| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Autoimmune Disorder (1732); Fatigue (1849); Flatus (1865); Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123); Arthralgia (2355); Heavier Menses (2666); No Code Available (3191)
|
| Event Date 11/01/2015 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device was beginning to separate and had fragmented"), autoimmune disorder ("auto immune disorder") and nervous system disorder ("nerve swelling") in a female patient who received essure for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective ("only one of her tubes was occluded").On (b)(6) 2014, the patient started essure.In (b)(6) 2015, the patient experienced device breakage (serious criteria medically significant and clinically significant/intervention required) with abdominal pain lower, dysmenorrhoea ("severe menstrual pain"), menorrhagia ("heavy menstrual bleeding and prolonged menses"), back pain ("severe back pain"), dyspareunia ("pain during intercourse") and migraine ("migraines").In (b)(6) 2015, the patient experienced alopecia ("hair loss") and autoimmune disorder (serious criterion medically significant).In (b)(6) 2016, the patient experienced vaginal discharge ("abnormal/irregular vaginal discharge").On an unknown date, the patient experienced arthralgia ("severe joint pain"), fatigue ("fatigue"), nervous system disorder (serious criterion medically significant), abdominal distension ("bloating"), menstrual disorder ("abnormal periods") and dysgeusia ("metallic taste").The patient was treated with surgery (essure removal via salpingectomy).Essure was withdrawn.At the time of the report, the device breakage, dysmenorrhoea, back pain, dyspareunia, migraine, alopecia, autoimmune disorder, vaginal discharge, arthralgia, fatigue, nervous system disorder, abdominal distension, menstrual disorder and dysgeusia outcome was unknown and the menorrhagia had not resolved.The reporter considered device breakage, dysmenorrhoea, menorrhagia, back pain, dyspareunia, migraine, alopecia, autoimmune disorder, vaginal discharge, arthralgia, fatigue, nervous system disorder, abdominal distension, menstrual disorder and dysgeusia to be related to essure.The reporter commented: it was at her (b)(6) 2016 visit that a physician told her that he believed her symptoms were related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): in (b)(6) 2015: hysterosalpingogram result was confirming full occlusion.In or about (b)(6) 2016, imaging determined that the right coil of the device was beginning to separate and had fragmented.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 and thus were 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.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following med dra llt: device ineffective.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events and the reported lack of efficacy cannot be totally excluded.A lack of efficacy and 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 7-dec-2016: new events added.Case upgraded to incident.Company causality comment: this spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced severe lower abdominal pain, autoimmune disorder and nerve swelling (seen as nervous system disorder).Upon follow-up receipt, it was reported that almost two years after essure insertion, imaging determined that her right coil of the device was beginning to separate and had fragmented (device breakage).Essure was removed via salpingectomy.Lower abdominal pain and device breakage are anticipated whereas autoimmune disorder and nervous system disorder are unanticipated in the reference safety information for essure.Abdominal pain and device breakage may occur during essure therapy.The exact date and mechanism of the device breakage are not known.However, considering the temporal relationship and the nature of events, a causal relationship between them and essure cannot be excluded.In this particular case, the autoimmune and nervous system disorders were not specified and needed further investigation.Nevertheless, considering the pathophysiology of autoimmune disorder and the most probable causes of nervous system disorder and local action of essure at fallopian tubes, causality between these events and essure was excluded.This case was regarded as incident, as a surgical intervention was required.In addition, non serious events were reported.A new product technical analysis is expected.Further information will be obtained through the litigation process.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device was beginning to separate and had fragmented"), autoimmune disorder ("auto mmune disorder") and nervous system disorder ("nerve swelling") in a (b)(6) year-old female patient who had essure (batch no.377710784) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "only one of her tubes was occluded/left fallopian tube is not completely occluded, as contrast is visualized around and slightly beyond the left essure device; however there is no evidence of free peritoneal spill of contrast".The patient's past medical history included multi gravida, parity 3 (live births on (b)(6) 1994, (b)(6) 1996, (b)(6) 1999), varicose veins of lower extremities, abortion, cervical conization (and loop elected, pr lapro tubal block) and non-tobacco user.She denied alcohol use.Previously administered products included for pregnancy prevention: ortho tri-cyclen from 2000 to (b)(6) 2014.Past adverse reactions to the above products included pregnancy with ortho tri-cyclen.Concurrent conditions included anesthesia, numbness (sometimes feels like her legs fall asleep and get numb) and chronic salpingitis.Family history included hypertension (paternal grandfather).Concomitant products included anaesthetics (anesthesia), bupivacaine (marcaine), hydrocodone, ibuprofen, lorazepam, medroxyprogesterone and povidone-iodine (betadine).On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced weight increased ("weight gain").On (b)(6) 2014, the patient experienced migraine ("migraines") and headache ("headaches").On (b)(6) 2014, the patient experienced arthralgia ("severe joint pain/joint pain"), fatigue ("fatigue"), musculoskeletal stiffness ("stiffness in ankles, knees, hips,hands"), peripheral swelling ("swelling in the hands and feet") and pelvic pain ("pain/.Pelvic pain").On (b)(6) 2015, the patient experienced rash ("rashes on: face/mouth area, torso, groin").In (b)(6) 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain lower, dysmenorrhoea ("severe menstrual pain"), menorrhagia ("heavy menstrual bleeding and and prolonged menses/menorrhagia"), back pain ("severe back pain/lower back pain") and dyspareunia ("pain during intercourse").In (b)(6) 2015, the patient experienced alopecia ("hair loss") and autoimmune disorder (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced vaginal discharge ("abnormal/irregular vaginal discharge/vaginal discharge").On (b)(6) 2017, the patient experienced vision blurred ("blurry vision").On an unknown date, the patient experienced nervous system disorder (seriousness criterion medically significant), abdominal distension ("bloating"), menstrual disorder ("abnormal periods"), dysgeusia ("metallic taste"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), abdominal pain lower ("lower abdomen pain"), fallopian tube spasm ("spasms in my fallopian tube so it took them 2-3x longer to insert the devices") and rash pruritic ("itchy patches on arms and legs").The patient was treated with ibuprofen (motrin), paracetamol (tylenol regular) and surgery (laparoscopic partial bilateral salpingectomy and removal contraceptive devices.).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, autoimmune disorder, nervous system disorder, abdominal distension, menstrual disorder and dysgeusia outcome was unknown, the dysmenorrhoea, menorrhagia, back pain, dyspareunia, migraine, alopecia, vaginal discharge, arthralgia, vaginal haemorrhage, headache, musculoskeletal stiffness, peripheral swelling, pelvic pain, weight increased, abdominal pain lower, fallopian tube spasm, rash and rash pruritic had resolved and the fatigue and vision blurred had not resolved.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, autoimmune disorder, back pain, device breakage, dysgeusia, dysmenorrhoea, dyspareunia, fallopian tube spasm, fatigue, headache, menorrhagia, menstrual disorder, migraine, musculoskeletal stiffness, nervous system disorder, pelvic pain, peripheral swelling, rash, rash pruritic, vaginal discharge, vaginal haemorrhage, vision blurred and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: it was at her (b)(6) 2016 visit that a physician told her that he believed her symptoms were related to essure.Doctor recommended taking iron supplements and a multivitamin for event rashes on: face/mouth area torso, groin and itchy patches on arms and legs.In (b)(6) 2015, she underwent laparoscopic tubal ligation, falope ring method due to failed essure.In (b)(6) 2016,the hysterosalpingogram showed bilateral fallopian tube occlusion by unchanged essure-micro inserts.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: complete right fallopian tube occlusion.In or about (b)(6) 2016, imaging determined that the right coil of the device was beginning to separate and had fragmented.On (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, hysterosalpingogram showed total bilateral occlusion, other-(l) complete right fallopian tube occlusion.The left fallopian tube is not completely occluded, as contrast is visualized around and slightly beyond the left essure device; however there is no evidence of free peritoneal spill of contrast.Persistent evidence of tubal patency on the left.Right tubal occlusion.Bilateral fallopian tube occlusion by unchanged essure-micro inserts.Endometrial cavity is normal in this study.On (b)(6) 2016, mammo screening bilateral digital.Findings included there are scattered areas of asymmetry and benign-appearing nodularity.There are no new worrisome parenchymal densities or suspicious micro calcifications.On (b)(6) 2016, transvaginal ultrasound was performed.Most recent follow-up information incorporated above includes: on 12-feb-2018: pfs and mr, new reporter, patient demographic information, lab data, relevant history, essure indication and lot number added, concomitant product,new event abnormal bleeding (vaginal menorrhagia), rashes on: face/mouth area torso, groin and itchy patches on arms and legs, migraines, stiffness in ankles, knees, hips, hands, swelling in the hands and feet, dyspareunia (painful sexual intercourse), pain/pelvic pain and spasms in my fallopian tube so it took them 2-3x longer to insert the devices around were added.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only 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.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("device was beginning to separate and had fragmented"), autoimmune disorder ("auto mmune disorder") and nervous system disorder ("nerve swelling") in a 42-year-old female patient who had essure (batch no.377710784 (invalid)) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "only one of her tubes was occluded/left fallopian tube is not completely occluded, as contrast is visualized around and slightly beyond the left essure device; however there is no evidence of free peritoneal spill of contrast".The patient's past medical history included multi gravida, parity 3 (live births on (b)(6) 1994, (b)(6) 1996, (b)(6) 1999), varicose veins of lower extremities, abortion, cervical conization (and loop elected, pr lapro tubal block) and non-tobacco user.She denied alcohol use.Previously administered products included for pregnancy prevention: ortho tri-cyclen from 2000 to (b)(6) 2014.Past adverse reactions to the above products included pregnancy with ortho tri-cyclen.Concurrent conditions included anesthesia, numbness (sometimes feels like her legs fall asleep and get numb) and chronic salpingitis.Family history included hypertension (paternal grandfather).Concomitant products included anaesthetics (anesthesia), bupivacaine (marcaine), hydrocodone, ibuprofen, lorazepam, medroxyprogesterone and povidone-iodine (betadine).On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced weight increased ("weight gain").On (b)(6) 2014, the patient experienced migraine ("migraines") and headache ("headaches").On (b)(6) 2014, the patient experienced arthralgia ("severe joint pain/joint pain"), fatigue ("fatigue"), joint stiffness ("stiffness in ankles, knees, hips,hands"), peripheral swelling ("swelling in the hands and feet") and pelvic pain ("pain/.Pelvic pain").On (b)(6) 2015, the patient experienced rash ("rashes on: face/mouth area, torso, groin").In (b)(6) 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain lower, dysmenorrhoea ("severe menstrual pain"), menorrhagia ("heavy menstrual bleeding and prolonged menses/menorrhagia"), back pain ("severe back pain/lower back pain") and dyspareunia ("pain during intercourse").In (b)(6) 2015, the patient experienced alopecia ("hair loss") and autoimmune disorder (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced vaginal discharge ("abnormal/irregular vaginal discharge/vaginal discharge").On (b)(6) 2017, the patient experienced vision blurred ("blurry vision").On an unknown date, the patient experienced nervous system disorder (seriousness criterion medically significant), abdominal distension ("bloating"), menstrual disorder ("abnormal periods"), dysgeusia ("metallic taste"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), abdominal pain lower ("lower abdomen pain"), fallopian tube spasm ("spasms in my fallopian tube so it took them 2-3x longer to insert the devices") and rash pruritic ("itchy patches on arms and legs").The patient was treated with ibuprofen (motrin), paracetamol (tylenol regular) and surgery (laparoscopic partial bilateral salpingectomy and removal contraceptive devices.).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, autoimmune disorder, nervous system disorder, abdominal distension, menstrual disorder and dysgeusia outcome was unknown, the dysmenorrhoea, menorrhagia, back pain, dyspareunia, migraine, alopecia, vaginal discharge, arthralgia, vaginal haemorrhage, headache, joint stiffness, peripheral swelling, pelvic pain, weight increased, abdominal pain lower, fallopian tube spasm, rash and rash pruritic had resolved and the fatigue and vision blurred had not resolved.The reporter considered abdominal distension, abdominal pain lower, alopecia, arthralgia, autoimmune disorder, back pain, device breakage, dysgeusia, dysmenorrhoea, dyspareunia, fallopian tube spasm, fatigue, headache, joint stiffness, menorrhagia, menstrual disorder, migraine, nervous system disorder, pelvic pain, peripheral swelling, rash, rash pruritic, vaginal discharge, vaginal haemorrhage, vision blurred and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: it was at her (b)(6) 2016 visit that a physician told her that he believed her symptoms were related to essure.Doctor recommended taking iron supplements and a multivitamin for event rashes on: face/mouth area torso, groin and itchy patches on arms and legs.In (b)(6) 2015, she underwent laparoscopic tubal ligation, falope ring method due to failed essure.In (b)(6) 2016,the hysterosalpingogram showed bilateral fallopian tube occlusion by unchanged essure-micro inserts.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.8 kg/sqm.Hysterosalpingogram - on (b)(6) 2015: complete right fallopian tube occlusion.In or about v2016, imaging determined that the right coil of the device was beginning to separate and had fragmented.On (b)(6) 2015, hysterosalpingogram showed total bilateral occlusion, other-(l) complete right fallopian tube occlusion.The left fallopian tube is not completely occluded, as contrast is visualized around and slightly beyond the left essure device; however there is no evidence of free peritoneal spill of contrast.(2)persistent evidence of tubal patency on the left.Right tubal occlusion.(3)bilateral fallopian tube occlusion by unchanged essure-micro inserts.Endometrial cavity is normal in this study.On (b)(6) 2016, mammo screening bilateral digital findings included there are scattered areas of asymmetry and benign-appearing nodularity.There are no new worrisome parenchymal densities.Or suspicious micro calcifications.On (b)(6) 2016, transvaginal ultrasound was performed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jul-2018: quality-safety evaluation of ptc.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.
|
| |
|
Search Alerts/Recalls
|
|
