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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 15-dec-2022.This spontaneous case was originally reported by a consumer (subsequently medically confirmed) and describes the occurrence of back pain ("back pain (these symptoms are broad and general but correlated with the date of insertion)") in a 41 year-old female patient who had essure inserted.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.In 2014 she was found to have liver function test abnormal ("changes of test results related to the liver").On unknown dates she experienced back pain (seriousness criterion medically important), arthralgia ("chronic pain joint pain"), depression ("depression "), fatigue ("general fatigue"), tendonitis ("chronic pain tendonitis"), device material issue ("galvanic corrosion related to the presence of 3 alloys in contact"), libido disorder ("libido") and rash ("sudden (2 or 3 times) and unexplained skin rashes for 1 week / can be generalised (whole body) or localised (armpits)").At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to back pain, arthralgia, depression, fatigue, tendonitis, device material issue, libido disorder, rash or liver function test abnormal.The reporter commented: period of occurrence: 2014-2022.Many symptoms potentially related to these implants galvanic corrosion related to the presence of 3 alloys in contact.Presence of tin.These symptoms are broad and general but correlated with the date of insertion: general fatigue.Chronic pain (tendonitis, joint pain).Back pain.Sudden (2 or 3 times) and unexplained skin rashes for 1 week.Can be generalised (whole body) or localised (armpits).Changes of test results related to the liver after 2014.Depression.Libido.Patient¿s current condition: all messed up.It is a rather global diagnosis and not really medical.Actions taken to treat the patient in the healthcare facility: not specified.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 65 kg.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

The below report was received by health authority ansm (reference number: (b)(4)) on 15-dec-2022.The most recent information was received on 26-dec-2022.This spontaneous case was originally reported by a consumer (subsequently medically confirmed) and describes the occurrence of back pain ("back pain (these symptoms are broad and general but correlated with the date of insertion)") in a 41 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("galvanic corrosion related to the presence of 3 alloys in contact").There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.In 2014 she was found to have liver function test abnormal ("changes of test results related to the liver").On unknown dates she experienced back pain (seriousness criterion medically important), arthralgia ("chronic pain joint pain"), depression ("depression "), fatigue ("general fatigue"), tendonitis ("chronic pain tendonitis"), libido disorder ("libido") and rash ("sudden (2 or 3 times) and unexplained skin rashes for 1 week / can be generalised (whole body) or localised (armpits)").The patient was treated with liver function test abnormal.At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to back pain, arthralgia, depression, fatigue, tendonitis, libido disorder, rash or liver function test abnormal.The reporter commented: period of occurrence: 2014-2022 many symptoms potentially related to these implants: galvanic corrosion related to the presence of 3 alloys in contact, presence of tin.These symptoms are broad and general but correlated with the date of insertion: general fatigue, chronic pain (tendonitis, joint pain), back pain, sudden (2 or 3 times) and unexplained skin rashes for 1 week.Can be generalised (whole body) or localised (armpits), changes of test results related to the liver after 2014; depression; libido.Patient¿s current condition: all messed up.It is a rather global diagnosis and not really medical.Actions taken to treat the patient in the healthcare facility: not specified.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 65 kg.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: 26-dec-2022: quality safety evaluation of ptc.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

The below report was received by health authority ansm (reference number: (b)(4)) on 15-dec-2022.The most recent information was received on 01-mar-2023.This spontaneous case was originally reported by a consumer (subsequently medically confirmed) and describes the occurrence of back pain ("back pain (these symptoms are broad and general but correlated with the date of insertion) / lower back pain") in a 41 year-old female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: device material corroded ("galvanic corrosion related to the presence of 3 alloys in contact").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.In 2014 she was found to have liver function test abnormal ("changes of test results related to the liver").An unknown time later she experienced back pain (seriousness criterion medically important), arthralgia ("chronic pain joint pain"), depression ("depression "), fatigue ("general fatigue"), tendonitis ("chronic pain tendonitis / tendinitis ligaments"), libido disorder ("libido / decreased libido"), rash ("sudden (2 or 3 times) and unexplained skin rashes for 1 week / can be generalised (whole body) or localised (armpits)"), asthenia ("asthenia"), dizziness ("dizziness"), breast swelling ("swollen breasts"), neck pain ("neck pain"), feeling cold ("chronic chilliness"), myalgia ("muscle pain"), pruritus ("itching"), urticaria ("urticaria"), hypersensitivity ("unexplained allergic and/or dermatologic reactions"), sleep disorder ("sleep disorders") and vision blurred ("difficulty in visual focus").The patient was treated with liver function test abnormal.At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to back pain, arthralgia, depression, fatigue, tendonitis, libido disorder, rash, liver function test abnormal, asthenia, dizziness, breast swelling, neck pain, feeling cold, myalgia, pruritus, urticaria, hypersensitivity, sleep disorder or vision blurred.The reporter commented: period of occurrence: 2014-2022.Many symptoms potentially related to these implants galvanic corrosion related to the presence of 3 alloys in contact.Presence of tin.These symptoms are broad and general but correlated with the date of insertion: general fatigue; chronic pain (tendonitis, joint pain); back pain; sudden (2 or 3 times) and unexplained skin rashes for 1 week.Can be generalised (whole body) or localised (armpits); changes of test results related to the liver after 2014; depression; libido.Patient¿s current condition: all messed up.It is a rather global diagnosis and not really medical.Actions taken to treat the patient in the healthcare facility: not specified.On follow-up 01-mar-2023 patient reports onset date between 2015-2023.For the following events astenia, dizziness,swollen breasts,lower back/neck, muscle, joint chronic pain, tendinitis, ligamentsimportant chronic chilliness, unexplained allergic and/or dermatologic reactions, itching, urticaria, sleep disorders, decreased libido, difficulty in visual focus.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 65 kg.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: 01-mar-2023: the follow information were included essure start date, asthenia, dizziness, breast swelling, neck pain, muscle pain, chilliness, allergic reaction nos, urticaria, itching, sleep disorder,difficulty focusing eyes.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: 16014282
• MDR Text Key: 305798741
• Report Number: 2951250-2022-01549
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 03/01/2023
• 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): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 65 KG