ESSURE
Report
- Report Number
- 2951250-2017-05310
- Event Type
- Injury
- Date Received
- October 23, 2017
- Date of Event
- January 1, 2012
- Report Date
- January 8, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BACK PAIN, NAUSEA, INGUINAL HERNIA, DIZZINESS, VOMITING, UTERINE SCAR AND SKIN IRRITATION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE 2012 AND HYDROCORTISONE SINCE 2012. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ECZEMA ("ECZEMA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ECZEMA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2012: THE ESSURE DEVICE WAS THEN PLACED IN THE LEFT TUBAL OSTIA AND DEPLOYED WITHOUT DIFFICULTY. THREE COILS REMAINED WITHIN THE UTERINE CAVITY. THE RIGHT TUBE WAS THEN CANNULATED AND THE ESSURE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY. SIX COILS REMAINED WITHIN THE UTERINE CAVITY ON THIS SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 65.76 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: BLOCKED TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-APR-2018: PFS+MR RECEIVED: NEW EVENTS: MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ECZEMA WERE ADDED. REPORTER, PATIENT DEMOGRAPHIC INFORMATION UPDATED. ALL OTHER RELEVANT HISTORY, PRODUCT LOT NUMBER 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: DISTAL END OF FALLOPIAN TUBE"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BACK PAIN, NAUSEA, INGUINAL HERNIA, DIZZINESS, VOMITING, UTERINE SCAR AND SKIN IRRITATION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE 2012, HYDROCORTISONE SINCE 2012 AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM JANUARY 2012 TO APRIL 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECZEMA ("RASHES OR SKIN CONDITIONS TYPE:ECZEMA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), SKIN IRRITATION ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN IRRITATION SKIN IRRITATION"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION DEPRESSION"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG,"), ALLERGY TO METALS ("NICKEL ALLERGY") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,") AND MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:FORGETFULNESS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, SKIN IRRITATION, VAGINAL INFECTION, DEPRESSION, FEELING ABNORMAL, MEMORY IMPAIRMENT, ALLERGY TO METALS AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ECZEMA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SKIN IRRITATION, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 12JAN2012: THE ESSURE DEVICE WAS THEN PLACED IN THE LEFT TUBAL OSTIA AND DEPLOYED WITHOUT DIFFICULTY. THREE COILS REMAINED WITHIN THE UTERINE CAVITY. THE RIGHT TUBE WAS THEN CANNULATED AND THE ESSURE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY. SIX COILS REMAINED WITHIN THE UTERINE CAVITY ON THIS SIDE. DISCREPANT INFORMATION-ESSURE REMOVAL: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED?, NO. IF YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL?, NO . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.2 KG/SQM. HYSTEROSALPINGOGRAM - ON 17-FEB-2016: RESULTS: TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BACK PAIN, NAUSEA, INGUINAL HERNIA, DIZZINESS, VOMITING, UTERINE SCAR AND SKIN IRRITATION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE 2012 AND HYDROCORTISONE SINCE 2012. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), ECZEMA ("ECZEMA"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE ECZEMA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, VAGINAL DISCHARGE, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2012: THE ESSURE DEVICE WAS THEN PLACED IN THE LEFT TUBAL OSTIA AND DEPLOYED WITHOUT DIFFICULTY. THREE COILS REMAINED WITHIN THE UTERINE CAVITY. THE RIGHT TUBE WAS THEN CANNULATED AND THE ESSURE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY. SIX COILS REMAINED WITHIN THE UTERINE CAVITY ON THIS SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 65.76 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: BLOCKED TUBES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2018: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT) UPDATE. 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 DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: DISTAL END OF FALLOPIAN TUBE"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BACK PAIN, NAUSEA, INGUINAL HERNIA, DIZZINESS, VOMITING, UTERINE SCAR AND SKIN IRRITATION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE 2012, HYDROCORTISONE SINCE 2012 AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6)2012 TO (B)(6)2012. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECZEMA ("RASHES OR SKIN CONDITIONS TYPE:ECZEMA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), SKIN IRRITATION ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN IRRITATION SKIN IRRITATION"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG,"), ALLERGY TO METALS ("NICKEL ALLERGY") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES,"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,") AND MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:FORGETFULNESS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, MENORRHAGIA, SKIN IRRITATION, VAGINAL INFECTION, DEPRESSION, FEELING ABNORMAL, MEMORY IMPAIRMENT, ALLERGY TO METALS AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ECZEMA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SKIN IRRITATION, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6)2012: THE ESSURE DEVICE WAS THEN PLACED IN THE LEFT TUBAL OSTIA AND DEPLOYED WITHOUT DIFFICULTY. THREE COILS REMAINED WITHIN THE UTERINE CAVITY. THE RIGHT TUBE WAS THEN CANNULATED AND THE ESSURE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY. SIX COILS REMAINED WITHIN THE UTERINE CAVITY ON THIS SIDE. DISCREPANT INFORMATION-ESSURE REMOVAL: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED?, NO. IF YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL?, NO . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2016: RESULTS: TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2019: NEW PFS RECEIVED- NEW EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN IRRITATION,INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION,MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: DISTAL END OF FALLOPIAN TUBE,NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG, FORGETFULNESS, NICKEL ALLERGY, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING WERE ADDED. 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 SALPINGITIS ('FALLOPIAN TUBE WITH CHRONIC INFLAMMATION'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: DISTAL END OF FALLOPIAN TUBE'), PELVIC PAIN ('PELVIC PAIN') AND GENITAL HEMORRHAGE ('HEAVY ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BACK PAIN, NAUSEA, INGUINAL HERNIA, DIZZINESS, VOMITING, UTERINE SCAR AND SKIN IRRITATION. CONCOMITANT PRODUCTS INCLUDED HYDROCODONE SINCE 2012, HYDROCORTISONE SINCE 2012 AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2012. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECZEMA ("RASHES OR SKIN CONDITIONS TYPE:ECZEMA"), VAGINAL HEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL"), MENORRHAGIA ("ABNORMAL BLEEDING MENORRHAGIA"), SKIN IRRITATION ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN IRRITATION SKIN IRRITATION"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION DEPRESSION"), FEELING ABNORMAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: BRAIN FOG,"), ALLERGY TO METALS ("NICKEL ALLERGY") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE,") AND MEMORY IMPAIRMENT ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE:FORGETFULNESS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL AND FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE SALPINGITIS, DEVICE DISLOCATION, PELVIC PAIN, GENITAL HEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, ABDOMINAL PAIN LOWER, MIGRAINE, HEADACHE, TOOTH DISORDER, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, VAGINAL HEMORRHAGE, MENORRHAGIA, SKIN IRRITATION, VAGINAL INFECTION, DEPRESSION, FEELING ABNORMAL, MEMORY IMPAIRMENT, ALLERGY TO METALS AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN AND THE ECZEMA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, ECZEMA, FATIGUE, FEELING ABNORMAL, GENITAL HEMORRHAGE, HEADACHE, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, PELVIC PAIN, SALPINGITIS, SKIN IRRITATION, TOOTH DISORDER, VAGINAL DISCHARGE, VAGINAL HEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2012: THE ESSURE DEVICE WAS THEN PLACED IN THE LEFT TUBAL OSTIA AND DEPLOYED WITHOUT DIFFICULTY. THREE COILS REMAINED WITHIN THE UTERINE CAVITY. THE RIGHT TUBE WAS THEN CANNULATED AND THE ESSURE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY. SIX COILS REMAINED WITHIN THE UTERINE CAVITY ON THIS SIDE. DISCREPANT INFORMATION-ESSURE REMOVAL: HAVE YOU HAD YOUR ESSURE (OR ANY PART OF THE DEVICE) REMOVED? NO. IF YOU HAVE NOT HAD YOUR ESSURE REMOVED, ARE YOU CURRENTLY PLANNING FOR ESSURE REMOVAL? NO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.2 KG/SQM. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: NO EVIDENCE OF ACUTE ABDOMINOPELVIC PATHOLOGY. NO FINDINGS TO EXPLAIN LEFT LOWER QUADRANT ABDOMINAL PAIN. INDWELLING ESSURE DEVICES. HYSTEROSALPINGOGRAM - ON (B)(6) 2016: RESULTS: TOTAL BILATERAL OCCLUSION,MIGRATION OF ESSURE DEVICE. ULTRASOUND PELVIS - ON (B)(6) 2016: NO EVIDENCE OF ACUTE PELVIC PATHOLOGY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-DEC-2020: MR RECEIVED. REPORTER INFORMATION ADDED. DATE OF REMOVAL UPDATED.EVENT: FALLOPIAN TUBE WITH CHRONIC INFLAMMATION 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 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 ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ABDOMINAL PAIN LOWER ("SEVERE CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (FORCED TO UNDERGO ONE OR MORE; SURGERIES TO REMOVE ONE OR MORE OF THE ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE, PELVIC PAIN AND VULVOVAGINAL 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 |
|---|---|---|---|---|---|---|---|
| 748929 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCODONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE| HYDROCORTISONE |