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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Pain (1994)

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 (batch no.C13140) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and was found to have uterine leiomyoma ("uterine fibroids").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and uterine leiomyoma outcome was unknown.The reporter considered pelvic pain and uterine leiomyoma to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint: most recent follow-up information incorporated above includes: on 09-dec-2020: medical records received.Information added: reporters, patient¿s initials and date of birth updated, insertion details, essure removal date and method (case upgraded to serious-incident), event uterine fibroids added.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/localised pain').In an adult female patient who had essure (batch no.C13140) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypersensitivity ("allergic symptoms"), abdominal distension ("bloating"), genital haemorrhage ("heavy/abnormal bleeding") and alopecia ("hair loss").And was found to have uterine leiomyoma ("uterine fibroids").And weight increased ("weight gain").The patient was treated with surgery (total laparoscopic hysterectomy, and bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and uterine leiomyoma outcome was unknown.And the hypersensitivity, abdominal distension, genital haemorrhage, alopecia and weight increased had resolved.The reporter considered abdominal distension, alopecia, genital haemorrhage, hypersensitivity, pelvic pain, uterine leiomyoma and weight increased to be related to essure.The reporter commented: essure insertion date was reported as (b)(6) 2015, (previously reported as (b)(6) 2015).Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain and genital bleeding.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021, medical records received: no new clinical information received, update to imdrf/fda codes only.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 / localised pain').In an adult female patient who had essure (batch no.C13140) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypersensitivity ("allergic symptoms"), abdominal distension ("bloating"), genital haemorrhage ("heavy/abnormal bleeding") and alopecia ("hair loss").And was found to have uterine leiomyoma ("uterine fibroids").And weight increased ("weight gain").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and uterine leiomyoma outcome was unknown.And the hypersensitivity, abdominal distension, genital haemorrhage, alopecia and weight increased had resolved.The reporter considered abdominal distension, alopecia, genital haemorrhage, hypersensitivity, pelvic pain, uterine leiomyoma and weight increased to be related to essure.The reporter commented: essure insertion date was reported as (b)(6) 2015, (previously reported as (b)(6) 2015).Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2021, patient initials updated.Events: allergy symptoms, bloating, hair loss, heavy/abnormal bleeding and weight gain added.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 / localised pain') in an adult female patient who had essure (batch no.C13140) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hypersensitivity ("allergic symptoms"), abdominal distension ("bloating"), genital haemorrhage ("heavy / abnormal bleeding") and alopecia ("hair loss") and was found to have uterine leiomyoma ("uterine fibroids") and weight increased ("weight gain").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain and uterine leiomyoma outcome was unknown and the hypersensitivity, abdominal distension, genital haemorrhage, alopecia and weight increased had resolved.The reporter considered abdominal distension, alopecia, genital haemorrhage, hypersensitivity, pelvic pain, uterine leiomyoma and weight increased to be related to essure.The reporter commented: essure insertion date was reported as (b)(6) 2015 (previously reported as (b)(6) 2015).Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain and genital bleeding.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 20-apr-2021: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain / localised pain') and blood loss anaemia ('anaemia due to heavy menstrual bleeding') in an adult female patient who had essure (batch no.C13140) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), blood loss anaemia (seriousness criterion medically significant), heavy menstrual bleeding ("heavy menstrual bleeding"), genital haemorrhage ("heavy / abnormal bleeding"), hypersensitivity ("allergic symptoms"), rash ("skin rash"), abdominal distension ("bloating"), headache ("headache") and alopecia ("hair loss") and was found to have uterine leiomyoma ("uterine fibroids") and weight increased ("weight gain").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingectomy) and blood transfusion.Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, blood loss anaemia, genital haemorrhage, hypersensitivity, rash, abdominal distension, headache, alopecia and weight increased had resolved and the heavy menstrual bleeding and uterine leiomyoma outcome was unknown.The reporter considered abdominal distension, alopecia, blood loss anaemia, genital haemorrhage, headache, heavy menstrual bleeding, hypersensitivity, pelvic pain, rash, uterine leiomyoma and weight increased to be related to essure.The reporter commented: essure insertion date was reported as (b)(6) 2015 (previously reported as (b)(6) 2015).After her hysterectomy, all symptoms resolved.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - in (b)(6) 2015: fallopian tubes were confirmed to be occluded and consequently, sterilisation was successful.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain and genital bleeding.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 28-jul-2021: summons recevied.Events: headache, rash, heavy menstrual bleeding and anemia added.Event pelvic pain outcome updated to recovered/ resolved.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: 11020494
• MDR Text Key: 222016812
• Report Number: 2951250-2020-15849
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2021

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: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C13140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 03/01/2021; 03/26/2021; 04/20/2021; 07/28/2021
• Supplement Dates FDA Received: 03/07/2021; 03/31/2021; 04/21/2021; 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention