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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Tissue Damage (2104); Weakness (2145); Burning Sensation (2146); Dizziness (2194); Anxiety (2328); Irritability (2421); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Blood Loss (2597); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of prolonged heavy periods ('period that last atleast 10 days and soak through two pads') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced diastasis recti abdominis ("diastasis recti (separated tummy muscles from pregnancy)"), haemorrhage ("lost lot of blood"), dizziness ("dizzy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), rash macular ("red dots over all her belly"), menorrhagia ("menorrhagia"), adenomyosis ("adenomyosis"), anxiety ("severe anxiety"), amnesia ("memory loss"), feeling abnormal ("memory fog"), pain ("body pain"), burning sensation ("burning"), prolonged heavy periods (seriousness criteria medically significant and intervention required), irritability ("severe irritability"), mood swings ("severe mood swings"), suicidal ideation ("suicidal thoughts"), fatigue ("tired "), asthenia ("weak"), gait disturbance ("cant even walk the mall "), hypertension ("blood pressure stays high on three medications"), hyposmia ("loss of sense of smell") and libido decreased ("barely feel sex"), underwent transfusion ("blood transfusion") and was found to have uterine leiomyoma ("fibroids").The patient was treated with magnesium, riboflavin (b2 asmedic) and surgery (essure removal surgery is next week).At the time of the report, the diastasis recti abdominis, haemorrhage, dizziness, transfusion, headache, dyspareunia, rash macular, uterine leiomyoma, menorrhagia, adenomyosis, anxiety, amnesia, feeling abnormal, pain, burning sensation, prolonged heavy periods, irritability, mood swings, suicidal ideation, fatigue, asthenia, gait disturbance, hypertension, hyposmia and libido decreased outcome was unknown.The reporter considered adenomyosis, amnesia, anxiety, asthenia, burning sensation, diastasis recti abdominis, dizziness, dyspareunia, fatigue, feeling abnormal, gait disturbance, haemorrhage, headache, hypertension, hyposmia, irritability, libido decreased, menorrhagia, mood swings, pain, rash macular, suicidal ideation, transfusion, uterine leiomyoma and prolonged heavy periods to be related to essure.The reporter commented: patient had diastasis recti (separated tummy muscles from pregnancy), so she always look pregnant.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media received.New event added : uterine leiomyoma, menorrhagia, adenomyosis, anxiety, amnesia, feeling abnormal, pain, burning sensation, prolonged heavy periods, irritability, mood swings, suicidal ideation, fatigue, asthenia, gait disturbance, hypertension, hyposmia and libido decreased reporter was added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer, and describes the occurrence of prolonged heavy periods ('period that last at least 10 days, and soak through two pads').In an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced, prolonged heavy periods (seriousness criteria medically significant and intervention required), diastasis recti abdominis ("diastasis recti (separated tummy muscles from pregnancy)"), haemorrhage ("lost lot of blood"), dizziness ("dizzy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), rash macular ("red dots over all her belly"), menorrhagia ("menorrhagia"), adenomyosis ("adenomyosis"), anxiety ("severe anxiety"), amnesia ("memory loss"), feeling abnormal ("memory fog"), pain ("body pain/ total body pain"), burning sensation ("burning"), irritability ("severe irritability"), mood swings ("severe mood swings"), suicidal ideation ("suicidal thoughts"), fatigue ("tired "), asthenia ("weak"), gait disturbance ("cant even walk the mall"), hypertension ("blood pressure stays high on three medications"), hyposmia ("loss of sense of smell"), libido decreased ("barely feel sex"), paraesthesia ("arm tingling"), hypoaesthesia ("numbness"), neck pain ("neck pain").And musculoskeletal pain ("shoulder pain"), underwent transfusion ("blood transfusion").And was found to have uterine leiomyoma ("fibroids/ uterine fibroids").The patient was treated with magnesium, riboflavin (b2 asmedic) and surgery (essure removal surgery is next week).Essure was removed.At the time of the report, the prolonged heavy periods, diastasis recti abdominis, haemorrhage, dizziness, transfusion, headache, dyspareunia, rash macular, uterine leiomyoma, menorrhagia, adenomyosis, anxiety, amnesia, feeling abnormal, pain, burning sensation, irritability, mood swings, suicidal ideation, fatigue, asthenia, gait disturbance, hypertension, hyposmia, libido decreased, paraesthesia, hypoaesthesia, neck pain and musculoskeletal pain outcome was unknown.The reporter considered adenomyosis, amnesia, anxiety, asthenia, burning sensation, diastasis recti abdominis, dizziness, dyspareunia, fatigue, feeling abnormal, gait disturbance, haemorrhage, headache, hypertension, hypoaesthesia, hyposmia, irritability, libido decreased, mood swings, musculoskeletal pain, neck pain, pain, paraesthesia, prolonged heavy periods, rash macular, suicidal ideation, transfusion, uterine leiomyoma and menorrhagia to be related to essure.The reporter commented: patient had diastasis recti (separated tummy muscles from pregnancy), so she always look pregnant.Concerning the injuries reported in this case, the following ones were reported in patient¿s social media records: arm tingling/ numbness, neck pain, shoulder pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020, social media received: reporter's information were added.Events added: arm tingling/ numbness, neck pain, shoulder pain.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of prolonged heavy periods ('period that last atleast 10 days and soak through two pads') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced prolonged heavy periods (seriousness criteria medically significant and intervention required), diastasis recti abdominis ("diastasis recti (separated tummy muscles from pregnancy)"), haemorrhage ("lost lot of blood"), dizziness ("dizzy"), headache ("headaches"), dyspareunia ("dyspareunia (painful sexual intercourse)"), rash macular ("red dots over all her belly"), menorrhagia ("menorrhagia"), adenomyosis ("adenomyosis"), anxiety ("severe anxiety"), amnesia ("memory loss"), feeling abnormal ("memory fog"), pain ("body pain/ total body pain"), burning sensation ("burning"), irritability ("severe irritability"), mood swings ("severe mood swings"), suicidal ideation ("suicidal thoughts"), fatigue ("tired "), asthenia ("weak"), gait disturbance ("cant even walk the mall"), hypertension ("blood pressure stays high on three medications"), hyposmia ("loss of sense of smell"), libido decreased ("barely feel sex"), paraesthesia ("arm tingling"), hypoaesthesia ("numbness"), neck pain ("neck pain") and musculoskeletal pain ("shoulder pain"), underwent transfusion ("blood transfusion") and was found to have uterine leiomyoma ("fibroids/ uterine fibroids").The patient was treated with magnesium, riboflavin (b2 asmedic) and surgery (essure removal surgery is next week).Essure was removed.At the time of the report, the prolonged heavy periods, diastasis recti abdominis, haemorrhage, dizziness, transfusion, headache, dyspareunia, rash macular, uterine leiomyoma, menorrhagia, adenomyosis, anxiety, amnesia, feeling abnormal, pain, burning sensation, irritability, mood swings, suicidal ideation, fatigue, asthenia, gait disturbance, hypertension, hyposmia, libido decreased, paraesthesia, hypoaesthesia, neck pain and musculoskeletal pain outcome was unknown.The reporter considered adenomyosis, amnesia, anxiety, asthenia, burning sensation, diastasis recti abdominis, dizziness, dyspareunia, fatigue, feeling abnormal, gait disturbance, haemorrhage, headache, hypertension, hypoaesthesia, hyposmia, irritability, libido decreased, mood swings, musculoskeletal pain, neck pain, pain, paraesthesia, prolonged heavy periods, rash macular, suicidal ideation, transfusion, uterine leiomyoma and menorrhagia to be related to essure.The reporter commented: patient had diastasis recti (separated tummy muscles from pregnancy), so she always look pregnant.Concerning the injuries reported in this case, the following ones were reported in patient¿s social media records: arm tingling/ numbness, neck pain, shoulder pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jul-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.

• 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: 9996136
• MDR Text Key: 188895652
• Report Number: 2951250-2020-05508
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 06/18/2020; 07/15/2020
• Supplement Dates FDA Received: 07/06/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention