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 Autoimmune Disorder (1732); Stroke/CVA (1770); Fever (1858); Hypersensitivity/Allergic reaction (1907); Pain (1994); Shaking/Tremors (2515); Weight Changes (2607); Genital Bleeding (4507)

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 inserted for female sterilisation.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 pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("hypersensitivity symptoms"), autoimmune disorder ("autoimmune symptoms"), cerebrovascular accident ("stroke like symptoms"), tremor ("uncontrolled shaking"), pyrexia ("fever") and pain ("soreness") and was found to have weight decreased ("she lost approximately 35 pounds").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, genital haemorrhage, hypersensitivity, autoimmune disorder, weight decreased, cerebrovascular accident, tremor, pyrexia and pain outcome was unknown.The reporter considered autoimmune disorder, cerebrovascular accident, genital haemorrhage, hypersensitivity, pain, pelvic pain, pyrexia, tremor and weight decreased to be related to essure.The reporter commented: discrepancy noted: essure implant date as per pfs is 2007/2008 as per pif: currently scheduled discuss a possible removal procedure in (b)(6) of 2020.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-dec-2020: pif received: case category upgraded to serious incident.Previously reported event 'pelvic pain' made intervention required due to added removal surgery.Removal date, action taken with drug 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 pelvic pain ('pain') in an adult female patient who had essure inserted for female sterilisation.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 pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding"), hypersensitivity ("hypersensitivity symptoms"), autoimmune disorder ("autoimmune symptoms"), cerebrovascular accident ("stroke like symptoms"), tremor ("uncontrolled shaking"), pyrexia ("fever") and pain ("soreness") and was found to have weight decreased ("she lost approximately 35 pounds").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, genital haemorrhage, hypersensitivity, autoimmune disorder, weight decreased, cerebrovascular accident, tremor, pyrexia and pain outcome was unknown.The reporter considered autoimmune disorder, cerebrovascular accident, genital haemorrhage, hypersensitivity, pain, pelvic pain, pyrexia, tremor and weight decreased to be related to essure.The reporter commented: discrepancy noted: essure implant date as per pfs is 2007/2008 as per pif: currently scheduled discuss a possible removal procedure in october of 2020.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jan-2021: quality-safety evaluation of ptc.(product technical complaint).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 ('pain') and genital haemorrhage ('abnormal bleeding') in an adult 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 menorrhagia, endometrial disorder, nickel sensitivity and enterocele.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), hypersensitivity ("hypersensitivity symptoms"), autoimmune disorder ("autoimmune symptoms"), cerebrovascular accident ("stroke like symptoms"), tremor ("uncontrolled shaking"), pyrexia ("fever") and pain ("soreness") and was found to have weight decreased ("she lost approximately 35 pounds").The patient was treated with surgery (thermoballon endometrial ablation and hysterectomy/lavh - bso,).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, genital haemorrhage, hypersensitivity, autoimmune disorder, weight decreased, cerebrovascular accident, tremor, pyrexia and pain outcome was unknown.The reporter considered autoimmune disorder, cerebrovascular accident, genital haemorrhage, hypersensitivity, pain, pelvic pain, pyrexia, tremor and weight decreased to be related to essure.The reporter commented: discrepancy noted: essure implant date as per pfs is 2007/2008 as per pif: currently scheduled discuss a possible removal procedure in october of 2020.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-jun-2021: mr received.Reporter information , other relevant history , date implanted 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.

• 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: 11055382
• MDR Text Key: 241252714
• Report Number: 2951250-2020-15926
• 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
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention