| Model Number ESS305 |
| Device Problems
Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Heavier Menses (2666); Foreign Body In Patient (2687)
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| Event Date 05/01/2009 |
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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 dislocation ("one of her essure coils had migrated/unable to locate during surgery one of the essure coils") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.In (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, genital haemorrhage (seriousness criterion medically significant), menorrhagia ("abnormally long menses"), back pain ("severe back pain"), dyspareunia ("painful intercourse"), dysmenorrhoea ("severe menstrual pain"), migraine ("migraine headaches") and alopecia ("hair loss").The patient was treated with surgery (on (b)(6) 2014, she underwent partial hysterectomy with bilateral salpingectomy).At the time of the report, the device dislocation, genital haemorrhage, menorrhagia, back pain, dyspareunia, dysmenorrhoea, migraine and alopecia had resolved.The reporter considered alopecia, back pain, device dislocation, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia and migraine to be related to essure.The reporter commented: essure was successfully implanted, without complications.During removal surgery, physician was unable to locate one of the essure coils in plaintiff's body.Diagnostic results: in (b)(6) 2014: imaging procedure showed one essure coils had migrated and was unable to be located.Company causality comment this litigation report refers to unspecified aged female plaintiff who had essure (fallopian tube occlusion insert) insertion on (b)(6) 2009 and reported adverse events including abnormal bleeding (regarded as genital bleeding).The plaintiff had imaging done which indicated that one of her essure coils had migrated.She underwent partial hysterectomy with bilateral salpingectomy in (b)(6) 2014.During removal surgery, the physician was unable to locate during surgery one of the essure coils in plaintiff's body.Sometimes migration through the fallopian tube is suspected by the reporter because the essure insert is found in abdomen and no apparent perforation can be identified.Often "migration" is reported when the exact time point of perforation is not known.Genital bleeding is highly prevalent in women and has multiple causes.In this case the exact mechanism of the events is not know.The case was classified as incident due to reported surgery.A product technical analysis is being sought.Follow-up information will be obtained through the litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one of her essure coils had migrated/unable to locate during surgery one of the essure coils") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.In (b)(6) 2009, the patient had essure inserted (intra-uterine).On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower, genital haemorrhage (seriousness criterion medically significant), menorrhagia ("abnormally long menses"), back pain ("severe back pain"), dyspareunia ("painful intercourse"), dysmenorrhoea ("severe menstrual pain"), migraine ("migraine headaches") and alopecia ("hair loss").The patient was treated with surgery (on (b)(6)2014, she underwent partial hysterectomy with bilateral salpingectomy).At the time of the report, the device dislocation, genital haemorrhage, menorrhagia, back pain, dyspareunia, dysmenorrhoea, migraine and alopecia had resolved.The reporter considered alopecia, back pain, device dislocation, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia and migraine to be related to essure.The reporter commented: essure was successfully implanted, without complications.During removal surgery, physician was unable to locate one of the essure coils in plaintiff's body.Diagnostic results: in (b)(6) 2014: imaging procedure showed one essure coils had migrated and was unable to be located.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 4-may-2017: quality-safety evaluation of product technical complaint.Company causality comment: this litigation report refers to unspecified aged female plaintiff who had essure (fallopian tube occlusion insert) insertion on (b)(6) 2009 and reported adverse events including abnormal bleeding (regarded as genital bleeding).The plaintiff had imaging done which indicated that one of her essure coils had migrated.She underwent partial hysterectomy with bilateral salpingectomy in (b)(6) 2014.During removal surgery, the physician was unable to locate during surgery one of the essure coils in plaintiff's body.Sometimes migration through the fallopian tube is suspected by the reporter because the essure insert is found in abdomen and no apparent perforation can be identified.Often "migration" is reported when the exact time point of perforation is not known.Genital bleeding is highly prevalent in women and has multiple causes.In this case the exact mechanism of the events is not known.The case was classified as incident due to reported surgery.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Follow-up information will be obtained through the litigation process.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one of her essure coils had migrated/unable to locate during surgery one of the essure coils") and genital haemorrhage ("abnormal bleeding") in a 31-year-old female patient who had essure (batch no.624485) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test: no".The patient's past medical history included gravida ii, parity 2 ((b)(6) 2005;(b)(6) 2006), c-section, vaginal delivery, vaginal discharge, vaginal bleeding, back pain, accident, headache and cystoscopy on (b)(6) 2014.Concurrent conditions included body mass index normal, menstrual disorder, anxiety, depression, alcohol use, pain, cough, fever, visual impairment, premenopausal symptoms, genital bleeding, pain in hip, knee pain, sneezing, nasal congestion, ear pain, sore throat, hematuria, urinary frequency, respiratory infection, asthma, hepatic disease and osteoarthritis.Concomitant products included alprazolam (xanax), budesonide (pulmicort), bupropion (wellbutrin), drospirenone + ethinylestradiol (yasmin), oxycocet (percocet), promethazine (phenergan), trazodone and vicodin.On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2009, 1 year 5 months after insertion of essure, the patient experienced migraine ("migraine headaches / migraines"), the first episode of menorrhagia ("abnormal bleeding (menorrhagia)"), psychiatric symptom ("psychological or psychiatric problems condition"), feeling abnormal ("feeling crazy"), anger ("angry"), irritability ("irritated"), headache ("headaches"), vaginal discharge ("vaginal discharge") and hormone level abnormal ("hormonal changes").On (b)(6) 2009, the patient experienced alopecia ("hair loss /hair loss") and fatigue ("fatigue").On (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower and pelvic pain, genital haemorrhage (seriousness criterion medically significant), the second episode of menorrhagia ("abnormally long menses"), back pain ("severe back pain"), dyspareunia ("painful intercourse"), dysmenorrhoea ("severe menstrual pain / menstrual pain"), premenstrual syndrome ("pms(premenstrual syndrome )"), night sweats ("night sweats"), hot flush ("hot flashes"), sleep disorder ("sleeping problems"), menstruation irregular ("irregular menses") and abdominal pain ("abdominal pain").The patient was treated with surgery (on (b)(6) 2014, she underwent partial hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, genital haemorrhage, the last episode of menorrhagia, back pain, dyspareunia, dysmenorrhoea, migraine, alopecia, premenstrual syndrome, night sweats, hot flush, vaginal haemorrhage, psychiatric symptom, feeling abnormal, anger, irritability, sleep disorder, headache, fatigue, menstruation irregular, vaginal discharge, hormone level abnormal and abdominal pain had resolved.The reporter considered abdominal pain, alopecia, anger, back pain, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, genital haemorrhage, headache, hormone level abnormal, hot flush, irritability, menstruation irregular, migraine, night sweats, premenstrual syndrome, psychiatric symptom, sleep disorder, vaginal discharge, vaginal haemorrhage, the first episode of menorrhagia and the second episode of menorrhagia to be related to essure.The reporter commented: essure was successfully implanted, without complications.During removal surgery, physician was unable to locate one of the essure coils in plaintiff¿s body.Pfs- patient underwent la vh, bilateral salpingo-oophorectomy, adhesiolysis, and cystoscopy for essure removal.Current weight 130.00 lbs.Mr- on (b)(6) 2007 : patient failed essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.4 kg/sqm.In (b)(6) 2014: imaging procedure showed one essure coils had migrated and was unable to be located.(b)(6) 2014 : x-ray abdomen, two views : findings: no evidence of acute intraabdominal pathology demonstrated.A radiopaque a linear structure projects over left pelvis on the frontal view and is not clearly demonstrated on the lateral view, remaining study unremarkable.(b)(6) 2014 : axial images through the pelvis : findings: visualized pelvic viscera are grossly normal there is no evidence of an inguinal hernia.Uterus is unremarkable.No free fluid is seen within the pelvis.Curvilinear metallic density is seen in the left aspect of the uterus, possibly representing an essure wire.However, no metallic wire is seen on the right.Clinical correlation is suggested.Visualized bowel appears to be within "nonnal1imits." impression: no acute findings within the pelvis.Specifically, no evidence of a hernia.(b)(6) 2014 : x-ray pelv1s 1-2 views : findings: two views of pelvis show a linear foreign body.Compatible with an essure coil, to project over the anterior pelvis on left.(b)(6) 2013: us abdomen complete : findings: the liver present diffuse increase of echogenicity suggestive for fatty infiltration.There is no focal lesion identified.The gallbladder and biliary passages are unremarkable with the common bile duct measuring 2 mm.Portions of the head and body of the pancreas are visualized and are unremarkable.The spleen is not enlarged.Visualized aorta and vena cava are of normal caliber.Both kidneys are visualized and are normal in shape, size, and echotexture without focal mass lesions, hydro nephrosis or calculi.The right kidney measures 11 x 4.4 x 5 cm and the left kidney measures 10.5 x 4.9 x 5.2 cm.Impression: 1.Fat infiltration of the liver.Otherwise unremarkable ultrasound examination of the abdomen.(b)(6) 2014 : x-ray abdomen, two views clinical history: abdominal pain : findings: no evidence of acute intraabdominal pathology demonstrated.A radiopaque a linear structure projects over left pelvis on the frontal view and is not clearly demonstrated on the lateral view.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: menorrhagia, back pain, abdominal pain, feeling abnormal, anger, irritability, sleep disorder, device dislocation, menstruation irregular.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events- "pms(premenstrual syndrome), night sweats, hot flashes, abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), psychological or psychiatric problems condition, feeling crazy, angry, irritated, sleeping problems, headaches, fatigue, irregular menses, vaginal discharge, hormonal changes, abdominal pain, did you undergo an essure confirmation test: no", reporter, lot number, historical condition added from pfs.Historical and concomitant condition, lab data added from medical record.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one of her essure coils had migrated/unable to locate during surgery one of the essure coils"), menstruation irregular ("irregular menses") and genital haemorrhage ("abnormal bleeding") in a 31-year-old female patient who had essure (batch no.624485) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test: no".The patient's past medical history included gravida ii, parity 2 (b)(6) 2005; (b)(6) 2006), c-section, vaginal delivery, vaginal discharge, vaginal bleeding, back pain, accident, headache and cystoscopy on (b)(6) 2014.Concurrent conditions included body mass index normal, menstrual disorder, anxiety, depression, alcohol use, pain, cough, fever, visual impairment, premenopausal symptoms, genital bleeding, pain in hip, knee pain, sneezing, nasal congestion, ear pain, sore throat, hematuria, urinary frequency, respiratory infection, asthma, hepatic disease and osteoarthritis.Concomitant products included alprazolam (xanax), budesonide (pulmicort), bupropion (wellbutrin), drospirenone + ethinylestradiol (yasmin), oxycocet (percocet), promethazine (phenergan), trazodone and vicodin.On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2009, 1 year 5 months after insertion of essure, the patient experienced menstruation irregular (seriousness criteria medically significant and intervention required), migraine ("migraine headaches / migraines"), the first episode of menorrhagia ("abnormal bleeding (menorrhagia)"), psychiatric symptom ("psychological or psychiatric problems condition"), feeling abnormal ("feeling crazy"), anger ("angry"), irritability ("irritated"), headache ("headaches"), vaginal discharge ("vaginal discharge") and hormone level abnormal ("hormonal changes").On (b)(6) 2009, the patient experienced alopecia ("hair loss /hair loss") and fatigue ("fatigue").On (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain lower and pelvic pain, genital haemorrhage (seriousness criterion medically significant), the second episode of menorrhagia ("abnormally long menses"), back pain ("severe back pain"), dyspareunia ("painful intercourse"), dysmenorrhoea ("severe menstrual pain / menstrual pain"), premenstrual syndrome ("pms(premenstrual syndrome )"), night sweats ("night sweats"), hot flush ("hot flashes"), sleep disorder ("sleeping problems") and abdominal pain ("abdominal pain").The patient was treated with surgery (on (b)(6) 2014, she underwent partial hysterectomy with bilateral salpingectomy) and surgery (ablation).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, menstruation irregular, genital hemorrhage, the last episode of menorrhagia, back pain, dyspareunia, dysmenorrhoea, migraine, alopecia, premenstrual syndrome, night sweats, hot flush, vaginal haemorrhage, psychiatric symptom, feeling abnormal, anger, irritability, sleep disorder, headache, fatigue, vaginal discharge, hormone level abnormal and abdominal pain had resolved.The reporter considered abdominal pain, alopecia, anger, back pain, device dislocation, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, genital hemorrhage, headache, hormone level abnormal, hot flush, irritability, menstruation irregular, migraine, night sweats, premenstrual syndrome, psychiatric symptom, sleep disorder, vaginal discharge, vaginal haemorrhage, the first episode of menorrhagia and the second episode of menorrhagia to be related to essure.The reporter commented: essure was successfully implanted, without complications.During removal surgery, physician was unable to locate one of the essure coils in plaintiff¿s body.Pfs- patient underwent la vh, bilateral salpingo-oophorectomy, adhesiolysis, and cystoscopy for essure removal.Current weight 130.00 lbs.Mr- on (b)(6) 2007 : patient failed essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.4 kg/sqm.In (b)(6) 2014: imaging procedure showed one essure coils had migrated and was unable to be located.(b)(6) 2014 : x-ray abdomen, two views : findings: no evidence of acute intraabdominal pathology demonstrated.A radiopaque a linear structure projects over left pelvis on the frontal view and is not clearl demonstrated on the lateral view, remaining study unremarkable.(b)(6) 2014 : axial images through the pelvis : findings: visualized pelvic viscera are grossly normal there is no evidence of an inguinal hernia.Uterus is unremarkable.No free fluid is seen within the pelvis.Curvilinear metallic density is seen in the left aspect of the uterus, possibly representing an essure wire.However, no metallic wire is seen on the right.Clinical correlation is suggested.Visualized bowel appears to be within nonnal1imits.Impression: no acute findings within the pelvis.Specifically, no evidence of a hernia.(b)(6) 2014 : x-ray pelv1s 1-2 views : findings: two views of pelvis show a linear foreign body.Compatible with an essure coil, to project over the anterior pelvis on left.(b)(6) 2013: us abdomen complete : findings: the liver present diffuse increase of echogenicity suggestive for fatty infiltration.There is no focal lesion identified.The gallbladder and biliary passages are unremarkable with the common bile duct measuring 2 mm.Portions of the head and body of the pancreas are visualized and are unremarkable.The spleen is not enlarged.Visualized aorta and vena cava are of normal caliber.Both kidneys are visualized and are normal in shape, size, and echotexture without focal mass lesions, hydro nephrosis or calculi.The right kidney measures 11 x 4.4 x 5 cm and the left kidney measures 10.5 x 4.9 x 5.2 cm.Impression: 1.Fat infiltration of the liver.Otherwise unremarkable ultrasound examination of the abdomen.(b)(6) 2014 : x-ray abdomen, two views clinical history: abdominal pain : findings: no evidence of acute intraabdominal pathology demonstrated.A radiopaque a linear structure projects over left pelvis on the frontal view and is not clearly demonstrated on the lateral view.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: menorrhagia, back pain, abdominal pain, feeling abnormal, anger, irritability, sleep disorder, device dislocation, menstruation irregular.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-jul-2018: quality safety evaluation of product technical complaint.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.
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