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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of back pain ('back pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "coil bent on one side when insert", device monitoring procedure not performed "device monitoring procedure not performed " and device ineffective "device ineffective".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), psychological trauma ("psych injury"), fatigue ("fatigue"), emotional disorder ("hormonal changes / emotional issues"), headache ("headaches"), night sweats ("night sweats"), hot flush ("hot flashes"), migraine ("migraines/headaches"), rash ("itching rash all over") and myalgia ("muscle aches"), was found to have a pregnancy with contraceptive device ("pregnancy: terminated") and was found to have weight increased ("weight gain").The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2019.At the time of the report, the back pain, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, menorrhagia, psychological trauma, fatigue, emotional disorder, headache, weight increased, night sweats, hot flush, rash and myalgia outcome was unknown and the genital haemorrhage and migraine had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered back pain, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, genital haemorrhage, headache, hot flush, menorrhagia, migraine, myalgia, night sweats, pregnancy with contraceptive device, psychological trauma, rash and weight increased to be related to essure.The reporter commented: discrepancy in essure insertion date as (b)(6) 2009.Current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram on (b)(6) 2009: unilateral occlusion (left tube occluded), right coil outside of cavity and looped upon itself.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-may-2020: pfs received: case become serious incident, essure removal date and surgery were 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 back pain ('back pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "coil bent on one side when insert", device monitoring procedure not performed "device monitoring procedure not performed " and device ineffective "device ineffective".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), psychological trauma ("psych injury"), fatigue ("fatigue"), emotional disorder ("hormonal changes / emotional issues"), headache ("headaches"), night sweats ("night sweats"), hot flush ("hot flashes"), migraine ("migraines/headaches"), rash ("itching rash all over"), myalgia ("muscle aches"), pruritus ("itching"), abdominal pain ("abdominal pain") and pelvic pain ("pelvic pain"), was found to have a pregnancy with contraceptive device ("pregnancy: terminated") and was found to have weight increased ("weight gain").The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2019.At the time of the report, the back pain, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, menorrhagia, psychological trauma, fatigue, emotional disorder, headache, weight increased, night sweats, hot flush, rash, myalgia, pruritus, abdominal pain and pelvic pain outcome was unknown and the genital haemorrhage and migraine had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, genital haemorrhage, headache, hot flush, menorrhagia, migraine, myalgia, night sweats, pelvic pain, pregnancy with contraceptive device, pruritus, psychological trauma, rash and weight increased to be related to essure.The reporter commented: discrepancy in essure insertion date as (b)(6) 2009.Current weight 207 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: unilateral occlusion (left tube occluded), right coil outside of cavity and looped upon itself.Most recent follow-up information incorporated above includes: on 19-aug-2020: pfs received: new events- pruritus, pelvic pain abdominal pain were 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 back pain ('back pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "coil bent on one side when insert", device monitoring procedure not performed "device monitoring procedure not performed " and device ineffective "device ineffective".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), psychological trauma ("psych injury"), fatigue ("fatigue"), emotional disorder ("hormonal changes / emotional issues"), headache ("headaches"), night sweats ("night sweats"), hot flush ("hot flashes"), migraine ("migraines/headaches"), rash ("itching rash all over"), myalgia ("muscle aches"), pruritus ("itching"), abdominal pain ("abdominal pain") and pelvic pain ("pelvic pain"), was found to have a pregnancy with contraceptive device ("pregnancy: terminated") and was found to have weight increased ("weight gain").The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2019.At the time of the report, the back pain, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, menorrhagia, psychological trauma, fatigue, emotional disorder, headache, weight increased, night sweats, hot flush, rash, myalgia, pruritus, abdominal pain and pelvic pain outcome was unknown and the genital haemorrhage and migraine had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, genital haemorrhage, headache, hot flush, menorrhagia, migraine, myalgia, night sweats, pelvic pain, pregnancy with contraceptive device, pruritus, psychological trauma, rash and weight increased to be related to essure.The reporter commented: discrepancy in essure insertion date as (b)(6) 2009.Current weight 207 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2009: unilateral occlusion (left tube occluded), right coil outside of cavity and looped upon itself.Most recent follow-up information incorporated above includes: on 26-aug-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of back pain ('back pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "coil bent on one side when insert", device monitoring procedure not performed "device monitoring procedure not performed " and device ineffective "device ineffective".The patient's medical history included adenomyosis and leiomyoma nos.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("general abnormal bleeding"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding)"), psychological trauma ("psych injury"), fatigue ("fatigue"), emotional disorder ("hormonal changes / emotional issues"), headache ("headaches"), night sweats ("night sweats"), hot flush ("hot flashes"), migraine ("migraines/headaches"), rash pruritic ("itching rash all over"), myalgia ("muscle aches"), pruritus ("itching"), abdominal pain ("abdominal pain") and pelvic pain ("pelvic pain"), was found to have a pregnancy with contraceptive device ("pregnancy: terminated") and was found to have weight increased ("weight gain").The patient was treated with surgery (supracervical hysterectomy (uterus only)).Essure was removed on (b)(6) 2019.At the time of the report, the back pain, pregnancy with contraceptive device, dysmenorrhoea, dyspareunia, heavy menstrual bleeding, psychological trauma, fatigue, emotional disorder, headache, weight increased, night sweats, hot flush, rash pruritic, myalgia, pruritus, abdominal pain and pelvic pain outcome was unknown and the genital haemorrhage and migraine had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as elective abortion.The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, emotional disorder, fatigue, genital haemorrhage, headache, heavy menstrual bleeding, hot flush, migraine, myalgia, night sweats, pelvic pain, pregnancy with contraceptive device, pruritus, psychological trauma, rash pruritic and weight increased to be related to essure.The reporter commented: discrepancy in essure insertion date as (b)(6) 2009.Current weight 207 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram: on (b)(6) 2009: unilateral occlusion (left tube occluded), right coil outside of cavity and looped upon itself.Most recent follow-up information incorporated above includes: on 24-may-2021: mr received.Reporter's information added.Medical history were added.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: 10161022
• MDR Text Key: 195370707
• Report Number: 2951250-2020-08836
• 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,Followup
• Report Date: 05/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 73