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

Model Number ESS205

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/30/2024

Event Type  Injury  

Event Description

The below report was received by health authority fda /manuf and user facility device exp (reference number: mw5151015) on 20-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvis pain") in a female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2007, the patient had essure inserted.On (b)(6) 2024 she experienced pelvic pain (seriousness criteria disability and medically important), abdominal distension ("experienced bloating"), nausea ("nausea") and back pain ("lower back pain").In (b)(6) 2024 she experienced migraine ("migraines").On unknown date she experienced heavy menstrual bleeding ("heavy and messy menstrual bleeding for several years").No causality assessment was received for essure with regard to abdominal distension, nausea, migraine, back pain, pelvic pain or heavy menstrual bleeding.The reporter commented: she had to go to the emergency room before and after christmas in 2023 due to complications with her essure.This past tuesday ((b)(6) 2024), reporter learned that her essure has been recalled for several years and had never been notified about the recall.She has a follow-up appointment this month for consultation for a hysterectomy due to damage caused by her implanted essure devices.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 22-feb-2024: processed with initial.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 fda /manuf and user facility device exp (reference number: mw5151015) on 20-feb-2024.The most recent information was received on 04-mar-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvis pain for several years") in a female patient who had essure (ess205) inserted (lot no.Ess205-invalid).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2007, the patient had essure (ess205) inserted.On (b)(6) 2024 she experienced nausea ("nausea for several years").In (b)(6) 2024 she experienced migraine ("migraines/headaches for several years").On unknown date she experienced pelvic pain (seriousness criteria disability and medically important), abdominal distension ("bloating for several years"), back pain ("lower back pain for several years") and heavy menstrual bleeding ("menstrual irregularities, heavy and messy menstrual bleeding for several years").Essure (ess205) treatment was not changed.The reporter considered abdominal distension, back pain, heavy menstrual bleeding, migraine, nausea and pelvic pain to be related to essure (ess205) administration.The reporter commented: after essure implantation she had events for several years.She had to go to the emergency room before and after (b)(6) 2023 due to complications with her essure.This past tuesday ((b)(6) 2024), reporter learned that her essure has been recalled for several years and had never been notified about the recall.She has a follow-up appointment this month for consultation for a hysterectomy due to damage caused by her implanted essure devices.Quality-safety evaluation of ptc: for essure (ess205): 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: 04-mar-2024: update of information (batch is invalid).We received an invalid lot number in this case.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 fda /manuf and user facility device exp (reference number: mw5151015) on 20-feb-2024.The most recent information was received on 28-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvis pain for several years") in a female patient who had essure (ess205) inserted.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2007, the patient had essure (ess205) inserted.On (b)(6) 2024 she experienced nausea ("nausea for several years").In (b)(6) 2024 she experienced migraine ("migraines/headaches for several years").On unknown date she experienced pelvic pain (seriousness criteria disability and medically important), abdominal distension ("bloating for several years"), back pain ("lower back pain for several years") and heavy menstrual bleeding ("menstrual irregularities, heavy and messy menstrual bleeding for several years").Essure (ess205) treatment was not changed.The reporter considered abdominal distension, back pain, migraine, nausea and pelvic pain to be related to essure (ess205) administration.The reporter commented: after essure implantation she had events for several years.She had to go to the emergency room before and after (b)(6) in 2023 due to complications with her essure.This past tuesday ((b)(6) 2024), reporter learned that her essure has been recalled for several years and had never been notified about the recall.She has a follow-up appointment this month for consultation for a hysterectomy due to damage caused by her implanted essure devices.Quality-safety evaluation of ptc: for essure (ess205): 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-feb-2024: quality safety evaluation of ptc.Upon review essure model was changed to ess205.Reporter considered the events related to essure 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: 18765944
• MDR Text Key: 336054086
• Report Number: 2951250-2024-00154
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• 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): Disability; Other
• Patient Sex: Female