ESSURE
Report
- Report Number
- 2951250-2017-00658
- Event Type
- Injury
- Date Received
- February 21, 2017
- Date of Event
- October 27, 2011
- Report Date
- July 31, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING"), PELVIC PAIN ("PAIN") AND UTERINE HAEMORRHAGE ("PROLONGED EXCESSIVE UTERINE BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED FEMALE CONDOM, MULTIPLE SCLEROSIS SINCE 2002, MIGRAINE SINCE 2000, DEPRESSION SINCE 2002, OBESITY, BLADDER INFECTION, DYSURIA, OVARIAN CYST, PELVIC ABSCESS, HYPERTENSION, PAP SMEAR ABNORMAL, PRURITUS, GASTROENTERITIS, CANDIDA VAGINAL AND URINE ODOUR ABNORMAL. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON (ZOFRAN) SINCE 2006 AND SUMATRIPTAN (IMITREX) SINCE 2006. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"). ON (B)(6) 2011, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION FUNGAL ("YEAST INFECTION-URINARY TRACT INFECTIONS") AND URINARY TRACT INFECTION ("RECURRENT UTIS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("SEVERE PAIN DURING HER MENSTRUAL CYCLE"). IN 2012, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTIONS"), MENORRHAGIA ("ABNORMAL/HEAVY MENSTRUAL BLEEDING / ABNORMAL BLEEDING: MENORRHAGIA"), BACK PAIN ("LOWER BACK PAIN"), PROCEDURAL PAIN ("POST-OPERATIVE RECOVERY") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), IBUPROFEN, SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION FUNGAL, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA AND PROCEDURAL PAIN WAS RESOLVING, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE URTICARIA AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, PROCEDURAL PAIN, URINARY TRACT INFECTION, URINARY TRACT INFECTION FUNGAL, URTICARIA, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. EVENT ¿RECURRENT UTIS¿ ADDED. 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 ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING"), UTERINE HAEMORRHAGE ("PROLONGED EXCESSIVE UTERINE BLEEDING") AND PELVIC PAIN ("PAIN") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED CONDOM, MULTIPLE SCLEROSIS SINCE 2002, MIGRAINE SINCE 2000, DEPRESSION SINCE 2002, OBESITY, BLADDER INFECTION, DYSURIA, OVARIAN CYST, PELVIC ABSCESS, HYPERTENSION, PAP SMEAR ABNORMAL, PRURITUS, GASTROENTERITIS, CANDIDA VAGINAL AND URINE ODOUR ABNORMAL. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON (ZOFRAN) SINCE 2006 AND SUMATRIPTAN (IMITREX) SINCE 2006. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"). ON (B)(6) 2011, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION FUNGAL ("YEAST INFECTION-URINARY TRACT INFECTIONS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE PAIN DURING HER MENSTRUAL CYCLE") AND PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2012, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTIONS"), MENORRHAGIA ("ABNORMAL/HEAVY MENSTRUAL BLEEDING / ABNORMAL BLEEDING: MENORRHAGIA"), BACK PAIN ("LOWER BACK PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), PROCEDURAL PAIN ("POST-OPERATIVE RECOVERY") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION FUNGAL, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA AND PROCEDURAL PAIN WAS RESOLVING, THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND PELVIC PAIN HAD RESOLVED AND THE URTICARIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, PROCEDURAL PAIN, URINARY TRACT INFECTION FUNGAL, URTICARIA, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.1 KG/SQM. HYSTEROSALPINGOGRAM - ON 19-JAN-2012: OCCLUSION OF FALLOPIAN TUBES MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PFS RECEIVED, REPORTER ADDED, PATIENT CONCOMITANT AND HISTORICAL CONDITION ADDED, CONCOMITANT AND HISTORICAL DRUG ADDED, LOT NUMBER RECEIVED, EVENTS ADDED AS :- VAGINAL HAEMORRHAGE, URTICARIA, PELVIA PAIN 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.
CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING"), PELVIC PAIN ("PAIN") AND UTERINE HAEMORRHAGE ("PROLONGED EXCESSIVE UTERINE BLEEDING") IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE AND BIRTH CONTROL PILLS. CONCURRENT CONDITIONS INCLUDED FEMALE CONDOM, MULTIPLE SCLEROSIS SINCE 2002, MIGRAINE SINCE 2000, DEPRESSION SINCE 2002, OBESITY, BLADDER INFECTION, DYSURIA, OVARIAN CYST, PELVIC ABSCESS, HYPERTENSION, PAP SMEAR ABNORMAL, PRURITUS, GASTROENTERITIS, CANDIDA VAGINAL AND URINE ODOUR ABNORMAL. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON (ZOFRAN) SINCE 2006 AND SUMATRIPTAN (IMITREX) SINCE 2006. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE"). ON (B)(6) 2011, 24 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URTICARIA ("HIVES"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION FUNGAL ("YEAST INFECTION-URINARY TRACT INFECTIONS") AND URINARY TRACT INFECTION ("RECURRENT UTIS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("SEVERE PAIN DURING HER MENSTRUAL CYCLE"). IN 2012, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN") AND ALOPECIA ("HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTIONS"), MENORRHAGIA ("ABNORMAL/HEAVY MENSTRUAL BLEEDING / ABNORMAL BLEEDING: MENORRHAGIA"), BACK PAIN ("LOWER BACK PAIN"), PROCEDURAL PAIN ("POST-OPERATIVE RECOVERY") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), IBUPROFEN, SURGERY (HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION FUNGAL, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA AND PROCEDURAL PAIN WAS RESOLVING, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE URTICARIA AND URINARY TRACT INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN, PROCEDURAL PAIN, URINARY TRACT INFECTION, URINARY TRACT INFECTION FUNGAL, URTICARIA, UTERINE HAEMORRHAGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 32.1 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: OCCLUSION OF FALLOPIAN TUBES QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER TOR THIS CASE. WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDR LL..T CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-MAR-2017: QUALITY-SAFETY EVALUATION RECEIVED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED ABDOMINAL CRAMPING AND PROLONGED EXCESSIVE UTERINE BLEEDING. A SURGERY WAS PERFORMED TO REMOVE MICRO-INSERTS 5 YEARS AFTER INSERTION. BOTH SERIOUS EVENTS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. ALSO, GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS PRESENT CASE, AFTER THE IMPLANT PROCEDURE CONSUMER PRESENTED THE EVENTS. GIVEN THEIR NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("ABDOMINAL CRAMPING") AND UTERINE HAEMORRHAGE ("PROLONGED EXCESSIVE UTERINE BLEEDING") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL INFECTION ("VAGINAL INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS"), MENORRHAGIA ("ABNORMAL/HEAVY MENSTRUAL BLEEDING"), DYSMENORRHOEA ("SEVERE PAIN DURING HER MENSTRUAL CYCLE"), BACK PAIN ("LOWER BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND PROCEDURAL PAIN ("POST-OPERATIVE RECOVERY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2016). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA AND PROCEDURAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION, MENORRHAGIA, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, WEIGHT INCREASED, ALOPECIA AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON (B)(6) 2012: HYSTEROSALPINGOGRAM RESULT WAS OCCLUSION OF FALLOPIAN TUBES. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHE PRESENTED ABDOMINAL CRAMPING AND PROLONGED EXCESSIVE UTERINE BLEEDING. A SURGERY WAS PERFORMED TO REMOVE MICRO-INSERTS 5 YEARS AFTER INSERTION. BOTH SERIOUS EVENTS DUE TO MEDICAL IMPORTANCE AND ANTICIPATED IN ESSURE'S REFERENCE SAFETY INFORMATION. AFTER ESSURE INSERTION, PELVIC, ABDOMINAL AND UNCHARACTERIZED PAIN MAY OCCUR. ALSO, GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS PRESENT CASE, AFTER THE IMPLANT PROCEDURE CONSUMER PRESENTED THE EVENTS. GIVEN THEIR NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS HAS BEEN SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128136 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other| R | IMITREX| IMITREX| IMITREX| ZOFRAN| ZOFRAN| ZOFRAN |