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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case describes the occurrence of pelvic pain ("pelvic pain female") in a female patient who had essure inserted (lot no.Unknown) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.Essure was removed in (b)(6) 2018.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), general physical health deterioration ("deteriorating state of health"), multi-organ disorder ("descent of organs"), genital haemorrhage ("a haemorrhage"), hernia ("two hernias"), allergy to metals ("she discovered that she was allergic to chromium and nickel"), a first episode of metal poisoning ("i had heavy metal poisoning"), skin discolouration ("hence my grey complexio"), fatigue ("fatigue"), a first episode of arthralgia ("joint and muscle pain"), asthma ("chronic asthma"), a second episode of metal poisoning ("heavy metal poisoning"), attention deficit hyperactivity disorder ("attention disorder"), visual impairment ("impaired vision"), a second episode of arthralgia ("joint and muscle pain") and perineal disorder ("perineum problem").The patient was treated with surgery (bilateral salpingectomy & hysteroctomy).At the time of the report, the pelvic pain, latest episode of metal poisoning, fatigue, latest episode of arthralgia, asthma, attention deficit hyperactivity disorder, visual impairment and perineal disorder had not resolved.The outcomes for general physical health deterioration, multi-organ disorder, genital haemorrhage, hernia, allergy to metals and skin discolouration were unknown.The reporter considered the first episode of arthralgia, the second episode of arthralgia, asthma, attention deficit hyperactivity disorder, the second episode of metal poisoning, pelvic pain, perineal disorder and visual impairment to be related to essure administration.No causality assessment was received for essure with regard to general physical health deterioration, multi-organ disorder, genital haemorrhage, hernia, allergy to metals, the first episode of metal poisoning, skin discolouration or fatigue.The reporter commented: she underwent five surgeries to remedy this.The most recent follow-up information incorporated above includes data received on: 27-mar-2024: upon internal review it was found that argus cases (b)(4) are found duplicates of each other.Therefore (b)(4) needs to mark foe deletion & case (b)(4) needs to retained.All source documents, references, events, reporters & other relevant history are transferred from deletion case to retention case.(legacy device number 2951250-2024-00211 ).Further company follow-up with the reporter is not possible.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 describes the occurrence of pelvic pain ("pelvic pain female") in a female patient who had essure inserted (lot no.Unknown) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), general physical health deterioration ("deteriorating state of health"), multi-organ disorder ("descent of organs"), genital haemorrhage ("a haemorrhage"), hernia ("two hernias"), allergy to metals ("she discovered that she was allergic to chromium and nickel"), a first episode of metal poisoning ("i had heavy metal poisoning"), skin discolouration ("hence my grey complexio"), fatigue ("fatigue"), a first episode of arthralgia ("joint and muscle pain"), asthma ("chronic asthma"), a second episode of metal poisoning ("heavy metal poisoning"), attention deficit hyperactivity disorder ("attention disorder"), visual impairment ("impaired vision"), a second episode of arthralgia ("joint and muscle pain") and perineal disorder ("perineum problem").The patient was treated with surgery (bilateral salpingectomy & hysteroctomy).At the time of the report, the pelvic pain, latest episode of metal poisoning, fatigue, latest episode of arthralgia, asthma, attention deficit hyperactivity disorder, visual impairment and perineal disorder had not resolved.Essure was removed in (b)(6) 2018.The outcomes for general physical health deterioration, multi-organ disorder, genital haemorrhage, hernia, allergy to metals and skin discolouration were unknown.The reporter considered the first episode of arthralgia, the second episode of arthralgia, asthma, attention deficit hyperactivity disorder, the second episode of metal poisoning, pelvic pain, perineal disorder and visual impairment to be related to essure administration.No causality assessment was received for essure with regard to general physical health deterioration, multi-organ disorder, genital haemorrhage, hernia, allergy to metals, the first episode of metal poisoning, skin discolouration or fatigue.The reporter commented: she underwent five surgeries to remedy this.The most recent follow-up information incorporated above includes data received on: 29-mar-2024: health authority reference number added.Further company follow-up with the reporter is not possible.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 describes the occurrence of pelvic pain ("pelvic pain female") in a female patient who had essure inserted (lot no.Unknown) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), genital haemorrhage ("a haemorrhage"), allergy to metals ("she discovered that she was allergic to chromium and nickel"), general physical health deterioration ("deteriorating state of health"), multi-organ disorder ("descent of organs"), hernia ("two hernias"), a first episode of metal poisoning ("i had heavy metal poisoning"), skin discolouration ("hence my grey complexio"), fatigue ("fatigue"), arthralgia ("joint and muscle pain"), asthma ("chronic asthma"), a second episode of metal poisoning ("heavy metal poisoning"), attention deficit hyperactivity disorder ("attention disorder"), visual impairment ("impaired vision") and perineal disorder ("perineum problem").Essure was removed in (b)(6) 2018.The patient was treated with surgery (bilateral salpingectomy & hysteroctomy).At the time of the report, the pelvic pain, latest episode of metal poisoning, fatigue, arthralgia, asthma, attention deficit hyperactivity disorder, visual impairment and perineal disorder had not resolved.The outcomes for genital haemorrhage, allergy to metals, general physical health deterioration, multi-organ disorder, hernia and skin discolouration were unknown.The reporter considered arthralgia, asthma, attention deficit hyperactivity disorder, the second episode of metal poisoning, pelvic pain, perineal disorder and visual impairment to be related to essure administration.No causality assessment was received for essure with regard to general physical health deterioration, multi-organ disorder, genital haemorrhage, hernia, allergy to metals, the first episode of metal poisoning, skin discolouration or fatigue.The reporter commented: she underwent five surgeries to remedy this.Quality-safety evaluation of ptc: for essure: ~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.The most recent follow-up information incorporated above includes data received on: 06-apr-2024: quality safety evaluation of product technical complaint.Further company follow-up with the reporter is not possible.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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18997462
• MDR Text Key: 338883554
• Report Number: 2951250-2024-00217
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/18/2024
• 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
• Patient Sex: Female