ESSURE
Report
- Report Number
- 2951250-2019-01776
- Event Type
- Injury
- Date Received
- May 9, 2019
- Date of Event
- June 1, 2018
- Report Date
- November 5, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)/ BECAME PREGNANT") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO THE ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6)1992, (B)(6)1995, (B)(6) 2002, (B)(6)2009, (B)(6)2011) AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (NEXPLANON), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND ORAL CONTRACEPTIVE NOS FROM 2009 TO 2011. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6)2018, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 6 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION"), ALOPECIA ("HAIR LOSS") AND INFECTION ("INFECTION (OTHER) DESCRIBE: UNKNOWN"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, MIGRAINE, TOOTH DISORDER, VISION BLURRED, WEIGHT INCREASED, ALOPECIA AND INFECTION OUTCOME WAS UNKNOWN, THE NAUSEA HAD RESOLVED AND THE HEADACHE WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALOPECIA, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 175 LBS. RIGHT ESSURE COIL ERODED THROUGH POSTERIOR SURFACE DISCREPANCY IN INSERTION DATE. PREVIOUSLY REPORTED AS 01DEC2010 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. LOT NUMBER: 880433 MANUFACTURE DATE: 2011-07,EXPIRATION DATE: 2014-07-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2019: QUALITY-SAFETY EVALUATION OF PTC INCIDENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION (UTERUS)'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (STILLBIRTH OR MISCARRIAGE)/ BECAME PREGNANT') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO THE ESSURE CONFIRMATION TEST.". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 1992, (B)(6) 1995, (B)(6) 2002, (B)(6) 2009, (B)(6) 2011) AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED ETONOGESTREL (NEXPLANON), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) AND ORAL CONTRACEPTIVE NOS FROM 2009 TO 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"). IN (B)(6) 2016, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN (B)(6) 2018, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 8 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2018, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), NAUSEA ("NAUSEA"), VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION"), ALOPECIA ("HAIR LOSS") AND INFECTION ("INFECTION (OTHER) DESCRIBE: UNKNOWN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, MIGRAINE, TOOTH DISORDER, WEIGHT INCREASED, ALOPECIA AND INFECTION OUTCOME WAS UNKNOWN, THE HEADACHE WAS RESOLVING AND THE NAUSEA AND VISION BLURRED HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALOPECIA, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 175 LBS. RIGHT ESSURE COIL ERODED THROUGH POSTERIOR SURFACE. DISCREPANCY IN INSERTION DATE. PREVIOUSLY REPORTED AS (B)(6) 2010 . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. LOT NUMBER: 880433. MANUFACTURE DATE: 2011-07,EXPIRATION DATE: 2014-07-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-OCT-2019: PFS RECEIVED. REPORTER'S INFORMATION WAS ADDED. UPDATED OUTCOME OF EVENT BLURRY VISION FROM UNKNOWN TO RECOVERED/RESOLVED. UPDATED EVENT ONSET DATE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (STILLBIRTH OR MISCARRIAGE)/ BECAME PREGNANT") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433,880433) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "PLAINTIFF DID NOT UNDERGO THE ESSURE CONFIRMATION TEST." THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA, PARITY 5 ((B)(6) 1992, (B)(6) 1995, (B)(6) 2002, (B)(6) 2009, (B)(6) 2011) AND OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES FROM 2009 TO 2011, ETONOGESTREL (NEXPLANON) AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). ON (B)(6) 2018, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 6 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), VISION BLURRED ("VISION/EYE PROBLEMS: BLURRY VISION"), ALOPECIA ("HAIR LOSS") AND INFECTION ("INFECTION (OTHER) DESCRIBE: UNKNOWN"), WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), TUBAL LIGATION). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, MIGRAINE, TOOTH DISORDER, VISION BLURRED, WEIGHT INCREASED, ALOPECIA AND INFECTION OUTCOME WAS UNKNOWN, THE NAUSEA HAD RESOLVED AND THE HEADACHE WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 5. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED ALOPECIA, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT (B)(6) LBS. RIGHT ESSURE COIL ERODED THROUGH POSTERIOR SURFACE. DISCREPANCY IN INSERTION DATE. PREVIOUSLY REPORTED AS (B)(6) 2010. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAY-2019: PFS WAS RECEIVED. REPORTER INFORMATION WAS UPDATED. NEW EVENTS: ABNORMAL BLEEDING (VAGINAL), PERFORATION (UTERUS), ABNORMAL BLEEDING (GENERAL), ABNORMAL BLEEDING (MENORRHAGIA),INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL, MIGRAINES, HEADACHES, NAUSEA, DENTAL PROBLEMS, VISION/EYE PROBLEMS: BLURRY VISION, WEIGHT GAIN, HAIR LOSS, DEVICE INEFFECTIVE, PREGNANCY (STILLBIRTH OR MISCARRIAGE)/ BECAME PREGNANT,INFECTION (OTHER) DESCRIBE: UNKNOWN AND PLAINTIFF DID NOT UNDERGO THE ESSURE CONFIRMATION TEST WERE ADDED. CONCOMITANT DRUG WAS ADDED. MEDICAL HISTORY WAS ADDED. ON 3-MAY-2019: PFS RECEIVED. CONCOMITANT MEDICATION ADDED. INCIDENT: 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390251 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880433 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| NEXPLANON| NEXPLANON| NEXPLANON| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| DEPO PROVERA| NEXPLANON| ORAL CONTRACEPTIVE NOS |