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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Cramp(s) (2193); Depression (2361); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2012

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 (fda-2014-n-0736-2433, awareness date 05-nov-2015).It refers to a (b)(6) female consumer in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2011.The consumer reported that she had problems since essure insertion.She had a period that would not end for months then it would stop for a few days and start up again.The cramping and pain were horrible.Before inserting essure she was very physically active.She stated essure changed her life in a negative way as she did not have the energy to be physically active.She became anemic and depressed.Her hormones were all over the place.Doctors wanted to prescribe her anti-depressants but she started acupuncture.In 2013, she did an ultrasound to try to explain all the trouble and her doctor did not see the connection with essure.She changed her doctor and finally two years after her ultrasound and doing acupuncture twice a month her new doctor agreed that essure coils needed to be removed.Surgery was scheduled to (b)(6) 2015.The consumer was very nervous about the surgery, fearing all the fragments will not be removed.She stated she could only imagine the damage the coils left behind.Quality assessment: in this case, no product sample was returned.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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported event(s) and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report identified during monitoring of postings on an fda hosted docket website refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and it was reported that essure coils needed to be removed, surgery was scheduled.Consumer was fearing all the fragments will not be removed (interpreted as device breakage).This event was considered serious and unlisted in the reference safety information for essure.In this case, it was unknown when the device has broken.However, considering its nature, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention will be required.Additionally, non-serious events were reported.According to product technical complaint, there is no relationship between the reported event(s) and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

Manufacturer Narrative

This case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-2433) on (b)(6) 2015.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fearing all the fragments will not be removed') and pelvic pain ('pain/ pain (pelvic pain) / burning in pelvic area') in a 42-year-old female patient who had essure (batch no.904751) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included acupuncture, anxiety, dizziness, irritability, rash, endometriosis, cyst and hypermenorrhea.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), menorrhagia ("period that would not end for months/ abnormal bleeding (menorrhagia)/ she had 21 day cycle"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and alopecia ("hair loss/ losing my hair not feeling like myself").In 2012, the patient experienced premenstrual syndrome ("hormonal changes: heightened pms symptoms got very intense"), rosacea ("rashes or skin conditions type: rosacea") and flushing ("random flushing").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal pain lower ("cramping"), polymenorrhoea ("period would stop for a few days and start up again"), vaginal discharge ("vaginal discharge"), asthenia ("did not have the energy to be physically active"), anaemia ("anemic"), depression ("depressed"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), fatigue ("fatigue"), inflammation ("inflammation"), endometriosis ("she had endometriosis left fallopain tube/ endometriosis in pelvic area behind my uterus within the muscle of my uterus") and fallopian tube cyst ("fallopian tube cyst covering right tube") and was found to have hormone level abnormal ("hormones were all over the place/ my hormones were going crazy").The patient was treated with surgery (hysterectomy with salpingectomy (bilateral removal of fallopian tubes and hysterectomy with salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, dyspareunia, polymenorrhoea, hormone level abnormal, asthenia, anaemia, depression, bladder disorder, urinary tract disorder, fatigue, alopecia, premenstrual syndrome, rosacea, flushing, inflammation, endometriosis and fallopian tube cyst outcome was unknown and the pelvic pain, dysmenorrhoea, abdominal pain lower, menorrhagia, vaginal haemorrhage and vaginal discharge had resolved.The reporter considered abdominal pain lower, alopecia, anaemia, asthenia, bladder disorder, depression, device breakage, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube cyst, fatigue, flushing, hormone level abnormal, inflammation, menorrhagia, pelvic pain, polymenorrhoea, premenstrual syndrome, rosacea, urinary tract disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: she reported that she out of control of periods, periods not stopping at all, acupuncture a little over a year ago, she also if felt so weird not having my period a few days ago, she had blood level was low.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2019: quality-safety evaluation of product technical complaint.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 case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-2433) on 05-nov-2015.The most recent information was received on 02-aug-2019.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fearing all the fragments will not be removed') and pelvic pain ('pain/ pain (pelvic pain)') in a 42-year-old female patient who had essure (batch no.904751) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included acupuncture, anxiety, dizziness, irritability, rash, endometriosis, cyst and hypermenorrhea.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("period that would not end for months/ abnormal bleeding (menorrhagia)/ she had 21 day cycle"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)") and alopecia ("hair loss/ losing my hair not feeling like myself").In 2012, the patient experienced premenstrual syndrome ("hormonal changes: heightened pms symptoms got very intense"), rosacea ("rashes or skin conditions type: rosacea") and flushing ("random flushing").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), polymenorrhoea ("period would stop for a few days and start up again"), abdominal pain lower ("cramping"), asthenia ("did not have the energy to be physically active"), anaemia ("anemic"), depression ("depressed"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), inflammation ("inflammation"), endometriosis ("she had endometriosis left fallopain tube/ endometriosis in pelvic area behind my uterus within the muscle of my uterus"), fallopian tube cyst ("fallopain tube cyst covering right tube") and burning sensation ("burning in pelviv area") and was found to have hormone level abnormal ("hormones were all over the place/ my hormones were going crazy").The patient was treated with surgery (hysterectomy with salpingectomy (bilateral removal of fallopian tubes and hysterectomy with salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, polymenorrhoea, asthenia, anaemia, depression, hormone level abnormal, bladder disorder, urinary tract disorder, dyspareunia, fatigue, alopecia, premenstrual syndrome, rosacea, flushing, inflammation, endometriosis, fallopian tube cyst and burning sensation outcome was unknown and the pelvic pain, menorrhagia, abdominal pain lower, vaginal haemorrhage, dysmenorrhoea and vaginal discharge had resolved.The reporter considered abdominal pain lower, alopecia, anaemia, asthenia, bladder disorder, burning sensation, depression, device breakage, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube cyst, fatigue, flushing, hormone level abnormal, inflammation, menorrhagia, pelvic pain, polymenorrhoea, premenstrual syndrome, rosacea, urinary tract disorder, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: she reported that she out of control of periods, periods not stopping at all, acupuncture a little over a year ago, she also if felt so weird not having my period a few days ago, she had blood level was low.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2019: reporter and patient demographics, medical history, laboratory data were added.Added suspect drug indication and lot number.On (b)(6) 2012, she implanted essure (previously reported as (b)(6) 2011).On (b)(6) 2015, she explanted essure.Added events abnormal bleeding (vaginal), bladder or urinary problems or changes, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, hair loss, hormonal changes: heightened pms symptoms, rashes or skin conditions type: rosacea and random flushing, vaginal discharge, inflammation, she had endometriosis left fallopain tube/ endometriosis in pelvic area behind my uterus within the muscle of my uterus, fallopain tube cyst covering right tube,.Updated outcome of event pelvic pain female, vaginal discharge, dysmenorrhoea, abdominal pain lower, menorrhagia, vaginal haemorrhage as recovered and event device breakage intervention required (device) was ticked.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 case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-2433) on 05-nov-2015.The most recent information was received on 15-aug-2019.This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fearing all the fragments will not be removed') and pelvic pain female ('pain/ pain (pelvic pain)') in a 42-year-old female patient who had essure (batch no.904751) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included acupuncture, anxiety, dizziness, irritability, rash, endometriosis, cyst and hypermenorrhea.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain female (seriousness criteria medically significant and intervention required), menorrhagia ("period that would not end for months/ abnormal bleeding (menorrhagia)/ she had 21 day cycle"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)") and alopecia ("hair loss/ losing my hair not feeling like myself").In 2012, the patient experienced premenstrual syndrome ("hormonal changes: heightened pms symptoms got very intense"), rosacea ("rashes or skin conditions type: rosacea") and flushing ("random flushing").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), polymenorrhoea ("period would stop for a few days and start up again"), abdominal pain lower ("cramping"), asthenia ("did not have the energy to be physically active"), anaemia ("anemic"), depression ("depressed"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), inflammation ("inflammation"), endometriosis ("she had endometriosis left fallopain tube/ endometriosis in pelvic area behind my uterus within the muscle of my uterus"), fallopian tube cyst ("fallopain tube cyst covering right tube") and pelvic pain ("burning in pelvic area") and was found to have hormone level abnormal ("hormones were all over the place/ my hormones were going crazy").The patient was treated with surgery (hysterectomy with salpingectomy (bilateral removal of fallopian tubes and hysterectomy with salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, polymenorrhoea, asthenia, anaemia, depression, hormone level abnormal, bladder disorder, urinary tract disorder, dyspareunia, fatigue, alopecia, premenstrual syndrome, rosacea, flushing, inflammation, endometriosis, fallopian tube cyst and pelvic pain outcome was unknown and the pelvic pain female, menorrhagia, abdominal pain lower, vaginal haemorrhage, dysmenorrhoea and vaginal discharge had resolved.The reporter considered abdominal pain lower, alopecia, anaemia, asthenia, bladder disorder, depression, device breakage, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube cyst, fatigue, flushing, hormone level abnormal, inflammation, menorrhagia, pelvic pain female, polymenorrhoea, premenstrual syndrome, rosacea, urinary tract disorder, vaginal discharge, vaginal haemorrhage and pelvic pain to be related to essure.The reporter commented: she reported that she out of control of periods, periods not stopping at all, acupuncture a little over a year ago, she also if felt so weird not having my period a few days ago, she had blood level was low.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 15-aug-2019: the case (b)(4) was identified as a follow up of this case.Therefore, the case (b)(4) was deleted from argus database.New reporter 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• MDR Report Key: 5266364
• MDR Text Key: 32674197
• Report Number: 2951250-2015-01841
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: ESS305
• Device Lot Number: 904751
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR