MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration") and device breakage ("fracturing") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.In 2015, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (she had surgery to remove the essure).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage and pelvic pain outcome was unknown.The reporter considered device breakage, device dislocation and pelvic pain to be related to essure.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration/ migrated to left ovary") and device breakage ("fracturing") in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not inderwent essure confirmation test." the patient's concurrent conditions included fatty liver.Concomitant products included ibuprofen and paracetamol (tylenol).On (b)(6) 2013, the patient had essure inserted.In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), migraine ("migraines"), headache ("headaches") and eye disorder ("eye disorder").On (b)(6) 2015, 6 months 5 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), fungal infection ("yeast infection"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), dizziness ("dizzy"), hemiparesis ("left side weakness"), facial paralysis ("facial droop"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("left side vaginal pain") and infection ("infection").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, vaginal haemorrhage, menorrhagia, fungal infection, female sexual dysfunction, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, dyspareunia, vaginal discharge, eye disorder, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, fatigue and infection had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, eye disorder, facial paralysis, fatigue, female sexual dysfunction, fungal infection, headache, hemiparesis, infection, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 50 kg/sqm.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet- all relevant medical history condition, concurrent condition, concomitant medication events abnormal bleeding (vaginal, menorrhagia) yeast infection, apareunia (inability to have sexual intercourse),depression, self-esteem, anger, migraines / headaches, migrated to left ovary, salpingectomy (bilateral removal of fallopian tubes), dizzy, left side weakness, facial droop, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), pain, vaginal discharge, vision/eye problems type: prescription glasses, fatigue, weight gain were added.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

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing'), device dislocation ('migration/ migrated to left ovary/ migration of essure device- location of device'), hemiparesis ('left side weakness') and facial paralysis ('facial droop') in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not underwent essure confirmation test".The patient's medical history included stress incontinence, hypertension, hypoactive sexual desire disorder, retained foreign body in eye, insomnia and seasonal allergy.Current weight as of (b)(6) 2018: 245 lbs.Approximate weight at time of essure placement: 220 lbs.Concurrent conditions included fatty liver and obesity.Concomitant products included ibuprofen since 2000 and paracetamol (tylenol) since 2000.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue") and vulvovaginal pain ("left side vaginal pain") and was found to have weight increased ("weight gain").In (b)(6) 2015, the patient experienced dizziness ("dizzy"), hemiparesis (seriousness criterion medically significant), facial paralysis (seriousness criterion medically significant) and visual impairment ("vision\eye problems-type: prescription glasses").In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain\left side").On (b)(6) 2015, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 2 years 6 months after insertion of essure.On an unknown date, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type:yeast infection\infections").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), hysterectomy(full)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device dislocation, vaginal haemorrhage, menorrhagia, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, vaginal discharge, visual impairment and weight increased outcome was unknown and the pelvic pain, vulvovaginal mycotic infection, female sexual dysfunction, dyspareunia, fatigue and vulvovaginal pain had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, facial paralysis, fatigue, female sexual dysfunction, headache, hemiparesis, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, visual impairment, vulvovaginal mycotic infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 44.9 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, dysmenorrhea, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-jun-2019: new pfs+mr received: outcome of event infection and dyspareunia updated from unknown to recovered/resolved.Product, patient & reporter information updated.Event yeast infection updated to vaginal yeast infection.Event infection clubbed with vaginal yeast infection.Event eye disorder updated to visual impairment.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration/ migrated to left ovary") and device breakage ("fracturing") in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not inderwent essure confirmation test".The patient's concurrent conditions included fatty liver.Concomitant products included ibuprofen and paracetamol (tylenol).On (b)(6) 2013, the patient had essure inserted.In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), migraine ("migraines"), headache ("headaches") and eye disorder ("eye disorder").On (b)(6) 2015, 6 months 5 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), fungal infection ("yeast infection"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), dizziness ("dizzy"), hemiparesis ("left side weakness"), facial paralysis ("facial droop"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("left side vaginal pain") and infection ("infection").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes),) and surgery (salpingectomy (bilateral removal of fallopian tubes),).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, vaginal haemorrhage, menorrhagia, fungal infection, female sexual dysfunction, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, dyspareunia, vaginal discharge, eye disorder, weight increased and vulvovaginal pain outcome was unknown and the pelvic pain, fatigue and infection had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, eye disorder, facial paralysis, fatigue, female sexual dysfunction, fungal infection, headache, hemiparesis, infection, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 50 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of product technical problem update.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

Contaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration/ migrated to left ovary/ migration of essure device- location of device"), device breakage ("fracturing") and hemiparesis ("left side weakness") in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not underwent essure confirmation test".The patient's concurrent conditions included fatty liver and obesity.Concomitant products included ibuprofen and paracetamol (tylenol).On (b)(6) 2013, the patient had essure inserted.In april 2015, the patient experienced dizziness ("dizzy").In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), migraine ("migraines"), headache ("headaches") and eye disorder ("eye disorder").On (b)(6) 2015, 6 months 5 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), fungal infection ("yeast infection"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), hemiparesis (seriousness criterion medically significant), facial paralysis ("facial droop"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), weight increased ("weight gain"), vulvovaginal pain ("left side vaginal pain") and infection ("infection").The patient was treated with surgery (on 12-11-2015:salpingectomy (bilateral removal of fallopian tubes), hysterectomy(full)).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, device breakage, vaginal haemorrhage, menorrhagia, fungal infection, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, dyspareunia, vaginal discharge, eye disorder and weight increased outcome was unknown and the pelvic pain, female sexual dysfunction, fatigue, vulvovaginal pain and infection had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, eye disorder, facial paralysis, fatigue, female sexual dysfunction, fungal infection, headache, hemiparesis, infection, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 44.9 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Event outcome was updated for the event: left side vaginal pain, inability to have sexual intercourse.Concomitant condition was added.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

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing'), device dislocation ('migration/ migrated to left ovary/ migration of essure device- location of device'), hemiparesis ('left side weakess') and facial paralysis ('facial droop') in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not underwent essure confirmation test".The patient's medical history included stress incontinence, hypertension, hypoactive sexual desire disorder, retained foreign body in eye, insomnia and seasonal allergy.Current weight as of (b)(6) 2018: 245 lbs.Approximate weight at time of essure placement: 220 lbs.Concurrent conditions included fatty liver and obesity.Concomitant products included ibuprofen since 2000 and paracetamol (tylenol) since 2000.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue") and vulvovaginal pain ("left side vaginal pain") and was found to have weight increased ("weight gain").In (b)(6) 2015, the patient experienced dizziness ("dizzy"), hemiparesis (seriousness criterion medically significant), facial paralysis (seriousness criterion medically significant) and visual impairment ("vision\eye problems-type:prescription glasses").In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain\left side").On (b)(6) 2015, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 2 years 6 months after insertion of essure.On an unknown date, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type:yeast infection\infections").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), hysterectom(full) and salpingectomy (bilateral removal of fallopian tubes),hysterectomy(full)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device dislocation, vaginal haemorrhage, menorrhagia, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, vaginal discharge, visual impairment and weight increased outcome was unknown and the pelvic pain, vulvovaginal mycotic infection, female sexual dysfunction, dyspareunia, fatigue and vulvovaginal pain had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, facial paralysis, fatigue, female sexual dysfunction, headache, hemiparesis, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, visual impairment, vulvovaginal mycotic infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 44.9 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records : pelvic pain, dysmenorrhea, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-oct-2019: this record was detected to be a duplicate to record # (b)(4) (social media case posted on (b)(6) 2015, medwatch 3500a mfr number 2951250-2019-10785) from which all information was transferred to this case record ((b)(4)), then duplicate record # (b)(4) will be deleted.No new information was added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing'), device dislocation ('migration/ migrated to left ovary/ migration of essure device- location of device'), hemiparesis ('left side weakess') and facial paralysis ('facial droop') in a 30-year-old female patient who had essure (batch no.A64633) 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 "she did not underwent essure confirmation test".The patient's medical history included stress incontinence, hypertension, hypoactive sexual desire disorder, retained foreign body in eye, insomnia and seasonal allergy.Current weight as of (b)(6)2018: 245 lbs approximate weight at time of essure placement: 220 lbs.Concurrent conditions included fatty liver and obesity.Concomitant products included ibuprofen since 2000 and paracetamol (tylenol) since 2000.On (b)(6)2013, the patient had essure inserted.In (b)(6)2014, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), depression ("depression"), self esteem decreased ("self-esteem"), anger ("anger"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue") and vulvovaginal pain ("left side vaginal pain") and was found to have weight increased ("weight gain").In (b)(6)2015, the patient experienced dizziness ("dizzy"), hemiparesis (seriousness criterion medically significant), facial paralysis (seriousness criterion medically significant) and visual impairment ("vision\eye problems-type:prescription glasses").In 2015, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain\left side").On (b)(6)2015, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 2 years 6 months after insertion of essure.On an unknown date, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type:yeast infection\infections").The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes), hysterectomy(full) and salpingectomy (bilateral removal of fallopian tubes),hysterectomy(full)).Essure was removed on (b)(6)2015.At the time of the report, the device breakage, device dislocation, vaginal haemorrhage, menorrhagia, depression, self esteem decreased, anger, migraine, headache, dizziness, hemiparesis, facial paralysis, dysmenorrhoea, vaginal discharge, visual impairment and weight increased outcome was unknown and the pelvic pain, vulvovaginal mycotic infection, female sexual dysfunction, dyspareunia, fatigue and vulvovaginal pain had resolved.The reporter considered anger, depression, device breakage, device dislocation, dizziness, dysmenorrhoea, dyspareunia, facial paralysis, fatigue, female sexual dysfunction, headache, hemiparesis, menorrhagia, migraine, pelvic pain, self esteem decreased, vaginal discharge, vaginal haemorrhage, visual impairment, vulvovaginal mycotic infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 44.9 kg/sqm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records : pelvic pain, dysmenorrhea, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-dec-2019: pfs received- malfunction of the event device breakage was updated.Eu/mir tab was updated.A technical investigation will be 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7078804
• MDR Text Key: 93593204
• Report Number: 2951250-2017-09684
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: ESS305
• Device Lot Number: A64633
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; TYLENOL; TYLENOL; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 100