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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 Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Blurred Vision (2137); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607)
Event Date 08/01/2016
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and genital haemorrhage ('abnormal bleeding (general)') in a female patient who had essure (batch no.B94872) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: mirena.Concurrent conditions included obesity, irregular periods, uterine bleeding, endometriosis and ovarian cyst nos.Concomitant products included ibuprofen, oral contraceptive nos, oxycodone hydrochloride; paracetamol (percocet) and paracetamol (tylenol).On (b)(6) 2016, the patient had essure inserted.In a(b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), mood swings ("hormonal changes describe: mood swings"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), migraine ("migraines / headaches"), nausea ("nausea"), vision blurred ("vision/eye problems type: blurriness"), epistaxis ("other injury(ies) or complication please describe: nose bleeds") and vulvovaginal pain ("vaginal pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced fatigue ("fatigue").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, genital haemorrhage, mood swings, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, dyspareunia, fatigue, abdominal distension, migraine, nausea, vision blurred, weight increased, epistaxis and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, dysmenorrhoea, dyspareunia, epistaxis, fatigue, female sexual dysfunction, genital haemorrhage, menorrhagia, migraine, mood swings, nausea, pelvic pain, vaginal haemorrhage, vision blurred, vulvovaginal pain and weight increased to be related to essure.The reporter commented: 3 coils noted to be protruding from the ostium.2 coils noted to be protruding from the right ostium.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.6 kg/sqm.Hysterosalpingogram - in (b)(6) 2017: result: total bilateral occlusion.Pathology test - on (b)(6) 2017: result: uterus, cervix, bilateral tubes: uterine cervix, no dysplasia identified.Uterine fundus with proliferative endometrium and unremarkable myometrium bilateral unremarkable fallopian tubes.Clinical information: pelvic pain, abnormal uterine bleeding.Ultrasound scan vagina - on (b)(6) 2017: result: the uterus is normal with regard to size and external contour.There are no fibroids or adenomyosis seen.Endometrial lining is thin and homogeneous.There is a small amount free fluid in the cul-de-sac.Most recent follow-up information incorporated above includes: on 22-jul-2019: pfs and mr received.Essure lot number, race and essure explant date were added.Product indication updated.Previously reported ¿injury¿ was updated to pelvic pain.Following events were added: abnormal bleeding (general), mood swings, abnormal bleeding (vaginal), menorrhagia, apareunia (inability to have sexual intercourse), dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, bloating, migraines / headaches, nausea, blurriness, weight gain, nose bleeds and vaginal pain.Event severity added for: pelvic pain and vaginal pain.Reporters, medical history, lab data, historical and concomitant drugs were added.Incident: we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's 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') and genital haemorrhage ('abnormal bleeding (general)') in a female patient who had essure (batch no.B94872) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: mirena.Concurrent conditions included obesity, irregular periods, uterine bleeding, endometriosis and ovarian cyst.Concomitant products included ibuprofen, oral contraceptive nos, oxycodone hydrochloride;paracetamol (percocet) and paracetamol (tylenol).On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), mood swings ("hormonal changes describe: mood swings"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), migraine ("migraines / headaches"), nausea ("nausea"), vision blurred ("vision/eye problems type: blurriness"), epistaxis ("other injury(ies) or complication please describe: nose bleeds") and vulvovaginal pain ("vaginal pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced fatigue ("fatigue").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, genital haemorrhage, mood swings, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, dyspareunia, fatigue, abdominal distension, migraine, nausea, vision blurred, weight increased, epistaxis and vulvovaginal pain outcome was unknown.The reporter considered abdominal distension, dysmenorrhoea, dyspareunia, epistaxis, fatigue, female sexual dysfunction, genital haemorrhage, menorrhagia, migraine, mood swings, nausea, pelvic pain, vaginal haemorrhage, vision blurred, vulvovaginal pain and weight increased to be related to essure.The reporter commented: 3 coils noted to be protruding from the ostium.2 coils noted to be protruding from the right ostium.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.6 kg/sqm.Hysterosalpingogram - in february 2017: result: total bilateral occlusion.Pathology test - on (b)(6) 2017: result: uterus, cervix, bilateral tubes: - uterine cervix, no dysplasia identified.- uterine fundus with proliferative endometrium and unremarkable myometium~ - bilateral unremarkable fallopian tubes.Clinical information: pelvic pain, abnormal uterine bleeding.Ultrasound scan vagina - on (b)(6) 2017: result: the uterus is normal with regard to size and external contour.There are no fibroids or adenomyosis seen.Endometrial lining is thin and homogeneous.There is a small amount free fluid in the cul-de-sac.Lot number: b94872 manufacturing date: 2013-11 expiration date: 2016-11 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc.Incident we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's 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') in an adult female patient who had essure (batch no.B94872) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: mirena.Concurrent conditions included obesity, irregular periods, uterine bleeding, endometriosis and ovarian cyst.Concomitant products included ibuprofen, oral contraceptive nos, oxycodone hydrochloride;paracetamol (percocet) and paracetamol (tylenol).On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding (general)"), mood swings ("hormonal changes describe: mood swings"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), migraine ("migraines / headaches"), nausea ("nausea"), vision blurred ("vision/eye problems type: blurriness"), epistaxis ("other injury(ies) or complication please describe: nose bleeds") and vulvovaginal pain ("vaginal pain") and was found to have weight increased ("weight gain").On an unknown date, the patient experienced fatigue ("fatigue"), vaginal discharge ("vaginal discharge"), abdominal pain ("pain abdominal") and vaginal disorder ("3+ treatments of silver nitrate to cauterize over growth on vaginal cuff,").The patient was treated with 3+ treatments of silver nitrate to cauterize over growth on vaginal cuff, and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, genital haemorrhage, mood swings, vaginal haemorrhage, menorrhagia, female sexual dysfunction, dysmenorrhoea, dyspareunia, fatigue, abdominal distension, migraine, nausea, vision blurred, weight increased, epistaxis, vulvovaginal pain, vaginal discharge, abdominal pain and vaginal disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain, dysmenorrhoea, dyspareunia, epistaxis, fatigue, female sexual dysfunction, genital haemorrhage, menorrhagia, migraine, mood swings, nausea, pelvic pain, vaginal discharge, vaginal disorder, vaginal haemorrhage, vision blurred, vulvovaginal pain and weight increased to be related to essure.The reporter commented: 3 coils noted to be protruding from the ostium.2 coils noted to be protruding from the right ostium.Discrepancy noted in date of hysterosalpingogram- (b)(6) 2016.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 37.6 kg/sqm.Hysterosalpingogram - in (b)(6) 2017: result: total bilateral occlusion.Imaging procedure - on (b)(6) 2016: essure confirmation test result- bilateral occlusion.Pathology test - on (b)(6) 2017: result: uterus, cervix, bilateral tubes: uterine cervix, no dysplasia identified.Uterine fundus with proliferative endometrium and unremarkable myometium.Bilateral unremarkable fallopian tubes.Clinical information: pelvic pain, abnormal uterine bleeding.Ultrasound scan vagina - on (b)(6) 2017: result: the uterus is normal with regard to size and external contour.There are no fibroids or adenomyosis seen.Endometrial lining is thin and homogeneous.There is a small amount free fluid in the cul-de-sac.Lot number: b94872 manufacturing date: 2013-11 expiration date: 2016-11.Concerning the injuries reported in this case, the following ones were confirmed in the patient's medical records : pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-mar-2020: plaintiff fact sheet and medical records received : reporters added.Events added- vaginal discharge, abdominal pain,3+ treatments of silver nitrate to cauterize over growth on vaginal cuff.Incident we received a lot number.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.
 
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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 Key8829875
MDR Text Key152316294
Report Number2951250-2019-04206
Device Sequence Number1
Product Code HHS
UDI-Device Identifier10888853003051
UDI-Public(01)10888853003051
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
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 Expiration Date11/30/2016
Device Model NumberESS305
Device Lot NumberB94872
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/22/2019
Initial Date FDA Received07/26/2019
Supplement Dates Manufacturer Received07/30/2019
07/30/2019
Supplement Dates FDA Received07/30/2019
03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IBUPROFEN; IBUPROFEN; IBUPROFEN; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; TYLENOL; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]; IBUPROFEN; ORAL CONTRACEPTIVE NOS; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; TYLENOL [PARACETAMOL]
Patient Outcome(s) Other; Required Intervention;
Patient Age23 YR
Patient Weight96
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