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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), arthralgia ("joint pain"), alopecia ("hair loss") and abdominal distension ("bloating").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, fatigue, arthralgia, alopecia and abdominal distension had not resolved.The reporter provided no causality assessment for abdominal distension, alopecia, arthralgia, fatigue and pelvic pain with essure.The reporter commented: this has been a nightmare, that has cost me time and money.I have been tested for lupus, crohn's disease, rheumatoid arthritis.And a number of other disorders.After years of testing, i am finally needing a hysterectomy at (b)(6) to remedy this issue.I feel maimed at the hands of bayer.Product in place discrepancy noted in essure insertion date: (b)(6) 2014.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 11-mar-2022: pif received.Case becomes serious incident as essure was removed.Reporter information, surgery name, rcc, essure start and stop dates 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in a 34-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), arthralgia ("joint pain"), alopecia ("hair loss") and abdominal distension ("bloating").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2021.At the time of the report, the pelvic pain, fatigue, arthralgia, alopecia and abdominal distension had not resolved.The reporter provided no causality assessment for abdominal distension, alopecia, arthralgia, fatigue and pelvic pain with essure.The reporter commented: this has been a nightmare, that has cost me time and money.I have been tested for lupus, crohn's disease, rheumatoid arthritis.And a number of other disorders.After years of testing, i am finally needing a hysterectomy at 34 years old to remedy this issue.I feel maimed at the hands of bayer.Product in place discrepancy noted in essure insertion date: (b)(6) 2014 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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 17-mar-2022: quality safety evaluation of 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13772799
• MDR Text Key: 288819006
• Report Number: 2951250-2022-00232
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 34 YR
• Patient Sex: Female