ESSURE
Report
- Report Number
- 2951250-2019-01210
- Event Type
- Injury
- Date Received
- March 25, 2019
- Report Date
- October 10, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN ON BOTH SIDES OF HER ABDOMEN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL ITCHING, OVARIAN CYST AND ADENOMYOSIS. DATE: (B)(6) 2011 ESSURE CONFIRMATION TEST: BILATERAL OCCLUSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINE/MIGRAINE/HEADACHE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS/GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"), HEADACHE ("HEADACHE"), MOOD ALTERED ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MOOD CHANGES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), CYSTITIS ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): TYPE:"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): TYPE:"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): TYPE:"), BACK PAIN ("BACK PAIN"), PAIN IN EXTREMITY ("LEG PAIN") AND FLANK PAIN ("LEFT AND RIGHT SIDE SIDES") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN") AND HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTETOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, PELVIC PAIN, MENORRHAGIA, BACK PAIN, PAIN IN EXTREMITY AND FLANK PAIN HAD RESOLVED AND THE DYSMENORRHOEA, FATIGUE, MIGRAINE, WEIGHT INCREASED, GASTROINTESTINAL DISORDER, PSYCHOLOGICAL TRAUMA, VAGINAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HEADACHE, MOOD ALTERED, VAGINAL DISCHARGE, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BLADDER DISORDER, CYSTITIS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FLANK PAIN, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, MOOD ALTERED, PAIN IN EXTREMITY, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 173 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: ESSURE WIRES IN THE FALLOPIAN TUBES BILATERALLY. THEY OCCLUDED.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PFS RECEIVED. EVENTS PER PFS: VAGINAL BLEEDING, HORMONAL CHANGES, HEADACHE, MOOD CHANGE, VAGINAL DISCHARGE, BLADDER/URINARY PROBLEMS, UTI, VAGINAL INFECTION, BACK PAIN, LEG PAIN, FLANK PAIN WERE ADDED. INCIDENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ('PAIN ON BOTH SIDES OF HER ABDOMEN') AND GENITAL HAEMORRHAGE ('HEAVY BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: DATE: (B)(6) 2011. ESSURE CONFIRMATION TEST: BILATERAL OCCLUSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), PELVIC PAIN ("PELVIC PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)."), FATIGUE ("FATIGUE"), MIGRAINE ("MIGRAINE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS") AND MENTAL DISORDER ("PSYCH INJURY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE, HYSTERECTOMY (FULL), SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA, PELVIC PAIN AND MENORRHAGIA HAD RESOLVED AND THE DYSMENORRHOEA, FATIGUE, MIGRAINE, WEIGHT INCREASED, GASTROINTESTINAL DISORDER AND MENTAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2019: PFS WAS RECEIVED- EVENT DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, MIGRAINE, WEIGHT GAIN, GI CONDITIONS AND PSYCH INJURY. PATIENT DETAILS WERE ADDED. INCIDENT: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("PAIN ON BOTH SIDES OF HER ABDOMEN") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED IN 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. INCIDENT 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 |
|---|---|---|---|---|---|---|---|
| 242206 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |