ESSURE
Report
- Report Number
- 2951250-2022-00569
- Event Type
- Injury
- Date Received
- May 27, 2022
- Date of Event
- January 1, 2013
- Report Date
- June 9, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE") AND ABORTION SPONTANEOUS ("SPONTANEOUS ABORTION") IN A 35 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("DEVICE INEFFECTIVE"). THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3 ((B)(6) 2003, (B)(6) 2008, (B)(6) 2011), MULTIGRAVIDA AND SPONTANEOUS ABORTION. *ON (B)(6) 2011 :HYSTEROSALPINGOGRAM ; RESULT WAS DEVICE PROPERLY PLACED. CURRENT WEIGHT 180 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM, DEPO PROVERA AND MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: WEIGHT GAIN WITH SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM AND PREGNANCY WITH DEPO PROVERA. CONCURRENT CONDITIONS WERE LISTED AS OVERWEIGHT, FEELING GUILTY, POOR CONCENTRATION, ENERGY DECREASED, DECREASED APPETITE AND SLEEP DISORDER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 39 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2013 SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING"), DYSPAREUNIA ("DYSPAREUNIA/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PRURITUS ("ITCHY SKIN"), A FIRST EPISODE OF MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014 SHE EXPERIENCED HEADACHE ("HEADACHES") AND A SECOND EPISODE OF MIGRAINE ("MIGRAINES"). ON (B)(6) 2016 SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY"). AN UNKNOWN TIME LATER SHE EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS OR THEIR LATEST EPISODE WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT'S TREATMENT DATES SUGGEST POTENTIAL FETAL EXPOSURE TO ESSURE DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, THE FIRST EPISODE OF MIGRAINE, THE SECOND EPISODE OF MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PRURITUS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IT WAS REPORTED THAT SHE HAD A SPONTANEOUS ABORTION IN MY TOILET AT HOME. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 29.869 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 07-JUN-2022: 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: RIGHT FALLOPIAN TUBE") AND ABORTION SPONTANEOUS ("SPONTANEOUS ABORTION") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("DEVICE INEFFECTIVE"). THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3 ((B)(6) 2003, (B)(6) 2008, (B)(6) 2011), MULTIGRAVIDA AND SPONTANEOUS ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM, DEPO PROVERA AND MIRENA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: WEIGHT GAIN WITH SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM AND PREGNANCY WITH DEPO PROVERA. CONCURRENT CONDITIONS WERE LISTED AS OVERWEIGHT, FEELING GUILTY, POOR CONCENTRATION, ENERGY DECREASED, DECREASED APPETITE AND SLEEP DISORDER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 39 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND HEAVY MENSTRUAL BLEEDING ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN 2013 SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING"), DYSPAREUNIA ("DYSPAREUNIA/ DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PRURITUS ("ITCHY SKIN"), A FIRST EPISODE OF MIGRAINE ("MIGRAINES") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2014 SHE EXPERIENCED HEADACHE ("HEADACHES") AND A SECOND EPISODE OF MIGRAINE ("MIGRAINES"). ON (B)(6) 2016 SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY"). AN UNKNOWN TIME LATER SHE EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, NONE OF THE OUTCOMES FOR THESE EVENTS WERE KNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT'S TREATMENT DATES SUGGEST POTENTIAL FETAL EXPOSURE TO ESSURE DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALOPECIA, BACK PAIN, DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, THE FIRST EPISODE OF MIGRAINE, THE SECOND EPISODE OF MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE, PRURITUS, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IT WAS REPORTED THAT SHE HAD A SPONTANEOUS ABORTION IN MY TOILET AT HOME. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 29.869 KG/SQM. ON (B)(6) 2011 :HYSTEROSALPINGOGRAM ; RESULT WAS DEVICE PROPERLY PLACED. CURRENT WEIGHT (B)(6). QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-SEP-2020: UPON INTERNAL REVIEW, FOLLOW-UP FROM 09-SEP-2020 SHOULD HAVE BEEN CONSIDERED SIGNIFICANT: PIF RECEIVED. REMOVAL DETAILS WERE UPDATED. THIS CASE IS BEING SUBMITTED RETROSPECTIVELY FOLLOWING AN INTERNAL REVIEW 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2711012 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female | Other| R |