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); Anemia (1706); Autoimmune Reaction (1733); Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia (heavy menstrual bleeding)') in an adult female patient who had essure (batch no.A69938) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, the patient experienced bacterial vaginosis ("bacterial vaginosis") and adnexa uteri pain ("pain in right ovary").In 2014, the patient experienced dysmenorrhoea ("dysmennorhea (cramping)").In (b)(6) 2016, the patient experienced pelvic pain ("pelvic/ abdominal").In (b)(6) 2017, the patient was found to have uterine leiomyoma ("fibroids").On an unknown date, the patient experienced menorrhagia (seriousness criterion medically significant), abdominal pain ("pelvic/ abdominal"), dyspareunia ("dyspareunia (painful sexual intercourse)"), female sexual dysfunction ("apareunia"), back pain ("back pain"), iron deficiency anaemia ("anemia"), endometriosis ("autoimmune diagnosed: endometriosis"), vaginal discharge ("bladder/urinary problems: vag.Discharge") and alopecia ("hair loss").Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, dysmenorrhoea, dyspareunia, female sexual dysfunction, back pain, iron deficiency anaemia, endometriosis, vaginal discharge, alopecia, bacterial vaginosis, uterine leiomyoma and adnexa uteri pain outcome was unknown.The reporter considered abdominal pain, adnexa uteri pain, alopecia, back pain, bacterial vaginosis, dysmenorrhoea, dyspareunia, endometriosis, female sexual dysfunction, iron deficiency anaemia, menorrhagia, pelvic pain, uterine leiomyoma and vaginal discharge to be related to essure.The reporter commented: trailing coils:, left -6, right -4 total bilateral occlusion.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2013: total bilateral occlusion.Ultrasound pelvis on (b)(6) 2016: possible leiomyoma versus adenomyosis.Concerning the injuries reported in this case, the following ones in patient¿s medical record; confirming- vaginal discharge, bacterial vaginosis, dysmenorrhea, uterine leiomyoma, pelvic pain, endometriosis, most recent follow-up information incorporated above includes: on 31-dec-2019: pfs and mr received.Reporter information updated.Lot number added.Preciously reported event: plaintiff did not undergo essure confirmation test deleted.New events: bacterial vaginosis, fibroids, pain in right ovary were added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of dyspareunia ('dyspareunia (painful sexual intercourse'), abdominal pain ('pelvic/ abdominal'), dysmenorrhoea ('dysmennorhea (cramping)'), menorrhagia ('menorrhagia (heavy menstrual bleeding)') and pelvic pain ('pelvic/ abdominal') in an adult female patient who had essure (batch no: a69938) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2014, the patient experienced bacterial vaginosis ("bacterial vaginosis") and adnexa uteri pain ("pain in right ovary").In 2014, the patient experienced dysmenorrhoea.On (b)(6) 2016, the patient experienced pelvic pain.On (b)(6) 2017, the patient was found to have uterine leiomyoma ("fibroids").On an unknown date, the patient experienced menorrhagia, abdominal pain, dyspareunia, female sexual dysfunction ("apareunia"), back pain ("back pain"), iron deficiency anaemia ("anemia"), endometriosis ("autoimmune diagnosed: endometriosis"), vaginal discharge ("bladder/urinary problems: vag.Discharge") and alopecia ("hair loss").Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, dysmenorrhoea, dyspareunia, female sexual dysfunction, back pain, iron deficiency anaemia, endometriosis, vaginal discharge, alopecia, bacterial vaginosis, uterine leiomyoma and adnexa uteri pain outcome was unknown.The reporter considered abdominal pain, adnexa uteri pain, alopecia, back pain, bacterial vaginosis, dysmenorrhoea, dyspareunia, endometriosis, female sexual dysfunction, iron deficiency anaemia, menorrhagia, pelvic pain, uterine leiomyoma and vaginal discharge to be related to essure.The reporter commented: trailing coils:, left -6, right -4 total bilateral occlusion.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2013: total bilateral occlusion.Ultrasound pelvis: on (b)(6) 2016: possible leiomyoma versus adenomyosis.Concerning the injuries reported in this case, the following ones were reported in patient's medical record: vaginal discharge, bacterial vaginosis, dysmenorrhea, uterine leiomyoma, pelvic pain, endometriosis.Lot number: a69938, manufacturing date: 2012-11, expiration date: 2015-11.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: after internal review, the event "menorrhagia" was downgraded to non-serious incident.No new follow-up information was received from the reporter.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: 9596665
• MDR Text Key: 175254588
• Report Number: 2951250-2020-00472
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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: 11/01/2015
• Device Model Number: ESS305
• Device Lot Number: A69938
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other