ESSURE
Report
- Report Number
- 2951250-2019-06292
- Event Type
- Injury
- Date Received
- September 12, 2019
- Date of Event
- February 1, 2012
- Report Date
- November 6, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PHYSICAL PAIN/PELVIC PAIN/CHRONIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUGMENTATION MAMMOPLASTY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DYSURIA, SUPRAPUBIC PAIN, IRREGULAR MENSTRUATION, UTERINE FIBROID, UTERINE BLEEDING, UTERINE ENLARGEMENT AND GASTRIC SUBMUCOSAL HEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (TAYTULLA), FERROUS SULFATE, IBUPROFEN AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEM"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANAEMIA ("ANEMIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES/HEADACHES"), NAUSEA ("NAUSEA") AND ANXIETY ("MENTAL ANGUISH/ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("OTHER INJURIES/SYMPTOMS : HAIR LOSS"). THE PATIENT WAS TREATED WITH PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND URINARY TRACT INFECTION HAD RESOLVED AND THE DEPRESSION, ALOPECIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, ANAEMIA, DYSPAREUNIA, FATIGUE, MIGRAINE, NAUSEA, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, CHRONIC,DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) GENERAL ABNORMAL. BLEEDING,PSYCH INJURY AND UTI. DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST IN CURRENT PFS: SHE DID NOT UNDERWENT AN ESSURE CONFIRMATION TEST BUT IN PREVIOUS FOLLOW-UP HSG RESULTS WERE PROVIDED AS ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: ANEMIA, ANXIETY, DEPRESSION, PELVIC PAIN, DYSMENORRHEA AND MENORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-OCT-2019: PFS AND MR RECEIVED : ESSURE LOT NUMBER ADDED. EVENTS ADDED - ABNORMAL BLEEDING (VAGINAL). APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), ANEMIA, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, MIGRAINES/HEADACHES, NAUSEA, MENTAL ANGUISH/ANXIETY AND WEIGHT GAIN. EVENT CLUBBED AND PT TERM UPDATED: PSYCH INJURY/DEPRESSION. REPORTERS, MEDICAL HISTORY, CONCOMITANT AND HISTORICAL DRUGS WERE 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 ('PHYSICAL PAIN/PELVIC PAIN/CHRONIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910515) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED AUGMENTATION MAMMOPLASTY. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, DYSURIA, SUPRAPUBIC PAIN, IRREGULAR MENSTRUATION, UTERINE FIBROID, UTERINE BLEEDING, UTERINE ENLARGEMENT AND GASTRIC SUBMUCOSAL HEMORRHAGE. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (TAYTULLA), FERROUS SULFATE, IBUPROFEN AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DEPRESSION ("PSYCH INJURY/DEPRESSION"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEM"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANAEMIA ("ANEMIA"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINES/HEADACHES"), NAUSEA ("NAUSEA") AND ANXIETY ("MENTAL ANGUISH/ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALOPECIA ("OTHER INJURIES/SYMPTOMS : HAIR LOSS"). THE PATIENT WAS TREATED WITH PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), SULFAMETHOXAZOLE;TRIMETHOPRIM (BACTRIM) AND SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN WAS RESOLVING, THE GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND URINARY TRACT INFECTION HAD RESOLVED AND THE DEPRESSION, ALOPECIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, ANAEMIA, DYSPAREUNIA, FATIGUE, MIGRAINE, NAUSEA, ANXIETY AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANAEMIA, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, CHRONIC,DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) GENERAL ABNORMAL. BLEEDING,PSYCH INJURY AND UTI. DISCREPANCY NOTED IN ESSURE CONFIRMATION TEST IN CURRENT PFS: SHE DID NOT UNDERWENT AN ESSURE CONFIRMATION TEST BUT IN PREVIOUS FOLLOW-UP HSG RESULTS WERE PROVIDED AS ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.3 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORD: ANEMIA, ANXIETY, DEPRESSION, PELVIC PAIN, DYSMENORRHEA AND MENORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-OCT-2019: QUALITY SAFETY EVALUATION OF PTC. 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 ('PHYSICAL PAIN/PELVIC PAIN/CHRONIC PAIN') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') 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), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEM") AND ALOPECIA ("OTHER INJURIES/SYMPTOMS: HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND URINARY TRACT INFECTION HAD RESOLVED AND THE PSYCHOLOGICAL TRAUMA AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PSYCHOLOGICAL TRAUMA AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR PELVIC/ABDOMINAL, CHRONIC,DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) GENERAL ABNORMAL. BLEEDING,PSYCH INJURY AND UTI. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED. EVENTS- GENERAL ABNORMAL BLEEDING, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING) MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), PSYCH INJURY, BLADDER/URINARY PROBLEM AND OTHER INJURIES/SYMPTOMS : HAIR LOSS. WERE ADDED. EVENT OUTCOME UPDATED FOR: PHYSICAL PAIN/PELVIC PAIN/CHRONIC PAIN. NO LOT NUMBER OR DEVICE SAMPLE 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 |
|---|---|---|---|---|---|---|---|
| 800884 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910515 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| FERROUS SULFATE| FERROUS SULFATE| IBUPROFEN| IBUPROFEN| TAYTULLA| TAYTULLA |