ESSURE
Report
- Report Number
- 2951250-2017-08071
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 1, 2014
- Report Date
- April 29, 2020
- 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
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114, 862114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 1. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, METAPLASIA AND ENDOMETRIOSIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, BACTERIAL VAGINOSIS, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS AND MR RECEIVED: NEW REPORTERS, PATIENT DEMOGRAPHIC INFORMATION, PRODUCT INDICATION, ONSET AND REMOVAL DATES UPDATED, LOT NO, TREATMENT MEDICATIONS, NEW EVENTS MENORRHAGIA, VAGINAL HAEMORRHAGE, BACTERIAL VAGINOSIS, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT DECREASED ADDED. OUTCOME FOR THE EVENT PELVIC PAIN UPDATED TO NOT RECOVERED / NOT 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114, 862114-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 1. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, SQUAMOUS CELL METAPLASIA AND ENDOMETRIOSIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, BACTERIAL VAGINOSIS, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM - ON 3-OCT-2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSPAREUNIA. LOT NUMBER: 952114 MAN DATE: 2012-02 EXP DATE: 2015-02 LOT NUMBER: 862114 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114, 862114-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 1. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, SQUAMOUS CELL METAPLASIA AND ENDOMETRIOSIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE, BACTERIAL VAGINOSIS, NAUSEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSPAREUNIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 PELVIC PAIN ("PAIN/ LEFT SIDE PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114, 862114-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 1. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, SQUAMOUS CELL METAPLASIA AND ENDOMETRIOSIS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"). IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, NAUSEA, FATIGUE AND WEIGHT DECREASED HAD RESOLVED. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSPAREUNIA. LOT NUMBER: 952114 MAN DATE: 2012-02 EXP DATE: 2015-02. LOT NUMBER: 862114 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT OUTCOME OF PELVIC PAIN WAS UPDATED TO RECOVERING FROM NOT RECOVERED AND EVENT NAUSEA, BACTERIAL VAGINOSIS, FATIGUE AND WEIGHT LOSS UPDATED TO RECOVERED FROM UNKNOWN. 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 PELVIC PAIN ('PAIN/ LEFT SIDE PELVIC PAIN/CONSTANT PAIN') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 952114, 862114-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1, UNINTENDED PREGNANCY, CESAREAN SECTION AND VOMITING. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, SQUAMOUS CELL METAPLASIA, ENDOMETRIOSIS AND NAUSEA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL; ETONOGESTREL (NUVARING) IN 2016, HYDROCODONE BITARTRATE; PARACETAMOL (VICODIN), IBUPROFEN (MOTRIN), MESTRANOL; NORETHISTERONE (NECON) IN 2012 AND ORAL CONTRACEPTIVE NOS FROM 2005 TO 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE"), CERVICITIS ("INFECTION (OTHER) DESCRIBE: CERVICITIS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN/LOSS(SPECIFY WHICH ONE) LOSS 25 LBS"). IN 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BENIGN ENDOMETRIOSIS"), 4 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND UTERINE POLYP ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BENIGN ENDOMETRIAL POLYP"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, CERVICITIS, DEPRESSION, ANXIETY, UTERINE POLYP, DYSMENORRHOEA AND ENDOMETRIOSIS OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, NAUSEA, FATIGUE AND WEIGHT DECREASED HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, BACTERIAL VAGINOSIS, CERVICITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSPAREUNIA. LOT NUMBER: 952114, MAN DATE: 2012-02 ,EXP DATE: 2015-02, LOT NUMBER: 862114, IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT, MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-DEC-2019: PFS AND SOCIAL MEDIA RECEIVED. NEW EVENTS CERVICITIS, DEPRESSION/ ANXIETY, BENIGN ENDOMETRIAL POLYP, DYSMENORRHEA (CRAMPING), BENIGN ENDOMETRIOSIS WERE ADDED. INCIDENT: 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/ LEFT SIDE PELVIC PAIN/CONSTANT PAIN') IN A 25-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114, 862114-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1, UNINTENDED PREGNANCY, CESAREAN SECTION AND VOMITING. CONCURRENT CONDITIONS INCLUDED UNDERWEIGHT, OVARIAN CYST, DYSMENORRHEA, ENDOMETRIAL POLYP, ADENOMYOSIS, CHRONIC CERVICITIS, SQUAMOUS CELL METAPLASIA, ENDOMETRIOSIS AND NAUSEA. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) IN 2016, HYDROCODONE BITARTRATE;PARACETAMOL (VICODIN), IBUPROFEN (MOTRIN), MESTRANOL;NORETHISTERONE (NECON) IN 2012 AND ORAL CONTRACEPTIVE NOS FROM 2005 TO 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: I HAD MULTIPLE BACTERIAL VAGINOSIS INFECTIONS"). IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), NAUSEA ("NAUSEA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CERVICITIS ("INFECTION (OTHER) DESCRIBE: CERVICITIS") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN/LOSS(SPECIFY WHICH ONE) LOSS 25 LBS"). IN 2014, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2016, THE PATIENT EXPERIENCED ENDOMETRIOSIS ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BENIGN ENDOMETRIOSIS"), 4 YEARS 4 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION:ANXIETY"), UTERINE POLYP ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: BENIGN ENDOMETRIAL POLYP") AND UNEVALUABLE EVENT ("I STILL GET FLUTTER"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE MENORRHAGIA, VAGINAL HAEMORRHAGE, DYSPAREUNIA, VAGINAL DISCHARGE, CERVICITIS, DEPRESSION, ANXIETY, UTERINE POLYP, DYSMENORRHOEA, ENDOMETRIOSIS AND UNEVALUABLE EVENT OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, NAUSEA, FATIGUE AND WEIGHT DECREASED HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, BACTERIAL VAGINOSIS, CERVICITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, UNEVALUABLE EVENT, UTERINE POLYP, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 4 COILS AND 2 COILS WERE VISIBLE RESPECTIVELY AT THE LEFT AND RIGHT EXTERNAL OS OF THE FALLOPIAN TUBE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 17.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA: NEW REPORTER AND EVENT I STILL GET FLUTTER ADDED. 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834727 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952114, 862114-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other| R | MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| NECON [MESTRANOL,NORETHISTERONE]| NECON [MESTRANOL,NORETHISTERONE]| NUVARING| NUVARING| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| VICODIN| VICODIN| VICODIN| VICODIN |