| Model Number ESS305 |
| Device Problems
Break (1069); Material Integrity Problem (2978); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Genital Bleeding (4507); Insufficient Information (4580)
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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 ('a distal fragment remaining in the right uterine horn') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included appendectomy (acute appendicitis with generalised peritonitis) in 2001, penicillin allergy, hereditary hemochromatosis, fructose intolerance, smoker (15 cigarettes a day) and lactose intolerance.Concomitant products included budesonide; formoterol fumarate (biresp) and cetirizine.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), complication of device removal ("it was decided to finish the surgery informing of the remaining part of the right essure."), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), alopecia ("hair loss"), myalgia ("muscular pain"), headache ("headaches"), hypoaesthesia ("numbness in the hands and feet"), abdominal pain upper ("stomach pains"), back pain ("lumbar pains"), eczema ("she states that she has eczema lesions in relation to surgical instruments"), menstrual disorder ("abnormal menstrual bleeding"), dysmenorrhoea ("dysmenorrhea"), abdominal distension ("abdominal swelling"), oral pain ("mouth pain"), tinnitus ("tinnitus"), onychoclasis ("brittle nails"), insomnia ("insomnia"), muscle spasms ("cramps") and paraesthesia ("paraesthesia").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, device breakage, complication of device removal, swelling, genital haemorrhage, alopecia, myalgia, headache, hypoaesthesia, abdominal pain upper, back pain, eczema, menstrual disorder, dysmenorrhoea, abdominal distension, oral pain, tinnitus, onychoclasis, insomnia, muscle spasms and paraesthesia outcome was unknown.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, complication of device removal, device breakage, dysmenorrhoea, eczema, genital haemorrhage, headache, hypoaesthesia, insomnia, menstrual disorder, muscle spasms, myalgia, onychoclasis, oral pain, paraesthesia, pelvic pain, swelling and tinnitus to be related to essure.The reporter commented: insertion of essure: insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Clinical process: patient who was admitted on (b)(6) 2009 for a bilateral tubal obstruction intervention using the essure system.Normal preoperative exam intervention ((b)(6) 2009): insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Number of rings in right ostium: 2.Number of rings in left ostium: 3.Immediate postoperative period was normal and patient was discharged on the same day of the intervention.Obstetric-gynaecological history: menarche: 9 births: no.Of pregnancies 0, no.Of births 0, no.Of abortions/miscarriages 0 menopause: no essure removal: surgical technique: a bilateral salpingectomy was performed and essure devices were extracted by laparoscopy, with a distal fragment remaining in the right uterine horn as seen in the portable xray of the pelvis.A hysteroscopy was preformed through the ostium with no findings of essure, the uterine cavity was normal and both ostia were visible.Given the reproductive wishes of the patient it was decided to finish the surgery informing of the remaining part of the right essure postoperative period: within the normal range.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test on an unknown date: epicutaneous tests with a variety of metals was negative.Coagulation test on (b)(6) 2019: prothrombin activity 99, prothrombin time international normalized ratio (inr) 1.01, ttpa 32.1, fibrinogen 228.Full blood count on (b)(6) 2018: red blood cells 4.50, haemoglobin 13.9, haematocrits 40.6, mean corpuscular volume (mcv) 90.2, mean corpuscular haemoglobin (mch) 30.9, mean corpuscular haemoglobin concentration (mchc) 34.2, red cell distribution width (rdw) 12.6, leukocytes 5.37, neutrophil (ne) % 42.9, neutrophils 2.30, lymphocyte % 46.0, lymphocytes 2.47, monocyte % 6.1, monocytes 0.33, eosinophil % 3.9, eosinophils 0.21, basophil % 1.1, basophils 0.06, platelets 188.0, mean platelet volume (mpv) 11.1; on (b)(6) 2019: serum biochemistry: osmolality serum/plasma calculated 274, estimate of glomerular filtrate rate chronic kidney disease epidemiology collaboration (ckd-epi).Ultrasound scan vagina - on an unknown date: uterus in anteroversoflection, 77x44mm triple line endometrium, 2 images compatible with myomas: posterior type 5 of 20x16mm and anterior type 3 of 22x185mm.Both essure devices are visible as normal inserts, without affecting the uterine cavity with a portion in the interstitial regio[n] of the fallopian tube with 9mm on the right side and 8mm on the left side.Adnexa right ovary: 30x35mm and normal echostructure left ovary: 25x18mm and normal echostructure.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 ('a distal fragment remaining in the right uterine horn') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included appendectomy (acute appendicitis with generalised peritonitis) in 2001, penicillin allergy, hereditary hemochromatosis, fructose intolerance, smoker (15 cigarettes a day), lactose intolerance and nulli gravida.Menarche: 9 yrs.Menopause: no.Concomitant products included budesonide; formoterol fumarate (biresp) and cetirizine.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), complication of device removal ("it was decided to finish the surgery informing of the remaining part of the right essure"), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), alopecia ("hair loss"), myalgia ("muscular pain"), headache ("headaches"), hypoaesthesia ("numbness in the hands and feet"), abdominal pain upper ("stomach pains"), back pain ("lumbar pains"), eczema ("she states that she has eczema lesions in relation to surgical instruments"), menstrual disorder ("abnormal menstrual bleeding"), dysmenorrhoea ("dysmenorrhea"), abdominal distension ("abdominal swelling"), oral pain ("mouth pain"), tinnitus ("tinnitus"), onychoclasis ("brittle nails"), insomnia ("insomnia"), muscle spasms ("cramps") and paraesthesia ("paraesthesia").The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6)2019.At the time of the report, the pelvic pain, device breakage, complication of device removal, swelling, genital haemorrhage, alopecia, myalgia, headache, hypoaesthesia, abdominal pain upper, back pain, eczema, menstrual disorder, dysmenorrhoea, abdominal distension, oral pain, tinnitus, onychoclasis, insomnia, muscle spasms and paraesthesia outcome was unknown.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, complication of device removal, device breakage, dysmenorrhoea, eczema, genital haemorrhage, headache, hypoaesthesia, insomnia, menstrual disorder, muscle spasms, myalgia, onychoclasis, oral pain, paraesthesia, pelvic pain, swelling and tinnitus to be related to essure.The reporter commented: insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Clinical process: patient who was admitted on (b)(6) 2009 for a bilateral tubal obstruction intervention using the essure system.Normal preoperative exam intervention (b)(6) 2009): insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Number of rings in right ostium: 2 number of rings in left ostium: 3 immediate postoperative period was normal and patient was discharged on the same day of the intervention.Essure removal: surgical technique: a bilateral salpingectomy was performed and essure devices were extracted by laparoscopy, with a distal fragment remaining in the right uterine horn as seen in the portable xray of the pelvis.A hysteroscopy was preformed through the ostium with no findings of essure, the uterine cavity was normal and both ostia were visible.Given the reproductive wishes of the patient it was decided to finish the surgery informing of the remaining part of the right essure postoperative period: within the normal range.Diagnostic results (normal ranges are provided in parenthesis if available): allergy test - on an unknown date: epicutaneous tests with a variety of metals was negative.Coagulation test - on (b)(6) 2019: prothrombin activity 99, prothrombin time international normalized ratio (inr) 1.01, ttpa 32.1, fibrinogen 228.Full blood count - on (b)(6) 2018: red blood cells 4.50, haemoglobin 13.9, haematocrits 40.6, mean corpuscular volume (mcv) 90.2, mean corpuscular haemoglobin (mch) 30.9, mean corpuscular haemoglobin concentration (mchc) 34.2, red cell distribution width (rdw) 12.6, leukocytes 5.37, neutrophil (ne) % 42.9, neutrophils 2.30, lymphocyte % 46.0, lymphocytes 2.47, monocyte % 6.1, monocytes 0.33, eosinophil % 3.9, eosinophils 0.21, basophil % 1.1, basophils 0.06, platelets 188.0, mean platelet volume (mpv) 11.1; on (b)(6) 2019: serum biochemistry: osmolality serum/plasma calculated 274, estimate of glomerular filtrate rate chronic kidney disease epidemiology collaboration (ckd-epi).Ultrasound scan vagina - on an unknown date: uterus in anteroversoflection, 77x44mm triple line endometrium, 2 images compatible with myomas: posterior type 5 of 20x16mm and anterior type 3 of 22x185mm.Both essure devices are visible as normal inserts, without affecting the uterine cavity with a portion in the interstitial regio[n] of the fallopian tube with 9mm on the right side and 8mm on the left side.Adnexa right ovary: 30x35mm and normal echostructure left ovary: 25x18mm and normal echostructure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-aug-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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pelvic pain") and device breakage ("a distal fragment remaining in the right uterine horn") in a female patient who had essure inserted (lot no.619533) for female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("it was decided to finish the surgery informing of the remaining part of the right essure").The patient had a medical history of appendectomy and appendectomy (acute appendicitis with generalised peritonitis) in 2001 and appendicitis, hemochromatosis, diarrhea, uterine fibroid, weight decrease, epigastric pain, vaginal dryness, amenorrhea, enthesopathy, colitis, gastroenteritis, thoracic pain, metrorrhagia, nulli gravida, lactose intolerance, smoker (15 cigarettes a day), fructose intolerance, hereditary hemochromatosis and penicillin allergy.Menarche: 9 yrs.Menopause: no.Concurrent conditions were listed as ankle sprain, penicillin allergy, fructose intolerance, asthma and hemochromatosis.Concomitant products included cetirizine and biresp (budesonide;formoterol fumarate).On (b)(6) 2009, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), alopecia ("hair loss"), myalgia ("muscular pain"), headache ("headaches"), hypoaesthesia ("numbness in the hands and feet"), abdominal pain upper ("stomach pains"), back pain ("lumbar pains"), eczema ("she states that she has eczema lesions in relation to surgical instruments"), menstrual disorder ("abnormal menstrual bleeding"), dysmenorrhoea ("dysmenorrhea"), abdominal distension ("abdominal swelling"), oral pain ("mouth pain"), tinnitus ("tinnitus"), onychoclasis ("brittle nails"), insomnia ("insomnia"), muscle spasms ("cramps"), paraesthesia ("paraesthesia"), vomiting ("vomiting") and pain in extremity ("limb pain").The patient was treated with surgery (bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, device breakage, dysmenorrhoea, eczema, genital haemorrhage, headache, hypoaesthesia, insomnia, menstrual disorder, muscle spasms, myalgia, onychoclasis, oral pain, pain in extremity, paraesthesia, pelvic pain, swelling, tinnitus and vomiting to be related to essure administration.The reporter commented: insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Clinical process: patient who was admitted on (b)(6) 2009 for a bilateral tubal obstruction intervention using the essure system.Normal preoperative exam intervention ((b)(6) 2009): insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Number of rings in right ostium: 2.Number of rings in left ostium: 3.Immediate postoperative period was normal and patient was discharged on the same day of the intervention.Essure removal: surgical technique: a bilateral salpingectomy was performed and essure devices were extracted by laparoscopy, with a distal fragment remaining in the right uterine horn as seen in the portable xray of the pelvis.A hysteroscopy was preformed through the ostium with no findings of essure, the uterine cavity was normal and both ostia were visible.Given the reproductive wishes of the patient it was decided to finish the surgery informing of the remaining part of the right essure postoperative period: within the normal range.Diagnostic results (normal ranges are provided in parenthesis if available): [allergy test] (date unknown): epicutaneous tests with a variety of metals was negative [coagulation test] on (b)(6) 2019: prothrombin activity 99, prothrombin time international normalized ratio (inr) 1.01, ttpa 32.1, fibrinogen 228 [full blood count] on (b)(6) 2018: red blood cells 4.50, haemoglobin 13.9, haematocrits 40.6, mean corpuscular volume (mcv) 90.2, mean corpuscular haemoglobin (mch) 30.9, mean corpuscular haemoglobin concentration (mchc) 34.2, red cell distribution width (rdw) 12.6, leukocytes 5.37, neutrophil (ne) % 42.9, neutrophils 2.30, lymphocyte % 46.0, lymphocytes 2.47, monocyte % 6.1, monocytes 0.33, eosinophil % 3.9, eosinophils 0.21, basophil % 1.1, basophils 0.06, platelets 188.0, mean platelet volume (mpv) 11.1; on (b)(6) 2019: serum biochemistry: osmolality serum/plasma calculated 274, estimate of glomerular filtrate rate chronic kidney disease epidemiology collaboration (ckd-epi) [ultrasound scan vagina] (date unknown): uterus in anteroversoflection, 77x44mm triple line endometrium, 2 images compatible with myomas: posterior type 5 of 20x16mm and anterior type 3 of 22x185mm.Both essure devices are visible as normal inserts, without affecting the uterine cavity with a portion in the interstitial regio[n] of the fallopian tube with 9mm on the right side and 8mm on the left side.Adnexa right ovary: 30x35mm and normal echostructure left ovary: 25x18mm and normal echostructure quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 20-jun-2022: plaintiff fact sheet & medical record received.Events limb pain & vomiting were added.Lot number added.Concomitant conditions & medical history added.Patient & reporter information updated.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") and device breakage ("a distal fragment remaining in the right uterine horn") in a 35 year-old female patient who had essure inserted (lot no.619533) for female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("it was decided to finish the surgery informing of the remaining part of the right essure").The patient had a medical history of appendectomy and appendectomy (acute appendicitis with generalised peritonitis) in 2001 and appendicitis, hemochromatosis, diarrhea, uterine fibroid, weight decrease, epigastric pain, vaginal dryness, amenorrhea, enthesopathy, colitis, gastroenteritis, thoracic pain, metrorrhagia, nulli gravida, lactose intolerance, smoker (15 cigarettes a day), fructose intolerance, hereditary hemochromatosis and penicillin allergy.Menarche: 9 yrs.Menopause: no.Concurrent conditions were listed as ankle sprain, penicillin allergy, fructose intolerance, asthma and hemochromatosis.Concomitant products included cetirizine and biresp (budesonide;formoterol fumarate).On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, 3221 days after essure insertion, she experienced abdominal discomfort ("abdominal discomfort").Essure was removed on (b)(6) 2019.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), alopecia ("hair loss"), myalgia ("muscular pain"), headache ("headaches"), hypoaesthesia ("numbness in the hands and feet"), abdominal pain upper ("stomach pains"), back pain ("lumbar pains"), eczema ("she states that she has eczema lesions in relation to surgical instruments"), menstrual disorder ("abnormal menstrual bleeding"), dysmenorrhoea ("dysmenorrhea"), abdominal distension ("abdominal swelling"), oral pain ("mouth pain"), tinnitus ("tinnitus"), onychoclasis ("brittle nails"), insomnia ("insomnia"), muscle spasms ("cramps"), paraesthesia ("paraesthesia"), vomiting ("vomiting"), pain in extremity ("limb pain"), premenstrual pain ("premenstrual pain"), cyst ("two very small cyst") and abdominal pain ("abdominal pain").The patient was treated with surgery (bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, alopecia, back pain, cyst, device breakage, dysmenorrhoea, eczema, genital haemorrhage, headache, hypoaesthesia, insomnia, menstrual disorder, muscle spasms, myalgia, onychoclasis, oral pain, pain in extremity, paraesthesia, pelvic pain, premenstrual pain, swelling, tinnitus and vomiting to be related to essure administration.The reporter commented: insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Clinical process: patient who was admitted on (b)(6) 2009 for a bilateral tubal obstruction intervention using the essure system.Normal preoperative exam intervention ((b)(6) 2009): insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Number of rings in right ostium: 2, number of rings in left ostium: 3.Immediate postoperative period was normal and patient was discharged on the same day of the intervention.Essure removal: surgical technique: a bilateral salpingectomy was performed and essure devices were extracted by laparoscopy, with a distal fragment remaining in the right uterine horn as seen in the portable xray of the pelvis.A hysteroscopy was preformed through the ostium with no findings of essure, the uterine cavity was normal and both ostia were visible.Given the reproductive wishes of the patient it was decided to finish the surgery informing of the remaining part of the right essure postoperative period: within the normal range.Diagnostic results (normal ranges are provided in parenthesis if available): [allergy test] (date unknown): epicutaneous tests with a variety of metals was negative [coagulation test] on (b)(6) 2019: prothrombin activity 99, prothrombin time international normalized ratio (inr) 1.01, ttpa 32.1, fibrinogen 228 [full blood count] on (b)(6) 2018: red blood cells 4.50, haemoglobin 13.9, haematocrits 40.6, mean corpuscular volume (mcv) 90.2, mean corpuscular haemoglobin (mch) 30.9, mean corpuscular haemoglobin concentration (mchc) 34.2, red cell distribution width (rdw) 12.6, leukocytes 5.37, neutrophil (ne) % 42.9, neutrophils 2.30, lymphocyte % 46.0, lymphocytes 2.47, monocyte % 6.1, monocytes 0.33, eosinophil % 3.9, eosinophils 0.21, basophil % 1.1, basophils 0.06, platelets 188.0, mean platelet volume (mpv) 11.1; on (b)(6) 2019: serum biochemistry: osmolality serum/plasma calculated 274, estimate of glomerular filtrate rate chronic kidney disease epidemiology collaboration (ckd-epi) [ultrasound scan vagina] on (b)(6) 2015: two very small cyst; (date unknown): uterus in anteroversoflection, 77x44mm triple line endometrium, 2 images compatible with myomas: posterior type 5 of 20x16mm and anterior type 3 of 22x185mm.Both essure devices are visible as normal inserts, without affecting the uterine cavity with a portion in the interstitial regio[n] of the fallopian tube with 9mm on the right side and 8mm on the left side.Adnexa right ovary: 30x35mm and normal echostructure left ovary: 25x18mm and normal echostructure lot number: 619533, manufacture date: 2009-02 and expiration date: 2012-02.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 14-jul-2022: summon received : events "premenstrual pain, two very small cyst, abdominal discomfort, abdominal pain", lab data added.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 relevant data; should any new and reportable information become available from our investigation, this 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") and device breakage ("a distal fragment remaining in the right uterine horn") in a female patient who had essure inserted (lot no.619533) for female sterilisation.Additional non-serious events are detailed below.Other product or product use issues identified: contraceptive device removal incomplete ("it was decided to finish the surgery informing of the remaining part of the right essure").The patient had a medical history of appendectomy and appendectomy (acute appendicitis with generalised peritonitis) in 2001 and appendicitis, hemochromatosis, diarrhea, uterine fibroid, weight decrease, epigastric pain, vaginal dryness, amenorrhea, enthesopathy, colitis, gastroenteritis, thoracic pain, metrorrhagia, nulli gravida, lactose intolerance, smoker (15 cigarettes a day), fructose intolerance, hereditary hemochromatosis and penicillin allergy.Menarche: 9 yrs.Menopause: no.Concurrent conditions were listed as ankle sprain, penicillin allergy, fructose intolerance, asthma and hemochromatosis.Concomitant products included cetirizine and biresp (budesonide;formoterol fumarate).On (b)(6) 2009, the patient had essure inserted.Essure was removed on (b)(6) 2019.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required), device breakage (seriousness criterion medically important), swelling ("swelling"), genital haemorrhage ("excessive bleeding"), alopecia ("hair loss"), myalgia ("muscular pain"), headache ("headaches"), hypoaesthesia ("numbness in the hands and feet"), abdominal pain upper ("stomach pains"), back pain ("lumbar pains"), eczema ("she states that she has eczema lesions in relation to surgical instruments"), menstrual disorder ("abnormal menstrual bleeding"), dysmenorrhoea ("dysmenorrhea"), abdominal distension ("abdominal swelling"), oral pain ("mouth pain"), tinnitus ("tinnitus"), onychoclasis ("brittle nails"), insomnia ("insomnia"), muscle spasms ("cramps"), paraesthesia ("paraesthesia"), vomiting ("vomiting") and pain in extremity ("limb pain").The patient was treated with surgery (bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal distension, abdominal pain upper, alopecia, back pain, device breakage, dysmenorrhoea, eczema, genital haemorrhage, headache, hypoaesthesia, insomnia, menstrual disorder, muscle spasms, myalgia, onychoclasis, oral pain, pain in extremity, paraesthesia, pelvic pain, swelling, tinnitus and vomiting to be related to essure administration.The reporter commented: insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Clinical process: patient who was admitted on (b)(6) 2009 for a bilateral tubal obstruction intervention using the essure system.Normal preoperative exam intervention ((b)(6) 2009): insertion of essure devices was performed by hysteroscopy (hysteroscope of 5 mm diameter with instillation of physiological saline solution) under sedation, without complications.Number of rings in right ostium: 2.Number of rings in left ostium: 3.Immediate postoperative period was normal and patient was discharged on the same day of the intervention.Essure removal: surgical technique: a bilateral salpingectomy was performed and essure devices were extracted by laparoscopy, with a distal fragment remaining in the right uterine horn as seen in the portable xray of the pelvis.A hysteroscopy was preformed through the ostium with no findings of essure, the uterine cavity was normal and both ostia were visible.Given the reproductive wishes of the patient it was decided to finish the surgery informing of the remaining part of the right essure postoperative period: within the normal range.Diagnostic results (normal ranges are provided in parenthesis if available): [allergy test] (date unknown): epicutaneous tests with a variety of metals was negative [coagulation test] on (b)(6) 2019: prothrombin activity 99, prothrombin time international normalized ratio (inr) 1.01, ttpa 32.1, fibrinogen 228 [full blood count] on (b)(6) 2018: red blood cells 4.50, haemoglobin 13.9, haematocrits 40.6, mean corpuscular volume (mcv) 90.2, mean corpuscular haemoglobin (mch) 30.9, mean corpuscular haemoglobin concentration (mchc) 34.2, red cell distribution width (rdw) 12.6, leukocytes 5.37, neutrophil (ne) % 42.9, neutrophils 2.30, lymphocyte % 46.0, lymphocytes 2.47, monocyte % 6.1, monocytes 0.33, eosinophil % 3.9, eosinophils 0.21, basophil % 1.1, basophils 0.06, platelets 188.0, mean platelet volume (mpv) 11.1; on (b)(6) 2019: serum biochemistry: osmolality serum/plasma calculated 274, estimate of glomerular filtrate rate chronic kidney disease epidemiology collaboration (ckd-epi) [ultrasound scan vagina] (date unknown): uterus in anteroversoflection, 77x44mm triple line endometrium, 2 images compatible with myomas: posterior type 5 of 20x16mm and anterior type 3 of 22x185mm.Both essure devices are visible as normal inserts, without affecting the uterine cavity with a portion in the interstitial regio[n] of the fallopian tube with 9mm on the right side and 8mm on the left side.Adnexa right ovary: 30x35mm and normal echostructure left ovary: 25x18mm and normal echostructure lot number: 619533, manufacture date: 2009-02 and expiration date: 2012-02.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 13-jul-2022: quality safety evaluation of product technical complaint.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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