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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Sticking (1597); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Uterine Perforation (2121); Arthralgia (2355); Malaise (2359); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a non-health professional and describes the occurrence of abdominal pain ("severe colics"), embedded device ("fragment of essure on uterus wall") and device breakage ("fragment of essure on uterus wall") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included allergy to metals.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure on uterus wall"), arthralgia ("joint pain"), myalgia ("muscle pain"), malaise ("general malaise"), gait disturbance ("went to work dragging her left leg"), pain ("pain on left side of body") and dysgeusia ("metallic taste in mouth, which only caused her to be laying in bed and covering her head").The patient was treated with surgery (removal of essure on (b)(6)2016, along with her fallopian tubes), surgery (uterus had to be removed on a second surgery) and surgery (uterus had to be removed on a second surgery).Essure was removed.At the time of the report, the abdominal pain, embedded device, device breakage, complication of device removal, arthralgia, myalgia, malaise, gait disturbance, pain and dysgeusia outcome was unknown.The reporter considered abdominal pain, arthralgia, complication of device removal, device breakage, dysgeusia, embedded device, gait disturbance, malaise, myalgia and pain to be related to essure.The reporter commented: essure was removed on (b)(6) 2016, along with her fallopian tubes.The consumer informed that on unspecified date, when she had her second menstrual period, all of her symptoms suddenly reappeared, even stronger than before.On unspecified date, after one year of tests, it was discovered that she still had a fragment of essure on uterus wall, reason for which her uterus had to be removed on a second surgery.Diagnostic results: during medical consultation, the unspecified laboratory tests revealed normal results.On unspecified date, after one year of tests, it was discovered that she still had a fragment of essure on uterus wall.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on 10-nov-2017 for the following meddra preferred terms: abdominal pain: the analysis in the global safety database revealed 1628 cases.Embedded device: the analysis in the global safety database revealed 404 cases.Device breakage: the analysis in the global safety database revealed 1926 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 pts.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 spontaneous case was reported by a non-health professional and describes the occurrence of abdominal pain ("severe colics"), embedded device ("fragment of essure on uterus wall") and device breakage ("fragment of essure on uterus wall") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included dermatitis due to metals.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("fragment of essure on uterus wall"), arthralgia ("joint pain"), myalgia ("muscle pain"), malaise ("general malaise"), gait disturbance ("went to work dragging her left leg"), the first episode of pain ("pain on left side of body"), dysgeusia ("metallic taste in mouth, which only caused her to be laying in bed and covering her head") and the second episode of pain ("suffered pain disabling").The patient was treated with surgery (removal of essure on apr-2016, along with her fallopian tubes and uterus had to be removed on a second surgery).Essure was removed.At the time of the report, the abdominal pain, embedded device, device breakage, complication of device removal, arthralgia, myalgia, malaise, gait disturbance, dysgeusia and the last episode of pain outcome was unknown.The reporter considered abdominal pain, arthralgia, complication of device removal, device breakage, dysgeusia, embedded device, gait disturbance, malaise, myalgia, the first episode of pain and the second episode of pain to be related to essure.The reporter commented: essure was removed on apr-2016, along with her fallopian tubes.The consumer informed that on unspecified date, when she had her second menstrual period, all of her symptoms suddenly reappeared, even stronger than before.On unspecified date, after one year of tests, it was discovered that she still had a fragment of essure on uterus wall, reason for which her uterus had to be removed on a second surgery.Diagnostic results: during medical consultation, the unspecified laboratory tests revealed normal results.On unspecified date, after one year of tests, it was discovered that she still had a fragment of essure on uterus wall.Most recent follow-up information incorporated above includes: on 26-nov-2018: report from tv program ¿liarla pardo¿ from the channel ¿la sexta¿.Consumer referred she has suffered pain disabling, underwent two surgeries to remove it, lost fallopian tubes and uterus.Event "pain disabling" added.Patient and the reporter information were updated.Incident: no lot number or device sample was received in this case.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: 7056134
• MDR Text Key: 92885908
• Report Number: 2951250-2017-07885
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention