitant products included prazepam (lysanxia) since (b)(6) 2016 for anxiety and delirium tremens, diosmectite (smecta) since (b)(6) 2016 for chronic diarrhoea, alimentary tract and metabolism since (b)(6) 2016 for diarrhoea, amoxicillin since (b)(6) 2016 for infectious disease carrier, neomycin sulfate;tixocortol pivalate (pivalone neomycine) since (b)(6) 2016 for inflammatory reaction and allergic respiratory symptom, metopimazine (vogalene) since (b)(6) 2016 for nausea and vomiting, paracetamol (paracetamol al) since (b)(6) 2016 for pain and fever, melaleuca viridiflora oil (niaouli oil) since (b)(6) 2016 for rhinitis, zolpidem tartrate (stilnox) since (b)(6) 2016 for sleep disturbance, cefpodoxime since (b)(6) 2016 for throat infection, chronic obstructive lung disease, otitis media acute, chest infection and sinusitis as well as cholecalciferol (uvedose) since (b)(6) 2016.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2008, the patient experienced toothache ("dental pain") and teeth brittle ("fragility of her teeth").On (b)(6) 2011, the patient experienced chronic abdominal pain ("persistent abdominal pain").On (b)(6) 2011, the patient experienced abdominal pain lower ("moderate pain in the right iliac fossa") and pain sacroiliac ("tenderness is present in the sacroiliac region").On (b)(6) 2011, the patient experienced the first episode of abdominal pain ("abdominal pain"), bloating ("bloating"), nausea ("nausea") and intestinal dilatation ("the small intestine was distended").On (b)(6) 2011, the patient experienced small intestinal obstruction (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced sinusitis aspergillus (seriousness criterion medically significant).On (b)(6) 2012, the patient experienced the first episode of peritoneal adhesions ("numerous adhesions between omentum and abdominal wall in para-umbilical region").In 2012, the patient experienced tooth abscess (seriousness criterion medically significant) and cyst ("curettage of cyst").In 2013, the patient experienced hyperaesthesia teeth ("very sensitive teeth") and the first episode of fatigue ("very tired").In (b)(6) 2014, the patient experienced the first episode of polymenorrhoea ("her periods twice in (b)(6)") and the first episode of back pain ("lumbar pain in a horizontal band starting months ago and major pain related to movement").On (b)(6) 2014, the patient experienced sleep disorder ("sleep disturbances") and hot flush ("hot flushes").On (b)(6) 2014, the patient experienced fatigue extreme ("excessive fatigue") and crying ("crying").On (b)(6) 2014, the patient experienced constipation ("phase of constipation and chronic diarrhoea") and diarrhoea ("phase of constipation and chronic diarrhoea").In (b)(6) 2014, the patient experienced the second episode of polymenorrhoea ("her periods twice in (b)(6)").On (b)(6) 2014, the patient experienced prolapse ("feeling of prolapse") and stress urinary incontinence ("minor urinary incontinence on effort").On (b)(6) 2015, the patient experienced the second episode of back pain ("lumbar pain") and muscle spasms ("abdominal spasms").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced premature menopause ("early menopause") with hot flush and menstruation irregular.On (b)(6) 2015, the patient experienced fibromyalgia ("the examination raised the question of a diagnosis of fibromyalgia").On (b)(6) 2015, the patient experienced back pain ("back pain"), dyspnoea ("shortness of breath") and the second episode of fatigue ("general fatigue").In (b)(6) 2015, the patient experienced hydronephrosis (seriousness criterion hospitalization) with back pain and pyrexia and nephrolithiasis (seriousness criterion medically significant).On (b)(6) 2015, the patient experienced musculoskeletal pain ("scapular pain").In 2015, the patient experienced amenorrhoea ("absence of menstrual periods for more than one year / amenorrhea starting 18 months earlier").In 2015, the patient experienced dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia"), menstruation irregular ("cycle irregularity") and acne ("acne").On (b)(6) 2016, the patient experienced sciatica ("sciatica").On (b)(6) 2016, the patient experienced the second episode of abdominal pain ("abdominal pain with intermittent bloating") and abdominal bloating ("abdominal pain with intermittent bloating").On (b)(6) 2016, the patient experienced the second episode of peritoneal adhesions ("numerous omentum adhesions").On (b)(6) 2016, the patient experienced synovial cyst ("unruptured cyst in the internal popliteal retrocondylar recess").In 2016, the patient experienced depression ("depression").On (b)(6) 2016, the patient experienced pelvic pain ("violent pain requiring pelvic ultrasound").In (b)(6) 2016, the patient experienced rash erythematous ("erythematous skin eruption").On (b)(6) 2016, the patient experienced hypoacusis ("reduction in hearing on the right"), haematuria ("haematuria"), respiratory disorder ("incipient respiratory involvement") and myopia ("defective near sight in one eye, corrected").On (b)(6) 2016, the patient experienced leukocyturia ("leucocyturia with no significant bacteriuria").On (b)(6) 2016, the patient experienced ovarian cyst ("small cystic formation measuring 13 mm on the right ovary") and was found to have uterine fibroid ("uterine fibroid on the paramedian uterine fundus, measuring 19 mm").On (b)(6) 2016, the patient experienced chest pain ("chest pain") and palpitations ("palpitations") and was found to have mean cell haemoglobin increased ("elevated mean corpuscular haemoglobin"), eosinophil count decreased ("low eosinophil count") and c-reactive protein increased ("elevated c-reactive protein level").On (b)(6) 2016, the patient experienced the third episode of abdominal pain ("abdominal pain") and chronic diarrhoea ("persistent diarrhoea").On (b)(6) 2016, the patient experienced obstructive airways disorder ("probably obstructive ventilatory defect").On (b)(6) 2016, the patient experienced the first episode of allergy to metals (seriousness criteria disability, medically significant and intervention required).On an unknown date, the patient experienced tooth fracture ("numerous broken teeth"), gingival disorder ("damage to gums / fragility of her gums"), decreased appetite ("loss of appetite"), cholelithiasis (seriousness criterion medically significant), spinal pain ("pain in spine"), arthralgia multiple ("multiple joints (predominating in wrists) pain / knee pain in internal compartment"), dizziness ("dizziness"), syncope (seriousness criterion medically significant), rheumatic disorder ("rheumatologic disorders"), ear disorder ("ent disorders"), nasal disorder ("ent disorders"), pharyngeal disorder ("ent disorders"), general physical health deterioration ("health status progressively deteriorated"), emphysema ("emphysema"), rhinitis ("rhinitis"), anxiety ("anxiety"), renal colic ("renal colic"), pyelonephritis (seriousness criterion medically significant), biliary colic ("hepatic colic"), malaise ("malaise") and the second episode of allergy to metals ("nickel hypersensitivity") and was found to have subserous leiomyoma of uterus ("small subserosal fibroma measuring 16 mm").The patient was hospitalized from (b)(6) 2015.The patient was treated with surgery (drainage of the left kidney was performed in emergency and antibiotic therapy was provided, the gallbladder was resected., bilateral meatotomy and hysterectomy with removal of uterine tubes on (b)(6) 2017).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, toothache, teeth brittle, tooth fracture, tooth abscess, gingival disorder, cyst, hyperaesthesia teeth, chronic abdominal pain, abdominal pain lower, pain sacroiliac, bloating, nausea, intestinal dilatation, small intestinal obstruction, decreased appetite, cholelithiasis, hepatic steatosis, abdominal bloating, the last episode of peritoneal adhesions, the last episode of abdominal pain, chronic diarrhoea, sinusitis aspergillus, hypoacusis, sleep disorder, hot flush, prolapse, stress urinary incontinence, the last episode of polymenorrhoea, dysmenorrhoea, amenorrhoea, ovarian cyst, uterine fibroid, fatigue extreme, crying, constipation, diarrhoea, the last episode of back pain, muscle spasms, back pain, dyspnoea, the last episode of fatigue, musculoskeletal pain, sciatica, spinal pain, arthralgia multiple, synovial cyst, hydronephrosis, nephrolithiasis, haematuria, leukocyturia, respiratory disorder, chest pain, palpitations, mean cell haemoglobin increased, eosinophil count decreased, c-reactive protein increased, obstructive airways disorder, myopia, dizziness, syncope, premature menopause, fibromyalgia, rheumatic disorder, ear disorder, nasal disorder, pharyngeal disorder, general physical health deterioration, subserous leiomyoma of uterus, emphysema, rhinitis, rash erythematous, menorrhagia, menstruation irregular, acne, anxiety, depression, renal colic, pyelonephritis, biliary colic, malaise and the last episode of allergy to metals outcome was unknown.The reporter provided no causality assessment for anxiety, biliary colic, depression, malaise, pyelonephritis and renal colic with essure (ess205).The reporter considered abdominal pain lower, acne, amenorrhoea, bloating, c-reactive protein increased, chest pain, cholelithiasis, chronic abdominal pain, constipation, crying, cyst, decreased appetite, diarrhoea, dizziness, dysmenorrhoea, dyspnoea, ear disorder, emphysema, eosinophil count decreased, fibromyalgia, general physical health deterioration, gingival disorder, haematuria, hepatic steatosis, hot flush, hydronephrosis, hyperaesthesia teeth, hypoacusis, intestinal dilatation, leukocyturia, mean cell haemoglobin increased, menorrhagia, menstruation irregular, muscle spasms, musculoskeletal pain, myopia, nasal disorder, nausea, nephrolithiasis, obstructive airways disorder, ovarian cyst, pain sacroiliac, palpitations, pelvic pain, pharyngeal disorder, premature menopause, prolapse, rash erythematous, respiratory disorder, rheumatic disorder, rhinitis, sciatica, sinusitis aspergillus, sleep disorder, small intestinal obstruction, spinal pain, stress urinary incontinence, syncope, synovial cyst, teeth brittle, tooth abscess, tooth fracture, toothache, uterine fibroid, the first episode of allergy to metals, the first episode of back pain, the first episode of fatigue, the first episode of peritoneal adhesions, the first episode of polymenorrhoea, abdominal bloating, arthralgia multiple, chronic diarrhoea, fatigue extreme, subserous leiomyoma of uterus, the first episode of abdominal pain, the second episode of allergy to metals, the second episode of back pain, the second episode of peritoneal adhesions, the second episode of polymenorrhoea, back pain, the second episode of abdominal pain, the second episode of fatigue and the third episode of abdominal pain to be related to essure (ess205).No further causality assessment were provided for the product.The reporter commented: right essure insert placement was done with no difficulty, 3 trailing coils.On (b)(6) 2016 she underwent spirometry and lung plethysmography.It was also reported that she was put on disability leave from (b)(6) 2016 to (b)(6) 2017.Immediately after her hysterectomy, she felt an improvement in her health status and, in particular, resolution of the various types of pain she had experienced constantly for several years.Medical expert assessment: the anxiety and depression are not caused by the essure implants, as well as the renal colic complicated by pyelonephritis and the hepatic colic.The patient indicates having been transformed after essure removal, but this coincides with menopause, which put an end to perimenopause - a period during which the alleged gynecological problems are likely.There is no organic pathology to explain the malaise and sensations that she feels.The malaise should be attributed to her reported excessive anxiety.A late diagnosis of depression is mentioned in 2016, but the patient describes symptoms of untreated severe anxiety.The gynecological symptoms are directly related to the patient's pre-menopausal hormonal state; the symptoms began 5 years prior to menopause in (b)(6) 2015.The urological and digestive pathologies have no relationship to the essure implants.Finally, the positivity of the nickel allergy tests are not representative of an allergy in this case, but rather a simple hypersensitivity.The general symptoms do not in any way correspond to a delayed nickel allergy.These tests do not constitute a medical indication for the removal of the essure implants.The essure implants are not the cause of the problems occurring between 2010 and 2017.Medical records: general symptoms do not match delayed nickel allergy, it reflects nickel hypersensitivity, not allergy.Conclusion : essure implants are not the cause of the effects reported between 2010 and 2017.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities; on (b)(6) 2016: results: no abnormalities.Computerised tomogram - on (b)(6) 2011: results: no abscess and no fluid collection.The small intestine is occluded.The colon was poorly visualised.The right colon appears to me to display slight remodelling; on (b)(6) 2016: results: no disparity in localised calibre and no topographic changes in bowel loops that would suggest peritoneal adhesion.No uptake in bowel wall suggestive of an active episode.Of note, a small nodular element with uptake, adjacent or perhaps dependent, in the region of the right uterine fundus-corpus (possibly subserous).The hypothesis of relapse of crohn¿s disease and of adhesions was therefore ruled out.Laparoscopy - on (b)(6) 2012: laparoscopy by the umbilical approach was performed due to abdominal pain.Numerous adhesions between omentum and abdominal wall in para-umbilical region were present.; on (b)(6) 2015: she again underwent laparoscopy due to sub-occlusion with loss of appetite and gallstones.Magnetic resonance imaging - on (b)(6) 2016: results: mri of right knee was performed due to knee pain in internal compartment.It was concluded to no abnormalities of meniscus or ligaments but found an ¿unruptured cyst in the internal popliteal retrocondylar recess.Smear cervix - on (b)(6) 2016: results: no abnormalities.Ultrasound kidney - on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.Ultrasound pelvis - on (b)(6) 2015: results: double-j catheter on the left.Total resolution of signs of left renal distress.No calculi in kidney, ureter or bladder this day.; on (b)(6) 2016: results: no ultrasonographic abnormalities of the kidneys or bladder.Small cystic formation measuring 13 mm on the right ovary and uterine fibroid on the paramedian uterine fundus, measuring 19 mm.; on (b)(6) 2016: results: no abnormalities.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: 6943323
• MDR Text Key: 89300381
• Report Number: 2951250-2017-04540
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 04/12/2018; 04/17/2018; 03/08/2019; 03/20/2019; 11/12/2019; 11/12/2019; 03/04/2020
• Supplement Dates FDA Received: 04/16/2018; 04/17/2018; 03/16/2019; 03/20/2019; 11/14/2019; 03/10/2020; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALIMENTARY TRACT AND METABOLISM; ALIMENTARY TRACT AND METABOLISM; ALIMENTARY TRACT AND METABOLISM; ALIMENTARY TRACT AND METABOLISM; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; AMOXICILLIN; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; CEFPODOXIME; LYSANXIA; LYSANXIA; LYSANXIA; LYSANXIA; LYSANXIA; LYSANXIA; LYSANXIA; LYSANXIA; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; NIAOULI OIL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PARACETAMOL AL; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; PIVALONE NEOMYCINE; SMECTA; SMECTA [DIOSMECTITE]; SMECTA [DIOSMECTITE]; SMECTA [DIOSMECTITE]; SMECTA [DIOSMECTITE]; SMECTA [SMECTITE]; SMECTA [SMECTITE]; SMECTA [SMECTITE]; STILLNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; STILNOX; ULTRA LEVURA; ULTRA LEVURA; ULTRA LEVURA; ULTRA LEVURA; UVEDOSE; UVEDOSE; UVEDOSE; UVEDOSE; UVEDOSE; UVEDOSE; UVEDOSE; UVEDOSE; VOGALENE; VOGALENE; VOGALENE; VOGALENE; VOGALENE; VOGALENE; VOGALENE; VOGALENE
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 45 YR