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

Model Number ESS305

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

Patient Problems Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Vomiting (2144); Myalgia (2238); Arthralgia (2355); Malaise (2359); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(4) (reference number: (b)(4)) on 27-nov-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("disturbed and longer menstrual cycle/ hemorrhagic menstruations") and arthralgia ("joint pain in the whole body") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), headache ("headaches"), myalgia ("muscle pain in the whole body"), arthralgia (seriousness criterion disability), bone pain ("bone pain in the whole body"), fatigue ("extreme fatigue"), insomnia ("insomnia"), weight increased ("weight gain"), amnesia ("memory loss"), disturbance in attention ("concentration difficulty"), mental impairment ("understanding difficulty"), dysmenorrhoea ("painful and more or less hemorrhagic menstruations"), diarrhoea ("diarrhea"), vomiting ("vomiting with malaises"), malaise ("vomiting with malaises"), mood swings ("mood swings"), fibromyalgia ("fibromyalgia") and menstrual disorder ("disturbed and longer menstrual cycle").The patient was treated with surgery (surgery for removal of essure).Essure was removed on (b)(6) 2017.At the time of the report, the menorrhagia, headache, myalgia, arthralgia, bone pain, fatigue, insomnia, weight increased, amnesia, disturbance in attention, mental impairment, dysmenorrhoea, diarrhoea, vomiting, malaise, mood swings, fibromyalgia and menstrual disorder outcome was unknown.The reporter provided no causality assessment for amnesia, arthralgia, bone pain, diarrhoea, disturbance in attention, dysmenorrhoea, fatigue, fibromyalgia, headache, insomnia, malaise, menorrhagia, menstrual disorder, mental impairment, mood swings, myalgia, vomiting and weight increased with essure.The reporter commented: current status of the patient: physiotherapy, rheumatologist and pain management.She lost her job.She was recognized as disabled worker.Diagnostic results: blood tests, xray, ct scan, and mri were performed but no results were provided.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term (pt).In this particular case a search in the global safety database was performed on 30-nov-2017 for the following meddra pt: menorrhagia.The analysis in the global safety database revealed 546 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the regulatory authority is not possible.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (chu toulouse, reference number: (b)(4), (b)(4) on (b)(6) 2017.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("waves of chronic pain starting on pelvis and then radiating in the back"), menorrhagia ("disturbed and longer menstrual cycle/ hemorrhagic menstruations") and fibromyalgia ("fibromyalgia") in a 34-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: blood tests, xray, ct scan, and mri were performed but no results were provided.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), fibromyalgia (seriousness criterion disability) with arthralgia, headache ("headaches"), myalgia ("muscle pain in the whole body"), bone pain ("bone pain in the whole body"), fatigue ("extreme fatigue"), insomnia ("insomnia"), amnesia ("memory loss"), disturbance in attention ("concentration difficulty"), cognitive disorder ("understanding difficulty"), dysmenorrhoea ("painful and more or less hemorrhagic menstruations"), diarrhoea ("diarrhea"), vomiting ("vomiting with malaises"), malaise ("vomiting with malaises"), mood swings ("mood swings") and menstrual disorder ("disturbed and longer menstrual cycle/ hemorrhagic menstruations") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced back pain ("waves of chronic pain starting on pelvis and then radiating in the back") and neck pain ("neck pain").The patient was treated with physical therapy (physiotherapy, rheumatologist and pain management) and surgery (salpingectomy with bilateral coronectomy with removal of both essure devices).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fibromyalgia, headache, myalgia, bone pain, fatigue, insomnia, weight increased, amnesia, disturbance in attention, cognitive disorder, dysmenorrhoea, diarrhoea, vomiting, malaise, mood swings, menstrual disorder, back pain and neck pain outcome was unknown.The reporter provided no causality assessment for amnesia, back pain, bone pain, cognitive disorder, diarrhoea, disturbance in attention, dysmenorrhoea, fatigue, fibromyalgia, headache, insomnia, malaise, menorrhagia, menstrual disorder, mood swings, myalgia, neck pain, pelvic pain, vomiting and weight increased with essure.The reporter commented: current status of the patient: she lost her job.She was recognized as disabled worker.The defective essure sample was not kept by the department most recent follow-up information incorporated above includes: on (b)(6) 2019: via health authority (additional number (b)(4) it was reported that the patient experienced waves of chronic pain starting on pelvis (event added - incident due to essure removal) and then radiating in the back (event added) with onset of neck pain (event added).Update of fda codes.The patient experienced diffuse arthralgia (term amended, specified as symptom) leading to the diagnosis of fibromyalgia, physical therapy transferred to event fibromyalgia as non-drug treatment.Salpingectomy with bilateral coronectomy was performed (surgery for removal was specified), both essure implants were removed.The defective sample was not kept by the department no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformance's data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4), (b)(4)) on 27-nov-2017.The most recent information was received on 01-feb-2019.This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("waves of chronic pain starting on pelvis and then radiating in the back"), menorrhagia ("disturbed and longer menstrual cycle/ hemorragic menstruations") and fibromyalgia ("fibromyalgia") in a 34-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included appendicectomy, cholecystectomy and obesity.Blood tests, xray, ct scan, and mri were performed but no results were provided.On (b)(6) 2014, the patient had essure inserted.In 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), fibromyalgia (seriousness criterion disability) with arthralgia, headache ("headaches"), myalgia ("muscle pain in the whole body"), bone pain ("bone pain in the whole body"), fatigue ("extreme fatigue"), insomnia ("insomnia"), amnesia ("memory loss"), disturbance in attention ("concentration difficulty"), cognitive disorder ("understanding difficulty"), dysmenorrhoea ("painful and more or less hemorrhagic menstruations"), diarrhoea ("diarrhea"), vomiting ("vomiting with malaises"), malaise ("vomiting with malaises"), mood swings ("mood swings") and menstrual disorder ("disturbed and longer menstrual cycle/ hemorragic menstruations") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced pain ("waves of chronic pain starting on pelvis and then radiating in the back") and neck pain ("neck pain").The patient was treated with physical therapy (physiotherapy, rheumatologist and pain management) and surgery (salpingectomy with bilateral cornuectomy via celioscopy with removal of both essure devices).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, menorrhagia, fibromyalgia, headache, myalgia, bone pain, fatigue, insomnia, weight increased, amnesia, disturbance in attention, cognitive disorder, dysmenorrhoea, diarrhoea, vomiting, malaise, mood swings, menstrual disorder, pain and neck pain outcome was unknown.The reporter considered amnesia, bone pain, cognitive disorder, diarrhoea, disturbance in attention, dysmenorrhoea, fatigue, fibromyalgia, headache, insomnia, malaise, menorrhagia, menstrual disorder, mood swings, myalgia, neck pain, pain, pelvic pain, vomiting and weight increased to be related to essure.The reporter commented: current status of the patient: she lost her job.She was recognized as disabled worker.The defective essure sample was not kept by the department.Essure was removed due to medical reasons, and chronic pain was reported as principal reason of the removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.7 kg/sqm.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 1-feb-2019: reporter¿s information was updated and new reporters were added.Patient¿s information and non-drug treatment notes for the event ¿pelvic pain¿ were updated.The reporter stated that the essure contributed to the onset of the adverse events.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this 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
• MDR Report Key: 7071130
• MDR Text Key: 93359325
• Report Number: 2951250-2017-09488
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 01/18/2019; 02/01/2019
• Supplement Dates FDA Received: 01/21/2019; 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 34 YR
• Patient Weight: 94