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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ('pain') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria disability and intervention required), palpitations ("palpitations"), genital haemorrhage ("haemorrhage"), fatigue ("chronic fatigue") and abdominal distension ("swollen belly / swelling of the stomach").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.At the time of the report, the pelvic pain, palpitations, genital haemorrhage, fatigue and abdominal distension outcome was unknown.The reporter provided no causality assessment for abdominal distension, fatigue, genital haemorrhage, palpitations and pelvic pain with essure.The reporter commented: that she has invisible handicap.The reporter informed that these case is a testimony from the patient on her ordeal which continues to this day, despite the removal of the essure implants.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 consumer and describes the occurrence of pelvic pain ('pain') in a 55-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.In 2011, the patient experienced pelvic pain (seriousness criteria disability and intervention required), palpitations ("palpitations") and genital haemorrhage ("haemorrhage").On an unknown date, the patient experienced fatigue ("chronic fatigue"), abdominal distension ("swollen belly / swelling of the stomach"), complication of device removal ("first surgery to remove the implant did not follow the health process and failed"), gait disturbance ("difficulty walking and sitting") and mobility decreased ("difficulty walking and sitting").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.At the time of the report, the pelvic pain, palpitations, genital haemorrhage, fatigue, abdominal distension and complication of device removal outcome was unknown.The reporter provided no causality assessment for abdominal distension, complication of device removal, fatigue, genital haemorrhage, palpitations and pelvic pain with essure.No further causality assessment were provided for the product.The reporter commented: that she has invisible handicap.The reporter informed that these case is a testimony from the patient on her ordeal which continues to this day, despite the removal of the essure implants."the article shares the testimony of a patient who used a bayer implant for several years (2011-2018).She says she suffered from various pains from the time the device was implanted in her body until it was removed.Today she says she suffers from a visible disability with difficulty walking and sitting, with a regularly swollen belly.A first surgery to remove the implant did not follow the health process and failed, having bad consequences for her body.Eventually, a second surgery was ordered to removed the implant completely, but had to remove her tubes and uterus to save her." most recent follow-up information incorporated above includes: on 9-feb-2022: adverse event "difficulty walking and sitting" added, reporter causality comment added; adverse events "pain", "palpitations", "genital haemorrhage" had the onset date updated; 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 consumer and describes the occurrence of pelvic pain ('pain') in a 55-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.In 2011, the patient experienced pelvic pain (seriousness criteria disability and intervention required), palpitations ("palpitations") and genital haemorrhage ("haemorrhage").On an unknown date, the patient experienced fatigue ("chronic fatigue"), abdominal distension ("swollen belly / swelling of the stomach"), complication of device removal ("first surgery to remove the implant did not follow the health process and failed"), gait disturbance ("difficulty walking and sitting") and mobility decreased ("difficulty walking and sitting").The patient was treated with surgery (removal of tubes and uterus).Essure was removed.At the time of the report, the pelvic pain, palpitations, genital haemorrhage, fatigue, abdominal distension and complication of device removal outcome was unknown.The reporter provided no causality assessment for abdominal distension, complication of device removal, fatigue, gait disturbance, genital haemorrhage, mobility decreased, palpitations and pelvic pain with essure.The reporter commented: that she has invisible handicap.The reporter informed that these case is a testimony from the patient on her ordeal which continues to this day, despite the removal of the essure implants."the article shares the testimony of a patient who used a bayer implant for several years (2011-2018).She says she suffered from various pains from the time the device was implanted in her body until it was removed.Today she says she suffers from a visible disability with difficulty walking and sitting, with a regularly swollen belly.A first surgery to remove the implant did not follow the health process and failed, having bad consequences for her body.Eventually, a second surgery was ordered to removed the implant completely, but had to remove her tubes and uterus to save her." amendment: the report was amended for the following reason: upon review this report was detected to be a duplicate to record #(b)(4) to which all information will be transferred, then this duplicate #(b)(4) will be deleted in bayer safety database.No new follow-up information was received from the reporter.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.

• 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: 13480293
• MDR Text Key: 288818178
• Report Number: 2951250-2022-00103
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• 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: 02/09/2022
• 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; Disability
• Patient Age: 55 YR
• Patient Sex: Female