ESSURE
Report
- Report Number
- 2951250-2018-01546
- Event Type
- Injury
- Date Received
- April 9, 2018
- Date of Event
- July 1, 2012
- Report Date
- April 28, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE"), GENITAL HAEMORRHAGE ("BLEEDING") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2015,ONE COIL REMOVED AND TUBAL LIGATION, UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: THAT MY TUBES WERE BLOCKED AND EVERYTHING LOOKED GOOD. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE:ONE COIL WAS LOST/LEFT COIL NOT FOUND"), GENITAL HAEMORRHAGE ("BLEEDING") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANT". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (LIVE BIRTH -(B)(6) 1999, (B)(6) 2004, (B)(6) 2011.) AND ABORTION. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2015-TUBAL LIGATION, (B)(6) 2018 UNILATERAL SALPINGECTOMY, PARTIAL SUPRACERVICAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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 DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN (B)(6) 2012, SHE LEARNED SHE WAS SIX WEEKS PREGNANT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2018: PFS RECEIVED. EVENT VERBATIM WAS UPDATED AS MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE: ONE COIL WAS LOST/LEFT COIL NOT FOUND. EVENT OUTCOME OF MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE:ONE COIL WAS LOST/LEFT COIL NOT FOUND WAS UPDATED RECOVERED/RESOLVED. EVENT ONSET DATE OF PREGNANCY WAS UPDATED AS (B)(6) 2012.EXPLANT DATE AND REMOVAL SURGERY DETAILS WERE ADDED. INCIDENT 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE"), GENITAL HAEMORRHAGE ("BLEEDING") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED CONTRACEPTIVES NOS. IN 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2015, ONE COIL REMOVED AND TUBAL LIGATION, UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: THAT MY TUBES WERE BLOCKED AND EVERYTHING LOOKED GOOD. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2018: PLAINTIFF FACT SHEET RECEIVED: NEW REPORTERS AND REPORTER INFORMATION ADDED. EVENTS OUTCOME UPDATED TO RECOVERED / RESOLVED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE:ONE COIL WAS LOST/LEFT COIL NOT FOUND / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OUTSIDE OF TUBE'), GENITAL HAEMORRHAGE ('BLEEDING') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668-INV,863568) 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 MULTIGRAVIDA, PARITY 3 (LIVE BIRTH -(B)(6) 1999, (B)(6) 2004, (B)(6) 2011.) AND ABORTION. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2015-TUBAL LIGATION, (B)(6) 2018 UNILATERAL SALPINGECTOMY, PARTIAL SUPRACERVICAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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 DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN (B)(6) 2012, SHE LEARNED SHE WAS SIX WEEKS PREGNANT. DISCREPANCY NOTED IN DATE(S) OF REMOVAL: (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION, THAT MY TUBES WERE BLOCKED AND EVERYTHING LOOKED GOOD.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER REPORTED 863668 IS INVALID. LOT NUMBER: 863568, MANUFACTURE DATE: 2011-05, EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-APR-2021: MR RECEIVED: REPORTER INFORMATION, PATIENT MIDDLE NAME WERE 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE:ONE COIL WAS LOST/LEFT COIL NOT FOUND / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OUTSIDE OF TUBE'), GENITAL HAEMORRHAGE ('BLEEDING') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 863668-INVALID,863568) 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 MULTIGRAVIDA, PARITY 3 (LIVE BIRTH ON (B)(6) 1999, ON (B)(6) 2004, ON (B)(6) 2011.) AND ABORTION. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN JULY 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (IN OCT-2015-TUBAL LIGATION, ON (B)(6) 2018 UNILATERAL SALPINGECTOMY, PARTIAL SUPRACERVICAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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 DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN MAY-2012, SHE LEARNED SHE WAS SIX WEEKS PREGNANT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER REPORTED 863668 IS INVALID. LOT NUMBER: 863568, MANUFACTURE DATE: 2011-05, EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ('MIGRATION OF THE ESSURE/MALPOSITION OF ESSURE DEVICE:ONE COIL WAS LOST/LEFT COIL NOT FOUND / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OUTSIDE OF TUBE'), GENITAL HAEMORRHAGE ('BLEEDING') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668-INVALID,863568) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANT". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (LIVE BIRTH -08JUL1999, 31JAN2004, 08SEP2011.) AND ABORTION. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (IN OCT-2015-TUBAL LIGATION, 05-NOV-2018 UNILATERAL SALPINGECTOMY, PARTIAL SUPRACERVICAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSMENORRHOEA, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 3. 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 DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: IN (B)(6) 2012, SHE LEARNED SHE WAS SIX WEEKS PREGNANT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. ULTRASOUND SCAN VAGINA - ON (B)(6) 2015: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. LOT NO ADDED. INCIDENT WE RECEIVED A LOT NUMBER SAMPLE 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE ESSURE"), GENITAL HAEMORRHAGE ("BLEEDING") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH TERMINATION 6 WEEKS GESTATIONAL AGE") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863668) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HEAVY PERIODS. IN 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), FATIGUE ("FATIGUE") AND DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (IN (B)(6) 2015,ONE COIL REMOVED AND TUBAL LIGATION). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, FATIGUE, MIGRAINE, HEADACHE AND DYSPAREUNIA OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE HAD NOT RESOLVED AND THE DYSMENORRHOEA HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED EVENTS ADDED FROM PFS- ABNORMAL BLEEDING VAGINAL AND MENORRHAGIA, PREGNANCY (TERMINATION), DYSMENORRHEA (CRAMPING), FATIGUE, MIGRAINES, HEADACHES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OUTSIDE, LOT NUMBER, HISTORICAL CONDITION, DEVICE INEFFECTIVE, CONCOMITANT DISEASE ADDED FROM PFS AND MR. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250264 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863668-INV,863568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | CONTRACEPTIVES NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |