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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 Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Death (1802); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Miscarriage (1962); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Vertigo (2134); Abdominal Distention (2601); Heavier Menses (2666); Pregnancy (3193)
Event Date 04/01/2017
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of pregnancy with contraceptive device ('pregnancy: stillbirth/miscarriage / pregnancy (with complications)') and abortion spontaneous ('stillbirth/miscarriage') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included ectopic pregnancy (unclear when the plaintiff experienced it.), parity (unclear when the plaintiff experienced it.), birth defects (unclear when the plaintiff experienced it.), body mass index normal, multigravida and parity 4 ((b)(6) 2002, (b)(6) 2006, (b)(6) 2009, (b)(6) 2017).Previously administered products included for prevent pregnancy: depo provera from (b)(6) 2010 to (b)(6) 2011.Concomitant products included acetylsalicylic acid; ascorbic acid (midol c) since (b)(6) 2011, gabapentin since (b)(6) 2019, ibuprofen from (b)(6) 2011 to (b)(6) 2019, meloxicam since (b)(6) 2019, naproxen sodium (aleve) from (b)(6) 2011 to (b)(6) 2019 and tramadol since (b)(6) 2019.In (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced device dislocation ("migration of essure device location of device: peritoneal cavity").In (b)(6) 2011, the patient experienced dysmenorrhoea ("chronic, dysmenorrhea (cramping),"), menorrhagia ("menorrhagia (heavy menstrual bleeding) / abnormal bleeding (menorrhagia)"), fatigue ("fatigue"), abdominal distension ("hormonal changes describe: bloating"), migraine ("migraines / headaches"), fibromyalgia ("fibromyalgia") and vertigo ("vertigo").In (b)(6) 2017, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced abortion spontaneous (seriousness criterion medically significant), dyspareunia ("dyspareunia (painful sexual intercourse)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), metrorrhagia ("metrorrhagia (bleeding b/w periods)"), psychological trauma ("psych injury related to essure"), bladder disorder ("bladder problems"), urinary tract infection ("uti"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain upper ("stomach pain"), neck pain ("neck pain") and pain in extremity ("legs pain").Essure treatment was not changed.At the time of the report, the pregnancy with contraceptive device, abortion spontaneous, dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, psychological trauma, bladder disorder, urinary tract infection, fatigue, tooth disorder, headache, nausea, abdominal distension, vaginal haemorrhage, migraine, device dislocation, fibromyalgia, vertigo, abdominal pain upper, neck pain and pain in extremity outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, abortion spontaneous, back pain, bladder disorder, device dislocation, dysmenorrhoea, dyspareunia, fatigue, fibromyalgia, headache, menorrhagia, metrorrhagia, migraine, nausea, neck pain, pain in extremity, pelvic pain, pregnancy with contraceptive device, psychological trauma, tooth disorder, urinary tract infection, vaginal haemorrhage and vertigo to be related to essure.The reporter commented: discrepancy noted in essure insertion date 2005, (b)(6) 2009 and (b)(6) 2011.Received treatment for bladder problems, uti.Current weight (b)(6) lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2011: migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: plaintiff fact sheet received.Events added from pfs- hormonal changes describe: bloating, abnormal bleeding (vaginal), migraines / headaches, migration of essure device location of device: peritoneal cavity, neurological conditions or problems type: fibromyalgia, vertigo, stomach pain, neck pain, legs pain.Onset date of event menorrhagia, dysmenorrhoea, fatigue, pregnancy with contraceptive device were updated.Reporter information, historical drug, concomitant drug, lab data were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of pregnancy with contraceptive device ('pregnancy: stillbirth/miscarriage / pregnancy (with complications)') and abortion spontaneous ('stillbirth/miscarriage') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included ectopic pregnancy (unclear when the plaintiff experienced it.), parity (unclear when the plaintiff experienced it.), birth defects (unclear when the plaintiff experienced it.), body mass index normal, multigravida and parity 4 ((b)(6) 2002, (b)(6) 2006, (b)(6) 2009, (b)(6) 2017).Previously administered products included for prevent pregnancy: depo provera from (b)(6) 2010 to (b)(6) 2011.Concomitant products included acetylsalicylic acid;ascorbic acid (midol c) since (b)(6) 2011, gabapentin since (b)(6) 2019, ibuprofen from (b)(6) 2011 to (b)(6) 2019, meloxicam since (b)(6) 2019, naproxen sodium (aleve) from (b)(6) 2011 to (b)(6) 2019 and tramadol since (b)(6) 2019.In (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced device dislocation ("migration of essure device location of device: peritoneal cavity").In (b)(6) 2011, the patient experienced dysmenorrhoea ("chronic, dysmenorrhea (cramping),"), menorrhagia ("menorrhagia (heavy menstrual bleeding) / abnormal bleeding (menorrhagia)"), fatigue ("fatigue"), abdominal distension ("hormonal changes describe: bloating"), migraine ("migraines / headaches"), fibromyalgia ("fibromyalgia") and vertigo ("vertigo").In (b)(6) 2017, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).On an unknown date, the patient experienced abortion spontaneous (seriousness criterion medically significant), dyspareunia ("dyspareunia (painful sexual intercourse)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), metrorrhagia ("metrorrhagia (bleeding b/w periods)"), psychological trauma ("psych injury related to essure"), bladder disorder ("bladder problems"), urinary tract infection ("uti"), tooth disorder ("dental problems"), headache ("headaches"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), abdominal pain upper ("stomach pain"), neck pain ("neck pain") and pain in extremity ("legs pain").Essure treatment was not changed.At the time of the report, the pregnancy with contraceptive device, abortion spontaneous, dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, psychological trauma, bladder disorder, urinary tract infection, fatigue, tooth disorder, headache, nausea, abdominal distension, vaginal haemorrhage, migraine, device dislocation, fibromyalgia, vertigo, abdominal pain upper, neck pain and pain in extremity outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 5, para 4.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth.It was unknown whether the child was healthy.The reporter considered abdominal distension, abdominal pain, abdominal pain upper, abortion spontaneous, back pain, bladder disorder, device dislocation, dysmenorrhoea, dyspareunia, fatigue, fibromyalgia, headache, menorrhagia, metrorrhagia, migraine, nausea, neck pain, pain in extremity, pelvic pain, pregnancy with contraceptive device, psychological trauma, tooth disorder, urinary tract infection, vaginal haemorrhage and vertigo to be related to essure.The reporter commented: discrepancy noted in essure insertion date 2005, (b)(6) 2009 and (b)(6) 2011.Received treatment for bladder problems, uti.Current weight 165 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.1 kg/sqm.Hysterosalpingogram - on (b)(6) 2011: migration of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-mar-2020: quality safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 Key9853340
MDR Text Key184097603
Report Number2951250-2020-02610
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,other
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberESS305
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2018
Initial Date FDA Received03/19/2020
Supplement Dates Manufacturer Received02/28/2020
Supplement Dates FDA Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALEVE; ALEVE; GABAPENTIN; GABAPENTIN; IBUPROFEN; IBUPROFEN; MELOXICAM; MELOXICAM; MIDOL C; MIDOL C; TRAMADOL; TRAMADOL; ALEVE; GABAPENTIN; IBUPROFEN; MELOXICAM; MIDOL C; TRAMADOL
Patient Outcome(s) Other;
Patient Age31 YR
Patient Weight54
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