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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragments of essure in my uterus") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("fragment of essure in my uterus he left behind").At the time of the report, the device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal and device breakage to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage" 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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragments of essure in my uterus") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind") and pelvic pain ("pain").At the time of the report, the device breakage, complication of device removal and pelvic pain outcome was unknown.The reporter considered complication of device removal, device breakage and pelvic pain to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage" most recent follow-up information incorporated above includes: on 25-jun-2018: new pfs received- new event pain was added.New event was 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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragments of essure in my uterus") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind") and pelvic pain ("pain").At the time of the report, the device breakage, complication of device removal and pelvic pain outcome was unknown.The reporter considered complication of device removal, device breakage and pelvic pain to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage" quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-nov-2018: quality safety evaluation of ptc.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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting upto 6 weeks") and post-traumatic stress disorder ("ptsd").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, mood swings, anxiety and menorrhagia outcome was unknown.The reporter considered anxiety, complication of device removal, device breakage, fatigue, menometrorrhagia, menorrhagia, mood swings, pelvic pain and post-traumatic stress disorder to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jan-2020: social media received.Reporter information and essure implant date added.New event: fatigue, mood swing , anxiety, ptsd, irregular periods, periods lasting upto 6 weeks were 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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting up to 6 weeks"), post-traumatic stress disorder ("ptsd"), bone pain ("stabbing pain on hip bone") and depressed mood ("sadness").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, mood swings, anxiety, menorrhagia, bone pain and depressed mood outcome was unknown.The reporter considered anxiety, bone pain, complication of device removal, depressed mood, device breakage, fatigue, menometrorrhagia, menorrhagia, mood swings, pelvic pain and post-traumatic stress disorder to be related to essure.The reporter commented: essure insertion discrepancy 2010 and on (b)(6) 2011.Concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage and bone pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media content received.New event added- bone pain, sadness.On 20-mar-2020: content from social media: no new information received.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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting upto 6 weeks"), post-traumatic stress disorder ("ptsd"), bone pain ("stabbing pain on hip bone"), depressed mood ("sadnes") and abdominal distension ("belly").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, mood swings, anxiety, menorrhagia, bone pain and depressed mood outcome was unknown and the abdominal distension had not resolved.The reporter considered abdominal distension, anxiety, bone pain, complication of device removal, depressed mood, device breakage, fatigue, menometrorrhagia, menorrhagia, mood swings, pelvic pain and post-traumatic stress disorder to be related to essure.The reporter commented: essure insertion discrepancy (b)(6) 2011.Concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage, bone pain, abdominal distension.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media received: event belly and reporter information was added.On 20-mar-2020: fu 8 & 9 were processed together.Social media received: reporter information was 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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting upto 6 weeks"), post-traumatic stress disorder ("ptsd"), bone pain ("stabbing pain on hip bone"), depressed mood ("sadness"), abdominal distension ("belly"), flatulence ("gas pain"), incision site pain ("incision pain"), arthralgia ("joint pain"), dysfunctional uterine bleeding ("dysfunctional bleeding"), alopecia ("hair loss"), weight fluctuation ("weight loss and gain"), autoimmune disorder ("autoimmune disorders") and genital haemorrhage ("bleeding").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, anxiety, menorrhagia, bone pain, depressed mood, flatulence, incision site pain, dysfunctional uterine bleeding, alopecia, weight fluctuation, autoimmune disorder and genital haemorrhage outcome was unknown, the mood swings was resolving, the abdominal distension had not resolved and the arthralgia had resolved.The reporter considered abdominal distension, alopecia, anxiety, arthralgia, autoimmune disorder, bone pain, complication of device removal, depressed mood, device breakage, dysfunctional uterine bleeding, fatigue, flatulence, genital haemorrhage, incision site pain, menometrorrhagia, menorrhagia, mood swings, pelvic pain, post-traumatic stress disorder and weight fluctuation to be related to essure.The reporter commented: essure insertion discrepancy- 2010 and (b)(6) 2011.Concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage, bone pain, abdominal distension, gas pain, incision pain, dysfunctional uterine bleeding, hair loss, weight loss and gain, autoimmune disorder, genital bleeding.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-jun-2020: social media content received: reporter added.Events added: gas pain, incision pain, dysfunctional bleeding, hair loss, weight loss and gain, autoimmune disorder, genital bleeding.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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting upto 6 weeks"), post-traumatic stress disorder ("ptsd"), bone pain ("stabbing pain on hip bone"), depressed mood ("sadness") and abdominal distension ("belly").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, mood swings, anxiety, menorrhagia, bone pain and depressed mood outcome was unknown and the abdominal distension had not resolved.The reporter considered abdominal distension, anxiety, bone pain, complication of device removal, depressed mood, device breakage, fatigue, menometrorrhagia, menorrhagia, mood swings, pelvic pain and post-traumatic stress disorder to be related to essure.The reporter commented: essure insertion discrepancy-2010 and (b)(6) 2011.Concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage, bone pain, abdominal distension.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-apr-2020: extension of expected date of next report.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 device breakage ('fragments of essure in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure in my uterus he left behind"), pelvic pain ("pain/crippling pain"), menometrorrhagia ("irregular heavy period"), fatigue ("fatigue"), mood swings ("mood swings"), anxiety ("anxiety"), menorrhagia ("periods lasting upto 6 weeks"), post-traumatic stress disorder ("ptsd"), bone pain ("stabbing pain on hip bone"), depressed mood ("sadnes"), abdominal distension ("belly"), flatulence ("gas pain"), incision site pain ("incision pain"), arthralgia ("joint pain"), dysfunctional uterine bleeding ("dysfunctional bleeding"), alopecia ("hair loss"), weight fluctuation ("weight loss and gain"), autoimmune disorder ("autoimmune disorders") and genital haemorrhage ("bleeding").The patient was treated with surgery (they took out my fallopian tubes (salpingectomy)).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, complication of device removal, pelvic pain, menometrorrhagia, fatigue, anxiety, menorrhagia, bone pain, depressed mood, flatulence, incision site pain, dysfunctional uterine bleeding, alopecia, weight fluctuation, autoimmune disorder and genital haemorrhage outcome was unknown, the mood swings was resolving, the abdominal distension had not resolved and the arthralgia had resolved.The reporter considered abdominal distension, alopecia, anxiety, arthralgia, autoimmune disorder, bone pain, complication of device removal, depressed mood, device breakage, dysfunctional uterine bleeding, fatigue, flatulence, genital haemorrhage, incision site pain, menometrorrhagia, menorrhagia, mood swings, pelvic pain, post-traumatic stress disorder and weight fluctuation to be related to essure.The reporter commented: essure insertion discrepancy-2010 and (b)(6) 2011.Concerning the injuries reported in this case, the following one/ones were described in social media: complication of device removal, device breakage, bone pain, abdominal distension, gas pain, incision pain, dysfunctional uterine bleeding, hair loss, weight loss and gain, autoimmune disorder, genital bleeding.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality-safety evaluation of ptc.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: 7649480
• MDR Text Key: 112704230
• Report Number: 2951250-2018-02891
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention