ESSURE
Report
- Report Number
- 2951250-2017-05659
- Event Type
- Injury
- Date Received
- October 28, 2017
- Date of Event
- October 3, 2014
- Report Date
- September 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE / DISAPPEARANCE OF ESSURE/ UNKNOWN LOCATION OF LEFT COIL / MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893681) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UMBILICAL HERNIA IN 2014, BROKEN FOOT, MULTIGRAVIDA, PARITY 3 ((B)(6) 2008; (B)(6) 2013; (B)(6) 2013), PREMATURE BABY (BORN WITH CEREBRAL PALSY) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DEPRESSION, ANXIETY AND BIPOLAR DISORDER. CONCOMITANT PRODUCTS INCLUDED BENZODIAZEPINE DERIVATIVES, DIAMORPHINE (HEROIN), FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 2016 TO 2017 AND TRAZODONE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2014, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2014-LAPAROSCOPY WITH LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, WEIGHT INCREASED, DYSPAREUNIA, MIGRAINE, VULVOVAGINAL PAIN, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.3 KG/SQM. ON (B)(6) 2014, HYSTEROSALPINGOGRAM TEST SHOWED, TUBAL OCCLUSION ON RIGHT WITH CORRECT COIL POSITION, HOWEVER. PATENT LEFT TUBE WITH COIL DISPLACED TO RIGHT SIDE. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). ON (B)(6) 2016, SURGICAL PATHOLOGY SHOWED, LEFT FALLOPIAN TUBE: FALLOPIAN TUBE, BENIGN WITHOUT SPECIFIC DIAGNOSTIC ABNORMALITIES EDEMATOUS APPEARING, TAN-PINK FALLOPIAN TUBE WITH ATTACHED FIMBRIATED END, MEASURING 1.3 X 2.4 CM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAY-2018: PFS RECEIVED: LOT NUMBER,OTHER RELEVANT HISTORY, LAB DATA, PRODUCT INFORMATION, EVENTS- UTI, BACTERIAL VAGINOSIS, DYSMENORRHEA (CRAMPING) WERE ADDED. ON 15-MAY-2018: AFTER ROUTINE QUALITY MONITORING, THE EVENT "MIGRATION/PERFORATION OF ESSURE COIL" WAS MERGED WITH THE DEVICE DISLOCATION INTO ABDOMINAL CAVITY ("DISAPPEARANCE OF ESSURE/ UNKNOWN LOCATION OF LEFT COIL / MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL"). 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 DEVICE DISLOCATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE / DISAPPEARANCE OF ESSURE/ UNKNOWN LOCATION OF LEFT COIL / MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893681(INVALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UMBILICAL HERNIA IN 2014, BROKEN FOOT, MULTIGRAVIDA, PARITY 3 (B)(6) 2008; (B)(6) 2013; (B)(6) 2013), PREMATURE BABY (BORN WITH CEREBRAL PALSY) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DEPRESSION, ANXIETY AND BIPOLAR DISORDER. CONCOMITANT PRODUCTS INCLUDED BENZODIAZEPINE DERIVATIVES, DIAMORPHINE (HEROIN), FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 2016 TO 2017 AND TRAZODONE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2014, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). THE PATIENT WAS TREATED WITH SURGERY (B)(6) 2014-LAPAROSCOPY WITH LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, WEIGHT INCREASED, DYSPAREUNIA, MIGRAINE, VULVOVAGINAL PAIN, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.3 KG/SQM. ON (B)(6) 2014, HYSTEROSALPINGOGRAM TEST SHOWED, TUBAL OCCLUSION ON RIGHT WITH CORRECT COIL POSITION, HOWEVER. PATENT LEFT TUBE WITH COIL DISPLACED TO RIGHT SIDE. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). ON (B)(6) 2016, SURGICAL PATHOLOGY SHOWED, LEFT FALLOPIAN TUBE: FALLOPIAN TUBE, BENIGN WITHOUT SPECIFIC DIAGNOSTIC ABNORMALITIES EDEMATOUS APPEARING, TAN-PINK FALLOPIAN TUBE WITH ATTACHED FIMBRIATED END, MEASURING 1.3 X 2.4 CM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. UPDATE OF INFORMATION (BATCH IS INVALID). FU PTC DECLINED BY QA (NO VALID BATCH, NO NEW PTC INFORMATION) 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE / DISAPPEARANCE OF ESSURE/ UNKNOWN LOCATION OF LEFT COIL / MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893681(INVALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UMBILICAL HERNIA IN 2014, BROKEN FOOT, MULTIGRAVIDA, PARITY 3 ((B)(6) 2008; (B)(6) 2013; (B)(6) 2013), PREMATURE BABY (BORN WITH CEREBRAL PALSY) AND C-SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DEPRESSION, ANXIETY AND BIPOLAR DISORDER. CONCOMITANT PRODUCTS INCLUDED BENZODIAZEPINE DERIVATIVES, DIAMORPHINE (HEROIN), FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 2016 TO 2017 AND TRAZODONE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2014, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN") AND BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2014-LAPAROSCOPY WITH LEFT SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, WEIGHT INCREASED, DYSPAREUNIA, MIGRAINE, VULVOVAGINAL PAIN, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.3 KG/SQM. ON (B)(6) 2014, HYSTEROSALPINGOGRAM TEST SHOWED, TUBAL OCCLUSION ON RIGHT WITH CORRECT COIL POSITION, HOWEVER. PATENT LEFT TUBE WITH COIL DISPLACED TO RIGHT SIDE. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). ON (B)(6) 2016, SURGICAL PATHOLOGY SHOWED, LEFT FALLOPIAN TUBE: FALLOPIAN TUBE, BENIGN WITHOUT SPECIFIC DIAGNOSTIC ABNORMALITIES EDEMATOUS APPEARING, TAN-PINK FALLOPIAN TUBE WITH ATTACHED FIMBRIATED END, MEASURING 1.3 X 2.4 CM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-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 PERFORATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL / DISAPPEARANCE OF ESSURE DEVICE/ UNKNOWN LOCATION OF LEFT COIL") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED UMBILICAL HERNIA IN 2014, BROKEN FOOT, GRAVIDA II, PARITY 3 ((B)(6) 2008; (B)(6) 2013; (B)(6) 2013), PREMATURE BABY AND CEREBRAL PALSY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND HEMOSTASIS. CONCOMITANT PRODUCTS INCLUDED BENZODIAZEPINE DERIVATIVES, DIAMORPHINE (HEROIN), FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 2016 TO 2017 AND TRAZODONE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA") AND MIGRAINE ("MIGRAINES"). ON (B)(6) 2014, 4 MONTHS 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2014 PELVIC SUGERY DONE TO TRY AND ALLEVIATE THE SYMPTOMS) AND SURGERY (UNILATERAL SALPINGECTOMY - LEFT SALPINGECTOMY; SURGICAL REMOVAL OF COIL). AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, WEIGHT INCREASED, DYSPAREUNIA, MIGRAINE AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, PERFORATION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.3 KG/SQM. ON (B)(6) 2014, HYSTEROSALPINGOGRAM TEST SHOWED, TUBAL OCCLUSION ON RIGHT WITH CORRECT COIL POSITION, HOWEVER. PATENT LEFT TUBE WITH COIL DISPLACED TO RIGHT SIDE. UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). ON (B)(6) 2016, SURGICAL PATHOLOGY SHOWED, LEFT FALLOPIAN TUBE: FALLOPIAN TUBE, BENIGN WITHOUT SPECIFIC DIAGNOSTIC ABNORMALITIES EDEMATOUS APPEARING, TAN-PINK FALLOPIAN TUBE WITH ATTACHED FIMBRIATED END, MEASURING 1.3 X 2.4 CM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-2018: PFS RECEIVED - NEW EVENTS, "MIGRATION OF ESSURE DEVICE WITH COIL DISPLACED TO RIGHT SIDE/ REMOVAL OF LEFT ESSURE FROM RIGHT PELVIC SIDEWALL/ DISAPPEARANCE OF ESSURE DEVICE/ UNKNOWN LOCATION OF LEFT COIL AND VAGINAL PAIN" WERE ADDED. NEW REPORTER WERE ADDED. HISTORICAL AND CONCOMITANT CONDITIONS AND TREATMENT MEDICATION WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("CHRONIC PELVIC PAIN"), WEIGHT INCREASED ("WEIGHT GAIN"), DYSPAREUNIA ("DYSPAREUNIA") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2014 PELVIC SURGERY DONE TO TRY AND ALLEVIATE THE SYMPTOMS). AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, PELVIC PAIN, WEIGHT INCREASED, DYSPAREUNIA AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, GENITAL HAEMORRHAGE, MIGRAINE, PELVIC PAIN, PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT 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 |
|---|---|---|---|---|---|---|---|
| 765496 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893681(INVALID) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | BENZODIAZEPINE DERIVATIVES| BENZODIAZEPINE DERIVATIVES| BENZODIAZEPINE DERIVATIVES| BENZODIAZEPINE DERIVATIVES| HEROIN| HEROIN| HEROIN| HEROIN| PROZAC| PROZAC| PROZAC| PROZAC| TRAZODONE| TRAZODONE| TRAZODONE| TRAZODONE |