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

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problems Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Hernia (2240); Ambulation Difficulties (2544); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("she underwent a first surgery to remove essure"), mobility decreased ("only moved with crutches or in wheelchair") and postoperative hernia ("hernias") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "one implant was cut, a piece of metal was remaining in her body/ surgeon found the presence of a part of essure insert".In (b)(6) 2015, the patient had essure inserted.In (b)(6) 2016, the patient experienced post procedural haematoma ("hematoma following the intervention").On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), mobility decreased (seriousness criterion disability), postoperative hernia (seriousness criterion medically significant), general physical health deterioration ("her health state got degraded"), the first episode of complication of device removal ("one implant was cut, a piece of metal was remaining in her body/ surgeon found the presence of a part of essure insert"), adverse reaction ("a piece of metal was remaining in her body causing strong disorders"), weight increased ("weight gain of (b)(6)"), feeling abnormal ("all the symptoms of a pregnant woman"), migraine ("migraine"), fatigue ("fatigue"), alopecia ("hair loss") and the second episode of complication of device removal ("hematoma following the intervention (to remove essure), two hernias").The patient was treated with morphine, surgery (essure removal performed in (b)(6) 2016.) and surgery (five months later, the patient was operated again ((b)(6) 2016)).Essure was removed.At the time of the report, the medical device removal, mobility decreased, postoperative hernia, post procedural haematoma, general physical health deterioration, adverse reaction, weight increased, feeling abnormal, migraine, fatigue, alopecia and the last episode of complication of device removal outcome was unknown.The reporter provided no causality assessment for post procedural haematoma, postoperative hernia and the second episode of complication of device removal with essure.The reporter considered adverse reaction, alopecia, fatigue, feeling abnormal, general physical health deterioration, medical device removal, migraine, mobility decreased, weight increased and the first episode of complication of device removal to be related to essure.The reporter commented: a piece of metal remaining in her body causing strong disorders.Removal was performed in (b)(6) 2016.She experienced hematoma following the intervention.Five months later, the patient was operated again, in vain (no reason for the intervention was provided).Patient consulted another surgeon because she experienced hernia.The surgeon found the presence of a part of essure insert.Then she experienced two hernias.At the time of the report, the patient was waiting for removal of the remaining part of essure insert.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on (b)(6) 2018 for the following meddra preferred term: medical device removal - the analysis in the global safety database revealed 816 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 consumer 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.

• 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 07981
• MDR Report Key: 7353998
• MDR Text Key: 103002423
• Report Number: 2951250-2018-01106
• 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,other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention; Disability