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

Lot Number C61984

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Dry Eye(s) (1814); Fall (1848); Fatigue (1849); Micturition Urgency (1871); Headache (1880); Itching Sensation (1943); Memory Loss/Impairment (1958); Skin Irritation (2076); Sprain (2083); Dizziness (2194); Tooth Fracture (2428); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666); Test Result (2695)

Event Date 03/08/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 04-jan-2018.This spontaneous case was reported by a consumer and describes the occurrence of genital haemorrhage ("haemorrhagic bleeding for one month after essure placement"), medical device removal ("device removal") and metal poisoning ("metal intoxication by implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device loosening "artificial crown which fell" on (b)(6) 2015.On (b)(6) 2015, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), diarrhoea ("daily diarrhoea"), fatigue ("chronic fatigue, invalidating"), insomnia ("nocturnal insomnia"), eczema ("eczema"), psoriasis ("psoriasis"), pruritus ("itching"), weight increased ("incomprehensible weight gain, more than 25 kg"), facial neuralgia ("facial neuralgia"), migraine ("worsened and more frequent migraines"), amnesia ("memory loss"), dizziness ("dizziness"), tooth fracture ("teeth which broke"), breast mass ("ball in right breast"), fall ("episodes of fall"), ligament sprain ("sprain"), micturition urgency ("constant urge to urinate"), mucosal dryness ("ocular and mucosa dryness"), dry eye ("ocular and mucosa dryness"), vitamin d deficiency ("vitamin d deficit") and hormone level abnormal ("parathormone disturbance").On (b)(6) 2017, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced metal poisoning (seriousness criterion medically significant).The patient was treated with surgery (essure removal by hysterectomy and bilateral salpingectomy on (b)(6) 2017) and surgery (essure removal by hysterectomy and bilateral salpingectomy on (b)(6) 2017).Essure was removed on (b)(6) 2017.In (b)(6) 2015, the genital haemorrhage had resolved.At the time of the report, the medical device removal, metal poisoning, diarrhoea, fatigue, insomnia, eczema, psoriasis, pruritus, weight increased, facial neuralgia, migraine, amnesia, dizziness, tooth fracture, breast mass, fall, ligament sprain, micturition urgency, mucosal dryness, dry eye, vitamin d deficiency and hormone level abnormal outcome was unknown.The reporter considered amnesia, breast mass, diarrhoea, dizziness, dry eye, eczema, facial neuralgia, fall, fatigue, genital haemorrhage, hormone level abnormal, insomnia, ligament sprain, medical device removal, metal poisoning, micturition urgency, migraine, mucosal dryness, pruritus, psoriasis, tooth fracture, vitamin d deficiency and weight increased to be related to essure.The reporter commented: immediate serious and recurrent health disorder, a consequence of essure placement until removal by hysterectomy and bilateral salpingectomy and sequelae due to metal intoxication contains in implant.Migraines followed by neurologist, daily disease-modifying treatment, triptans in case of episodes.No further information was provided.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 08-jan-2018 for the following meddra preferred term: genital haemorrhage ¿ analysis in the global safety database revealed 751 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 these meddra pt.Further company follow-up with the consumer or 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 (b)(6) (reference number: (b)(4)) on 04-jan-2018.The most recent information was received on 17-jan-2018.This spontaneous case was reported by a consumer and describes the occurrence of genital haemorrhage ("haemorrhagic bleeding for one month after essure placement") and metal poisoning ("metal intoxication by implant") in a female patient who had essure (batch no.C61984) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device loosening "artificial crown which fell" on (b)(6)-2015.On (b)(6)-2015, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), diarrhoea ("daily diarrhoea"), fatigue ("chronic fatigue, invalidating"), insomnia ("nocturnal insomnia"), eczema ("eczema"), psoriasis ("psoriasis"), pruritus ("itching"), weight increased ("incomprehensible weight gain, more than 25 kg"), facial neuralgia ("facial neuralgia"), migraine ("worsened and more frequent migraines"), amnesia ("memory loss"), dizziness ("dizziness"), tooth fracture ("teeth which broke"), breast mass ("ball in right breast"), fall ("episodes of fall"), ligament sprain ("sprain"), micturition urgency ("constant urge to urinate"), mucosal dryness ("occular and mucosa dryness"), dry eye ("occular and mucosa dryness"), vitamin d deficiency ("vitamin d deficit") and hormone level abnormal ("parathormone disturbance").On an unknown date, the patient experienced metal poisoning (seriousness criterion medically significant).The patient was treated with surgery (essure removal by hysterectomy and bilateral salpingectomy on (b)(6)-2017).Essure was removed on (b)(6)-2017.In (b)(6) 2015, the genital haemorrhage had resolved.At the time of the report, the metal poisoning, diarrhoea, fatigue, insomnia, eczema, psoriasis, pruritus, weight increased, facial neuralgia, migraine, amnesia, dizziness, tooth fracture, breast mass, fall, ligament sprain, micturition urgency, mucosal dryness, dry eye, vitamin d deficiency and hormone level abnormal outcome was unknown.The reporter considered amnesia, breast mass, diarrhoea, dizziness, dry eye, eczema, facial neuralgia, fall, fatigue, genital haemorrhage, hormone level abnormal, insomnia, ligament sprain, metal poisoning, micturition urgency, migraine, mucosal dryness, pruritus, psoriasis, tooth fracture, vitamin d deficiency and weight increased to be related to essure.The reporter commented: immediate serious and recurrent health disorder, a consequence of essure placement until removal by hysterectomy and bilateral salpingectomy and sequelae due to metal intoxication contains in implant.Migraines followed by neurologist, daily disease-modifying treatment, triptans in case of episodes.No further information was provided.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 19-jan-2018 for the following meddra preferred term: genital haemorrhage.The analysis in the global safety database revealed 761 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.Quality-safety evaluation of ptc: unable to confirm complaint further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 17-jan-2018: quality safety evaluation of ptc incident at the time of reporting, 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
• MDR Report Key: 7171361
• MDR Text Key: 96601355
• Report Number: 2951250-2018-00208
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Lot Number: C61984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention