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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Hypoglycemia (1912); Inflammation (1932); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Palpitations (2467); Shaking/Tremors (2515); Sleep Dysfunction (2517); Abdominal Distention (2601); Heavier Menses (2666)

Event Date 06/06/2012

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 17-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("painful heavy menstrual periods"), basedow's disease ("basedow's disease") and cholecystectomy ("gallbladder resection") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included fallopian tube disorder.On an unknown date, the patient had essure inserted.On (b)(6) 2012, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), basedow's disease (seriousness criterion medically significant), cholecystectomy (seriousness criterion medically significant), palpitations ("palpitations"), productive cough ("frequent clearing of throat"), diarrhoea ("chronic diarrhoea"), abdominal distension ("bloating"), fatigue ("chronic fatigue every day"), dysmenorrhoea ("painful heavy menstrual periods"), musculoskeletal pain ("muscle and bone pain in hips and lower back"), dyspnoea ("shortness of breath"), nausea ("nausea every day"), tremor ("trembling in fingers"), hypoglycaemia ("hypoglycaemia"), alopecia ("hair loss"), iron deficiency ("lack of iron"), insomnia ("lack of sleep"), sleep disorder ("sleep disturbance") and stress ("stress").On (b)(6) 2012, the patient underwent menorrhagia (seriousness criteria medically significant and intervention required), basedow's disease (seriousness criterion medically significant), cholecystectomy (seriousness criterion medically significant), palpitations ("palpitations"), productive cough ("frequent clearing of throat"), diarrhoea ("chronic diarrhoea"), abdominal distension ("bloating"), fatigue ("chronic fatigue every day"), dysmenorrhoea ("painful heavy menstrual periods"), musculoskeletal pain ("muscle and bone pain in hips and lower back"), dyspnoea ("shortness of breath"), nausea ("nausea every day"), tremor ("trembling in fingers"), hypoglycaemia ("hypoglycaemia"), alopecia ("hair loss"), iron deficiency ("lack of iron"), insomnia ("lack of sleep"), sleep disorder ("sleep disturbance") and stress ("stress").On (b)(6) 2017, the patient experienced complication of device removal ("complicated removal procedure due to unexplained inflammation of uterus").On an unknown date, the patient experienced uterine inflammation ("unexplained inflammation of uterus").The patient was treated with paracetamol (doliprane), nomegestrol acetate (lutenyl), tranexamic acid (exacyl) and surgery (hysterectomy for removal of essure insert).Essure was removed on (b)(6) 2017.In (b)(6) 2017, the menorrhagia, basedow's disease, palpitations, productive cough, diarrhoea, abdominal distension, fatigue, dysmenorrhoea, musculoskeletal pain, dyspnoea, nausea, tremor, hypoglycaemia, alopecia, iron deficiency, insomnia, sleep disorder, stress and uterine inflammation had resolved.At the time of the report, the cholecystectomy had resolved.The reporter provided no causality assessment for abdominal distension, alopecia, basedow's disease, cholecystectomy, complication of device removal, diarrhoea, dysmenorrhoea, dyspnoea, fatigue, hypoglycaemia, insomnia, iron deficiency, menorrhagia, musculoskeletal pain, nausea, palpitations, productive cough, sleep disorder, stress, tremor and uterine inflammation with essure.The reporter commented: all of the symptoms stopped almost immediately after (b)(6) 2017, following hysterectomy for removal of essure insert.Diagnostic results (normal ranges are provided in parenthesis if available): cardiovascular examination - on an unknown date: found nothing of note.Endoscopy - on an unknown date: for chronic diarrhoea - found nothing of note.Laparoscopy - on an unknown date: for chronic diarrhoea - found nothing of note.X-ray - on an unknown date: for muscle and bone pain - found nothing of note.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 22-aug-2017 for the following meddra preferred terms: menorrhagia.The analysis in the global safety database revealed 453.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.

• 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 07981-0915
• MDR Report Key: 6847933
• MDR Text Key: 85132269
• Report Number: 2951250-2017-03405
• Device Sequence Number: 1
• Product Code: HHS
• 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: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2017

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: 08/17/2017
• Initial Date FDA Received: 09/07/2017
• 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