Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Anemia (1706); Fatigue (1849); Hair Loss (1877); Headache (1880); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Hot Flashes/Flushes (2153); Sweating (2444); Lethargy (2560); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)
Event Date 11/01/2015
Event Type  Injury  
Event Description
"ntaneous" case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain / pain") and genital haemorrhage ("abnormal excessive bleeding/blood clots") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight, hot flashes, panic attacks, vaginal odor, menopausal syndrome, smoker, uterine bleeding, uterine leiomyoma, iron deficiency anemia, taste metallic, pain in hip, lethargy, night sweats and polymenorrhoea.In (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced weight increased ("weight gain"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").In (b)(6) 2009, the patient experienced nausea ("nausea").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2010, the patient experienced alopecia ("hair loss").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2017, the patient experienced anaemia ("anemia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysgeusia ("metallic taste in mouth") and allergy to metals ("allergic or hypersensitivity reaction type: nickel jewelry").The patient was treated with surgery (hysterectomy with bilateral salpingectomy - total laparoscopic hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, migraine, nausea, vaginal discharge and anaemia had resolved, the genital haemorrhage, weight increased, dysgeusia, allergy to metals and headache outcome was unknown and the fatigue and alopecia was resolving.The reporter considered allergy to metals, alopecia, anaemia, dysgeusia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient physician has recommended removal of the device.Her surgery has not been scheduled.(b)(6).Previously reported insertion date - 2006.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - in january 2009: total bilateral occlusion.Pregnancy test - on 22-aug-2016: negative.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events- "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), allergic or hypersensitivity reaction type: nickel jewelry, migraines, headaches, nausea, fatigue, hair loss, vaginal discharge, anemia", essure model number change to essure-305, concomitant condition, lab data added from pfs and medical record.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
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain / pain") and genital haemorrhage ("abnormal excessive bleeding/blood clots") in a 39-year-old female patient who had essure (batch no.Oj10353) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included grand multiparity.Concurrent conditions included overweight, hot flashes, panic attacks, vaginal odor, menopausal syndrome, smoker, uterine bleeding, uterine leiomyoma, iron deficiency anemia, taste metallic, pain in hip, lethargy, night sweats, polymenorrhoea, dysmenorrhoea and incontinence.Concomitant products included medroxyprogesterone (depo provera).In (b)(6) 2009, the patient experienced weight increased ("weight gain"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced nausea ("nausea").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2010, the patient experienced alopecia ("hair loss").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2017, the patient experienced anaemia ("anemia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysgeusia ("metallic taste in mouth"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and allergy to metals ("allergic or hypersensitivity reaction type: nickel jewelry").The patient was treated with iron (iron supplement), bismuth subsalicylate (pepto bismol), miconazole nitrate (monistat) and surgery (hysterectomy with bilateral salpingectomy - total laparoscopic hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, migraine, nausea, vaginal discharge and anaemia had resolved, the genital haemorrhage, weight increased, dysgeusia, allergy to metals and headache outcome was unknown and the fatigue and alopecia was resolving.The reporter considered allergy to metals, alopecia, anaemia, dysgeusia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient physician has recommended removal of the device.Her surgery has not been scheduled.Current weight 220 lbs.Previously reported insertion date - 2006.Discrepancy noted in insertion date.Previously reported (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2011: total bilateral occlusion; in (b)(6) 2009: total bilateral occlusion.Pregnancy test - on (b)(6) 2016: negative.On (b)(6) 2010 pelvic sono/endometrial biopsy was done and fsh, tsh, and h&h found normal.Upt is negative.Pelvic ultrasound is performed.Please see report for details.Endometrial biopsy is performed in the usual fashion without difficulty.The uterus sounds to approx 9 cm.There is moderate descent of uterus with tenaculum traction.On (b)(6) 2010 ultrasound performed and impressions are - 1.Small anteverted uterus with small left anterior intramural myoma as noted.2.Essentially unremarkable study of pelvis otherwise concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records- menorrhagia, fatigue, abnormal bleeding.Most recent follow-up information incorporated above includes: on 10-sep-2018: pfs and mr received.New reporters and reporter information added.Concomitant conditions, historical conditions and treatment drug added.Lot number added.Product implanted date updated.Events onset date added.Lab data 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 pelvic pain ("chronic pelvic pain / pain") and genital haemorrhage ("abnormal excessive bleeding/blood clots") in a 39-year-old female patient who had essure (batch no.Oj10353-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiparous.Concurrent conditions included overweight, hot flashes, panic attacks, vaginal odor, menopausal syndrome, smoker, uterine bleeding, uterine leiomyoma, iron deficiency anemia, taste metallic, pain in hip, lethargy, night sweats, polymenorrhoea, dysmenorrhoea and incontinence.Concomitant products included medroxyprogesterone (depo provera).On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced weight increased ("weight gain"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").In(b)(6) 2010, the patient experienced nausea ("nausea").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2010, the patient experienced alopecia ("hair loss").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2017, the patient experienced anaemia ("anemia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysgeusia ("metallic taste in mouth"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and allergy to metals ("allergic or hypersensitivity reaction type: nickel jewelry").The patient was treated with iron (iron supplement), bismuth subsalicylate (pepto bismol), miconazole nitrate (monistat) and surgery (hysterectomy with bilateral salpingectomy - total laparoscopic hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, migraine, nausea, vaginal discharge and anaemia had resolved, the genital haemorrhage, weight increased, dysgeusia, allergy to metals and headache outcome was unknown and the fatigue and alopecia was resolving.The reporter considered allergy to metals, alopecia, anaemia, dysgeusia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient physician has recommended removal of the device.Her surgery has not been scheduled.Current weight 220 lbs.Previously reported insertion date - 2006.Discrepancy noted in insertion date.Previously reported (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2011: total bilateral occlusion; in january 2009: total bilateral occlusion pregnancy test - on (b)(6) 2016: negative.On (b)(6) 2010 pelvic sono/endometrial biopsy was done and fsh, tsh, and h&h found normal.Upt is negative.Pelvic ultrasound is performed.Please see report for details.Endometrial biopsy is performed in the usual fashion without difficulty.The uterus sounds to approx 9 cm.There is moderate descent of uterus with tenaculum traction.On (b)(6) 2010 ultrasound performed and impressions are - 1.Small anteverted uterus with small left anterior intramural myoma as noted.2.Essentially unremarkable study of pelvis otherwise.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records- menorrhagia, fatigue, abnormal bleeding.Most recent follow-up information incorporated above includes: on 25-sep-2018: update of information (batch is invalid).Incident: no valid 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 spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain / pain') and genital haemorrhage ('abnormal excessive bleeding/blood clots') in a 39-year-old female patient who had essure (batch no.Oj10353-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiparous.Concurrent conditions included overweight, hot flashes, panic attacks, vaginal odor, menopausal syndrome, smoker, uterine bleeding, uterine leiomyoma, iron deficiency anemia, taste metallic, pain in hip, lethargy, night sweats, polymenorrhoea, dysmenorrhoea and incontinence.Concomitant products included medroxyprogesterone acetate (depo provera).In (b)(6) 2009, the patient was found to have weight increased ("weight gain") and experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2010, the patient experienced nausea ("nausea").In (b)(6) 2010, the patient experienced migraine ("migraines") and headache ("headaches").In (b)(6) 2010, the patient experienced alopecia ("hair loss").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2017, the patient experienced anaemia ("anemia").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dysgeusia ("metallic taste in mouth"), allergy to metals ("allergic or hypersensitivity reaction type: nickel jewelry"), back pain ("see your doctor about your back pain") and gastric disorder ("i'd also see a gi specialist about your stomach").The patient was treated with drugs for acid related disorders, iron, miconazole nitrate (monistat) and surgery (hysterectomy with bilateral salpingectomy - total laparoscopic hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, migraine, nausea, vaginal discharge and anaemia had resolved, the genital haemorrhage, weight increased, dysgeusia, allergy to metals, headache, back pain and gastric disorder outcome was unknown and the fatigue and alopecia was resolving.The reporter considered allergy to metals, alopecia, anaemia, back pain, dysgeusia, fatigue, gastric disorder, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient physician has recommended removal of the device.Her surgery has not been scheduled.Current weight 220 lbs.Previously reported insertion date - 2006 discrepancy noted in insertion date.Previously reported (b)(6) 2008.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.3 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: results: total bilateral occlusion; on (b)(6) 2011: results: total bilateral occlusion.Pregnancy test - on (b)(6) 2016: results: negative.On (b)(6) 2010 pelvic sono/endometrial biopsy was done and fsh, tsh, and h&h found normal.Upt is negative.Pelvic ultrasound is performed.Please see report for details.Endometrial biopsy is performed in the usual fashion without difficulty.The uterus sounds to approx 9 cm.There is moderate descent of uterus with tenaculum traction.On (b)(6) 2010 ultrasound performed and impressions are - 1.Small anteverted uterus with small left anterior intramural myoma as noted.2.Essentially unremarkable study of pelvis otherwise concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records- menorrhagia, fatigue, abnormal bleeding.Most recent follow-up information incorporated above includes: on 26-nov-2019: social media received : following events were added : see your doctor about your back pain, i'd also see a gi specialist about your stomach.Reporter information added.No valid lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event 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 Key7841171
MDR Text Key119023756
Report Number2951250-2018-03864
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,Followup,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESS305
Device Lot NumberOJ10353-NOT VALID
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DEPO PROVERA; DEPO PROVERA; DEPO PROVERA
Patient Outcome(s) Other; Required Intervention;
Patient Age39 YR
Patient Weight79
-
-