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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 Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Anemia (1706); Fatigue (1849); Nausea (1970); Pain (1994); Perforation (2001); Uterine Perforation (2121); Arthralgia (2355); Sweating (2444); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration of the essure insert / perforation (uterus)"), fallopian tube perforation ("perforation (fallopian tube)") and genital haemorrhage ("heavy bleeding/abnormal bleeding (general)") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included arthritis.Concurrent conditions included overweight.Concomitant products included meloxicam (mobic) for arthritis as well as baclofen from 2006 to 2012, cyclobenzaprine hydrochloride (flexeril) since 2012, ibuprofen since 2004, iron since (b)(6) 2012 and paracetamol (tylenol cold) since 2004.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), menorrhagia ("prolonged and abnormal menses/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and nausea ("nausea").In (b)(6) 2009, the patient experienced dysmenorrhoea ("severe and abnormal menstrual pain / dysmenorrhea (cramping)").In (b)(6) 2009, the patient experienced premenstrual dysphoric disorder ("premenstrual dysphoric disorder").In august 2009, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), adnexa uteri pain ("pain: ovaries pain") and arthralgia ("pain: hip pain").In (b)(6) 2015, the patient experienced weight increased ("weight gain").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe lower abdominal pain /abdominal cramping"), back pain ("back pain"), dyspareunia ("pain during intercourse"), weight fluctuation ("weight fluctuations"), anaemia ("blood or heart disorder/condition type: anemia"), tooth disorder ("dental problems"), treatment noncompliance ("plaintiff did not use any birth control other than essure during this time period") and arthritis ("arthritis").The patient was treated with surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2017)).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, fallopian tube perforation, treatment noncompliance and arthritis outcome was unknown and the genital haemorrhage, abdominal pain lower, pelvic pain, back pain, adnexa uteri pain, dysmenorrhoea, menorrhagia, vaginal haemorrhage, dyspareunia, fatigue, weight fluctuation, premenstrual dysphoric disorder, anaemia, nausea, tooth disorder, arthralgia and weight increased had not resolved.The reporter considered abdominal pain lower, adnexa uteri pain, anaemia, arthralgia, arthritis, back pain, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, genital haemorrhage, menorrhagia, nausea, pelvic pain, premenstrual dysphoric disorder, tooth disorder, treatment noncompliance, uterine perforation, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: patient will need to undergo surgical intervention as a result of her essure implants.Current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - in 2009: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2018: reporter information was added.This case concerns (b)(6) patient.Her demographic was added.Her concurrent and historical condition was added.Lab data was amended.Essure indication was amended.Essure removal date was added.Her concomitant medications were added.Following events: perforation (uterus) clubbed with migration of the essure insert, perforation (fallopian tube), abnormal bleeding (vaginal), premenstrual dysphoric disorder, anemia, nausea, dental problems, pain: hip pain, pain: ovaries pain, weight gain, arthritis and plaintiff did not use any birth control other than essure during this time period were added.She had not recovered from any of the aforementioned events.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 spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('migration of the essure insert / perforation (uterus)'), fallopian tube perforation ('perforation (fallopian tube)') and genital haemorrhage ('heavy bleeding/abnormal bleeding (general)') in a 37-year-old female patient who had essure (batch no.637215) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "plaintiff did not use any birth control other than essure during this time period".The patient's medical history included arthritis.Concurrent conditions included overweight, migraine, aneurysm cerebral and stroke.Concomitant products included meloxicam (mobic) for arthritis as well as since 2012, baclofen from 2006 to 2012, ibuprofen since 2004, iron since (b)(6)2012, meloxicam and paracetamol since 2004.On (b)(6)2009, the patient had essure inserted.In (b)(6)2009, the patient experienced dysmenorrhoea ("severe and abnormal menstrual pain / dysmenorrhea (cramping)").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), menorrhagia ("prolonged and abnormal menses/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and nausea ("nausea").In (b)(6)2009, the patient experienced premenstrual dysphoric disorder ("premenstrual dysphoric disorder").In (b)(6)2009, the patient experienced fatigue ("fatigue").In (b)(6)2012, the patient experienced pelvic pain ("pelvic pain"), adnexa uteri pain ("pain: ovaries pain") and arthralgia ("pain: hip pain").In (b)(6)2015, the patient was found to have weight increased ("weight gain").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe lower abdominal pain /abdominal cramping"), back pain ("back pain"), dyspareunia ("pain during intercourse"), weight fluctuation ("weight fluctuations"), anaemia ("blood or heart disorder/condition type: anemia"), tooth disorder ("dental problems") and arthritis ("arthritis").The patient was treated with surgery (hysterectomy with bilateral salpingectomy (b)(6)2017)).Essure was removed on (b)(6)2017.At the time of the report, the uterine perforation, fallopian tube perforation and arthritis outcome was unknown and the genital haemorrhage, abdominal pain lower, pelvic pain, back pain, adnexa uteri pain, dysmenorrhoea, menorrhagia, vaginal haemorrhage, dyspareunia, fatigue, weight fluctuation, premenstrual dysphoric disorder, anaemia, nausea, tooth disorder, arthralgia and weight increased had not resolved.The reporter considered abdominal pain lower, adnexa uteri pain, anaemia, arthralgia, arthritis, back pain, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, genital haemorrhage, menorrhagia, nausea, pelvic pain, premenstrual dysphoric disorder, tooth disorder, uterine perforation, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: patient will need to undergo surgical intervention as a result of her essure implants.Current weight 190 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - in (b)(6)2009: results: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 19-sep-2019: pfs received : lot number added.Concomitant conditions and reporter information added.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 uterine perforation ('migration of the essure insert / perforation (uterus)'), fallopian tube perforation ('perforation (fallopian tube)') and genital haemorrhage ('heavy bleeding/abnormal bleeding (general)') in a 37-year-old female patient who had essure (batch no.637215) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "plaintiff did not use any birth control other than essure during this time period".The patient's medical history included arthritis.Concurrent conditions included overweight, migraine, aneurysm cerebral and stroke.Concomitant products included meloxicam (mobic) for arthritis as well as since 2012, baclofen from 2006 to 2012, ibuprofen since 2004, iron since (b)(6) 2012, meloxicam and paracetamol since 2004.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("severe and abnormal menstrual pain / dysmenorrhea (cramping)").In 2009, the patient experienced genital haemorrhage (seriousness criterion medically significant), menorrhagia ("prolonged and abnormal menses/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and nausea ("nausea").In (b)(6) 2009, the patient experienced premenstrual dysphoric disorder ("premenstrual dysphoric disorder").In (b)(6) 2009, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), adnexa uteri pain ("pain: ovaries pain") and arthralgia ("pain: hip pain").In (b)(6) 2015, the patient was found to have weight increased ("weight gain").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe lower abdominal pain /abdominal cramping"), back pain ("back pain"), dyspareunia ("pain during intercourse"), weight fluctuation ("weight fluctuations"), anaemia ("blood or heart disorder/condition type: anemia"), tooth disorder ("dental problems") and arthritis ("arthritis").The patient was treated with surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2017)).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, fallopian tube perforation and arthritis outcome was unknown and the genital haemorrhage, abdominal pain lower, pelvic pain, back pain, adnexa uteri pain, dysmenorrhoea, menorrhagia, vaginal haemorrhage, dyspareunia, fatigue, weight fluctuation, premenstrual dysphoric disorder, anaemia, nausea, tooth disorder, arthralgia and weight increased had not resolved.The reporter considered abdominal pain lower, adnexa uteri pain, anaemia, arthralgia, arthritis, back pain, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, genital haemorrhage, menorrhagia, nausea, pelvic pain, premenstrual dysphoric disorder, tooth disorder, uterine perforation, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: patient will need to undergo surgical intervention as a result of her essure implants.Current weight 190 lbs.Discrepancy noted in essure confirmation test(s) conducted: (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28.3 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-oct-2019: quality safety evaluation of product technical complaint.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 uterine perforation ('migration of the essure insert / perforation (uterus)') and fallopian tube perforation ('perforation (fallopian tube)') in a (b)(6) female patient who had essure (batch no.637215) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: treatment noncompliance "plaintiff did not use any birth control other than essure during this time period".The patient's medical history included arthritis.Concurrent conditions included overweight, migraine, aneurysm cerebral and stroke.Concomitant products included meloxicam (mobic) for arthritis as well as since 2012, baclofen from 2006 to 2012, ibuprofen since 2004, iron since (b)(6) 2012, meloxicam and paracetamol since 2004.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2009, the patient experienced dysmenorrhoea ("severe and abnormal menstrual pain / dysmenorrhea (cramping)").In 2009, the patient experienced genital haemorrhage ("heavy bleeding/abnormal bleeding (general)"), menorrhagia ("prolonged and abnormal menses/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and nausea ("nausea").In (b)(6) 2009, the patient experienced premenstrual dysphoric disorder ("premenstrual dysphoric disorder").In (b)(6) 2009, the patient experienced fatigue ("fatigue").In (b)(6) 2012, the patient experienced pelvic pain ("pelvic pain"), adnexa uteri pain ("pain: ovaries pain") and arthralgia ("pain: hip pain").In (b)(6) 2015, the patient was found to have weight increased ("weight gain").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), abdominal pain lower ("severe lower abdominal pain /abdominal cramping"), back pain ("back pain"), dyspareunia ("pain during intercourse"), weight fluctuation ("weight fluctuations"), anaemia ("blood or heart disorder/condition type: anemia"), tooth disorder ("dental problems"), arthritis ("arthritis"), herpes zoster ("shingles"), haemorrhoids ("hemorrhoids") and gastrooesophageal reflux disease ("acid reflux issues").The patient was treated with surgery (hysterectomy with bilateral salpingectomy ((b)(6) 2017)).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, fallopian tube perforation, arthritis, herpes zoster, haemorrhoids and gastrooesophageal reflux disease outcome was unknown and the genital haemorrhage, abdominal pain lower, pelvic pain, back pain, adnexa uteri pain, dysmenorrhoea, menorrhagia, vaginal haemorrhage, dyspareunia, fatigue, weight fluctuation, premenstrual dysphoric disorder, anaemia, nausea, tooth disorder, arthralgia and weight increased had not resolved.The reporter considered abdominal pain lower, adnexa uteri pain, anaemia, arthralgia, arthritis, back pain, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrooesophageal reflux disease, genital haemorrhage, haemorrhoids, herpes zoster, menorrhagia, nausea, pelvic pain, premenstrual dysphoric disorder, tooth disorder, uterine perforation, vaginal haemorrhage, weight fluctuation and weight increased to be related to essure.The reporter commented: patient will need to undergo surgical intervention as a result of her essure implants.Current weight 190 lbs.Discrepancy noted in essure confirmation test(s) conducted: (b)(6) 2009 diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - in (b)(6) 2009: results: total bilateral occlusion.Concerning the injuries reported in this case, the following ones were reported via social media : herpes zoster, hemorrhoids quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: social media received.Reporter information added.Event : shingles, hemorrhoids added.This is a retention case.All the information including event acid reflux issues, source document, reporter and references from deletion case (b)(4) has been transferred to this case.A technical investigation will be 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 Key7612260
MDR Text Key111438789
Report Number2951250-2018-02646
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
Report Date 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2012
Device Model NumberESS305
Device Lot Number637215
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BACLOFEN; BACLOFEN; BACLOFEN; BACLOFEN; FLEXERIL; IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; IRON; IRON; IRON; IRON; MELOXICAM; MELOXICAM; MELOXICAM; MOBIC; MOBIC; MOBIC; MOBIC; OTHER THERAPEUTIC PRODUCTS; OTHER THERAPEUTIC PRODUCTS; OTHER THERAPEUTIC PRODUCTS; PARACETAMOL; PARACETAMOL; PARACETAMOL; TYLENOL COLD [PARACETAMOL]
Patient Outcome(s) Other; Required Intervention;
Patient Age37 YR
Patient Weight75
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