ESSURE
Report
- Report Number
- 2951250-2019-07747
- Event Type
- Injury
- Date Received
- September 23, 2019
- Date of Event
- November 1, 2013
- Report Date
- January 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2030344- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL ODOR, VAGINITIS AND UTERINE BLEEDING. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)/DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED CYSTITIS ("BLADDER INFECTION/BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION/INFECTION TYPE: BLADDER; URINARY TRACT; VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/MIGRAINES / HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ANAEMIA ("ANEMIA/BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEM/DENTAL PROBLEMS"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BLADDER DISORDER ("BLADDER PROBLEM/BLADDER OR URINARY PROBLEMS OR CHANGES"). IN 2014, THE PATIENT EXPERIENCED RASH ("RASHES,"). IN 2016, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA(BLEEDING B/W PERIODS)"), ALLERGY TO METALS ("NICKEL ALLERGY"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL CONDITIONS"), HEADACHE ("HEADACHE"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), CONSTIPATION ("CHRONIC CONSTIPATION") AND PAIN IN EXTREMITY ("LEG PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTYERECTOMY(FULL), SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN , FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, METRORRHAGIA, ANAEMIA, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, TOOTH DISORDER, FATIGUE, VISION BLURRED, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, RASH, ABDOMINAL DISTENSION, CONSTIPATION AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANAEMIA, BACK PAIN, BLADDER DISORDER, CONSTIPATION, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR-DYSMENORRHEA, DYSPAREUNIA, BACK, PAIN, ABDOMINAL PAIN, CHRONIC PELVIC PAIN, APEREUNIA, MENORRHAGIA, METRORRHAGIA, ANEMIA, NICKEL ALLERGY, BLADDER PROBLEM, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GI CONDITIONS, HAIR LOSS, MIGRAINE, HEADACHES, DENTAL PROBLEM, FATIGUE, VISION PROBLEM AND WEIGHT GAIN. 2 COILS WERE VISUALIZED IN THE PATIENT¿S RIGHT TUBAL OSTIA, 2 ESSURE COILS WERE VISUALIZED IN THE LEFT TUBAL OSTIA, DISCREPANCY NOTED IN REMOVAL INFORMATION: AS PER (B)(6) 2019, ESSURE IS NOT REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: NO EXTRAVASATION OF CONTRAST WITHIN THE PELVIS AND NO FILLING OF THE FALLOPIAN TUBES WITH CONTRAST IN THIS PATIENT STATUS POST. THE LOT NUMBER REPORTED (2030344) IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JAN-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2030344) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL ODOR, VAGINITIS AND UTERINE BLEEDING. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)/DYSMENORRHEA (CRAMPING)"). IN (B)(6)2013, THE PATIENT EXPERIENCED CYSTITIS ("BLADDER INFECTION/BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION/INFECTION TYPE: BLADDER; URINARY TRACT; VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). IN (B)(6)2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/MIGRAINES / HEADACHES"). IN (B)(6)2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA/APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), ANAEMIA ("ANEMIA/BLOOD OR HEART DISORDER/CONDITION TYPE: ANEMIA"), ALOPECIA ("HAIR LOSS/HAIR LOSS"), TOOTH DISORDER ("DENTAL PROBLEM/DENTAL PROBLEMS"), FATIGUE ("FATIGUE") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6)2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND BLADDER DISORDER ("BLADDER PROBLEM/BLADDER OR URINARY PROBLEMS OR CHANGES"). IN 2014, THE PATIENT EXPERIENCED RASH ("RASHES,"). IN 2016, THE PATIENT EXPERIENCED VISION BLURRED ("VISION/EYE PROBLEMS TYPE: BLURRED VISION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA(BLEEDING B/W PERIODS)"), ALLERGY TO METALS ("NICKEL ALLERGY"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL CONDITIONS"), HEADACHE ("HEADACHE"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), CONSTIPATION ("CHRONIC CONSTIPATION") AND PAIN IN EXTREMITY ("LEG PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL), SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, METRORRHAGIA, ANAEMIA, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, TOOTH DISORDER, FATIGUE, VISION BLURRED, WEIGHT INCREASED, VAGINAL HAEMORRHAGE, RASH, ABDOMINAL DISTENSION, CONSTIPATION AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANAEMIA, BACK PAIN, BLADDER DISORDER, CONSTIPATION, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR-DYSMENORRHEA, DYSPAREUNIA, BACK, PAIN, ABDOMINAL PAIN, CHRONIC PELVIC PAIN, APEREUNIA, MENORRHAGIA, METRORRHAGIA, ANEMIA, NICKEL ALLERGY, BLADDER PROBLEM, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GI CONDITIONS, HAIR LOSS, MIGRAINE, HEADACHES, DENTAL PROBLEM, FATIGUE, VISION PROBLEM AND WEIGHT GAIN. 2 COILS WERE VISUALIZED IN THE PATIENT¿S RIGHT TUBAL OSTIA, 2 ESSURE COILS WERE VISUALIZED IN THE LEFT TUBAL OSTIA, DISCREPANCY NOTED IN REMOVAL INFORMATION: AS PER (B)(6)2019, ESSURE IS NOT REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: NO EXTRAVASATION OF CONTRAST WITHIN THE PELVIS AND NO FILLING OF THE FALLOPIAN TUBES WITH CONTRAST IN THIS PATIENT STATUS POST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-DEC-2019: PFS RECEIVED. EVENTS PER PFS: VAGINAL BLEEDING, RASHES, BLOATING, CONSTIPATION, LEG PAIN WERE ADDED. LOT NUMBER RECEIVED. EVENT VISUAL PROBLEMS WAS UPDATED TO BLURRED VISION. 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 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 ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)"), BACK PAIN ("BACK PAIN"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA"), MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORRHAGIA(BLEEDING B/W PERIODS)"), ANAEMIA ("ANEMIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), BLADDER DISORDER ("BLADDER PROBLEM"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL CONDITIONS"), ALOPECIA ("HAIR LOSS"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE"), TOOTH DISORDER ("DENTAL PROBLEM"), FATIGUE ("FATIGUE") AND VISUAL IMPAIRMENT ("VISION PROBLEM") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL), SALPINGECTOMY(BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, METRORRHAGIA, ANAEMIA, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL DISORDER, ALOPECIA, MIGRAINE, HEADACHE, TOOTH DISORDER, FATIGUE, VISUAL IMPAIRMENT AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ALOPECIA, ANAEMIA, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GASTROINTESTINAL DISORDER, HEADACHE, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, TOOTH DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR-DYSMENORRHEA, DYSPAREUNIA, BACK, PAIN, ABDOMINAL PAIN, CHRONIC PELVIC PAIN, APEREUNIA, MENORRHAGIA, METRORRHAGIA, ANEMIA, NICKEL ALLERGY, BLADDER PROBLEM, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GI CONDITIONS, HAIR LOSS, MIGRAINE, HEADACHES, DENTAL PROBLEM, FATIGUE, VISION PROBLEM AND WEIGHT GAIN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-SEP-2019: PFS RECEIVED-PREVIOUSLY REPORTED EVENT "INJURY TO HERSELF" UPDATED TO "PELVIC PAIN FEMALE", EVENTS- "DYSMENORRHEA(CRAMPING), DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE), BACK PAIN, APAREUNIA, MENORRHAGIA(HEAVY MENSTRUAL BLEEDING), METRORRHAGIA (BLEEDING B/W PERIODS), ANEMIA, NICKEL ALLERGY, BLADDER PROBLEM, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, GASTROINTESTINAL CONDITIONS, HAIR LOSS, MIGRAINE, HEADACHE, DENTAL PROBLEM, FATIGUE, VISION PROBLEM AND WEIGHT INCREASED" REPORTER AND PATIENT DEMOGRAPHY,LAB DATA WAS ADDED. NO LOT NUMBER WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898033 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 2030344- NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |