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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Event Description

This spontaneous case describes the occurrence of medical device removal ("had the implants removed") in a 44 year-old 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.In 2015, the patient had essure inserted.In 2020 she underwent medical device removal (seriousness criterion intervention required).Essure was removed on an unknown date in the same year.On unknown date she experienced fatigue ("my fatigue had increased"), arthralgia ("i had joint pain"), myalgia ("muscle pain problems too"), paraesthesia ("tingling in my hands"), middle insomnia ("sleep that was even more impaired with nocturnal awakenings"), tooth disorder ("problems with my teeth"), tooth fracture ("problems with my teeth, with some of them breaking"), tinnitus ("tinnitus") and depression ("state of depression").The patient was treated with surgery (to remove essure).At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to fatigue, arthralgia, myalgia, paraesthesia, middle insomnia, tooth fracture, tinnitus, depression, medical device removal or tooth disorder.The reporter commented: i felt like an 80-year-old grandmother.The doctors were in denial, saying that it was age, that it¿s normal, that at age 44 it was menopause.But i felt that it wasn¿t normal.I searched alone, the doctors told me i was in a state of depression.When we talk to doctors about our implants, it's not taken into account.In any case, there¿s no examination in this respect and it¿s a shame because we'd save time.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 medical device removal ("had the implants removed") in a 44 year-old 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.In 2015, the patient had essure inserted.In 2020 she underwent medical device removal (seriousness criterion intervention required).Essure was removed on an unknown date in the same year.On unknown date she experienced fatigue ("my fatigue had increased"), arthralgia ("i had joint pain"), myalgia ("muscle pain problems too"), paraesthesia ("tingling in my hands"), middle insomnia ("sleep that was even more impaired with nocturnal awakenings"), tooth disorder ("problems with my teeth"), tooth fracture ("problems with my teeth, with some of them breaking"), tinnitus ("tinnitus") and depression ("state of depression").The patient was treated with surgery (to remove essure).At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to fatigue, arthralgia, myalgia, paraesthesia, middle insomnia, tooth fracture, tinnitus, depression, medical device removal or tooth disorder.The reporter commented: i felt like an 80-year-old grandmother.The doctors were in denial, saying that it was age, that it¿s normal, that at age 44 it was menopause.But i felt that it wasn¿t normal.I searched alone, the doctors told me i was in a state of depression.When we talk to doctors about our implants, it's not taken into account.In any case, there¿s no examination in this respect and it¿s a shame because we'd save time.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: 28-mar-2024: quality safety evaluation of ptc.27-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 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 describes the occurrence of medical device removal ("had the implants removed") in a 44 year-old 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.In 2015, the patient had essure inserted.In 2020 she underwent medical device removal (seriousness criterion intervention required).Essure was removed on an unknown date in the same year.On unknown date she experienced fatigue ("my fatigue had increased"), arthralgia ("i had joint pain"), myalgia ("muscle pain problems too"), paraesthesia ("tingling in my hands"), middle insomnia ("sleep that was even more impaired with nocturnal awakenings"), tooth disorder ("problems with my teeth"), tooth fracture ("problems with my teeth, with some of them breaking"), tinnitus ("tinnitus") and depression ("state of depression").The patient was treated with surgery (to remove essure).At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to fatigue, arthralgia, myalgia, paraesthesia, middle insomnia, tooth fracture, tinnitus, depression, medical device removal or tooth disorder.The reporter commented: i felt like an 80-year-old grandmother.The doctors were in denial, saying that it was age, that it¿s normal, that at age 44 it was menopause.But i felt that it wasn¿t normal.I searched alone, the doctors told me i was in a state of depression.When we talk to doctors about our implants, it's not taken into account.In any case, there¿s no examination in this respect and it¿s a shame because we'd save time.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: 28-mar-2024: upon receipt of new follow up it was confirmed that argus cases (b)(4) are duplicate of each other therefore case (b)(4).Marked for deletion.All source documents, references , events (myalgia, tinnitus, & tooth disorder) , reporters are transferred to retention case.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: 18977109
• MDR Text Key: 338551500
• Report Number: 2951250-2024-00212
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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 Age: 44 YR
• Patient Sex: Female