| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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| Patient Problems
Abdominal Pain (1685); Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and device breakage ('full removal was not achieved, although most parts of the devices were removed') in a (b)(6) female patient who had essure inserted for sterilization.The occurrence of additional non-serious events is detailed below.In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criterion hospitalization), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage ("excessive bleeding"), swelling ("swelling"), hypersensitivity ("allergic reaction"), back pain ("lumbar pain"), abdominal distension ("abdominal bloating"), spinal muscular atrophy ("spinal muscular atrophy"), headache ("cephalea") and complication of device removal ("incomplete removal of device").The patient was hospitalized from (b)(6) 2017 to (b)(6) 2017.The patient was treated with surgery (hysterectomy on (b)(6) 2018 and total bilateral salpingectomy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device breakage, genital haemorrhage, swelling, hypersensitivity, back pain, abdominal distension, spinal muscular atrophy and headache had resolved and the complication of device removal outcome was unknown.The reporter considered abdominal distension, back pain, complication of device removal, device breakage, genital haemorrhage, headache, hypersensitivity, pelvic pain, spinal muscular atrophy and swelling to be related to essure.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and device breakage ('full removal was not achieved, although most parts of the devices were removed') in a 43-year-old female patient who had essure inserted for sterilization.The occurrence of additional non-serious events is detailed below.Concomitant products included levonorgestrel (mirena).In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), device breakage (seriousness criteria medically significant and intervention required), menorrhagia ("heavy menstrual bleeding"), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction"), swelling ("swelling"), abdominal distension ("abdominal bloating"), back pain ("lumbar pain"), headache ("cephalea") and complication of device removal ("incomplete removal of device").The patient was hospitalized from 21-feb-2017 to 22-feb-2017.The patient was treated with surgery (hysterectomy on (b)(6) 2018 and total bilateral salpingectomy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device breakage, menorrhagia, genital haemorrhage, hypersensitivity, swelling, abdominal distension, back pain and headache had resolved and the complication of device removal outcome was unknown.The reporter considered abdominal distension, back pain, complication of device removal, device breakage, genital haemorrhage, headache, hypersensitivity, menorrhagia, pelvic pain and swelling to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and device breakage ('full removal was not achieved, although most parts of the devices were removed') in a 43-year-old female patient who had essure inserted for sterilization.The occurrence of additional non-serious events is detailed below.Concomitant products included levonorgestrel (mirena).In 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria hospitalization and intervention required), device breakage (seriousness criteria medically significant and intervention required), menorrhagia ("heavy menstrual bleeding"), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction"), swelling ("swelling"), abdominal distension ("abdominal bloating"), back pain ("lumbar pain"), headache ("cephalea") and complication of device removal ("incomplete removal of device").The patient was hospitalized from (b)(6) 2017.The patient was treated with surgery (hysterectomy on (b)(6) 2018 and total bilateral salpingectomy on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device breakage, menorrhagia, genital haemorrhage, hypersensitivity, swelling, abdominal distension, back pain and headache had resolved and the complication of device removal outcome was unknown.The reporter considered abdominal distension, back pain, complication of device removal, device breakage, genital haemorrhage, headache, hypersensitivity, menorrhagia, pelvic pain and swelling to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021: no new information received, update to imdrf/fda codes only.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain, pain in the left ileal fossa that radiates to the inguinal area"), device breakage ("full removal was not achieved, although most parts of the devices were removed") and abdominal pain ("pain in the right lower quadrant with vomits and diarrhea") in a 43 year-old female patient who had essure inserted for sterilization.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("incomplete removal of device") and device removal failed ("complication of device removal" on (b)(6) 2017).The patient had a medical history of prepyloric ulcer (small) and gastritis erosive on (b)(6) 2016, de quervain's tenosynovitis and unilateral carpal tunnel syndrome (mild, right) in 2013, umbilical hernia repair in 2009, blepharitis (emergency episode due to pain in right eye) and dysmenorrhea (in gynecology clinic) in 2007, renal colic in 2006, cyst nos (knee, removed), ovarian cyst (removed) and fall (on the left lower limbs, pain, cramps, inflammation) in 2004 and thyroid carcinoma (total thyroidectomy and lymphadenectomy), umbilical hernia (complications: nausea and vomit), multiple caesarean sections (2), uterine anteflexion, traffic accident and anxiety.As concurrent condition the report mentioned smoker.The only concomitant product mentioned was lorazepam for anxiety.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, 353 days after essure insertion, she experienced amenorrhoea ("amenorrhea").On (b)(6) 2011 she experienced lumbago ("lumbago").On (b)(6) 2011 she experienced dysmenorrhoea ("dysmenorrhea, recurrent").On (b)(6) 2011 she experienced intermenstrual bleeding ("metrorrhagia with clots") and was found to have uterine leiomyoma ("25 x 12 mm submucosal intramural fibroid.").In 2011 she experienced urticaria chronic ("allergic reaction/ generalized chronic urticaria"), conjunctivitis ("rhinoconjunctivitis") and asthma ("moderate bronchial asthma").On (b)(6) 2017 she experienced inflammation ("abdominal inflammation") and headache ("headaches").On (b)(6) 2017 she experienced bronchospasm ("bronchospasm during anesthesia").An unknown time later she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), device breakage (seriousness criteria medically important and intervention required), abdominal pain (seriousness criterion hospitalisation), heavy menstrual bleeding ("heavy menstrual bleeding, excessive bleeding with clots"), swelling ("swelling"), abdominal distension ("abdominal bloating"), lumbar pain ("lumbar pain") and cephalgia ("cephalea").The patient was hospitalised from (b)(6) 2017 to (b)(6) 2017.The patient was treated with mirena (levonorgestrel), microgynon [ethinylestradiol;levonorgestrel], amchafibrin (tranexamic acid), primolut n (norethisterone), tranexamic acid, ibuprofen, naproxen, analgesics, paracetamol, nolotil [metamizole magnesium], nsaids, loratadine and progesteron (progesterone) as well as surgery (total bilateral salpingectomy on (b)(6) 2017, hysterectomy on (b)(6) 2018 and ).At the time of the report, the pelvic pain, device breakage, heavy menstrual bleeding, urticaria chronic, swelling, abdominal distension, lumbar pain and cephalgia had resolved.The outcomes for abdominal pain, dysmenorrhoea, uterine leiomyoma, intermenstrual bleeding, amenorrhoea, conjunctivitis, asthma, back pain, inflammation, headache and bronchospasm were unknown.The reporter considered abdominal distension, abdominal pain, amenorrhoea, asthma, lumbago, lumbar pain, bronchospasm, conjunctivitis, device breakage, dysmenorrhoea, headache, cephalgia, heavy menstrual bleeding, inflammation, intermenstrual bleeding, pelvic pain, swelling, urticaria chronic and uterine leiomyoma to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 103.5 kg.[allergy test] on (b)(6) 2016: positive specific ige to anisakis [computerised tomogram] on (b)(6) 2013: with contrast: essure is observed.Right gluteal subcutaneous emphysema (probably related to medication administration); on (b)(6) 2016: in sections of the lung included in the study, a 4 mm nodule can be seen in the right lung base, non-specific.In segment vi of the hepatic parenchyma, a millimetric hypodense lesion can be seen, which cannot be catalogued.Pancreas, adrenals and both kidneys without alterations., normal spleen, with an accessory spleen of 1.6 mm.No image of free fluid or pneumoperitoneum.No significant intra-abdominal adenopathies the layout of the essures devices is striking.It is recommended to rule out tubal patency by hysterosalpingography if iud is removed; on (b)(6) 2018: fatty liver.Cystic lesion of 3.7 cm in the right ovary and round, hyperdense lesion of about 3.8 cm in the left ovary; on (b)(6) 2018: no findings.Fatty liver; on (b)(6) 2019: diastasis recti anterior at the umbilical and infraumbilical levels.The distance between the medial ends of the recti is approximately 8 cm.Fatty liver [electromyogram] on (b)(6) 2013: due to paresthesias in last three fingers of right hand: clinical judgment: de quervain-tendinitis and mild right carpal tunnel syndrome [endoscopy gastrointestinal] on (b)(6) 2016: diagnosis: erosive gastritis and small prepyloric ulcer [haemoglobin ( 12.0- 8.0 g/dl)] on (b)(6) 2018: 11.7 g/dl [hysteroscopy] on (b)(6) 2008: successful essure placement; on (b)(6) 2011: secretory endometrium.Mirena iud [pathology test] on (b)(6) 2017: 3 tubular fragments with fimbriae, 4.3 and 7 cm, are received.Total inclusion in 2 blocks.Uterus of 120 grams and 7.5x6.5x3 cm.Serial cuts show a 3 mm intrafallopian spiral metal device in one of the intramural portions of the fallopian tubes.Carving and representative inclusion block 1 endocervix, blocks 2-5: endometrium.Diagnosis: oviduct segments with nonspecific changes, endometrium and cervix without alterations; on (b)(6) 2018: serial cuts show a 3-mm intrafallopian spiral metal device in one of the intramural portions of the fallopian tubes.; on (b)(6) 2019: ppapillary thyroid carcinoma of 15 mm (tall cell variety and lymphatic metastasis level vi and perithyroid focal extension).Post-surgery hypothyroidism [physical examination] on (b)(6) 2011: pain in the back and in the upper limbs.Lumbago for 5 days.Significant limitation of flexo-extension with pain on palpation of high lumbar spinosis apophysis [pulmonary function test] on (b)(6) 2018: all tests within normal limits [red blood cell count ( 4.20- 6.10 t/l)] on (b)(6) 2018: 4.51 t/l [skin test] on (b)(6) 2017: negativ.Nickel allergy ruled out [ultrasound scan] on (b)(6) 2011: antecedent uterus with 7mm endometrium, 25x12mm intramural-submucosal myoma, free normal adnexa; on (b)(6) 2013: essure is observed.Right gluteal subcutaneous emphysema (probably related to medication administration); on (b)(6) 2013: 3 x 2.5 fibroid seen [x-ray] on (b)(6) 2011: lumbar spine rectification [x-ray of pelvis and hip] on (b)(6) 2018: essure fragments in the theoretical area of the intramyometrial portions of the tubes 1.6 mm right, 1.8 mm left.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 25-may-2022: follow up received via lawyer: report now medically confirmed, reporters, plaintiff birth date, medical history, test data added (none reported previously).Addition of events: amenorrhea, metrorrhagia, uterine fibroid, lumbago, abdominal pain localised.Abdominal inflammation, dysmenorrhea, headaches, conjunctivitis, bronchial asthma, bronchospasm, complication of device removal.Hypersensitivity specified to urticaria.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Manufacturer Narrative
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This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain, pain in the left ileal fossa that radiates to the inguinal area"), device breakage ("full removal was not achieved, although most parts of the devices were removed") and abdominal pain lower ("pain in the right lower quadrant with vomits and diarrhea") in a 43 year-old female patient who had essure inserted for sterilization.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("incomplete removal of device") and device removal failed ("complication of device removal" on (b)(6) 2017).The patient had a medical history of prepyloric ulcer (small) and gastritis erosive on (b)(6) 2016, de quervain's tenosynovitis and unilateral carpal tunnel syndrome (mild, right) in 2013, umbilical hernia repair in 2009, blepharitis (emergency episode due to pain in right eye) and dysmenorrhea (in gynecology clinic) in 2007, renal colic in 2006, cyst nos (knee, removed), ovarian cyst (removed) and fall (on the left lower limbs, pain, cramps, inflammation) in 2004 and thyroid cancer recurrent (total thyroidectomy and lymphadenectomy), umbilical hernia (complications: nausea and vomit), multiple caesarean sections (2), uterine anteflexion, traffic accident and anxiety.As concurrent condition the report mentioned smoker.The only concomitant product mentioned was lorazepam for anxiety.On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, 353 days after essure insertion, she experienced amenorrhoea ("amenorrhea").On (b)(6) 2011 she experienced lumbago ("lumbago").On (b)(6) 2011 she experienced dysmenorrhoea ("dysmenorrhea, recurrent").On (b)(6) 2011 she experienced intermenstrual bleeding ("metrorrhagia with clots") and was found to have uterine leiomyoma ("25 x 12 mm submucosal intramural fibroid.").In 2011 she experienced urticaria chronic ("allergic reaction/ generalized chronic urticaria"), conjunctivitis ("rhinoconjunctivitis") and asthma ("moderate bronchial asthma").On (b)(6) 2017 she experienced inflammation ("abdominal inflammation") and headache ("headaches").On (b)(6) 2017 she experienced bronchospasm ("bronchospasm during anesthesia").An unknown time later she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), device breakage (seriousness criteria medically important and intervention required), abdominal pain lower (seriousness criterion hospitalisation), heavy menstrual bleeding ("heavy menstrual bleeding, excessive bleeding with clots"), swelling ("swelling"), abdominal distension ("abdominal bloating"), lumbar pain ("lumbar pain") and cephalgia ("cephalea").The patient was hospitalised from (b)(6) 2017 to (b)(6) 2017.The patient was treated with mirena (levonorgestrel), microgynon [ethinylestradiol;levonorgestrel], amchafibrin (tranexamic acid), primolut n (norethisterone), tranexamic acid, ibuprofen, naproxen, analgesics, paracetamol, nolotil [metamizole magnesium], nsaids, loratadine and progesteron (progesterone) as well as surgery (total bilateral salpingectomy on (b)(6) 2017, hysterectomy on (b)(6) 2018 and ).At the time of the report, the pelvic pain, device breakage, heavy menstrual bleeding, urticaria chronic, swelling, abdominal distension, lumbar pain and cephalgia had resolved.The outcomes for abdominal pain lower, dysmenorrhoea, uterine leiomyoma, intermenstrual bleeding, amenorrhoea, conjunctivitis, back pain, inflammation, headache and bronchospasm were unknown.The reporter considered abdominal distension, abdominal pain lower, amenorrhoea, asthma, lumbago, lumbar pain, bronchospasm, conjunctivitis, device breakage, dysmenorrhoea, headache, cephalgia, heavy menstrual bleeding, inflammation, intermenstrual bleeding, pelvic pain, swelling, urticaria chronic and uterine leiomyoma to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 103.5 kg.[allergy test] on (b)(6) 2016: positive specific ige to anisakis [computerised tomogram] on (b)(6) 2013: with contrast: essure is observed.Right gluteal subcutaneous emphysema (probably related to medication administration); on (b)(6) 2016: in sections of the lung included in the study, a 4 mm nodule can be seen in the right lung base, non-specific.In segment vi of the hepatic parenchyma, a millimetric hypodense lesion can be seen, which cannot be catalogued.Pancreas, adrenals and both kidneys without alterations., normal spleen, with an accessory spleen of 1.6 mm.No image of free fluid or pneumoperitoneum.No significant intra-abdominal adenopathies the layout of the essures devices is striking.It is recommended to rule out tubal patency by hysterosalpingography if iud is removed; on 08-sep-2018: fatty liver.Cystic lesion of 3.7 cm in the right ovary and round, hyperdense lesion of about 3.8 cm in the left ovary; on (b)(6) 2018: no findings.Fatty liver; on (b)(6) 2019: diastasis recti anterior at the umbilical and infraumbilical levels.The distance between the medial ends of the recti is approximately 8 cm.Fatty liver [electromyogram] on (b)(6) 2013: due to paresthesias in last three fingers of right hand: clinical judgment: de quervain-tendinitis and mild right carpal tunnel syndrome [endoscopy gastrointestinal] on (b)(6) 2016: diagnosis: erosive gastritis and small prepyloric ulcer [haemoglobin ( 12.0- 8.0 g/dl)] on (b)(6) 2018: 11.7 g/dl [hysteroscopy] on (b)(6) 2008: successful essure placement; on 18-nov-2011: secretory endometrium.Mirena iud [pathology test] on (b)(6) 2017: 3 tubular fragments with fimbriae, 4.3 and 7 cm, are received.Total inclusion in 2 blocks.Uterus of 120 grams and 7.5x6.5x3 cm.Serial cuts show a 3 mm intrafallopian spiral metal device in one of the intramural portions of the fallopian tubes.Carving and representative inclusion block 1 endocervix, blocks 2-5: endometrium.Diagnosis: oviduct segments with nonspecific changes, endometrium and cervix without alterations; on (b)(6) 2018: serial cuts show a 3-mm intrafallopian spiral metal device in one of the intramural portions of the fallopian tubes.; on (b)(6) 2019: ppapillary thyroid carcinoma of 15 mm (tall cell variety and lymphatic metastasis level vi and perithyroid focal extension).Post-surgery hypothyroidism [physical examination] on (b)(6) 2011: pain in the back and in the upper limbs.Lumbago for 5 days.Significant limitation of flexo-extension with pain on palpation of high lumbar spinosis apophysis [pulmonary function test] on (b)(6) 2018: all tests within normal limits [red blood cell count ( 4.20- 6.10 t/l)] on 23-jun-2018: 4.51 t/l [skin test] on (b)(6) 2017: negativ.Nickel allergy ruled out [ultrasound scan] on (b)(6) 2011: antecedent uterus with 7mm endometrium, 25x12mm intramural-submucosal myoma, free normal adnexa; on (b)(6) 2013: essure is observed.Right gluteal subcutaneous emphysema (probably related to medication administration); on (b)(6) 2013: 3 x 2.5 fibroid seen [x-ray] on (b)(6) 2011: lumbar spine rectification [x-ray of pelvis and hip] on (b)(6) 2018: essure fragments in the theoretical area of the intramyometrial portions of the tubes 1.6 mm right, 1.8 mm left 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 reported complaint reason.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: (b)(6) 2022: quality safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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Search Alerts/Recalls
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