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 Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Injury (2348); Abdominal Distention (2601); Heavier Menses (2666)

Event Date 01/01/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('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 monitoring procedure not performed "plaintiff did not underwent essure confirmation test".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("heavy menstrual bleeding / menorrhagia"), psychological trauma ("psych injury"), fatigue ("fatigue"), tooth disorder ("dental problems"), nausea ("nausea,"), headache ("headaches"), abdominal distension ("bloating") and abdominal pain lower ("cramping") and was found to have hormone level abnormal ("hormonal changes").The patient was treated with surgery (performed a hysterectomy and removed essure).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, psychological trauma, fatigue, hormone level abnormal, tooth disorder, nausea, headache, abdominal distension and abdominal pain lower outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, fatigue, headache, hormone level abnormal, menorrhagia, nausea, pelvic pain, psychological trauma and tooth disorder to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2019: pfs received.This case is incident now.The previously reported event injury was replaced with pelvic pain, menorrhagia (heavy menstrual bleeding), psych injury, fatigue, hormonal changes, dental problems, nausea, headache, bloating, severe cramping, plaintiff did not underwent essure confirmation test.Essure model was changed to 305 as new essure insertion date and removal date were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformance's data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('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 monitoring procedure not performed "plaintiff did not underwent essure confirmation test".On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("heavy menstrual bleeding/menorrhagia"), fatigue ("fatigue"), asthenia ("hormonal changes/drained"), tooth disorder ("dental problems"), nausea ("nausea,"), headache ("headaches"), abdominal distension ("bloating"), abdominal pain lower ("cramping"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), cystitis ("infection (bladder/urinary tract/vaginal)"), urinary tract infection ("infection (bladder/urinary tract/vaginal)"), vaginal infection ("infection (bladder/urinary tract/vaginal)"), vaginal disorder ("vaginosis"), depression ("depression"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").The patient was treated with surgery (performed a hysterectomy and removed essure).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fatigue, asthenia, tooth disorder, nausea, headache, abdominal distension, abdominal pain lower, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, vaginal disorder, depression, migraine and dysmenorrhoea outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, asthenia, cystitis, depression, dysmenorrhoea, fatigue, headache, menorrhagia, migraine, nausea, pelvic pain, tooth disorder, urinary tract infection, vaginal disorder, vaginal haemorrhage and vaginal infection to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-sep-2019: pfs received.Reporter information added.Event : abnormal bleeding (vaginal), infection (bladder/urinary tract/vaginal), vaginosis, migraines / headaches, dysmenorrhea (cramping) added.Event hormonal changes were updated as hormonal changes/drained and psych injury to depression.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('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 monitoring procedure not performed "plaintiff did not underwent essure confirmation test".The patient's medical history included hypothyroidism.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding/menorrhagia/menorrhagia"), asthenia ("hormonal changes/drained/felt drained"), tooth disorder ("dental problems"), nausea ("nausea,"), headache ("headaches"), abdominal distension ("bloating"), abdominal pain lower ("cramping"), vaginal haemorrhage ("abnormal bleeding (vaginal)/vaginal bleeding"), cystitis ("infection (bladder/urinary tract/vaginal)"), urinary tract infection ("infection (bladder/urinary tract/vaginal)"), vaginal infection ("infection (bladder/urinary tract/vaginal)"), vaginal disorder ("vaginosis/infection (bladder/urinary tract/vaginal)"), depression ("depression"), abdominal pain ("abdominal pain"), menstrual disorder ("menstrual cycle disorder") and constipation ("constipation").The patient was treated with surgery (performed a hysterectomy and removed essure).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fatigue, asthenia, tooth disorder, nausea, headache, abdominal pain lower, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, vaginal disorder, depression, dysmenorrhoea and abdominal pain outcome was unknown and the abdominal distension, migraine, menstrual disorder and constipation was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, asthenia, constipation, cystitis, depression, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, tooth disorder, urinary tract infection, vaginal disorder, vaginal haemorrhage and vaginal infection to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 27-dec-2019: pfs received.Events per pfs: abdominal pain, menstrual cycle disorder, constipation 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 pelvic pain ('pain') in an adult female patient who had essure (batch no.623215,664437) 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 "plaintiff did not underwent essure confirmation test".The patient's medical history included hypothyroidism.Concurrent conditions included chronic cervicitis, vaginal discharge, amenorrhea, frequency urinary, hypothyroidism, hydronephrosis, anxiety, menopause, irritability and mood swings.Concomitant products included lidocaine.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding/menorrhagia/menorrhagia"), asthenia ("hormonal changes/drained/felt drained"), tooth disorder ("dental problems"), nausea ("nausea,"), headache ("headaches"), abdominal distension ("bloating"), abdominal pain lower ("cramping"), vaginal haemorrhage ("abnormal bleeding (vaginal)/vaginal bleeding"), cystitis ("infection (bladder/urinary tract/vaginal)"), urinary tract infection ("infection (bladder/urinary tract/vaginal)"), vaginal infection ("infection (bladder/urinary tract/vaginal)"), vaginal disorder ("vaginosis/infection (bladder/urinary tract/vaginal)"), depression ("depression"), abdominal pain ("abdominal pain"), menstrual disorder ("menstrual cycle disorder") and constipation ("constipation").The patient was treated with surgery (hysterectomy and removed essure, oophorectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fatigue, asthenia, tooth disorder, nausea, headache, abdominal pain lower, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, vaginal disorder, depression, dysmenorrhoea and abdominal pain outcome was unknown and the abdominal distension, migraine, menstrual disorder and constipation was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, asthenia, constipation, cystitis, depression, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, tooth disorder, urinary tract infection, vaginal disorder, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: discrepancy date of insertion: (b)(6) 2009 (as per pif).Patient was hospitalized.Retained date: (b)(6) 2018.Insertion details:- the essure device was inserted into the tubal ostia bilaterally with 5-6 coils noted outside of each ostia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram- on (b)(6) 2010: no evidence of spilling of contrast in to the peritoneal cavity with bilateral tubal ligation wires in place.Most recent follow-up information incorporated above includes: on 28-may-2020: medical record was received.Lot number were added.Reporter information, medical history were added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure (batch no.623215,664437) 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 "plaintiff did not underwent essure confirmation test".The patient's medical history included hypothyroidism.Concurrent conditions included chronic cervicitis, vaginal discharge, amenorrhea, frequency urinary, hypothyroidism, hydronephrosis, anxiety, menopause, irritability and mood swings.Concomitant products included lidocaine.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), migraine ("migraines / headaches") and dysmenorrhoea ("dysmenorrhea (cramping)").On an unknown date, the patient experienced menorrhagia ("heavy menstrual bleeding/menorrhagia/menorrhagia"), asthenia ("hormonal changes/drained/felt drained"), tooth disorder ("dental problems"), nausea ("nausea,"), headache ("headaches"), abdominal distension ("bloating"), abdominal pain lower ("cramping"), vaginal haemorrhage ("abnormal bleeding (vaginal)/vaginal bleeding"), cystitis ("infection (bladder/urinary tract/vaginal)"), urinary tract infection ("infection (bladder/urinary tract/vaginal)"), vaginal infection ("infection (bladder/urinary tract/vaginal)"), vaginal disorder ("vaginosis/infection (bladder/urinary tract/vaginal)"), depression ("depression"), abdominal pain ("abdominal pain"), menstrual disorder ("menstrual cycle disorder") and constipation ("constipation").The patient was treated with surgery (hysterectomy and removed essure, oophorectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fatigue, asthenia, tooth disorder, nausea, headache, abdominal pain lower, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, vaginal disorder, depression, dysmenorrhoea and abdominal pain outcome was unknown and the abdominal distension, migraine, menstrual disorder and constipation was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, asthenia, constipation, cystitis, depression, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, tooth disorder, urinary tract infection, vaginal disorder, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: discrepancy date of insertion: (b)(6) 2009 (as per pif).Patient was hospitalized.Retained date: (b)(6) 2018.Insertion details: the essure device was inserted into the tubal ostia bilaterally with 5-6 coils noted outside of each ostia.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2010: no evidence of spilling of contrast in to the peritoneal cavity with bilateral tubal ligation wires in place.Lot number: 623215, manufacture date: 2009-03, expiration date:2012-03.Lot number: 664437, manufacture date: 2009-08, expiration date:2012-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jun-2020: quality-safety evaluation of ptc.A technical investigation was 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: 8948745
• MDR Text Key: 156266192
• Report Number: 2951250-2019-05197
• 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,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2012
• Device Model Number: ESS305
• Device Lot Number: 623215,664437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIDOCAINE; LIDOCAINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR