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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Anemia (1706); Ectopic Pregnancy (1819); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Visual Disturbances (2140); Fungal Infection (2419); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ('pregnancy: ectopic') and menorrhagia ('menorrhagia (heavy menstrual bleeding)') 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 ineffective "device ineffective".In 2014, the patient had essure inserted.On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), metrorrhagia ("metorhagia (bleeding between periods)"), iron deficiency anaemia ("anemia"), psychological trauma ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headache"), nausea ("nausea") and visual impairment ("vision problems") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the ectopic pregnancy with contraceptive device, menorrhagia, pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, metrorrhagia, iron deficiency anaemia, psychological trauma, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, alopecia, tooth disorder, hormone level abnormal, headache, nausea, visual impairment and weight increased outcome was unknown.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 reporter considered abdominal pain, alopecia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, ectopic pregnancy with contraceptive device, fatigue, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection, visual impairment and weight increased to be related to essure.The reporter commented: discrepancy noted for insertion date (b)(6) 2016 received treatment for pain and psych injury.Unable to afford surgery.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-sep-2019: plaintiff fact sheet received.Category of case changed to incident.Event injury is replaced by pain.New events chronic pain, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), metorhagia (bleeding between periods), anemia, psych injury, pregnancy: ectopic, bladder problems, urinary problems, bladder infections, uti, vaginal infections, vaginal discharge, fatigue, hair loss, dental problems, hormonal changes, headaches, nausea, vision problems and weight gain were added.Patient demographic added.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ('pregnancy: ectopic') and menorrhagia ('menorrhagia (heavy menstrual bleeding)') 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 ineffective "device ineffective".In 2014, the patient had essure inserted.On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), metrorrhagia ("metorhagia (bleeding between periods)"), iron deficiency anaemia ("anemia"), psychological trauma ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headache"), nausea ("nausea") and visual impairment ("vision problems") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the ectopic pregnancy with contraceptive device, menorrhagia, pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, metrorrhagia, iron deficiency anaemia, psychological trauma, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, alopecia, tooth disorder, hormone level abnormal, headache, nausea, visual impairment and weight increased outcome was unknown.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 reporter considered abdominal pain, alopecia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, ectopic pregnancy with contraceptive device, fatigue, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection, visual impairment and weight increased to be related to essure.The reporter commented: discrepancy noted for insertion date (b)(6) 2016.Received treatment for pain and psych injury.Unable to afford surgery.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: significant change ppc & ccc added.No new follow-up information was received from the reporter.Incident no lot number or device sample was received in this case.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 ectopic pregnancy with contraceptive device ('pregnancy: ectopic') in an adult female patient who had essure (batch no.B82471) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Medical conditions: patient underwent essure confirmation test.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), metrorrhagia ("metorhagia (bleeding between periods)"), iron deficiency anaemia ("anemia"), psychological trauma ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headache"), nausea ("nausea") and visual impairment ("vision problems") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the ectopic pregnancy with contraceptive device, menorrhagia, pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, metrorrhagia, iron deficiency anaemia, psychological trauma, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, alopecia, tooth disorder, hormone level abnormal, headache, nausea, visual impairment and weight increased outcome was unknown.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 reporter considered abdominal pain, alopecia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, ectopic pregnancy with contraceptive device, fatigue, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection, visual impairment and weight increased to be related to essure.The reporter commented: discrepancy noted for insertion date (b)(6) 2016.Received treatment for pain and psych injury.Unable to afford surgery.Trailing coils left:01 right :02.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2014: negative.Lot number: b82471 manufacturing date: 2013-10-11 expiration date:2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-mar-2020: quality-safety evaluation of ptc.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 ectopic pregnancy with contraceptive device ('pregnancy: ectopic') in an adult female patient who had essure (batch no.B82471) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".Medical conditions: patient underwent essure confirmation test.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), metrorrhagia ("metorhagia (bleeding between periods)"), iron deficiency anaemia ("anemia"), psychological trauma ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infection"), urinary tract infection ("uti"), vaginal infection ("vaginal infections"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), alopecia ("hair loss"), tooth disorder ("dental problems"), headache ("headache"), nausea ("nausea") and visual impairment ("vision problems") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the ectopic pregnancy with contraceptive device, menorrhagia, pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, metrorrhagia, iron deficiency anaemia, psychological trauma, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, alopecia, tooth disorder, hormone level abnormal, headache, nausea, visual impairment and weight increased outcome was unknown.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 reporter considered abdominal pain, alopecia, back pain, bladder disorder, cystitis, dysmenorrhoea, dyspareunia, ectopic pregnancy with contraceptive device, fatigue, headache, hormone level abnormal, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, pelvic pain, psychological trauma, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection, visual impairment and weight increased to be related to essure.The reporter commented: discrepancy noted for insertion date (b)(6) 2016 received treatment for pain and psych injury.Unable to afford surgery trailing coils left:01 right :02.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on (b)(6) 2014: negative.Most recent follow-up information incorporated above includes: on 5-mar-2020: pfs and mr received : reporter, lot number, lab data 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.

• 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: 9153219
• MDR Text Key: 167762633
• Report Number: 2951250-2019-09405
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: ESS305
• Device Lot Number: B82471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 09/12/2019; 03/05/2020
• Supplement Dates FDA Received: 10/04/2019; 03/27/2020; 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention