| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Perforation (2001); Scarring (2061); Swelling (2091); Vomiting (2144); Weakness (2145); Burning Sensation (2146); Myalgia (2238); Anxiety (2328); Arthralgia (2355); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165)
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| Event Date 01/01/2011 |
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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 device breakage ("she had a second surgery and a hysterectomy to remove essure fragments"), pelvic pain ("severe pelvic pain/pain she endured for 4 years/persistent stabbing"), abdominal pain lower ("lower abdominal pain"), back pain ("severe persistent chronic back pain/lower back pain") and medical device pain ("pain from essure") in a (b)(6) -year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida (total number of pregnancies: 5), parity 3 (total number of live births: 3 ; date of births: (b)(6) 1992, (b)(6) 2002, (b)(6) 2008), device insertion failed (first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.) in 2008 and overweight.Previously administered products included for an unreported indication: mirena from 2003 to 2007.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), back pain (seriousness criterion hospitalization), inflammation ("inflammation of her whole body"), swelling ("swelling") and the first episode of abdominal pain ("abdominal pain").In 2011, the patient experienced abdominal pain lower (seriousness criteria hospitalization, medically significant and intervention required), burning sensation ("burning"), myalgia ("muscle pain") and asthenia ("chronic weakness").In (b)(6) 2013, the patient experienced depression ("depression").In (b)(6) 2014, the patient experienced arthralgia ("joint pain") and the second episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced the third episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced medical device pain (seriousness criteria medically significant and intervention required).In 2015, the patient experienced postmenopause ("symptoms of early menopause following the hysterectomy surgery").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), scar ("severe scarring on her abdomen from multiple surgeries to remove essure"), anxiety ("anxiety"), emotional distress ("emotional pain"), allergy to metals ("hypersensitivity reaction to nickel"), feeling abnormal ("feeling her body over heating like if there was a chemical eating her insides away"), fatigue ("fatigue"), weight increased ("weight gain"), diarrhoea ("diarrhea"), vomiting ("vomiting"), weight decreased ("weight loss"), dental caries ("tooth decay"), haematosalpinx ("could not see her fallopian tube because they were filled with blood") and abdominal distension ("abdominal bloating").The patient was hospitalized from an unknown date until (b)(6) 2015.The patient was treated with ibuprofen, clonazepam, quetiapine (seroquel), obetrol (adderall), loratadine (loradin), surgery (on (b)(6) 2015, davinci-assisted total laparoscopic hysterectomy), surgery (in (b)(6) 2015, fallopian tubes removed (bilateral salpingectomy)), surgery (hysterectomy in (b)(6) 2015) and surgery (hysterectomy in (b)(6) 2015).Essure was removed on(b)(6) 2015.At the time of the report, the device breakage, pelvic pain, back pain, inflammation, weight increased, diarrhoea, vomiting, weight decreased, dental caries, abdominal distension and the last episode of abdominal pain had resolved and the abdominal pain lower, medical device pain, postmenopause, scar, depression, anxiety, emotional distress, swelling, burning sensation, myalgia, allergy to metals, feeling abnormal, fatigue, arthralgia, haematosalpinx and asthenia outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, anxiety, arthralgia, asthenia, back pain, burning sensation, dental caries, depression, device breakage, diarrhoea, emotional distress, fatigue, feeling abnormal, haematosalpinx, inflammation, medical device pain, myalgia, pelvic pain, postmenopause, scar, swelling, vomiting, weight decreased, weight increased, the first episode of abdominal pain, the second episode of abdominal pain and the third episode of abdominal pain to be related to essure.The reporter commented: on (b)(6) 2008, 8 weeks after she gave birth to her son, first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.From: 2011-2015, patient was hospitalized for lower abdominal pain and back pain.From: she was 2014-2015, hospitalized for lower abdominal pain and back pain.From: 2002-2015, she was hospitalized for lower abdominal pain, pelvic pain and back pain.At the completion of the procedure at 3 coils of each device, was seen to travel into the uterine cavity.Plaintiff had never experienced the claimed injuries before the date of essure placement.She did not claim that essure worsened a previously existing injury/condition.Following events: severe persistent pelvic and abdominal pain, back pain, abdominal bloating, inflammation of her whole body, fatigue, weight gain, diarrhea, vomiting, weight loss and tooth decay dissipated after essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.Hysterosalpingogram - on (b)(6) 2009: bilateral tubal occlusion.(b)(6) -1996-present: routine check up blood pressure.On (b)(6) 2014, hysterosalpingogram, showed tubes remain occluded following prior placement of essure coils, appearance in this respect was unchanged.Since prior study 5 years ago.2.No positional change of either essure coil.In particular, nothing to indicate that the right sided coil was no longer in the tube.-(b)(6) -present: bladder and kidneys.-(b)(6) -present: mammogram.-on (b)(6) 2015, anatomic pathology report revealed fallopian tube, right and left, bilateral salpingectomy: complete cross section fimbriated fallopian tubes wall and lumen with vascular congestion.-on (b)(6) 2015, surgical pathology report revealed uterus: adenomyosis, cervix with squamous metaplasia.Preop/clinical diagnosis included pelvic pain.Gross description: labeled ¿uterus, cervix, complete labeled ¿uterus, cervix, complete with coils¿ received and blood tinged formlin was a 97 gram corpus with attached cervix and bilateral white metal coils at the cornua.Most recent follow-up information incorporated above includes: on (b)(6) 2017: case incident category updated.Patient¿s demographics were updated.Lab data, historical condition, essure implantation date and explanation date and events severe persistent chronic back pain/lower back pain, severe pelvic pain/pain she endured for 4 years/persistent stabbing, abdominal pain, symptoms of early menopause following the hysterectomy surgery, depression, anxiety, emotional pain, lower abdominal pain, inflammation of her whole body, swelling, burning, muscle pain, chronic weakness, hypersensitivity reaction to nickel, feeling her body over heating like if there was a chemical eating her insides away, abdominal bloating, fatigue, weight gain, diarrhea, vomiting, weight loss, tooth decay, joint pain, pain were added.Essure legal manufacture has changed from bayer healthcare, (b)(4) to bayer pharma (b)(40, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('she had a second surgery and a hysterectomy to remove essure fragments'), pelvic pain ('severe pelvic pain/pain she endured for 4 years/persistent stabbing'), abdominal pain lower ('lower abdominal pain'), back pain ('severe persistent chronic back pain/lower back pain'), medical device pain ('pain from essure'), perforation ('perforation') and device dislocation ('migration') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included device insertion failed (first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.) in 2008, multigravida (total number of pregnancies: 5), parity 3 (total number of live births: 3 ; date of births: (b)(6) 1992, (b)(6) 2002, (b)(6) 2008) and overweight.Previously administered products included for an unreported indication: mirena from 2003 to 2007.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), back pain (seriousness criterion hospitalization), inflammation ("inflammation of her whole body"), swelling ("swelling") and the first episode of abdominal pain ("abdominal pain").In 2011, the patient experienced abdominal pain lower (seriousness criteria hospitalization, medically significant and intervention required), burning sensation ("burning"), myalgia ("muscle pain") and asthenia ("chronic weakness").In (b)(6) 2013, the patient experienced depression ("depression").In (b)(6) 2014, the patient experienced arthralgia ("joint pain") and the second episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced the third episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced medical device pain (seriousness criteria medically significant and intervention required).In 2015, the patient experienced premature menopause ("symptoms of early menopause following the hysterectomy surgery").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), emotional distress ("emotional pain"), allergy to metals ("hypersensitivity reaction to nickel"), feeling hot ("feeling her body over heating like if there was a chemical eating her insides away"), fatigue ("fatigue"), diarrhoea ("diarrhea"), vomiting ("vomiting"), dental caries ("tooth decay"), haematosalpinx ("could not see her fallopian tube because they were filled with blood") and abdominal distension ("abdominal bloating"), underwent abdominal operation ("severe scarring on her abdomen from multiple surgeries to remove essure") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").The patient was hospitalized from an unknown date until (b)(6) 2015.The patient was treated with amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall), clonazepam, ibuprofen, loratadine (loradin), quetiapine fumarate (seroquel) and surgery (hysterectomy in (b)(6) 2015, in (b)(6) 2015, fallopian tubes removed (bilateral salpingectomy), on (b)(6) 2015, davinci-assisted total laparoscopic hysterectomy, davinci-assisted total laparoscopic hysterectomy and hysterectomy in (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, pelvic pain, back pain, inflammation, weight increased, diarrhoea, vomiting, weight decreased, dental caries, abdominal distension and the last episode of abdominal pain had resolved and the abdominal pain lower, medical device pain, perforation, device dislocation, premature menopause, abdominal operation, depression, anxiety, emotional distress, swelling, burning sensation, myalgia, allergy to metals, feeling hot, fatigue, arthralgia, haematosalpinx and asthenia outcome was unknown.The reporter considered abdominal distension, abdominal operation, abdominal pain lower, allergy to metals, anxiety, arthralgia, asthenia, back pain, burning sensation, dental caries, depression, device breakage, device dislocation, diarrhoea, emotional distress, fatigue, feeling hot, haematosalpinx, inflammation, medical device pain, myalgia, pelvic pain, perforation, premature menopause, swelling, vomiting, weight decreased, weight increased, the first episode of abdominal pain, the second episode of abdominal pain and the third episode of abdominal pain to be related to essure.The reporter commented: on (b)(6) 2008, 8 weeks after she gave birth to her son, first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.From: 2011-2015, patient was hopspitalized for lower abdominal pain and back pain.From: she was 2014-2015, hopspitalized for lower abdominal pain and back pain.From: 2002-2015, she was hopspitalized for lower abdominal pain, pelvic pain and back pain.At the completion of the procedure at 3 coils of each device, was seen to travel into the uterine cavity.Plaintiff had never experienced the claimed injuries before the date of essure placement.She did not claim that essure worsened a previously existing injury/condition.Following events: severe persistent pelvic and abdominal pain, back pain, abdominal bloating, inflammation of her whole body, fatigue, weight gain, diarrhea, vomiting, weight loss and tooth decay dissipated after essure removal.1discripancy noted as insertion date: (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: results: bilateral tubal occlusion.(b)(6) 1996-present: routine check up blood pressure.On (b)(6) 2014, hysterosalpingogram, showed tubes remain occluded following prior placement of essure coils, appearance in this respect was unchanged.Since prior study 5 years ago.2.No positional change of either essure coil.In particular, nothing to indicate that the right sided coil was no longer in the tube.(b)(6) 2016-present: bladder and kidneys.(b)(6) 2015-present: mammogram.On (b)(6) 2015, anatomic pathology report revealed fallopian tube, right and left, bilateral salpingectomy: complete cross section fimbriated fallopian tubes wall and lumen with vascular congestion.On (b)(6) 2015, surgical pathology report revealed uterus: adenomyosis, cervix with squamous metaplasia.Preop/clinical diagnosis included pelvic pain.Gross description: labeled ¿uterus, cervix, complete labeled ¿uterus, cervix, complete with coils¿ received and blood tinged formlin was a 97 gram corpus with attached cervix and bilateral white metal coils at the cornua.Most recent follow-up information incorporated above includes: on 28-jan-2020: pif received.New events added: perforation, migration.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 device breakage ('she had a second surgery and a hysterectomy to remove essure fragments'), pelvic pain ('severe pelvic pain/pain she endured for 4 years/persistent stabbing'), abdominal pain lower ('lower abdominal pain'), back pain ('severe persistent chronic back pain/lower back pain'), medical device pain ('pain from essure'), perforation ('perforation') and device dislocation ('migration') in a 32-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included device insertion failed (first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.) in 2008, multigravida (total number of pregnancies: 5), parity 3 (total number of live births: 3 ; date of births: (b)(6) 1992, (b)(6) 2002, (b)(6) 2008 and overweight.Previously administered products included for an unreported indication: mirena from 2003 to 2007.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria hospitalization, medically significant and intervention required), back pain (seriousness criterion hospitalization), inflammation ("inflammation of her whole body"), swelling ("swelling") and the first episode of abdominal pain ("abdominal pain").In 2011, the patient experienced abdominal pain lower (seriousness criteria hospitalization, medically significant and intervention required), burning sensation ("burning"), myalgia ("muscle pain") and asthenia ("chronic weakness").In (b)(6) 2013, the patient experienced depression ("depression").In (b)(6) 2014, the patient experienced arthralgia ("joint pain") and the second episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced the third episode of abdominal pain ("abdominal pain").In (b)(6) 2015, the patient experienced medical device pain (seriousness criteria medically significant and intervention required).In 2015, the patient experienced premature menopause ("symptoms of early menopause following the hysterectomy surgery").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), emotional distress ("emotional pain"), allergy to metals ("hypersensitivity reaction to nickel"), feeling hot ("feeling her body over heating like if there was a chemical eating her insides away"), fatigue ("fatigue"), diarrhoea ("diarrhea"), vomiting ("vomiting"), dental caries ("tooth decay"), haematosalpinx ("could not see her fallopian tube because they were filled with blood") and abdominal distension ("abdominal bloating"), underwent abdominal operation ("severe scarring on her abdomen from multiple surgeries to remove essure") and was found to have weight increased ("weight gain") and weight decreased ("weight loss").The patient was hospitalized from an unknown date until (b)(6) 2015.The patient was treated with amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (adderall), clonazepam, ibuprofen, loratadine (loradin), quetiapine fumarate (seroquel) and surgery (hysterectomy in (b)(6) 2015, in (b)(6) 2015, fallopian tubes removed (bilateral salpingectomy), on (b)(6) 2015, davinci-assisted total laparoscopic hysterectomy, davinci-assisted total laparoscopic hysterectomy and hysterectomy in (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, pelvic pain, back pain, inflammation, weight increased, diarrhoea, vomiting, weight decreased, dental caries, abdominal distension and the last episode of abdominal pain had resolved and the abdominal pain lower, medical device pain, perforation, device dislocation, premature menopause, abdominal operation, depression, anxiety, emotional distress, swelling, burning sensation, myalgia, allergy to metals, feeling hot, fatigue, arthralgia, haematosalpinx and asthenia outcome was unknown.The reporter considered abdominal distension, abdominal operation, abdominal pain lower, allergy to metals, anxiety, arthralgia, asthenia, back pain, burning sensation, dental caries, depression, device breakage, device dislocation, diarrhoea, emotional distress, fatigue, feeling hot, haematosalpinx, inflammation, medical device pain, myalgia, pelvic pain, perforation, premature menopause, swelling, vomiting, weight decreased, weight increased, the first episode of abdominal pain, the second episode of abdominal pain and the third episode of abdominal pain to be related to essure.The reporter commented: on (b)(6) 2008, 8 weeks after she gave birth to her son, first attempt was made when she was still bleeding and told the doctor but she tried to insert and then did not succeed.From: 2011-2015, patient was hospitalized for lower abdominal pain and back pain.From: she was 2014-2015, hospitalized for lower abdominal pain and back pain.From: 2002-2015, she was hospitalized for lower abdominal pain, pelvic pain and back pain.At the completion of the procedure at 3 coils of each device, was seen to travel into the uterine cavity.Plaintiff had never experienced the claimed injuries before the date of essure placement.She did not claim that essure worsened a previously existing injury/condition.Following events: severe persistent pelvic and abdominal pain, back pain, abdominal bloating, inflammation of her whole body, fatigue, weight gain, diarrhea, vomiting, weight loss and tooth decay dissipated after essure removal.Discrepancy noted as insertion date: (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: results: bilateral tubal occlusion.On (b)(6) 1996-present: routine check up blood pressure.On (b)(6) 2014, hysterosalpingogram, showed tubes remain occluded following prior placement of essure coils, appearance in this respect was unchanged.Since prior study 5 years ago.2.No positional change of either essure coil.In particular, nothing to indicate that the right sided coil was no longer in the tube.On (b)(6) 2016-present: bladder and kidneys.On (b)(6) 2015-present: mammogram.On (b)(6) 2015, anatomic pathology report revealed fallopian tube, right and left, bilateral salpingectomy: complete cross section fimbriated fallopian tubes wall and lumen with vascular congestion.On (b)(6) 2015, surgical pathology report revealed uterus: adenomyosis, cervix with squamous metaplasia.Preop/clinical diagnosis included pelvic pain.Gross description: labeled ¿uterus, cervix, complete labeled ¿uterus, cervix, complete with coils¿ received and blood tinged formlin was a 97 gram corpus with attached cervix and bilateral white metal coils at the cornua.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jun-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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