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Bayer case number: (b)(4) pelvic pain female [pelvic pain female], right lumbar fossa pain [flank pain], chronic abdominal pain [chronic abdominal pain] , rheumatic pain [rheumatics] , spinal pain [spinal pain] , left shoulder pain radiating to the head [shoulder pain] , radiation into the paraspinal muscles [muscle pain] , thrusting pain [sore throat] , pain on weight-bearing [pain] , sensation of heat associated with pain [sensation of heat], pain worsened by exertion and activities [pain upon movement] , pain at pressure points [pain localized] , neck pain [neck pain] , arnold's neuralgia [arnold neuralgia] , significant asthenia [asthenia], persistent fatigue despite rest [chronic fatigue], insomnia [insomnia] , fragmented sleep [sleep maintenance insomnia] , iron deficiency [iron deficiency], folate deficiency [folate deficiency] , menorrhagia [menorrhagia] , constipation [constipation] , large thyroid goiter [hyperthyroid goiter] , large right thyroid nodule [thyroid nodule], compressive discomfort [discomfort] , burnout [burnout syndrome] , anxiety attacks [anxiety attack] , depression [depression] , flucrative mood [mood change] , reanl cell carcinoma [renal cell carcinoma] , left subcapsular liver cyst [hepatic cyst], panic attack [panic attack] , intolerable rheumatic pain [rheumatics] , psychological pain [psychalgia] , significantly disrupted her daily life [impaired quality of life] , revealed multi-metal poisoning [heavy metal poisoning] , sick leave [sick leave].Case narrative: this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain female") in a female patient who had essure inserted (lot no.He0119j) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of parity 2.The patient had a family history of kidney cancer (paternal grandmother).On (b)(6) 2016, the patient had essure inserted.Essure was removed on (b)(6) 2025.On unknown date she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), flank pain ("right lumbar fossa pain"), abdominal pain ("chronic abdominal pain"), a first episode of rheumatic disorder ("rheumatic pain"), spinal pain ("spinal pain "), arthralgia ("left shoulder pain radiating to the head"), myalgia ("radiation into the paraspinal muscles"), oropharyngeal pain ("thrusting pain"), pain ("pain on weight-bearing"), feeling hot ("sensation of heat associated with pain"), pain upon movement ("pain worsened by exertion and activities"), pain localized ("pain at pressure points"), neck pain ("neck pain "), occipital neuralgia ("arnold's neuralgia "), asthenia ("significant asthenia"), fatigue ("persistent fatigue despite rest"), insomnia ("insomnia"), middle insomnia ("fragmented sleep "), iron deficiency ("iron deficiency "), folate deficiency ("folate deficiency"), heavy menstrual bleeding ("menorrhagia"), constipation ("constipation"), toxic nodular goitre ("large thyroid goiter"), thyroid mass ("large right thyroid nodule "), discomfort ("compressive discomfort"), burnout syndrome ("burnout"), anxiety ("anxiety attacks"), depression ("depression"), mood altered ("flucrative mood"), hepatic cyst ("left subcapsular liver cyst"), panic attack ("panic attack"), a second episode of rheumatic disorder (" intolerable rheumatic pain"), somatic symptom disorder ("psychological pain"), impaired quality of life ("significantly disrupted her daily life"), metal poisoning (" revealed multi-metal poisoning") and sick leave ("sick leave") and was found to have renal cell carcinoma ("reanl cell carcinoma").The patient was hospitalised from (b)(6) 2025.The patient was treated with arcoxia (etoricoxib), tardyferon (ferrous sulfate) and speciafoldine (folic acid) as well as surgery (bilateral salpingectomy under general anesthesia and partial nephrectomy on (b)(6) 2022).At the time of the report, the outcomes for pelvic pain, flank pain, abdominal pain, spinal pain, arthralgia, oropharyngeal pain, pain, feeling hot, pain upon movement, pain localized, neck pain, occipital neuralgia, asthenia, fatigue, insomnia, middle insomnia, iron deficiency, folate deficiency, heavy menstrual bleeding, constipation, toxic nodular goitre, thyroid mass, discomfort, burnout syndrome, anxiety, depression, mood altered, hepatic cyst, panic attack, somatic symptom disorder, impaired quality of life, metal poisoning, sick leave and the last episode of rheumatic disorder were unknown.The reporter considered abdominal pain, anxiety, arthralgia, asthenia, burnout syndrome, constipation, depression, discomfort, fatigue, feeling hot, flank pain, folate deficiency, heavy menstrual bleeding, hepatic cyst, impaired quality of life, insomnia, iron deficiency, metal poisoning, middle insomnia, mood altered, myalgia, neck pain, occipital neuralgia, oropharyngeal pain, pain upon movement, pain, pain localized, panic attack, pelvic pain, renal cell carcinoma, the first episode of rheumatic disorder, the second episode of rheumatic disorder, sick leave, somatic symptom disorder, spinal pain, thyroid mass and toxic nodular goitre to be related to essure administration.The reporter commented: on (b)(6) 2016, the patient underwent an implantation procedure of the medical device essure.Subsequently, she developed several symptoms.Due to her health condition, the implant was removed on (b)(6) 2025, by bilateral salpingectomy under general anesthesia.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2025: the results were normal.A bilateral mammogram was performed the same day.Nothing suspicious was detected: no focal abnormality of the breast echostructure was found.There was no visible suspicious ultrasound image [computerised tomogram pelvis] on (b)(6) 2022: a multilocular cystic mass was found: multilocular cystic mass with a thickened wall, containing vegetations, with significant enhancement, measuring 5 cm in its longest axis, at the upper pole of the left kidney.[computerised tomogram thorax] on (b)(6) 2022: as part of the investigation for a probable 47 mm tumor in the upper left pole of the kidney.The examination was generally reassuring, with no pulmonary or lymph node abnormalities, but revealed a goiter associated with a right thyroid nodule.There were no pulmonary parenchymal abnormalities or thoracic lymphadenopathy.The thyroid goiter with a hypodense nodule in the right lobe should be correlated with the patient's history or with a thyroid ultrasound.A 6 mm hypodense subcapsular nodule was also found in segment iv of the liver; on (b)(6) 2022:.A small cyst was found: post-operative changes in the left kidney.No particularly noticeable adverse findings.A small left subcapsular liver cyst was also noted.[computerised tomogram thorax] on (b)(6) 2022: as part of the investigation for a probable 47 mm tumor in the upper left pole of the kidney.The examination was generally reassuring, with no pulmonary or lymph node abnormalities, but revealed a goiter associated with a right thyroid nodule.There were no pulmonary parenchymal abnormalities or thoracic lymphadenopathy.The thyroid goiter with a hypodense nodule in the right lobe should be correlated with the patient's history or with a thyroid ultrasound.A 6 mm hypodense subcapsular nodule was also found in segment iv of the liver; on (b)(6) 2022:.A small cyst was found: post-operative changes in the left kidney.No particularly noticeable adverse findings.A small left subcapsular liver cyst was also noted.[hair metal test] on (b)(6) 2025: it revealed high levels of barium, cobalt, manganese, strontium, nickel, cerium, and gadolinium [mammogram] on (b)(6) 2023: the results were normal: overall, the breast imaging was reassuring.Mammography classified as acr i, according to the bi-rads classification of the acr adapted by the anaes [microbiology test] on (b)(6) 2022: no abnormalities were found: no evidence of a urinary tract infection.[ultrasound abdomen] on (b)(6) 2022: she experienced pain in the right lower back following a bowel.Disorder.A mass was then noted in the upper pole of the left kidney.No other notable ultrasound abnormalities.[ultrasound pelvis] on (b)(6) 2024: the findings were normal: the uterus was normally positioned, of normal.Size and morphology, measuring 91 x 48 x 68 mm.Its echostructure was homogeneous.Its midline cavity was virtually.Nonexistent.The endometrium was hyperechoic and regular, measuring 4.5 mm thick for both layers.Both ovaries were of normal.Morphology, echostructure, and size.There were no visible cysts or abnormal masses.No fluid was visible in the pouch of douglas.The renal pelvis and calyces of both kidneys were not dilated.; on (b)(6) 2025: no significant anatomical abnormalities.[x-ray] on (b)(6) 2024: nothing abnormal was detected: tubal devices in pelvic projection.Right pelvic phleboliths.No bone structure abnormalities.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly; no signal was observed with regard to the reason for the reported complaint.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 02-apr-2026: medical record received.Event medical device removal is replaced with pelvic pain female.New events flank pain, abdominal pain, spinal pain, arthralgia, oropharyngeal pain, pain, feeling hot, pain upon movement, pain localized, neck pain, occipital neuralgia, asthenia, fatigue, insomnia, middle insomnia, iron deficiency, folate deficiency, heavy menstrual bleeding, constipation, toxic nodular goitre, thyroid mass, discomfort, burnout syndrome, anxiety, depression, mood altered, hepatic cyst, panic attack, somatic symptom disorder, impaired quality of life, metal poisoning, sick rheumatic disorder were added.Medical history, patients date of birth, lab data & treatment drugs were added.Lot number added.01-apr-2026: health authority reference number added.Case comments: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.In case a sample is received the investigation might lead to destruction of the sample if required to perform a proper analysis.
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