ESSURE
Report
- Report Number
- 2951250-2019-01012
- Event Type
- Injury
- Date Received
- March 5, 2019
- Report Date
- July 22, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC ABSCESS ('ABSCESS'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING / ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366, 855624) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, GROIN PAIN, HEMATURIA, OVARIAN CYST, GRAVIDA II, PARITY 2, UTERINE BLEEDING, PAINFUL PERIODS, BLEEDING MENSTRUAL HEAVY, VAGINAL BLEEDING AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC ABSCESS (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC- ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC ABSCESS, PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ALOPECIA, MIGRAINE, ABDOMINAL DISTENSION, WEIGHT INCREASED, PAIN IN EXTREMITY, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PAIN IN EXTREMITY, PELVIC ABSCESS, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. DISCREPANCY NOTED IN INSERTION AND IMPLANT DATE: (B)(6) 2014 AND (B)(6) 2017. MORE THAN ONE SURGERIES PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: QUESTION OF MILD ADENOMYOCLIS. THE FALLOPIAN TUBES APPEAR OBSTRUCTED BY THE MICROINSCRTS. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO COMPLICATION.. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, UTERINE LEIOMYOMA. LOT NUMBER:822366, MANUFACTURE DATE: 2011-01, EXPIRATION DATE: 2014-01. LOT NUMBER:855624, MANUFACTURE DATE:2011-04, EXPIRATION DATE: 2014-04. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 PELVIC ABSCESS ('ABSCESS'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING / ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366, 855624) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, GROIN PAIN, HEMATURIA, OVARIAN CYST, GRAVIDA II, PARITY 2, UTERINE BLEEDING, PAINFUL PERIODS, BLEEDING MENSTRUAL HEAVY, VAGINAL BLEEDING AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC ABSCESS (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC- ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC ABSCESS, PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ALOPECIA, MIGRAINE, ABDOMINAL DISTENSION, WEIGHT INCREASED, PAIN IN EXTREMITY, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PAIN IN EXTREMITY, PELVIC ABSCESS, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. DISCREPANCY NOTED IN INSERTION AND IMPLANT DATE: (B)(6) 2014 AND (B)(6) 2017. MORE THAN ONE SURGERIES PERFORMED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: QUESTION OF MILD ADENOMYOCLIS. THE FALLOPIAN TUBES APPEAR OBSTRUCTED BY THE MICROINSCRTS. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO COMPLICATION. PREGNANCY TEST ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, UTERINE LEIOMYOMA. LOT NUMBER:822366, MANUFACTURE DATE: 2011-01, & EXPIRATION DATE: 2014-01 . LOT NUMBER:855624, MANUFACTURE DATE:2011-04, & EXPIRATION DATE: 2014-04 . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PIF RECEIVED: NEW EVENT ABSCESS ADDED. REPORTER DETAILS 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 PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING / ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366, 855624) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, GROIN PAIN, HEMATURIA, OVARIAN CYST, GRAVIDA II, PARITY 2, UTERINE BLEEDING, PAINFUL PERIODS, BLEEDING MENSTRUAL HEAVY, VAGINAL BLEEDING AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC- ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ALOPECIA, MIGRAINE, ABDOMINAL DISTENSION, WEIGHT INCREASED, PAIN IN EXTREMITY, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INTRODUCER WAS RETRACTED AND APPROXIAMTELY 2 COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2012: QUESTION OF MILD ADENOMYOCLIS. THE FALLOPIAN TUBES APPEAR OBSTRUCTED BY THE MICROINSCRTS. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO COMPLICATION.. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, UTERINE LEIOMYOMA. LOT NUMBER:822366 MANUFACTURE DATE: 2011-01 EXPIRATION DATE: 2014-01 LOT NUMBER:855624 MANUFACTURE DATE:2011-04 EXPIRATION DATE: 2014-04 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT~ MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-APR-2019: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINTS). 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 PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING/ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366, 855624) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, GROIN PAIN, HEMATURIA, OVARIAN CYST, GRAVIDA II, PARITY 2, UTERINE BLEEDING, PAINFUL PERIODS, BLEEDING MENSTRUAL HEAVY, VAGINAL BLEEDING AND UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINES"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING"), PAIN IN EXTREMITY ("LEG PAIN") AND BACK PAIN ("BACK PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC- ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, ALOPECIA, MIGRAINE, ABDOMINAL DISTENSION, WEIGHT INCREASED, PAIN IN EXTREMITY, BACK PAIN AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE INTRODUCER WAS RETRACTED AND APPROXIMATELY 2 COILS WERE VISUALIZED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: QUESTION OF MILD ADENOMYOSIS. THE FALLOPIAN TUBES APPEAR OBSTRUCTED BY THE MICROINSCRTS. THE PATIENT TOLERATED THE PROCEDURE VERY WELL. NO COMPLICATION. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRM IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, UTERINE LEIOMYOMA. 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 |
|---|---|---|---|---|---|---|---|
| 182712 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822366, 855624 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA |