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

Model Number ESS305

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Occlusion (1984); Pain (1994); Genital Bleeding (4507)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain / severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included general anesthesia on (b)(6) 2016.Before essure®, plaintiff (b)(6) menstrual cycles were regular and moderate to light.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("cycles became very heavy / passed material that resembled tissue") and metrorrhagia ("breakthrough bleeding during her cycle").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016) and surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, abdominal pain, menorrhagia and metrorrhagia had resolved.The reporter considered abdominal pain, menorrhagia, metrorrhagia, pelvic pain and uterine haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: occlusion of tubes / confirmed the position.Ultrasound pélvis on (b)(6) 2012 to investigate her symptoms.Company causality comment: this litigation case report refers to an adult female patient who had (fallopian tube occlusion insert) inserted in (b)(6) 2011 and reported adverse events including abnormal uterine bleeding and chronic pelvic pain / severe pelvic pain.On (b)(6) 2016, plaintiff underwent surgery (laparoscopic hysterectomy and bilateral salpingectomy) and essure was removed.Pelvic pain and genital bleeding have multiple causes.In this particular case, alternative explanation was not available for the events.This case was regarded as incident since essure was removed via surgical intervention.A product technical analysis is being sought.Follow-up information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain / severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included general anesthesia on (b)(6) 2016.Before essure®, plaintiff leviere's menstrual cycles were regular and moderate to light.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("cycles became very heavy / passed material that resembled tissue") and metrorrhagia ("breakthrough bleeding during her cycle").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016) and surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, abdominal pain, menorrhagia and metrorrhagia had resolved.The reporter considered abdominal pain, menorrhagia, metrorrhagia, pelvic pain and uterine haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: occlusion of tubes / confirmed the position ultrasound pelvis on (b)(6) 2012 to investigate her symptoms.Quality-safety evaluation of ptc: due to no sample or valid lot number being available, the quality unit was unable to conduct a review of the manufacturing batch record or perform an investigation therefore they are unable to confirm any quality defect or device malfunction.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.The quality unit concluded a quality defect was not confirmed.Based on the available information, there is no relationship between the reported medical events and a quality defect.Most recent follow-up information incorporated above includes: on 3-may-2017: quality-safety evaluation of product technical complaints.Company causality comment this litigation case report refers to an adult female patient who had (fallopian tube occlusion insert) inserted in (b)(6) 2011 and reported adverse events including abnormal uterine bleeding and chronic pelvic pain / severe pelvic pain.On (b)(6) 2016, plaintiff underwent surgery (laparoscopic hysterectomy and bilateral salpingectomy) and essure was removed.Pelvic pain and genital bleeding have multiple causes.In this particular case, alternative explanation was not available for the events.This case was regarded as incident since essure was removed via surgical intervention.The reported medical events are not necessarily indicative of a quality defect.The quality unit concluded a quality defect was not confirmed.Based on the available information, there is no relationship between the reported medical events and a quality defect.Follow-up information will be obtained through the litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain / severe pelvic pain") and uterine haemorrhage ("abnormal uterine bleeding") in a 35-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included general anesthesia on (b)(6)2016.Before essure®, plaintiff leviere¿s menstrual cycles were regular and moderate to light.On (b)(6)2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("cycles became very heavy / passed material that resembled tissue / large clots"), metrorrhagia ("breakthrough bleeding during her cycle") and dysmenorrhoea ("dysmenorrhea").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6)2016).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, uterine haemorrhage, abdominal pain, menorrhagia, metrorrhagia and dysmenorrhoea had resolved.The reporter considered abdominal pain, dysmenorrhoea, menorrhagia, metrorrhagia, pelvic pain and uterine haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2011: occlusion of tubes / confirmed the position ultrasound pélvis on (b)(6)2012 to investigate her symptoms quality-safety evaluation of ptc: due to no sample or valid lot number being available, the quality unit was unable to conduct a review of the manufacturing batch record or perform an investigation therefore they are unable to confirm any quality defect or device malfunction.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.The reported medical events are not necessarily indicative of a quality defect.The quality unit concluded a quality defect was not confirmed.Based on the available information, there is no relationship between the reported medical events and a quality defect.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2018: reporter, age and event dysmenorrhea added.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain/worsening pain/ severe pelvic pain') and uterine haemorrhage ('abnormal uterine bleeding') in a 35-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia on (b)(6) 2016.Before essure®, plaintiff leviere¿s menstrual cycles were regular and moderate to light.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("cycles became very heavy / passed material that resembled tissue / large clots"), metrorrhagia ("breakthrough bleeding during her cycle"), dysmenorrhoea ("dysmenorrhea") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, uterine haemorrhage, abdominal pain, menorrhagia, metrorrhagia and dysmenorrhoea had resolved and the genital haemorrhage outcome was unknown.The reporter considered abdominal pain, dysmenorrhoea, genital haemorrhage, menorrhagia, metrorrhagia, pelvic pain and uterine haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: occlusion of tubes / confirmed the position.Diagnostic results: ultrasound pélvis on (b)(6) 2012 to investigate her symptoms quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 18-sep-2020: quality-safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was 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 ('chronic pelvic pain/worsening pain/ severe pelvic pain') and uterine haemorrhage ('abnormal uterine bleeding') in a 35-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia on (b)(6)2016.Before essure®, plaintiff leviere¿s menstrual cycles were regular and moderate to light.On (b)(6)2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), uterine haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), menorrhagia ("cycles became very heavy / passed material that resembled tissue / large clots"), metrorrhagia ("breakthrough bleeding during her cycle"), dysmenorrhoea ("dysmenorrhea") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6)2016).Essure was removed on (b)(6)2016.At the time of the report, the pelvic pain, uterine haemorrhage, abdominal pain, menorrhagia, metrorrhagia and dysmenorrhoea had resolved and the genital haemorrhage outcome was unknown.The reporter considered abdominal pain, dysmenorrhoea, genital haemorrhage, menorrhagia, metrorrhagia, pelvic pain and uterine haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2011: results: occlusion of tubes / confirmed the position.Diagnostic results: ultrasound pélvis on (b)(6)2012 to investigate her symptoms quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6)2020: pif received- new event abnormal bleeding added.Based on the available information, a review of our complaint records and other relevant data was 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 ('chronic pelvic pain/worsening pain/ severe pelvic pain') and abnormal uterine bleeding ('abnormal uterine bleeding') in a 35-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included general anesthesia on (b)(6) 2016.Before essure®, plaintiff leviere¿s menstrual cycles were regular and moderate to light.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abnormal uterine bleeding (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), heavy menstrual bleeding ("cycles became very heavy / passed material that resembled tissue / large clots"), intermenstrual bleeding ("breakthrough bleeding during her cycle"), dysmenorrhoea ("dysmenorrhea") and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (laparoscopic hysterectomy and bilateral salpingectomy on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, abnormal uterine bleeding, abdominal pain, heavy menstrual bleeding, intermenstrual bleeding and dysmenorrhoea had resolved and the genital haemorrhage outcome was unknown.The reporter considered abdominal pain, abnormal uterine bleeding, dysmenorrhoea, genital haemorrhage, heavy menstrual bleeding, intermenstrual bleeding and pelvic pain to be related to essure.The reporter commented: trailing coils: right-3.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: occlusion of tubes / confirmed the position.Diagnostic results: ultrasound pelvis on (b)(6) 2012 to investigate her symptoms.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 3-jun-2021: mr received.Reporter, rcc and dob 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.

• 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: 6521911
• MDR Text Key: 73705071
• Report Number: 2951250-2017-01694
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/10/2021

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided; 03/29/2018; 08/28/2020; 09/18/2020; 06/03/2021
• Supplement Dates FDA Received: 05/23/2017; 04/13/2018; 09/11/2020; 09/25/2020; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR