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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Weight Changes (2607); Heavier Menses (2666)
Event Date 11/01/2009
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain,pain") in an adult patient who had essure (batch no.664437) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight and ovarian cyst.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),"), fatigue ("fatigue,") and weight increased ("weight gain").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches,").In (b)(6) 2010, the patient experienced pelvic pain (seriousness criterion medically significant) and back pain ("back pain").In (b)(6) 2011, the patient experienced rash ("rashes or skin conditions type: rashes"), cystitis ("infection a infection (bladder/urinary tract/vaginal) type: bladder infection"), bladder disorder ("bladder or urinary problems or changes") and urinary tract disorder ("bladder or urinary problems or changes").In (b)(6) 2012, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").In january 2013, the patient experienced diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), abdominal discomfort ("gastrointestinal or digestive system condition type: upset stomach") and constipation ("gastrointestinal or digestive system condition type: constipation,").In may 2017, the patient experienced nausea ("nausea,").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (ablation on date 03/12/2015).At the time of the report, the menorrhagia, pelvic pain, vaginal haemorrhage, menstrual disorder, dysmenorrhoea, diarrhoea, back pain, rash, cystitis, bladder disorder, urinary tract disorder, migraine, headache, nausea, fatigue, weight increased, abdominal discomfort and constipation outcome was unknown.The reporter considered abdominal discomfort, back pain, bladder disorder, constipation, cystitis, diarrhoea, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, urinary tract disorder, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: essure successfully occluded most recent follow-up information incorporated above includes: on 22-may-2018: pfs received: new event: vaginal haemorrhage, menorrhagia, rash, bladder disorder, urinary tract disorder, migraine, headache, nausea, dysmenorrhoea, fatigue, weight increased, abdominal discomfort, constipation, diarrhea, back pain were added and previously reported event infection updated to cystitis.Reporter, patient demographic information, concomitant disease, product lot number added.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.
 
Manufacturer Narrative
Ntaneous case was reported by a lawyer and describes the occurrence of menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain,pain") in an adult patient who had essure (batch no.664437) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight, ovarian cyst, diabetes and asthma.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),"), fatigue ("fatigue,") and weight increased ("weight gain").In (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches,").In (b)(6) 2010, the patient experienced pelvic pain (seriousness criterion medically significant) and back pain ("back pain").In (b)(6) 2011, the patient experienced rash ("rashes or skin conditions type: rashes"), cystitis ("infectionainfection (bladder/urinary tract/vaginal) type: bladder infection") and urinary incontinence ("bladder or urinary problems or changes urinary incontinence").In (b)(6) 2013, the patient experienced diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), abdominal discomfort ("gastrointestinal or digestive system condition type: upset stomach"), constipation ("gastrointestinal or digestive system condition type: constipation,"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish").In (b)(6) 2017, the patient experienced nausea ("nausea,").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (ablation on date (b)(6) 2015).At the time of the report, the menorrhagia, pelvic pain, vaginal haemorrhage, menstrual disorder, dysmenorrhoea, diarrhoea, back pain, rash, cystitis, migraine, headache, nausea, fatigue, weight increased, abdominal discomfort, constipation, depression, anxiety and urinary incontinence outcome was unknown.The reporter considered abdominal discomfort, anxiety, back pain, constipation, cystitis, depression, diarrhoea, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, urinary incontinence, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: essure successfully occluded.Most recent follow-up information incorporated above includes: on 25-jul-2018: pfs received- new events added: psychological or psychiatric problems condition: depression and mental anguish, urinary incontinence were added.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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ("abnormal bleeding (menorrhagia)") and pelvic pain ("pelvic pain, pain") in an adult patient who had essure (batch no.664437) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight, ovarian cyst, diabetes and asthma.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),"), fatigue ("fatigue,") and weight increased ("weight gain").In (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal)").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches,").In (b)(6) 2010, the patient experienced pelvic pain (seriousness criterion medically significant) and back pain ("back pain").In (b)(6) 2011, the patient experienced rash ("rashes or skin conditions type: rashes"), cystitis ("infectionainfection (bladder/urinary tract/vaginal) type: bladder infection") and urinary incontinence ("bladder or urinary problems or changes urinary incontinece").In (b)(6) 2013, the patient experienced diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), abdominal discomfort ("gastrointestinal or digestive system condition type: upset stomach"), constipation ("gastrointestinal or digestive system condition type: constipation,"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("mental anguish").In (b)(6) 2017, the patient experienced nausea ("nausea,").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (ablation on date (b)(6) 2015).At the time of the report, the menorrhagia, pelvic pain, vaginal haemorrhage, menstrual disorder, dysmenorrhoea, diarrhoea, back pain, rash, cystitis, migraine, headache, nausea, fatigue, weight increased, abdominal discomfort, constipation, depression, anxiety and urinary incontinence outcome was unknown.The reporter considered abdominal discomfort, anxiety, back pain, constipation, cystitis, depression, diarrhoea, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, urinary incontinence, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: essure successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-aug-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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain,pain/pelvic area') and menorrhagia ('abnormal bleeding (menorrhagia)') in a 42-year-old patient who had essure (batch no.664437) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: essure confirmation test(s) conducted - everything was working fine, (b)(6) 2010.Previously administered products included for an unreported indication: singulair.Concurrent conditions included overweight, ovarian cyst, diabetes, asthma and high cholesterol.Concomitant products included adenosine (tricor), cetirizine hydrochloride, codeine phosphate;paracetamol (tylenol with codeine no.3), fluoxetine hydrochloride (prozac), ibuprofen, rosuvastatin calcium (crestor) and salbutamol.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and fatigue ("fatigue,") and was found to have weight increased ("weight gain").In (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)") and back pain ("back pain").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches,").In (b)(6) 2011, the patient experienced rash ("rashes or skin conditions type: rashes"), cystitis ("infectionainfection (bladder/urinary tract/vaginal) type: bladder infection") and urinary incontinence ("bladder or urinary problems or changes urinary incontinece").On (b)(6) 2011, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish"), 2 years after insertion of essure.In (b)(6) 2013, the patient experienced diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), abdominal discomfort ("gastrointestinal or digestive system condition type: upset stomach") and constipation ("gastrointestinal or digestive system condition type: constipation,").In (b)(6) 2017, the patient experienced nausea ("nausea,").On an unknown date, the patient experienced menstrual disorder ("menstruation issues").The patient was treated with surgery (ablation on date (b)(6) 2015 and hysterectomy and bilateral salpingectomy ((b)(6) 2018)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menorrhagia, vaginal haemorrhage, menstrual disorder, dysmenorrhoea, diarrhoea, back pain, rash, cystitis, migraine, headache, nausea, fatigue, weight increased, abdominal discomfort, constipation and urinary incontinence outcome was unknown and the depression and anxiety had not resolved.The reporter considered abdominal discomfort, anxiety, back pain, constipation, cystitis, depression, diarrhoea, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, urinary incontinence, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: discrepancy noted in removal date and date of birth.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: results: essure successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-may-2019: pfs received.Events outcome : depression and anxiety were updated to not recovered / resolved.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain,pain/pelvic area') and menorrhagia ('abnormal bleeding (menorrhagia)') in a 42-year-old female patient who had essure (batch no.664437) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: essure confirmation test(s) conducted - everything was working fine, (b)(6) 2010.Previously administered products included for an unreported indication: singulair.Concurrent conditions included overweight, ovarian cyst, diabetes, asthma and high cholesterol.Concomitant products included adenosine (tricor), cetirizine hydrochloride, codeine phosphate;paracetamol (tylenol with codeine no.3), fluoxetine hydrochloride (prozac), ibuprofen, rosuvastatin calcium (crestor) and salbutamol.On (b)(6) 2009, the patient had essure inserted.In october 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping),") and fatigue ("fatigue,") and was found to have weight increased ("weight gain").In november 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)") and back pain ("back pain").In april 2010, the patient experienced migraine ("migraines") and headache ("headaches,").In january 2011, the patient experienced rash ("rashes or skin conditions type: rashes"), cystitis ("infection / infection (bladder/urinary tract/vaginal) type: bladder infection") and urinary incontinence ("bladder or urinary problems or changes urinary incontinece").On (b)(6) 2011, the patient experienced depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: mental anguish"), 2 years after insertion of essure.In january 2013, the patient experienced diarrhoea ("gastrointestinal or digestive system condition type: diarrhea"), abdominal discomfort ("gastrointestinal or digestive system condition type: upset stomach") and constipation ("gastrointestinal or digestive system condition type: constipation,").In may 2017, the patient experienced nausea ("nausea,").On an unknown date, the patient experienced menstrual disorder ("menstruation issues") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (ablation on date (b)(6) 2015 and hysterectomy and bilateral salpingectomy (b)(6) 2018.Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menorrhagia, vaginal haemorrhage, cystitis, urinary incontinence and vaginal discharge had resolved, the menstrual disorder, dysmenorrhoea, diarrhoea, back pain, rash, migraine, headache, nausea, fatigue, weight increased, abdominal discomfort and constipation outcome was unknown and the depression and anxiety had not resolved.The reporter considered abdominal discomfort, anxiety, back pain, constipation, cystitis, depression, diarrhoea, dysmenorrhoea, fatigue, headache, menorrhagia, menstrual disorder, migraine, nausea, pelvic pain, rash, urinary incontinence, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: discrepancy noted in removal date and date of birth.Patient received treatment for pain, bleeding.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - on 21-jan-2010: results: essure successfully occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: event vaginal discharge added.Event outcome of vaginal hemorrhage, pelvic pain, menorrhagia, urinary incontinence, were updated as recovered.Rcc note added.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
 
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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 Key7590296
MDR Text Key110719734
Report Number2951250-2018-02579
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2012
Device Model NumberESS305
Device Lot Number664437
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CETIRIZINE HYDROCHLORIDE; CETIRIZINE HYDROCHLORIDE; CETIRIZINE HYDROCHLORIDE; CETIRIZINE HYDROCHLORIDE; CRESTOR; CRESTOR; IBUPROFEN; IBUPROFEN; PROZAC; PROZAC; SALBUTAMOL; SALBUTAMOL; TRICOR [ADENOSINE]; TRICOR [ADENOSINE]; TYLENOL WITH CODEINE NO.3; TYLENOL WITH CODEINE NO.3
Patient Outcome(s) Other; Required Intervention;
Patient Age42 YR
Patient Weight73
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