ESSURE
Report
- Report Number
- 2951250-2018-01296
- Event Type
- Injury
- Date Received
- March 28, 2018
- Date of Event
- August 1, 2012
- Report Date
- August 16, 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
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / ABNORMAL BLEEDING (GENERAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE DIFFICULT TO USE "SCAR TISSUE UNABLE TO REMOVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED CHOLECALCIFEROL (VITAMIN D) FOR FATIGUE, ANTIBIOTICS FOR GENITAL HEMORRHAGE, VAGINAL BLEEDING, MENORRHAGIA AND VAGINAL DISCHARGE AND PANADIENE CO (TYLENOL #3) FOR HEADACHE, MIGRAINE AND MENSTRUAL CRAMPS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("PAIN IN LOWER LEFT ABDOMINAL AREA"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) / DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES: HOT FLASHES"), HIRSUTISM ("FACIAL HAIR / EXCESSIVE FACIAL HAIR"), MOOD ALTERED ("MOOD CHANGES") AND INTERVERTEBRAL DISC PROTRUSION ("FEELS LIKE A BULGE ON THE INSIDE"). IN JANUARY 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION / TAKES OVER AN HOUR TO ELIMINATE FECES"), ALOPECIA ("HAIR LOSS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: CRAMPS"), HEADACHE ("HEADACHES"), NECK MASS ("RASHES OR SKIN CONDITIONS: KNOTS IN NECK AREA") AND SKIN DISCOLOURATION ("BROWN PATCHES ON FACE"). IN AUGUST 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PAIN"), BACK PAIN ("LOWER LEFT BACK PAIN"), ADNEXA UTERI PAIN ("PAIN IN OVARIAN AREA") AND SCAR ("SCAR TISSUE: UNABLE TO REMOVE"). THE PATIENT WAS TREATED WITH ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, CURCUMA LONGA (TUMERIC), IBUPROFEN, TOCOPHEROL (VITAMIN E), SURGERY (ABLATION), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN LOWER, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ADNEXA UTERI PAIN, VAGINAL DISCHARGE, FATIGUE, CONSTIPATION, ALOPECIA, SCAR, ABDOMINAL DISTENSION, GASTROINTESTINAL PAIN, HOT FLUSH, HIRSUTISM, MOOD ALTERED, HEADACHE, NECK MASS, SKIN DISCOLOURATION AND INTERVERTEBRAL DISC PROTRUSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HIRSUTISM, HOT FLUSH, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NECK MASS, PELVIC PAIN, SCAR, SKIN DISCOLOURATION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCAR TISSUE MAKES IT UNREMOVABLE AN 8-MINUTE BURN CYCLE WAS ACCOMPLISHED. DIAGNOSTIC RESULTS: CT SCAN WAS DONE DUE TO EXTREME PAIN MY OVARIAN AREA, SCAR TISSUE MAKES IT UNREMOVABLE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / ABNORMAL BLEEDING (GENERAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE DIFFICULT TO USE "SCAR TISSUE UNABLE TO REMOVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D) FOR FATIGUE, ANTIBIOTICS FOR GENITAL HEMORRHAGE, VAGINAL BLEEDING, MENORRHAGIA AND VAGINAL DISCHARGE AND PANADEINE CO (TYLENOL #3) FOR HEADACHE, MIGRAINE AND MENSTRUAL CRAMPS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("PAIN IN LOWER LEFT ABDOMINAL AREA"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) / DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES: HOT FLASHES"), HIRSUTISM ("FACIAL HAIR / EXCESSIVE FACIAL HAIR"), MOOD ALTERED ("MOOD CHANGES") AND INTERVERTEBRAL DISC PROTRUSION ("FEELS LIKE A BULGE ON THE INSIDE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION / TAKES OVER AN HOUR TO ELIMINATE FECES"), ALOPECIA ("HAIR LOSS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: CRAMPS"), HEADACHE ("HEADACHES"), NECK MASS ("RASHES OR SKIN CONDITIONS: KNOTS IN NECK AREA") AND SKIN DISCOLOURATION ("BROWN PATCHES ON FACE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PAIN"), BACK PAIN ("LOWER LEFT BACK PAIN"), ADNEXA UTERI PAIN ("PAIN IN OVARIAN AREA") AND SCAR ("SCAR TISSUE: UNABLE TO REMOVE"). THE PATIENT WAS TREATED WITH ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, CURCUMA LONGA (TUMERIC), IBUPROFEN, TOCOPHEROL (VITAMIN E), SURGERY (ABLATION), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN LOWER, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ADNEXA UTERI PAIN, VAGINAL DISCHARGE, FATIGUE, CONSTIPATION, ALOPECIA, SCAR, ABDOMINAL DISTENSION, GASTROINTESTINAL PAIN, HOT FLUSH, HIRSUTISM, MOOD ALTERED, HEADACHE, NECK MASS, SKIN DISCOLOURATION AND INTERVERTEBRAL DISC PROTRUSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HIRSUTISM, HOT FLUSH, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NECK MASS, PELVIC PAIN, SCAR, SKIN DISCOLOURATION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCAR TISSUE MAKES IT UNREMOVABLE AN 8-MINUTE BURN CYCLE WAS ACCOMPLISHED. DIAGNOSTIC RESULTS: CT SCAN WAS DONE DUE TO EXTREME PAIN MY OVARIAN AREA, SCAR TISSUE MAKES IT UNREMOVABLE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2018: CODING CORRECTION: EVENT WAS CODED AGAIN ACCORDING TO REPORTED DESCRIPTION AND CONCEPT WAS CLARIFIED. 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 GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) / ABNORMAL BLEEDING (GENERAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA) / ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" AND DEVICE DIFFICULT TO USE "SCAR TISSUE UNABLE TO REMOVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED COLECALCIFEROL (VITAMIN D) FOR FATIGUE, ANTIBIOTICS FOR GENITAL HEMORRHAGE, VAGINAL BLEEDING, MENORRHAGIA AND VAGINAL DISCHARGE AND PANADEINE CO (TYLENOL #3) FOR HEADACHE, MIGRAINE AND MENSTRUAL CRAMPS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("PAIN IN LOWER LEFT ABDOMINAL AREA"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / URINARY PROBLEMS"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES / BLADDER PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING) / DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE"), HOT FLUSH ("HORMONAL CHANGES: HOT FLASHES"), HIRSUTISM ("FACIAL HAIR / EXCESSIVE FACIAL HAIR"), MOOD ALTERED ("MOOD CHANGES") AND INTERVERTEBRAL DISC PROTRUSION ("FEELS LIKE A BULGE ON THE INSIDE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), CONSTIPATION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION / TAKES OVER AN HOUR TO ELIMINATE FECES"), ALOPECIA ("HAIR LOSS"), ABDOMINAL DISTENSION ("BLOATING"), GASTROINTESTINAL PAIN ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: CRAMPS"), HEADACHE ("HEADACHES"), NECK MASS ("RASHES OR SKIN CONDITIONS: KNOTS IN NECK AREA") AND SKIN DISCOLOURATION ("BROWN PATCHES ON FACE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN / PAIN"), BACK PAIN ("LOWER LEFT BACK PAIN"), ADNEXA UTERI PAIN ("PAIN IN OVARIAN AREA") AND SCAR ("SCAR TISSUE: UNABLE TO REMOVE"). THE PATIENT WAS TREATED WITH ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, CURCUMA LONGA (TUMERIC), IBUPROFEN, TOCOPHEROL (VITAMIN E), SURGERY (ABLATION), SURGERY (ABLATION) AND SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN LOWER, FEMALE SEXUAL DYSFUNCTION, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ADNEXA UTERI PAIN, VAGINAL DISCHARGE, FATIGUE, CONSTIPATION, ALOPECIA, SCAR, ABDOMINAL DISTENSION, GASTROINTESTINAL PAIN, HOT FLUSH, HIRSUTISM, MOOD ALTERED, HEADACHE, NECK MASS, SKIN DISCOLOURATION AND INTERVERTEBRAL DISC PROTRUSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ADNEXA UTERI PAIN, ALOPECIA, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL PAIN, GENITAL HAEMORRHAGE, HEADACHE, HIRSUTISM, HOT FLUSH, INTERVERTEBRAL DISC PROTRUSION, MENORRHAGIA, MIGRAINE, MOOD ALTERED, NAUSEA, NECK MASS, PELVIC PAIN, SCAR, SKIN DISCOLOURATION, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCAR TISSUE MAKES IT UNREMOVABLE AN 8-MINUTE BURN CYCLE WAS ACCOMPLISHED. DIAGNOSTIC RESULTS: CT SCAN WAS DONE DUE TO EXTREME PAIN MY OVARIAN AREA, SCAR TISSUE MAKES IT UNREMOVABLE. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-JUN-2018: CODING CORRECTION: FOLLOWING COMPANY INTERNAL CODING REVIEW, THE EVENT FACIAL HAIR / EXCESSIVE FACIAL HAIR WAS CODED TO MEDDRA LLT HIRSUTISM 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 GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 844600) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "SCAR TISSUE UNABLE TO REMOVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSFUNCTIONAL UTERINE BLEEDING. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), RASH ("RASHES OR SKIN CONDITIONS"), SKIN DISORDER ("RASHES OR SKIN CONDITIONS"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ADNEXA UTERI PAIN ("PAIN IN OVARIAN AREA"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), ALOPECIA ("HAIR LOSS") AND SCAR ("SCAR TISSUE: UNABLE TO REMOVE"). THE PATIENT WAS TREATED WITH ANTIINFLAMMATORY/ANTIRHEUMATIC PRODUCTS, CURCUMA LONGA (TUMERIC), IBUPROFEN AND SURGERY (ABLATION). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, PELVIC PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, RASH, SKIN DISORDER, URINARY TRACT DISORDER, BLADDER DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, ADNEXA UTERI PAIN, VAGINAL DISCHARGE, FATIGUE, GASTROINTESTINAL DISORDER, ALOPECIA AND SCAR OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ALOPECIA, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, SCAR, SKIN DISORDER, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SCAR TISSUE; UNABLE TO REMOVE FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. 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 |
|---|---|---|---|---|---|---|---|
| 222101 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 844600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | ANTIBIOTICS| TYLENOL #3| VITAMIN D |