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

Model Number ESS305

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

Patient Problems Contusion (1787); Cyst(s) (1800); Diarrhea (1811); Fall (1848); Bone Fracture(s) (1870); Headache (1880); Hearing Loss (1882); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Liver Damage/Dysfunction (1954); Memory Loss/Impairment (1958); Pain (1994); Ulceration (2116); Vomiting (2144); Burning Sensation (2146); Dizziness (2194); Discomfort (2330); Fibrosis (3167); Constipation (3274)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("moderate hypersensitivity to nickel"), cholelithiasis ("dilatation of the gallbladder with an enormous amount of sludge"), cholecystitis acute ("acute exudative cholecystitis"), cholelithiasis ("gallstones"), arnold-chiari malformation ("low lying cerebellar tonsils"), and spinal fracture ("fracture of the junction of c1 posterior arch") in a (b)(6) female patient who had essure 305 inserted for sterilization.The occurrence of additional non-serious events is detailed below.The patient had 2 children.On (b)(6) 2008, patient underwent sterilisation with the essure method.On (b)(6) 2008, the devices were in place.No features suggestive of pelvic infection.She had no relevant medical history.She had regular gynaecological follow-up.Just a few months after placement of the inserts, patient started to experience a certain number of disturbances and lesions that were unusual for her.On (b)(6) 2008, her ferritin level was 406 ng/ml (n 20-160) and had been normal in (b)(6) 2007.On (b)(6) 2008, abdominal ultrasound was normal.On (b)(6) 2010, ferritin was 247.3 ng/ml; on (b)(6) 2015, ferritin was 245.7 ng/ml.On (b)(6) 2015, abdominal ultrasound showed "fatty liver".On (b)(6) 2008, patient consulted with a two-day history of ocular discomfort.Examination found a small ulceration, with fluorescein uptake, in the temporal region.Prescription of ciloxan, vitamin a and vitamin b-12.The ocular discomfort persisted.She developed pain in the limbs for which she underwent x-rays of the knees and feet, as well as the cervical spine, on (b)(6) 2010.No abnormalities were found.On (b)(6) 2010 she experienced vomiting, "epigastric heaviness or burning" and bowel disturbances - frank colon pain and enlarged caecum, which prompted fibroscopy.On (b)(6) 2010, fibroscopy was nearly normal apart from minimal hiatus hernia with no current complications.On (b)(6) 2010, abdominal ultrasound found dilatation of the gallbladder with an enormous amount of sludge and pain on passage of the probe.On (b)(6) 2010, she underwent cholecystectomy with hospitalization from 9 to (b)(6) 2010: acute exudative cholecystitis on chronic reactional cholecystitis due to gallstones.No dysplasia or suspect foci.On (b)(6) 2011, the patient was operated for epigastric hernia on the scar from her cholecystectomy (eventration), as well as resection of two fibroids on the thighs, one on the right and one on the left.Starting 1 year ago, abdominal pain, primarily on right, with gynaecological assessment, i.E.Mri and ultrasound, normal, takes fruit for constipation, not relieved by antispasmodics and spagulax, bloated.Examination found left colon pain with notable faecal matter, but also on right with colon dilated.Pain every day, starting one year ago, at 10 or more on visual analogue scale during menses was reported.On (b)(6) 2014, colonoscopy was normal, although megadolichocolon was diagnosed - goes from constipation to diarrhea, sometimes has untimely diarrhoea for 2-3 weeks.She reported headaches, memory loss, dizziness with loss of balance, which has made her fall several times.On (b)(6) 2010, mri of head due to pain in nape of neck starting about 2 years earlier with reported history of memory loss and irritability.Examination found a type-i chiari malformation, confirmed by repeat mri on (b)(6) 2010.On (b)(6) 2010, electromyography found: electrical signals suggestive of nerve trunk involvement, i.E.Bilateral carpal tunnel syndrome, very mild today on left and moderate on right.On (b)(6) 2010, cervical spine mri due to persistent cervical pain accompanied by paraesthesia in hands with reduction in muscle strength.On (b)(6) 2010, the neurosurgeon, stated that the chiari malformation did not at all account for the patient's symptoms.On (b)(6) 2010 the patient experienced dorsal lumbar trauma due to a fall on the stairs.X-ray and ct-scan found a contusion of the chest and abdominal wall.On (b)(6) 2010, due to persistent sharp pain, she underwent x-ray, which found fracture of the junction of c1 posterior arch.On (b)(6) 2010, x-ray of coccyx and sacrum.On (b)(6) 2010, mri of coccyx and sacrum due to post-traumatic pain in coccyx and sacrum.On (b)(6) 2011, x-ray of pelvis and right hip due to trochanter pain due to trauma.On (b)(6) 2011, pain persisted leading to mri, which found: tenosynovitis at insertion point of gluteus medius on trochanter.On (b)(6) 2011 the patient experienced headaches, neck pain on effort, cough, laughing and dizziness.Flow mri found low lying cerebellar tonsils.On (b)(6) 2011 she experienced major headaches all day, refractory to medical treatment, accompanied by quite frequent dizziness.In (b)(6) 2014, the patient again fell due to dizziness.On (b)(6) 2014, x-ray found posterior fracture of tenth rib on left.On (b)(6) 2010, progressive onset of hearing loss starting approximately one year earlier with feeling of instability.The patient's status was described as being totally satisfactory from an ent standpoint.The patient still had the feeling that her hearing was deteriorating.On (b)(6) 2015, repeat audiogram was performed.On (b)(6) 2015, ct-scan of petrous temporal bone, prescribed due to calcification of left tympanum in posterior-superior portion found only slight thickening and incrustation of calcium on left tympanum.On (b)(6) 2011, the patient underwent 24-hour holter ecg due to palpitations suggestive of ectopic beats, which the patient experienced almost every day.She experienced medial chest pain, more likely oesophageal, and was prescribed spasfon and inexium.Holter ecg found only moderate non-repetitive ventricular ectopic beats with usual features of benign nature.On (b)(6) 2012, she consulted a rheumatologist, who prescribed 12 sessions of physiotherapy due to tendonitis of gluteus medius, more marked on right, with difficulty sleeping on her side.On (b)(6) 2012, due to pain in elbows, x-ray was performed and found slight irregularity of epicondyle.On (b)(6) 2012, groin pain affecting the thigh, at night, along a nerve path, crural in the ankle with heel pain and pain in right elbow (had trouble carrying).On (b)(6) 2012, she had pain in elbows, hips and feet, wakening every night, plantar fasciitis.Since (b)(6), she has had 2 episodes of neck pain with radiation to shoulder blades lasting 4 days and again in late (b)(6), as well as lumbar pain, bilateral heel pain, sacroiliac pain and neck pain.The differential diagnosis between spondylarthropathy with enthesopathy and fibromyalgia was difficult to establish given that the patient was hla b27-negative.She experienced lumbar pain with very long limbering up in the morning with radiation to sacrum at times.Celebrex was very effective.On (b)(6) 2013, the patient underwent digital x-ray of the feet for assessment of bilateral heel pain.On (b)(6) 2013, mri of lumbar spine and sacroiliac joints ruled out the diagnosis of spondylarthropathy (non-radiographic spondylarthropathy) the patient has both enthesopathic and spinal pain, which started a little more than a year ago, i.E.Spinal pain with more or less bilateral radiation to the buttocks, which manifested after a bad fall.Currently, she has lower spine pain with pain in the elbows, gluteus medius and heels.The pain is highly sensitive to anti-inflammatories, however the patient is forced to take them continuously since the pain recurs, especially in the morning, with a limbering up time of 30 minutes and major fatigue.On (b)(6) 2013, full spine mri found no active lesions of enthesitis.Gynaecological disorders: ovarian cyst, fibroids, pelvic pain, herpes and nipple inversion, on (b)(6) 2010, the tests performed as a result of the patient's violent fall found left ovarian cyst with a thin layer of effusion in the recto-uterine pouch.She reported sometimes very violent pelvic pain on right and irregular menstrual cycles.On (b)(6) 2013, due to violent pelvic pain, patient underwent pelvic ultrasound, which found two interstitial fibroids.On (b)(6) 2013, further mri to investigate pelvic endometriosis found no abnormalities.In (b)(6) 2014, she consulted for herpes, and again in (b)(6) 2015.On (b)(6) 2015, she underwent mammography due to recent, minor nipple inversion on right.At the end of 2008, patient reported urinary leakage on effort.The leakages recurred for years.Overactive bladder was diagnosed, as well as incontinence on coughing with full bladder.Treatment with vesicare was introduced.An episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours.Lower limb venous doppler ultrasound found musculoskeletal problem with a lumbar-sacral point of origin recommended osteopathy.Allergy test found moderate hypersensitivity to nickel.On (b)(6) 2017, patient underwent hysterectomy and salpingectomy by the vaginal route without morcellation.Findings of pathological anatomy examination of uterus were pending.An allergy specialist diagnosed moderate hypersensitivity to nickel.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality-safety evaluation of ptc.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) 2017 for the following meddra preferred term: allergy to metals.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ("moderate hypersensitivity to nickel"), cholelithiasis ("dilatation of the gallbladder with an enormous amount of sludge"), cholecystitis acute ("acute exudative cholecystitis"), arnold-chiari malformation ("low lying cerebellar tonsils") and cervical vertebral fracture ("fracture of the junction of c1 posterior arch") in a 35-year-old female patient who had essure (batch no.624275) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 2 (two children (a girl born on (b)(6) 1998 and a boy born on (b)(6) 2006 ectopic pregnancy in 1997, appendicectomy ((age of 10 or 12 years old)), cholecystectomy in 2010, epigastric herniorrhaphy in 2011, bouveret-hoffmann syndrome (two episodes at 18 years old (tachycardia) and bouveret episode at 18 weeks of amenorhhea (pregnancy) - (normal thyroid)) and lobar pneumonia in 2004.Hla b27-negative, gynecological regular follow up, married on (b)(6) 2000.Concurrent conditions included arnold-chiari malformation type i.Family history included non-insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus, psoriasis, hemochromatosis and family history of cardiovascular disorder.Concomitant products included alprazolam (xanax).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient was found to have serum ferritin increased ("increase in serum ferritin"), 1 month 29 days after insertion of essure.In 2008, the patient experienced the first episode of neck pain ("pain in nape of neck"), urinary incontinence ("incontinence on coughing with full bladder / urinary leakage on effort") and abdominal pain lower ("pain in right iliac fossa").In october 2008, the patient experienced eye ulcer ("eye small ulceration") with ocular discomfort.On (b)(6) 2010, the patient experienced vomiting ("vomiting"), abdominal discomfort ("epigastric heaviness or burning") and dyspepsia ("epigastric heaviness or burning").On (b)(6) 2010, the patient experienced cholelithiasis (seriousness criterion hospitalization) and gallbladder enlargement ("dilatation of the gallbladder with an enormous amount of sludge").On (b)(6) 2010, the patient experienced deafness ("progressive onset of hearing loss").On (b)(6) 2010, the patient experienced carpal tunnel syndrome ("bilateral carpal tunnel syndrome").On (b)(6) 2010, the patient experienced the second episode of neck pain ("persistent cervical pain"), paraesthesia ("paraesthesia in hands") and muscular weakness ("reduction in muscle strength").On (b)(6) 2010, the patient experienced cholecystitis acute (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced back injury ("dorsal lumbar trauma due to a fall on the stairs") with back pain and post-traumatic pain and the first episode of fall ("dorsal lumbar trauma due to a fall on the stairs").On (b)(6) 2011, the patient experienced bone pain ("trochanter pain").On (b)(6) 2011, the patient experienced tenosynovitis ("tenosynovitis at insertion point of gluteus medius on trochanter").On (b)(6) 2011, the patient experienced the third episode of neck pain ("neck pain").On (b)(6) 2011, the patient experienced palpitations ("palpitations suggestive of ectopic beats"), ventricular extrasystoles ("moderate non-repetitive ventricular ectopic beats") and chest pain ("medial chest pain").On (b)(6) 2012, the patient experienced tendonitis ("tendonitis of gluteus medius").On (b)(6) 2012, the patient experienced the first episode of arthralgia ("pain in elbows").On (b)(6) 2012, the patient experienced the first episode of pain in extremity ("heel pain").On (b)(6) 2012, the patient experienced groin pain ("groin pain affecting the thigh").On (b)(6) 2013, the patient was found to have uterine leiomyoma ("two interstitial fibroids").On (b)(6) 2014, the patient experienced rib fracture ("posterior fracture of tenth rib on left").In 2014, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea") and herpes virus infection ("herpes").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced tympanic membrane disorder ("calcification of left tympanum in posterior-superior portion / slight thickening and incrustation of calcium on left tympanum").In 2016, the patient experienced abdominal pain ("abdominal pain") and abdominal distension ("bloated").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), arnold-chiari malformation (seriousness criterion medically significant), cervical vertebral fracture (seriousness criterion medically significant), dry eye ("dry eye"), the second episode of pain in extremity ("pain in the limbs"), gastrointestinal disorder ("bowel disturbances"), the first episode of gastrointestinal pain ("frank colon pain"), hiatus hernia ("minimal hiatus hernia"), incisional hernia ("epigastric hernia on the scar from her cholecystectomy (eventration)"), the second episode of gastrointestinal pain ("left colon pain"), intestinal dilatation ("dilated colon / enlarged caecum"), headache ("headaches"), amnesia ("memory loss"), dizziness ("dizziness"), balance disorder ("loss of balance"), the second episode of fall ("fall several times"), irritability ("irritability"), the first episode of back pain ("post-traumatic pain in coccyx and sacrum"), bone disorder ("slight irregularity of epicondyle"), the second episode of arthralgia ("pain in hip"), the third episode of pain in extremity ("pain in feet"), plantar fasciitis ("plantar fasciitis"), the second episode of back pain ("lumbar pain"), the third episode of arthralgia ("sacroiliac pain"), pain ("pain with radiation to shoulder blades"), spondyloarthropathy ("non-radiographic spondylarthropathy"), fatigue ("major fatigue"), ovarian cyst ("ovarian cyst"), pelvic pain ("pelvic pain"), retracted nipple ("nipple inversion"), hypertonic bladder ("overactive bladder"), the fourth episode of pain in extremity ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), feeling hot ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), musculoskeletal disorder ("musculoskeletal problem with a lumbar-sacral point of origin"), eye burns ("eye burns"), adenomyosis ("pathological anatomy examination showed uterus with adenomyosis"), uterine inflammation ("pathological anatomy examination showed showed slight chronic inflammatory remodelling in both tubes") and sinusitis ("sinusitis"), was found to have fibroma ("two fibroids on the thighs") and experienced menstruation irregular.The patient was hospitalized from 9-may-2010 to 13-may-2010.The patient was treated with celecoxib (celebrex), ciprofloxacin hydrochloride (ciloxan), cyanocobalamin, esomeprazole, other drugs for functional gastrointestinal disorders, plantago ovata (spagulax), retinol, solifenacin succinate (vesicare) and surgery (cholecystectomy, hysterectomy and salpingectomy by the vaginal route without morcelation and resection).Essure was removed on (b)(6) 2017.On (b)(6) 2010, the cholecystitis acute had resolved.At the time of the report, the allergy to metals, cholelithiasis, arnold-chiari malformation, serum ferritin increased, hepatic steatosis, eye ulcer, dry eye, vomiting, abdominal discomfort, dyspepsia, gastrointestinal disorder, hiatus hernia, gallbladder enlargement, incisional hernia, fibroma, abdominal pain, abdominal distension, the last episode of gastrointestinal pain, intestinal dilatation, constipation, diarrhoea, headache, amnesia, dizziness, balance disorder, the last episode of fall, irritability, carpal tunnel syndrome, paraesthesia, muscular weakness, back injury, bone pain, tenosynovitis, the last episode of neck pain, rib fracture, deafness, tympanic membrane disorder, palpitations, ventricular extrasystoles, chest pain, tendonitis, bone disorder, plantar fasciitis, the last episode of back pain, the last episode of arthralgia, pain, spondyloarthropathy, fatigue, ovarian cyst, uterine leiomyoma, pelvic pain, herpes virus infection, retracted nipple, hypertonic bladder, urinary incontinence, the last episode of pain in extremity, feeling hot, musculoskeletal disorder, eye burns, abdominal pain lower, adenomyosis, uterine inflammation and sinusitis outcome was unknown.The reporter considered abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, amnesia, arnold-chiari malformation, back injury, balance disorder, bone disorder, bone pain, carpal tunnel syndrome, cervical vertebral fracture, chest pain, cholecystitis acute, cholelithiasis, constipation, deafness, diarrhoea, dizziness, dry eye, dyspepsia, eye burns, eye ulcer, fatigue, feeling hot, fibroma, gallbladder enlargement, gastrointestinal disorder, groin pain, headache, hepatic steatosis, herpes virus infection, hiatus hernia, hypertonic bladder, incisional hernia, intestinal dilatation, irritability, menstruation irregular, muscular weakness, musculoskeletal disorder, ovarian cyst, pain, palpitations, paraesthesia, pelvic pain, plantar fasciitis, retracted nipple, rib fracture, serum ferritin increased, sinusitis, spondyloarthropathy, tendonitis, tenosynovitis, tympanic membrane disorder, urinary incontinence, uterine inflammation, uterine leiomyoma, ventricular extrasystoles, vomiting, the first episode of arthralgia, the first episode of back pain, the first episode of fall, the first episode of gastrointestinal pain, the first episode of neck pain, the first episode of pain in extremity, the second episode of arthralgia, the second episode of back pain, the second episode of fall, the second episode of gastrointestinal pain, the second episode of neck pain, the second episode of pain in extremity, the third episode of arthralgia, the third episode of neck pain, the third episode of pain in extremity and the fourth episode of pain in extremity to be related to essure.The reporter commented: tests performed: on (b)(6) 2014 - urodynamic assessment found small, hypersensitive but stable bladder, no urethral instability, good closure pressure.Transmission defect in middle portion of the urethra, leak when coughing with full bladder, corrected by sub-urethral support.On (b)(6) 2016, venous echo-doppler of lower limbs performed: the deep veins, the right greater saphenous and the small saphenous veins on the right and left are thoroughly present and open.There is limited loss of trunk valves from the hunter to the boyd perforator, with re-entry in a division branch of the left greater saphenous.The problem is more musculo-skeletal, with a lumbosacral point of departure.The patient would certainly benefit from having osteopathy.Pathological anatomy examination performed on (b)(6) 2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on (b)(6) 2018, showed slight chronic inflammatory remodeling.Diagnostic results (normal ranges are provided in parenthesis if available): c-reactive protein (10 mg/l) - on 14-mar-2008: assessment: elevated results: 19 mg/l; on 19-mar-2008: assessment: abnormal nos results: 2 mg/l.Nuclear magnetic resonance imaging - on 21-nov-2013: conclusion: absence of sign of inflammatory enthesopathy.Serum ferritin - in july 2007: normal; on 14-mar-2008: 406 ng/ml; on 12-mar-2009: 201.9; on 26-apr-2010: 247.3; on 20-may-2015: 245.7.Skin test - on (b)(6) 2016: skin tests showed moderate hypersensitivity.Ultrasound abdomen - on (b)(6) 2008: results: normal; on (b)(6) 2015: results: fatty liver.X-ray of pelvis and hip - on (b)(6) 2017: presence of two filiform pelvic shadows, one of the right and the other on the left, radio-opaque, corresponding to two tubal implants on the right and left.Also noted is a rupture of the continuity of the sphericity of the left femoral head at the height of the fovea.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-feb-2019: information received from attorney via legal department.Following insertion of essure, the patient experienced local complications including pain in right iliac fossa.Patient also experienced sinusitis.Mri of heels was performed on (b)(6) 2013 for suspicion of spondyloarthropathy and inflammatory heel pain.Conclusion: absence of sign of inflammatory enthesopathy.Pathological anatomy examination performed on 15-feb-2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on 04-dec-2018, showed slight chronic inflammatory remodeling.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of allergy to metals ('moderate hypersensitivity to nickel'), cholelithiasis ('dilatation of the gallbladder with an enormous amount of sludge'), cholecystitis acute ('acute exudative cholecystitis') and cervical vertebral fracture ('fracture of the junction of c1 posterior arch') in a 35-year-old female patient who had essure (batch no.624275) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included epigastric herniorrhaphy in 2011, cholecystectomy in 2010, breast pain female from 2006 to 2007, cervicalgia in 2005, lobar pneumonia in 2004, flushing (without endocrine pathology) in 2004, ectopic pregnancy in 1997, parity 2 (two children (a girl born on (b)(6) 1998 and a boy born on (b)(6) 2006)), appendicectomy ((age of 10 or 12 years old)), bouveret-hoffmann syndrome (two episodes at 18 years old (tachycardia) and bouveret episode at 18 weeks of amenorrhea (pregnancy) - (normal thyroid)) and medical device pain.Hla b27-negative, gynecological regular follow up, married on (b)(6) 2000.Previously administered products included for hormonal deregulation: melinae in 2005; for libido problems: varnoline; for an unreported indication: cerazette from (b)(6) 2007 to (b)(6) 2007, harmonet from 2001 to 2005 and iud after first pregnancy.Concurrent conditions included arnold-chiari malformation type i.Family history included non-insulin-dependent diabetes mellitus (father, paternal grandmother), psoriasis (father), hemochromatosis (father) and thrombosis (mother).Concomitant products included clobazam (urbanyl) from 2004 to 2005, fluoxetine from 2004 to 2005 and prazepam (lysanxia) from 2004 to 2005 for anxiety and depression, pregabalin (lyrica) since (b)(6) 2010 for fractured sacrum, nomegestrol acetate (lutenyl) since (b)(6) 2013 for menopause as well as alprazolam (xanax).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient was found to have serum ferritin increased ("increase in serum ferritin"), 1 month 29 days after insertion of essure.In 2008, the patient experienced the first episode of neck pain ("pain in nape of neck"), urinary incontinence ("incontinence on coughing with full bladder / urinary leakage on effort") and abdominal pain lower ("pain in right iliac fossa").In (b)(6) 2008, the patient experienced eye ulcer ("eye small ulceration") with ocular discomfort.In 2009, the patient experienced mental fatigue ("psychological exhaustion due to problem with 3 year old son").On (b)(6) 2010, the patient experienced vomiting ("vomiting"), abdominal discomfort ("epigastric heaviness or burning") and dyspepsia ("epigastric heaviness or burning").On (b)(6) 2010, the patient experienced cholelithiasis (seriousness criterion hospitalization) and gallbladder enlargement ("dilatation of the gallbladder with an enormous amount of sludge").On (b)(6) 2010, the patient experienced deafness ("progressive onset of hearing loss").On (b)(6) 2010, the patient experienced carpal tunnel syndrome ("bilateral carpal tunnel syndrome").On (b)(6) 2010, the patient experienced the second episode of neck pain ("persistent cervical pain"), paraesthesia ("paraesthesia in hands") and muscular weakness ("reduction in muscle strength").On (b)(6) 2010, the patient experienced cholecystitis acute (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced back injury ("dorsal lumbar trauma due to a fall on the stairs") with back pain and post-traumatic pain and falling down ("dorsal lumbar trauma due to a fall on the stairs").On (b)(6) 2011, the patient experienced bone pain ("trochanter pain").On (b)(6) 2011, the patient experienced tenosynovitis ("tenosynovitis at insertion point of gluteus medius on trochanter").In 2011, the patient experienced bulimia nervosa ("bulimia with weight gain").On (b)(6) 2011, the patient experienced the third episode of neck pain ("neck pain").On (b)(6) 2011, the patient experienced palpitations ("palpitations suggestive of ectopic beats"), ventricular extrasystoles ("moderate non-repetitive ventricular ectopic beats") and chest pain ("medial chest pain").On (b)(6) 2012, the patient experienced tendonitis ("tendonitis of gluteus medius").On (b)(6) 2012, the patient experienced pain in elbow ("pain in elbows").On (b)(6) 2012, the patient experienced pain in heel ("heel pain").On (b)(6) 2012, the patient experienced groin pain ("groin pain affecting the thigh").In (b)(6) 2013, the patient experienced lumbar pain ("lumbar pain / lumbago").In 2013, the patient experienced menstruation irregular ("irregular menstruations / heavy irregular cycles") and dysmenorrhoea ("dysmenorrhea lateralized to the "ovaries"").On (b)(6) 2013, the patient was found to have uterine leiomyoma ("two interstitial fibroids / uterine myomas (26 ans 16mm)").On (b)(6) 2014, the patient experienced rib fracture ("posterior fracture of tenth rib on left").In 2014, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea") and herpes virus infection ("herpes").On (b)(6) 2015, the patient experienced hot flush ("hot flushes").In (b)(6) 2015, the patient experienced the first episode of oropharyngeal pain ("sore throats").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced tympanic membrane disorder ("calcification of left tympanum in posterior-superior portion / slight thickening and incrustation of calcium on left tympanum").In (b)(6) 2015, the patient experienced lumbago ("lumbago").In 2016, the patient experienced abdominal pain ("abdominal pain") and abdominal distension ("bloated").In (b)(6) 2016, the patient experienced stomatitis ("mouth sores").In (b)(6) 2016, the patient experienced the second episode of oropharyngeal pain ("sore throats").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), cervical vertebral fracture (seriousness criterion medically significant), dry eye ("dry eye"), pain in extremity ("pain in the limbs"), gastrointestinal disorder ("bowel disturbances"), the first episode of gastrointestinal pain ("frank colon pain"), hiatus hernia ("minimal hiatus hernia"), incisional hernia ("epigastric hernia on the scar from her cholecystectomy (eventration)"), the second episode of gastrointestinal pain ("left colon pain"), intestinal dilatation ("dilated colon / enlarged caecum"), headache ("headaches"), amnesia ("memory loss"), dizziness ("dizziness"), balance disorder ("loss of balance"), falling ("fall several times"), irritability ("irritability"), sacral pain ("post-traumatic pain in coccyx and sacrum"), bone disorder ("slight irregularity of epicondyle"), pain in hip ("pain in hip"), painful feet ("pain in feet"), plantar fasciitis ("plantar fasciitis"), arthralgia ("sacroiliac pain"), pain ("pain with radiation to shoulder blades"), spondyloarthropathy ("non-radiographic spondylarthropathy"), fatigue ("major fatigue"), ovarian cyst ("ovarian cyst"), pelvic pain ("pelvic pain"), retracted nipple ("nipple inversion"), hypertonic bladder ("overactive bladder"), pain in thigh ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), feeling hot ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), musculoskeletal disorder ("musculoskeletal problem with a lumbar-sacral point of origin"), eye burns ("eye burns"), adenomyosis ("pathological anatomy examination showed uterus with adenomyosis"), salpingitis ("pathological anatomy examination showed slight chronic inflammatory remodelling in both tubes"), sinusitis ("sinusitis"), oedema peripheral ("edema of lower limbs") and asthenia ("appeared fragile and weak") and was found to have fibroma ("two fibroids on the thighs") and weight increased ("10kg weight gain in 10 years").The patient was hospitalized from (b)(6) 2010 to (b)(6) 2010.The patient was treated with celecoxib (celebrex), ciprofloxacin hydrochloride (ciloxan), cyanocobalamin, esomeprazole, other drugs for functional gastrointestinal disorders, plantago ovata (spagulax), retinol, solifenacin succinate (vesicare) and surgery (cholecystectomy, resection and vaginal hysterectomy and salpingectomy without morcelation).Essure was removed on (b)(6) 2017.On (b)(6) 2010, the cholecystitis acute had resolved.At the time of the report, the allergy to metals, cholelithiasis, cervical vertebral fracture, serum ferritin increased, hepatic steatosis, eye ulcer, dry eye, pain in extremity, vomiting, abdominal discomfort, dyspepsia, gastrointestinal disorder, hiatus hernia, gallbladder enlargement, incisional hernia, fibroma, abdominal pain, abdominal distension, the last episode of gastrointestinal pain, intestinal dilatation, constipation, diarrhoea, headache, amnesia, dizziness, balance disorder, falling, irritability, carpal tunnel syndrome, paraesthesia, muscular weakness, back injury, bone pain, tenosynovitis, the last episode of neck pain, rib fracture, deafness, tympanic membrane disorder, palpitations, ventricular extrasystoles, chest pain, tendonitis, pain in elbow, bone disorder, pain in heel, painful feet, plantar fasciitis, lumbar pain, arthralgia, pain, spondyloarthropathy, fatigue, ovarian cyst, uterine leiomyoma, pelvic pain, herpes virus infection, retracted nipple, hypertonic bladder, urinary incontinence, pain in thigh, feeling hot, musculoskeletal disorder, eye burns, falling down, abdominal pain lower, adenomyosis, salpingitis and sinusitis outcome was unknown.The reporter considered abdominal discomfort, abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, amnesia, asthenia, back injury, balance disorder, bone disorder, bone pain, bulimia nervosa, carpal tunnel syndrome, cervical vertebral fracture, chest pain, cholecystitis acute, cholelithiasis, constipation, deafness, diarrhoea, dizziness, dry eye, dysmenorrhoea, dyspepsia, eye burns, eye ulcer, falling down, fatigue, feeling hot, fibroma, gallbladder enlargement, gastrointestinal disorder, groin pain, headache, hepatic steatosis, herpes virus infection, hiatus hernia, hot flush, hypertonic bladder, incisional hernia, intestinal dilatation, irritability, lumbar pain, menstruation irregular, mental fatigue, muscular weakness, musculoskeletal disorder, oedema peripheral, ovarian cyst, pain, pain in elbow, pain in heel, palpitations, paraesthesia, pelvic pain, plantar fasciitis, retracted nipple, rib fracture, salpingitis, serum ferritin increased, sinusitis, spondyloarthropathy, stomatitis, tendonitis, tenosynovitis, tympanic membrane disorder, urinary incontinence, uterine leiomyoma, ventricular extrasystoles, vomiting, weight increased, the first episode of gastrointestinal pain, the first episode of neck pain, the first episode of oropharyngeal pain, falling, lumbago, pain in extremity, pain in hip, the second episode of gastrointestinal pain, the second episode of neck pain, the second episode of oropharyngeal pain, arthralgia, painful feet, sacral pain, the third episode of neck pain and pain in thigh to be related to essure.No further causality assessment were provided for the product.The reporter commented: tests performed: on (b)(6) 2014 - urodynamic assessment found small, hypersensitive but stable bladder, no urethral instability, good closure pressure.Transmission defect in middle portion of the urethra, leak when coughing with full bladder, corrected by sub-urethral support.On (b)(6) 2016, venous echo-doppler of lower limbs performed: the deep veins, the right greater saphenous and the small saphenous veins on the right and left are thoroughly present and open.There is limited loss of trunk valves from the hunter to the boyd perforator, with re-entry in a division branch of the left greater saphenous.The problem is more musculo-skeletal, with a lumbosacral point of departure.The patient would certainly benefit from having osteopathy.Pathological anatomy examination performed on (b)(6) 2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on (b)(6) 2018, showed slight chronic inflammatory remodeling.Medical history: functional colonopathy with constipation since 1993, heterozygous mhtfr mutation, cerazette (desogestrel) with amenorrhea but stopped due to "polymenorrhea".The insertion technique and post-insertion monitoring were without problems.All of these events were authenticated as secondary to acknowledged organic and/or functional disorders.Several episodes of anxiety/depression, the cause of the physical and psychological exhaustion, were diagnosed and treated during this period.The anxiodepressive events pre-dated the essure insertion.None of these events is secondary to the alleged essure implant toxicity.There is no allergic event responsible for the patient's symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): c-reactive protein (10 mg/l) - on (b)(6) 2008: 19 mg/l; on (b)(6) 2008: 2 mg/l.Magnetic resonance imaging - on (b)(6) 2013: conclusion: absence of sign of inflammatory enthesopathy.Serum ferritin - in (b)(6) 2007: normal; on (b)(6) 2008: 406 ng/ml; on (b)(6) 2009: 201.9 ng/ml; on (b)(6) 2010: 247.3 ng/ml; on (b)(6) 2015: 245.7 ng/ml.Skin test - on (b)(6) 2016: skin tests showed moderate hypersensitivity.Ultrasound abdomen - on (b)(6) 2008: normal; on (b)(6) 2015: fatty liver.X-ray of pelvis and hip - on (b)(6) 2017: presence of two filiform pelvic shadows, one of the right and the other on the left, radio-opaque, corresponding to two tubal implants on the right and left.Also noted is a rupture of the continuity of the sphericity of the left femoral head at the height of the fovea.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: new reporter, medical history, historical drug, concomitant drugs, events: 10kg weight gain in 10 years, edema of lower limbs, appeared fragile and weak, psychological exhaustion due to problem with 3 year old son, bulimia with weight gain, lumbago, hot flushes, mouth sores, sore throats, dysmenorrhea lateralized to the "ovaries" added.Arnold-chiari-malformation deleted as it was reported as a preexisting condition (medical history).We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other non-conformant data; should any new and reportable information become available as a result, 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 ('moderate hypersensitivity to nickel'), cholelithiasis ('dilatation of the gallbladder with an enormous amount of sludge'), cholecystitis acute ('acute exudative cholecystitis') and cervical vertebral fracture ('fracture of the junction of c1 posterior arch') in a 35-year-old female patient who had essure (batch no.624275) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included epigastric herniorrhaphy in 2011, cholecystectomy in 2010, breast pain female from 2006 to 2007, cervicalgia in 2005, lobar pneumonia in 2004, flushing (without endocrine pathology) in 2004, ectopic pregnancy in 1997, parity 2 (two children (a girl born on (b)(6) 1998 and a boy born on (b)(6) 2006)), appendicectomy ((age of 10 or 12 years old)), bouveret-hoffmann syndrome (two episodes at 18 years old (tachycardia) and bouveret episode at 18 weeks of amenorhhea (pregnancy) - (normal thyroid)) and medical device pain.Hla b27-negative, gynecological regular follow up, married on (b)(6) 2000.Previously administered products included for hormonal deregulation: meliane in 2005; for libido problems: varnoline; for an unreported indication: cerazette from (b)(6) 2007 to (b)(6) 2007, harmonet from 2001 to 2005 and iud after first pregnancy.Concurrent conditions included arnold-chiari malformation type i.Family history included non-insulin-dependent diabetes mellitus (father, paternal grandmother), psoriasis (father), hemochromatosis (father) and thrombosis (mother).Concomitant products included clobazam (urbanyl) from 2004 to 2005, fluoxetine from 2004 to 2005 and prazepam (lysanxia) from 2004 to 2005 for anxiety and depression, pregabalin (lyrica) since (b)(6) 2010 for fractured sacrum, nomegestrol acetate (lutenyl) since (b)(6) 2013 for premenopausal symptoms as well as alprazolam (xanax).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient was found to have serum ferritin increased ("increase in serum ferritin"), 1 month 29 days after insertion of essure.In 2008, the patient experienced the first episode of neck pain ("pain in nape of neck"), urinary incontinence ("incontinence on coughing with full bladder / urinary leakage on effort") and abdominal pain lower ("pain in right iliac fossa").In (b)(6) 2008, the patient experienced eye ulcer ("eye small ulceration") with ocular discomfort.In 2009, the patient experienced mental fatigue ("psychological exhaustion due to problem with 3 year old son").On (b)(6) 2010, the patient experienced vomiting ("vomiting"), epigastric discomfort ("epigastric heaviness or burning") and dyspepsia ("epigastric heaviness or burning").On (b)(6)2010, the patient experienced cholelithiasis (seriousness criterion hospitalization) and gallbladder enlargement ("dilatation of the gallbladder with an enormous amount of sludge").On (b)(6) 2010, the patient experienced deafness ("progressive onset of hearing loss").On (b)(6) 2010, the patient experienced carpal tunnel syndrome ("bilateral carpal tunnel syndrome").On (b)(6)2010, the patient experienced the second episode of neck pain ("persistent cervical pain"), paraesthesia ("paraesthesia in hands") and muscular weakness ("reduction in muscle strength").On (b)(6) 2010, the patient experienced cholecystitis acute (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced back injury ("dorsal lumbar trauma due to a fall on the stairs") with back pain and post-traumatic pain and falling down ("dorsal lumbar trauma due to a fall on the stairs").On (b)(6) 2011, the patient experienced bone pain ("trochanter pain").On (b)(6)2011, the patient experienced tenosynovitis ("tenosynovitis at insertion point of gluteus medius on trochanter").In 2011, the patient experienced bulimia nervosa ("bulimia with weight gain").On (b)(6) 2011, the patient experienced the third episode of neck pain ("neck pain").On (b)(6) 2011, the patient experienced palpitations ("palpitations suggestive of ectopic beats"), ventricular extrasystoles ("moderate non-repetitive ventricular ectopic beats") and chest pain ("medial chest pain").On (b)(6) 2012, the patient experienced tendonitis ("tendonitis of gluteus medius").On (b)(6) 2012, the patient experienced pain in elbow ("pain in elbows / joint pain").On (b)(6) 2012, the patient experienced pain in heel ("heel pain").On (b)(6) 2012, the patient experienced groin pain ("groin pain affecting the thigh").In (b)(6) 2013, the patient experienced lumbar pain ("lumbar pain / lumbago").In 2013, the patient experienced menometrorrhagia ("irregular menstruations / heavy irregular cycles / abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)"), dysmenorrhoea ("dysmenorrhea lateralized to the "ovaries"") and menopausal symptoms ("pre-menopause was diagnosed clinically by shortening cycles and then spacing").On (b)(6) 2013, the patient was found to have uterine leiomyoma ("two interstitial fibroids / uterine myomas (26 ans 16mm)").On (b)(6) 2014, the patient experienced rib fracture ("posterior fracture of tenth rib on left").In 2014, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea") and herpes virus infection ("herpes").On (b)(6) 2015, the patient experienced hot flush ("hot flushes").In (b)(6) 2015, the patient experienced the first episode of oropharyngeal pain ("sore throats").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced tympanic membrane disorder ("calcification of left tympanum in posterior-superior portion / slight thickening and incrustation of calcium on left tympanum").In (b)(6)2015, the patient experienced lumbago ("lumbago").In 2016, the patient experienced abdominal pain ("abdominal pain") and abdominal distension ("bloated").In (b)(6) 2016, the patient experienced stomatitis ("mouth sores").In (b)(6) 2016, the patient experienced the second episode of oropharyngeal pain ("sore throats").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), cervical vertebral fracture (seriousness criterion medically significant), dry eye ("dry eye"), pain in extremity ("pain in the limbs"), gastrointestinal disorder ("bowel disturbances"), the first episode of gastrointestinal pain ("frank colon pain"), hiatus hernia ("minimal hiatus hernia"), incisional hernia ("epigastric hernia on the scar from her cholecystectomy (eventration)"), the second episode of gastrointestinal pain ("left colon pain"), intestinal dilatation ("dilated colon / enlarged caecum"), headache ("headaches"), amnesia ("memory loss"), dizziness ("dizziness"), balance disorder ("loss of balance"), falling ("fall several times"), irritability ("irritability"), sacral pain ("post-traumatic pain in coccyx and sacrum"), bone disorder ("slight irregularity of epicondyle"), pain in hip ("pain in hip"), painful feet ("pain in feet"), plantar fasciitis ("plantar fasciitis"), arthralgia ("sacroiliac pain"), pain ("pain with radiation to shoulder blades"), spondyloarthropathy ("non-radiographic spondylarthropathy"), fatigue ("major fatigue"), ovarian cyst ("ovarian cyst"), pelvic pain ("pelvic pain"), retracted nipple ("nipple inversion"), hypertonic bladder ("overactive bladder"), pain in thigh ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), feeling hot ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), musculoskeletal disorder ("musculoskeletal problem with a lumbar-sacral point of origin"), eye burns ("eye burns"), adenomyosis ("pathological anatomy examination showed uterus with adenomyosis"), salpingitis ("pathological anatomy examination showed slight chronic inflammatory remodelling in both tubes"), sinusitis ("sinusitis"), oedema peripheral ("edema of lower limbs"), asthenia ("appeared fragile and weak"), anxiety ("anxiety"), depression ("depressive disorder"), hyperacusis ("temporary hyperacusis"), spinal pain ("spinal mechanic pain"), musculoskeletal pain ("musculoskeletal pain"), menorrhagia ("menorrhagia") and polymenorrhoea ("abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)") and was found to have fibroma ("two fibroids on the thighs") and weight increased ("10kg weight gain in 10 years").The patient was hospitalized from (b)(6) 2010 to (b)(6) 2010.The patient was treated with antidepressants, anxiolytics, celecoxib (celebrex), ciprofloxacin hydrochloride (ciloxan), cyanocobalamin, esomeprazole, other drugs for functional gastrointestinal disorders, plantago ovata (spagulax), retinol, solifenacin succinate (vesicare) and surgery (cholecystectomy, resection and vaginal hysterectomy and salpingectomy without morcelation).Essure was removed on (b)(6) 2017.On (b)(6) 2010, the cholecystitis acute had resolved.At the time of the report, the allergy to metals, cholelithiasis, cervical vertebral fracture, serum ferritin increased, hepatic steatosis, eye ulcer, dry eye, pain in extremity, vomiting, epigastric discomfort, dyspepsia, gastrointestinal disorder, hiatus hernia, gallbladder enlargement, incisional hernia, fibroma, abdominal pain, abdominal distension, the last episode of gastrointestinal pain, intestinal dilatation, constipation, diarrhoea, headache, amnesia, dizziness, balance disorder, falling, irritability, carpal tunnel syndrome, paraesthesia, muscular weakness, back injury, bone pain, tenosynovitis, the last episode of neck pain, rib fracture, deafness, tympanic membrane disorder, palpitations, ventricular extrasystoles, chest pain, tendonitis, pain in elbow, bone disorder, pain in heel, painful feet, plantar fasciitis, lumbar pain, arthralgia, pain, spondyloarthropathy, fatigue, ovarian cyst, uterine leiomyoma, pelvic pain, herpes virus infection, retracted nipple, menometrorrhagia, hypertonic bladder, urinary incontinence, pain in thigh, feeling hot, musculoskeletal disorder, eye burns, falling down, abdominal pain lower, adenomyosis, salpingitis, sinusitis, anxiety, depression, hyperacusis, spinal pain, musculoskeletal pain, menopausal symptoms, menorrhagia and polymenorrhoea outcome was unknown.The reporter considered headache, menometrorrhagia, menopausal symptoms, menorrhagia and uterine leiomyoma to be unrelated to essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, amnesia, anxiety, asthenia, back injury, balance disorder, bone disorder, bone pain, bulimia nervosa, carpal tunnel syndrome, cervical vertebral fracture, chest pain, cholecystitis acute, cholelithiasis, constipation, deafness, depression, diarrhoea, dizziness, dry eye, dysmenorrhoea, dyspepsia, epigastric discomfort, eye burns, eye ulcer, falling down, fatigue, feeling hot, fibroma, gallbladder enlargement, gastrointestinal disorder, groin pain, hepatic steatosis, herpes virus infection, hiatus hernia, hot flush, hyperacusis, hypertonic bladder, incisional hernia, intestinal dilatation, irritability, lumbar pain, mental fatigue, muscular weakness, musculoskeletal disorder, musculoskeletal pain, oedema peripheral, ovarian cyst, pain, pain in elbow, pain in heel, palpitations, paraesthesia, pelvic pain, plantar fasciitis, polymenorrhoea, retracted nipple, rib fracture, salpingitis, serum ferritin increased, sinusitis, spinal pain, spondyloarthropathy, stomatitis, tendonitis, tenosynovitis, tympanic membrane disorder, urinary incontinence, ventricular extrasystoles, vomiting, weight increased, the first episode of gastrointestinal pain, the first episode of neck pain, the first episode of oropharyngeal pain, falling, lumbago, pain in extremity, pain in hip, the second episode of gastrointestinal pain, the second episode of neck pain, the second episode of oropharyngeal pain, arthralgia, painful feet, sacral pain, the third episode of neck pain and pain in thigh to be related to essure.No further causality assessment were provided for the product.The reporter commented: tests performed: on (b)(6)2014 - urodynamic assessment found small, hypersensitive but stable bladder, no urethral instability, good closure pressure.Transmission defect in middle portion of the urethra, leak when coughing with full bladder, corrected by sub-urethral support.On (b)(6)2016, venous echo-doppler of lower limbs performed: the deep veins, the right greater saphenous and the small saphenous veins on the right and left are thoroughly present and open.There is limited loss of trunk valves from the hunter to the boyd perforator, with re-entry in a division branch of the left greater saphenous.The problem is more musculo-skeletal, with a lumbosacral point of departure.The patient would certainly benefit from having osteopathy.Pathological anatomy examination performed on (b)(6)2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on (b)(6)2018, showed slight chronic inflammatory remodeling.Medical history: functional colonopathy with constipation since 1993, heterozygous mhtfr mutation, cerazette (desogestrel) with amenorrhea but stopped due to "polikamenorrhea".The insertion technique and post-insertion monitoring were without problems.All of these events were authenticated as secondary to acknowledged organic and/or functional disorders.Several episodes of anxiety/depression, the cause of the physical and psychological exhaustion, were diagnosed and treated during this period.The anxiodepressive events pre-dated the essure insertion.None of these events is secondary to the alleged essure implant toxicity.There is no allergic event responsible for the patient's symptoms.Temporary hyperacusis was not organic.The patient¿s gynecological disorders are directly linked to the hormonal changes induced by pre-menopause.Diagnostic results (normal ranges are provided in parenthesis if available): c-reactive protein (10 mg/l) - on (b)(6) 2008: 19 mg/l; on (b)(6) 2008: 2 mg/l.Magnetic resonance imaging - on (b)(6) 2013: conclusion: absence of sign of inflammatory enthesopathy.Serum ferritin - in (b)(6) 2007: normal; on (b)(6) 2008: 406 ng/ml; on (b)(6) 2009: 201.9 ng/ml; on (b)(6)2010: 247.3 ng/ml; on (b)(6) 2015: 245.7 ng/ml.Skin test - on (b)(6) 2016: skin tests showed moderate hypersensitivity.Ultrasound abdomen - on (b)(6)2008: normal; on (b)(6) 2015: fatty liver.X-ray of pelvis and hip - on (b)(6) 2017: presence of two filiform pelvic shadows, one of the right and the other on the left, radio-opaque, corresponding to two tubal implants on the right and left.Also noted is a rupture of the continuity of the sphericity of the left femoral head at the height of the fovea.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-may-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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 ('moderate hypersensitivity to nickel'), cholelithiasis ('dilatation of the gallbladder with an enormous amount of sludge'), cholecystitis acute ('acute exudative cholecystitis') and cervical vertebral fracture ('fracture of the junction of c1 posterior arch') in a 35-year-old female patient who had essure (batch no.624275) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included epigastric herniorrhaphy in 2011, cholecystectomy in 2010, breast pain female from 2006 to 2007, cervicalgia in 2005, lobar pneumonia in 2004, flushing (without endocrine pathology) in 2004, ectopic pregnancy in 1997, parity 2 (two children (a girl born on (b)(6) 1998 and a boy born on (b)(6) 2006)), appendicectomy ((age of 10 or 12 years old)), bouveret-hoffmann syndrome (two episodes at 18 years old (tachycardia) and bouveret episode at 18 weeks of amenorhhea (pregnancy) - (normal thyroid)) and medical device pain.Hla b27-negative, gynecological regular follow up, married on (b)(6) 2000.Previously administered products included for hormonal deregulation: meliane in 2005; for libido problems: varnoline; for an unreported indication: cerazette from (b)(6) 2007 to (b)(6) 2007, harmonet from 2001 to 2005 and iud after first pregnancy.Concurrent conditions included arnold-chiari malformation type i.Family history included non-insulin-dependent diabetes mellitus (father, paternal grandmother), psoriasis (father), hemochromatosis (father) and thrombosis (mother).Concomitant products included clobazam (urbanyl) from 2004 to 2005, fluoxetine from 2004 to 2005 and prazepam (lysanxia) from 2004 to 2005 for anxiety and depression, pregabalin (lyrica) since (b)(6) 2010 for fractured sacrum, nomegestrol acetate (lutenyl) since (b)(6) 2013 for premenopausal symptoms as well as alprazolam (xanax).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient was found to have serum ferritin increased ("increase in serum ferritin"), 1 month 29 days after insertion of essure.In 2008, the patient experienced the first episode of neck pain ("pain in nape of neck"), urinary incontinence ("incontinence on coughing with full bladder / urinary leakage on effort") and abdominal pain lower ("pain in right iliac fossa").In (b)(6) 2008, the patient experienced eye ulcer ("eye small ulceration") with ocular discomfort.In 2009, the patient experienced mental fatigue ("psychological exhaustion due to problem with 3 year old son").On (b)(6) 2010, the patient experienced vomiting ("vomiting"), epigastric discomfort ("epigastric heaviness or burning") and dyspepsia ("epigastric heaviness or burning").On (b)(6) 2010, the patient experienced cholelithiasis (seriousness criterion hospitalization) and gallbladder enlargement ("dilatation of the gallbladder with an enormous amount of sludge").On (b)(6) 2010, the patient experienced deafness ("progressive onset of hearing loss").On (b)(6) 2010, the patient experienced carpal tunnel syndrome ("bilateral carpal tunnel syndrome").On (b)(6) 2010, the patient experienced the second episode of neck pain ("persistent cervical pain"), paraesthesia ("paraesthesia in hands") and muscular weakness ("reduction in muscle strength").On (b)(6) 2010, the patient experienced cholecystitis acute (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced back injury ("dorsal lumbar trauma due to a fall on the stairs") with back pain and post-traumatic pain and falling down ("dorsal lumbar trauma due to a fall on the stairs").On (b)(6) 2011, the patient experienced bone pain ("trochanter pain").On (b)(6) 2011, the patient experienced tenosynovitis ("tenosynovitis at insertion point of gluteus medius on trochanter").In 2011, the patient experienced bulimia nervosa ("bulimia with weight gain").On (b)(6) 2011, the patient experienced the third episode of neck pain ("neck pain").On (b)(6) 2011, the patient experienced palpitations ("palpitations suggestive of ectopic beats"), ventricular extrasystoles ("moderate non-repetitive ventricular ectopic beats") and chest pain ("medial chest pain").On (b)(6) 2012, the patient experienced tendonitis ("tendonitis of gluteus medius").On (b)(6) 2012, the patient experienced pain in elbow ("pain in elbows / joint pain").On (b)(6) 2012, the patient experienced pain in heel ("heel pain").On (b)(6) 2012, the patient experienced groin pain ("groin pain affecting the thigh").In (b)(6) 2013, the patient experienced lumbar pain ("lumbar pain / lumbago").In 2013, the patient experienced menometrorrhagia ("irregular menstruations / heavy irregular cycles / abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)"), dysmenorrhoea ("dysmenorrhea lateralized to the "ovaries"") and menopausal symptoms ("pre-menopause was diagnosed clinically by shortening cycles and then spacing").On (b)(6) 2013, the patient was found to have uterine leiomyoma ("two interstitial fibroids / uterine myomas (26 ans 16mm)").On (b)(6) 2014, the patient experienced rib fracture ("posterior fracture of tenth rib on left").In 2014, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea") and herpes virus infection ("herpes").On (b)(6) 2015, the patient experienced hot flush ("hot flushes").In (b)(6) 2015, the patient experienced the first episode of oropharyngeal pain ("sore thoats").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced tympanic membrane disorder ("calcification of left tympanum in posterior-superior portion / slight thickening and incrustation of calcium on left tympanum").In (b)(6) 2015, the patient experienced lumbago ("lumbago").In 2016, the patient experienced abdominal pain ("abdominal pain") and abdominal distension ("bloated").In (b)(6) 2016, the patient experienced stomatitis ("mouth sores").In (b)(6) 2016, the patient experienced the second episode of oropharyngeal pain ("sore thoats").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), cervical vertebral fracture (seriousness criterion medically significant), dry eye ("dry eye"), pain in extremity ("pain in the limbs"), gastrointestinal disorder ("bowel disturbances"), the first episode of gastrointestinal pain ("frank colon pain"), hiatus hernia ("minimal hiatus hernia"), incisional hernia ("epigastric hernia on the scar from her cholecystectomy (eventration)"), the second episode of gastrointestinal pain ("left colon pain"), intestinal dilatation ("dilated colon / enlarged caecum"), headache ("headaches"), amnesia ("memory loss"), dizziness ("dizziness"), balance disorder ("loss of balance"), falling ("fall several times"), irritability ("irritability"), sacral pain ("post-traumatic pain in coccyx and sacrum"), bone disorder ("slight irregularity of epicondyle"), pain in hip ("pain in hip"), painful feet ("pain in feet"), plantar fasciitis ("plantar fasciitis"), arthralgia ("sacroiliac pain"), pain ("pain with radiation to shoulder blades"), spondyloarthropathy ("non-radiographic spondylarthropathy"), fatigue ("major fatigue"), ovarian cyst ("ovarian cyst"), pelvic pain ("pelvic pain"), retracted nipple ("nipple inversion"), hypertonic bladder ("overactive bladder"), pain in thigh ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), feeling hot ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), musculoskeletal disorder ("musculoskeletal problem with a lumbar-sacral point of origin"), eye burns ("eye burns"), adenomyosis ("pathological anatomy examination showed uterus with adenomyosis"), salpingitis ("pathological anatomy examination showed showed slight chronic inflammatory remodelling in both tubes"), sinusitis ("sinusitis"), oedema peripheral ("edema of lower limbs"), asthenia ("appeared fragile and weak"), anxiety ("anxiety"), depression ("depressive disorder"), hyperacusis ("temporary hyperacusis"), spinal pain ("spinal mechanic pain"), musculoskeletal pain ("musculoskeletal pain"), menorrhagia ("menorrhagia") and menstrual disorder ("abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)") and was found to have fibroma ("two fibroids on the thighs") and weight increased ("10kg weight gain in 10 years").The patient was hospitalized from (b)(6) 2010 to (b)(6) 2010.The patient was treated with antidepressants, anxiolytics, celecoxib (celebrex), ciprofloxacin hydrochloride (ciloxan), cyanocobalamin, esomeprazole, other drugs for functional gastrointestinal disorders, plantago ovata (spagulax), retinol, solifenacin succinate (vesicare) and surgery (cholecystectomy, resection and vaginal hysterectomy and salpingectomy without morcelation).Essure was removed on (b)(6) 2017.On (b)(6) 2010, the cholecystitis acute had resolved.At the time of the report, the allergy to metals, cholelithiasis, cervical vertebral fracture, serum ferritin increased, hepatic steatosis, eye ulcer, dry eye, pain in extremity, vomiting, epigastric discomfort, dyspepsia, gastrointestinal disorder, hiatus hernia, gallbladder enlargement, incisional hernia, fibroma, abdominal pain, abdominal distension, the last episode of gastrointestinal pain, intestinal dilatation, constipation, diarrhoea, headache, amnesia, dizziness, balance disorder, falling, irritability, carpal tunnel syndrome, paraesthesia, muscular weakness, back injury, bone pain, tenosynovitis, the last episode of neck pain, rib fracture, deafness, tympanic membrane disorder, palpitations, ventricular extrasystoles, chest pain, tendonitis, pain in elbow, bone disorder, pain in heel, painful feet, plantar fasciitis, lumbar pain, arthralgia, pain, spondyloarthropathy, fatigue, ovarian cyst, uterine leiomyoma, pelvic pain, herpes virus infection, retracted nipple, menometrorrhagia, hypertonic bladder, urinary incontinence, pain in thigh, feeling hot, musculoskeletal disorder, eye burns, falling down, abdominal pain lower, adenomyosis, salpingitis, sinusitis, anxiety, depression, hyperacusis, spinal pain, musculoskeletal pain, menopausal symptoms, menorrhagia and menstrual disorder outcome was unknown.The reporter considered headache, menometrorrhagia, menopausal symptoms, menorrhagia and uterine leiomyoma to be unrelated to essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, amnesia, anxiety, asthenia, back injury, balance disorder, bone disorder, bone pain, bulimia nervosa, carpal tunnel syndrome, cervical vertebral fracture, chest pain, cholecystitis acute, cholelithiasis, constipation, deafness, depression, diarrhoea, dizziness, dry eye, dysmenorrhoea, dyspepsia, epigastric discomfort, eye burns, eye ulcer, falling down, fatigue, feeling hot, fibroma, gallbladder enlargement, gastrointestinal disorder, groin pain, hepatic steatosis, herpes virus infection, hiatus hernia, hot flush, hyperacusis, hypertonic bladder, incisional hernia, intestinal dilatation, irritability, lumbar pain, menstrual disorder, mental fatigue, muscular weakness, musculoskeletal disorder, musculoskeletal pain, oedema peripheral, ovarian cyst, pain, pain in elbow, pain in heel, palpitations, paraesthesia, pelvic pain, plantar fasciitis, retracted nipple, rib fracture, salpingitis, serum ferritin increased, sinusitis, spinal pain, spondyloarthropathy, stomatitis, tendonitis, tenosynovitis, tympanic membrane disorder, urinary incontinence, ventricular extrasystoles, vomiting, weight increased, the first episode of gastrointestinal pain, the first episode of neck pain, the first episode of oropharyngeal pain, falling, lumbago, pain in extremity, pain in hip, the second episode of gastrointestinal pain, the second episode of neck pain, the second episode of oropharyngeal pain, arthralgia, painful feet, sacral pain, the third episode of neck pain and pain in thigh to be related to essure.The reporter commented: tests performed: on (b)(6) 2014 - urodynamic assessment found small, hypersensitive but stable bladder, no urethral instability, good closure pressure.Transmission defect in middle portion of the urethra, leak when coughing with full bladder, corrected by sub-urethral support.On (b)(6) 2016, venous echo-doppler of lower limbs performed: the deep veins, the right greater saphenous and the small saphenous veins on the right and left are thoroughly present and open.There is limited loss of trunk valves from the hunter to the boyd perforator, with re-entry in a division branch of the left greater saphenous.The problem is more musculo-skeletal, with a lumbosacral point of departure.The patient would certainly benefit from having osteopathy.Pathological anatomy examination performed on (b)(6) 2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on (b)(6) 2018, showed slight chronic inflammatory remodeling.Medical history: functional colonopathy with constipation since 1993, heterozygous mhtfr mutation, cerazette (desogestrel) with amenorrhea but stopped due to "polikamenorrhea".The insertion technique and post-insertion monitoring were without problems.All of these events were authenticated as secondary to acknowledged organic and/or functional disorders.Several episodes of anxiety/depression, the cause of the physical and psychological exhaustion, were diagnosed and treated during this period.The anxiodepressive events pre-dated the essure insertion.None of these events is secondary to the alleged essure implant toxicity.There is no allergic event responsible for the patient's symptoms.T emporary hyperacusis was not organic.The patient¿s gynecological disorders are directly linked to the hormonal changes induced by pre-menopause.Diagnostic results (normal ranges are provided in parenthesis if available): c-reactive protein (10 mg/l) - on (b)(6) 2008: 19 mg/l; on (b)(6) 2008: 2 mg/l.Magnetic resonance imaging - on (b)(6) 2013: conclusion: absence of sign of inflammatory enthesopathy.Serum ferritin - (b)(6) skin test - on (b)(6) 2016: skin tests showed moderate hypersensitivity.Ultrasound abdomen - on (b)(6) 2008: normal; on (b)(6) 2015: fatty liver.X-ray of pelvis and hip - on (b)(6) 2017: presence of two filiform pelvic shadows, one of the right and the other on the left, radio-opaque, corresponding to two tubal implants on the right and left.Also noted is a rupture of the continuity of the sphericity of the left femoral head at the height of the fovea.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-feb-2020: events (anxiety, depressive disorder, spinal mechanic pain, musculoskeletal pain, pre-menopause was diagnosed clinically by shortening cycles and then spacing, menorrhagia) added.Reporter¿s causality of the events ¿uterine myomas, irregular menstruations / heavy irregular cycles / abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea), headaches¿ were changed from ¿related¿ to ¿not related¿.A technical investigation was conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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 ('moderate hypersensitivity to nickel'), cholelithiasis ('dilatation of the gallbladder with an enormous amount of sludge'), cholecystitis acute ('acute exudative cholecystitis') and cervical vertebral fracture ('fracture of the junction of c1 posterior arch') in a 35-year-old female patient who had essure (batch no.624275) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included epigastric herniorrhaphy in 2011, cholecystectomy in 2010, breast pain female from 2006 to 2007, cervicalgia in 2005, lobar pneumonia in 2004, flushing (without endocrine pathology) in 2004, ectopic pregnancy in 1997, parity 2 (two children (a girl born on (b)(6) 1998 and a boy born on (b)(6) 2006)), appendicectomy ((age of 10 or 12 years old)), bouveret-hoffmann syndrome (two episodes at 18 years old (tachycardia) and bouveret episode at 18 weeks of amenorhhea (pregnancy) - (normal thyroid)) and medical device pain.Hla b27-negative, gynecological regular follow up, married on (b)(6) 2000.Previously administered products included for hormonal deregulation: meliane in 2005; for libido problems: varnoline; for an unreported indication: cerazette from march 2007 to july 2007, harmonet from 2001 to 2005 and iud after first pregnancy.Concurrent conditions included arnold-chiari malformation type i.Family history included non-insulin-dependent diabetes mellitus (father, paternal grandmother), psoriasis (father), hemochromatosis (father) and thrombosis (mother).Concomitant products included clobazam (urbanyl) from 2004 to 2005, fluoxetine from 2004 to 2005 and prazepam (lysanxia) from 2004 to 2005 for anxiety and depression, pregabalin (lyrica) since (b)(6) 2010 for fractured sacrum, nomegestrol acetate (lutenyl) since (b)(6) 2013 for premenopausal symptoms as well as alprazolam (xanax).On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient was found to have serum ferritin increased ("increase in serum ferritin"), 1 month 29 days after insertion of essure.In 2008, the patient experienced the first episode of neck pain ("pain in nape of neck"), urinary incontinence ("incontinence on coughing with full bladder / urinary leakage on effort") and abdominal pain lower ("pain in right iliac fossa").In (b)(6) 2008, the patient experienced eye ulcer ("eye small ulceration") with ocular discomfort.In 2009, the patient experienced mental fatigue ("psychological exhaustion due to problem with 3 year old son").On (b)(6) 2010, the patient experienced vomiting ("vomiting"), epigastric discomfort ("epigastric heaviness or burning") and dyspepsia ("epigastric heaviness or burning").On (b)(6) 2010, the patient experienced cholelithiasis (seriousness criterion hospitalization) and gallbladder enlargement ("dilatation of the gallbladder with an enormous amount of sludge").On (b)(6) 2010, the patient experienced deafness ("progressive onset of hearing loss").On (b)(6) 2010, the patient experienced carpal tunnel syndrome ("bilateral carpal tunnel syndrome").On (b)(6) 2010, the patient experienced the second episode of neck pain ("persistent cervical pain"), paraesthesia ("paraesthesia in hands") and muscular weakness ("reduction in muscle strength").On (b)(6) 2010, the patient experienced cholecystitis acute (seriousness criterion medically significant).On (b)(6) 2010, the patient experienced back injury ("dorsal lumbar trauma due to a fall on the stairs") with back pain and post-traumatic pain and falling down ("dorsal lumbar trauma due to a fall on the stairs").On (b)(6) 2011, the patient experienced bone pain ("trochanter pain").On (b)(6) 2011, the patient experienced tenosynovitis ("tenosynovitis at insertion point of gluteus medius on trochanter").In 2011, the patient experienced bulimia nervosa ("bulimia with weight gain").On (b)(6) 2011, the patient experienced the third episode of neck pain ("neck pain").On (b)(6) 2011, the patient experienced palpitations ("palpitations suggestive of ectopic beats"), ventricular extrasystoles ("moderate non-repetitive ventricular ectopic beats") and chest pain ("medial chest pain").On (b)(6) 2012, the patient experienced tendonitis ("tendonitis of gluteus medius").On (b)(6) 2012, the patient experienced pain in elbow ("pain in elbows / joint pain").On (b)(6) 2012, the patient experienced pain in heel ("heel pain").On (b)(6) 2012, the patient experienced groin pain ("groin pain affecting the thigh").In (b)(6) 2013, the patient experienced lumbar pain ("lumbar pain / lumbago").In 2013, the patient experienced menometrorrhagia ("irregular menstruations / heavy irregular cycles / abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)"), dysmenorrhoea ("dysmenorrhea lateralized to the "ovaries"") and menopausal symptoms ("pre-menopause was diagnosed clinically by shortening cycles and then spacing").On (b)(6) 2013, the patient was found to have uterine leiomyoma ("two interstitial fibroids / uterine myomas (26 ans 16mm)").On (b)(6) 2014, the patient experienced rib fracture ("posterior fracture of tenth rib on left").In 2014, the patient experienced constipation ("constipation"), diarrhoea ("diarrhea") and herpes virus infection ("herpes").On (b)(6) 2015, the patient experienced hot flush ("hot flushes").In (b)(6) 2015, the patient experienced the first episode of oropharyngeal pain ("sore thoats").On (b)(6) 2015, the patient experienced hepatic steatosis ("fatty liver").On (b)(6) 2015, the patient experienced tympanic membrane disorder ("calcification of left tympanum in posterior-superior portion / slight thickening and incrustation of calcium on left tympanum").In (b)(6) 2015, the patient experienced lumbago ("lumbago").In 2016, the patient experienced abdominal pain ("abdominal pain") and abdominal distension ("bloated").In (b)(6) 2016, the patient experienced stomatitis ("mouth sores").In (b)(6) 2016, the patient experienced the second episode of oropharyngeal pain ("sore thoats").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), cervical vertebral fracture (seriousness criterion medically significant), dry eye ("dry eye"), pain in extremity ("pain in the limbs"), gastrointestinal disorder ("bowel disturbances"), the first episode of gastrointestinal pain ("frank colon pain"), hiatus hernia ("minimal hiatus hernia"), incisional hernia ("epigastric hernia on the scar from her cholecystectomy (eventration)"), the second episode of gastrointestinal pain ("left colon pain"), intestinal dilatation ("dilated colon / enlarged caecum"), headache ("headaches"), amnesia ("memory loss"), dizziness ("dizziness"), balance disorder ("loss of balance"), falling ("fall several times"), irritability ("irritability"), sacral pain ("post-traumatic pain in coccyx and sacrum"), bone disorder ("slight irregularity of epicondyle"), pain in hip ("pain in hip"), painful feet ("pain in feet"), plantar fasciitis ("plantar fasciitis"), arthralgia ("sacroiliac pain"), pain ("pain with radiation to shoulder blades"), spondyloarthropathy ("non-radiographic spondylarthropathy"), fatigue ("major fatigue"), ovarian cyst ("ovarian cyst"), pelvic pain ("pelvic pain"), retracted nipple ("nipple inversion"), hypertonic bladder ("overactive bladder"), pain in thigh ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), feeling hot ("an episode of major pain in internal aspect of left thigh with a feeling of warmth for 48 hours"), musculoskeletal disorder ("musculoskeletal problem with a lumbar-sacral point of origin"), eye burns ("eye burns"), adenomyosis ("pathological anatomy examination showed uterus with adenomyosis"), salpingitis ("pathological anatomy examination showed showed slight chronic inflammatory remodelling in both tubes"), sinusitis ("sinusitis"), oedema peripheral ("edema of lower limbs"), asthenia ("appeared fragile and weak"), anxiety ("anxiety"), depression ("depressive disorder"), hyperacusis ("temporary hyperacusis"), spinal pain ("spinal mechanic pain"), musculoskeletal pain ("musculoskeletal pain"), menorrhagia ("menorrhagia") and menstrual disorder ("abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea)") and was found to have fibroma ("two fibroids on the thighs") and weight increased ("10kg weight gain in 10 years").The patient was hospitalized from (b)(6) 2010.The patient was treated with antidepressants, anxiolytics, celecoxib (celebrex), ciprofloxacin hydrochloride (ciloxan), cyanocobalamin, esomeprazole, other drugs for functional gastrointestinal disorders, plantago ovata (spagulax), retinol, solifenacin succinate (vesicare) and surgery (cholecystectomy, resection and vaginal hysterectomy and salpingectomy without morcelation).Essure was removed on (b)(6)2017.On (b)(6) 2010, the cholecystitis acute had resolved.At the time of the report, the allergy to metals, cholelithiasis, cervical vertebral fracture, serum ferritin increased, hepatic steatosis, eye ulcer, dry eye, pain in extremity, vomiting, epigastric discomfort, dyspepsia, gastrointestinal disorder, hiatus hernia, gallbladder enlargement, incisional hernia, fibroma, abdominal pain, abdominal distension, the last episode of gastrointestinal pain, intestinal dilatation, constipation, diarrhoea, headache, amnesia, dizziness, balance disorder, falling, irritability, carpal tunnel syndrome, paraesthesia, muscular weakness, back injury, bone pain, tenosynovitis, the last episode of neck pain, rib fracture, deafness, tympanic membrane disorder, palpitations, ventricular extrasystoles, chest pain, tendonitis, pain in elbow, bone disorder, pain in heel, painful feet, plantar fasciitis, lumbar pain, arthralgia, pain, spondyloarthropathy, fatigue, ovarian cyst, uterine leiomyoma, pelvic pain, herpes virus infection, retracted nipple, menometrorrhagia, hypertonic bladder, urinary incontinence, pain in thigh, feeling hot, musculoskeletal disorder, eye burns, falling down, abdominal pain lower, adenomyosis, salpingitis, sinusitis, anxiety, depression, hyperacusis, spinal pain, musculoskeletal pain, menopausal symptoms, menorrhagia and menstrual disorder outcome was unknown.The reporter considered headache, menometrorrhagia, menopausal symptoms, menorrhagia and uterine leiomyoma to be unrelated to essure.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, amnesia, anxiety, asthenia, back injury, balance disorder, bone disorder, bone pain, bulimia nervosa, carpal tunnel syndrome, cervical vertebral fracture, chest pain, cholecystitis acute, cholelithiasis, constipation, deafness, depression, diarrhoea, dizziness, dry eye, dysmenorrhoea, dyspepsia, epigastric discomfort, eye burns, eye ulcer, falling down, fatigue, feeling hot, fibroma, gallbladder enlargement, gastrointestinal disorder, groin pain, hepatic steatosis, herpes virus infection, hiatus hernia, hot flush, hyperacusis, hypertonic bladder, incisional hernia, intestinal dilatation, irritability, lumbar pain, menstrual disorder, mental fatigue, muscular weakness, musculoskeletal disorder, musculoskeletal pain, oedema peripheral, ovarian cyst, pain, pain in elbow, pain in heel, palpitations, paraesthesia, pelvic pain, plantar fasciitis, retracted nipple, rib fracture, salpingitis, serum ferritin increased, sinusitis, spinal pain, spondyloarthropathy, stomatitis, tendonitis, tenosynovitis, tympanic membrane disorder, urinary incontinence, ventricular extrasystoles, vomiting, weight increased, the first episode of gastrointestinal pain, the first episode of neck pain, the first episode of oropharyngeal pain, falling, lumbago, pain in extremity, pain in hip, the second episode of gastrointestinal pain, the second episode of neck pain, the second episode of oropharyngeal pain, arthralgia, painful feet, sacral pain, the third episode of neck pain and pain in thigh to be related to essure.The reporter commented: tests performed: on (b)(6) 2014 - urodynamic assessment found small, hypersensitive but stable bladder, no urethral instability, good closure pressure.Transmission defect in middle portion of the urethra, leak when coughing with full bladder, corrected by sub-urethral support.On (b)(6) 2016, venous echo-doppler of lower limbs performed: the deep veins, the right greater saphenous and the small saphenous veins on the right and left are thoroughly present and open.There is limited loss of trunk valves from the hunter to the boyd perforator, with re-entry in a division branch of the left greater saphenous.The problem is more musculo-skeletal, with a lumbosacral point of departure.The patient would certainly benefit from having osteopathy.Pathological anatomy examination performed on (b)(6) 2017 showed no histological abnormality for fallopian tubes, uterus with adenomyosis.Pathological anatomy examination of new sections on distal part of the right and left tubes, performed on (b)(6) 2018, showed slight chronic inflammatory remodeling.Medical history: functional colonopathy with constipation since 1993, heterozygous mhtfr mutation, cerazette (desogestrel) with amenorrhea but stopped due to "polikamenorrhea".The insertion technique and post-insertion monitoring were without problems.All of these events were authenticated as secondary to acknowledged organic and/or functional disorders.Several episodes of anxiety/depression, the cause of the physical and psychological exhaustion, were diagnosed and treated during this period.The anxiodepressive events pre-dated the essure insertion.None of these events is secondary to the alleged essure implant toxicity.There is no allergic event responsible for the patient's symptoms.T emporary hyperacusis was not organic.The patient¿s gynecological disorders are directly linked to the hormonal changes induced by pre-menopause.Diagnostic results (normal ranges are provided in parenthesis if available): c-reactive protein (10 mg/l) - on (b)(6) 2008: 19 mg/l; on (b)(6) 2008: 2 mg/l.Magnetic resonance imaging - on (b)(6) 2013: conclusion: absence of sign of inflammatory enthesopathy.Serum ferritin - in (b)(6) 2007: normal; on (b)(6) 2008: 406 ng/ml; on (b)(6) 2009: 201.9 ng/ml; on (b)(6) 2010: 247.3 ng/ml; on (b)(6) 2015: 245.7 ng/ml.Skin test - on (b)(6) 2016: skin tests showed moderate hypersensitivity.Ultrasound abdomen - on (b)(6) 2008: normal; on (b)(6) 2015: fatty liver.X-ray of pelvis and hip - on (b)(6) 2017: presence of two filiform pelvic shadows, one of the right and the other on the left, radio-opaque, corresponding to two tubal implants on the right and left.Also noted is a rupture of the continuity of the sphericity of the left femoral head at the height of the fovea.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: events (anxiety, depressive disorder, spinal mechanic pain, musculoskeletal pain, pre-menopause was diagnosed clinically by shortening cycles and then spacing, menorrhagia) added.Reporter¿s causality of the events ¿uterine myomas, irregular menstruations / heavy irregular cycles / abnormality in the duration of the menstrual cycle (spaniomenorrhea alternating with pollakimenorrhea), headaches¿ were changed from ¿related¿ to ¿not related¿.A technical investigation was conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 6940261
• MDR Text Key: 89253286
• Report Number: 2951250-2017-04469
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2009
• Device Model Number: ESS305
• Device Lot Number: 624275
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOXETINE.; FLUOXETINE.; FLUOXETINE.; FLUOXETINE.; LUTENYL.; LUTENYL.; LUTENYL.; LUTENYL.; LYRICA.; LYRICA.; LYRICA.; LYRICA.; LYSANXIA.; LYSANXIA.; LYSANXIA.; LYSANXIA.; URBANYL.; URBANYL.; URBANYL.; URBANYL.; XANAX (ALPRAZOLAM).; XANAX.; XANAX.; XANAX.; XANAX.; XANAX.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR