ESSURE
Report
- Report Number
- 2951250-2018-01909
- Event Type
- Injury
- Date Received
- April 20, 2018
- Report Date
- July 4, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN/PAIN,"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE 2017. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION,"), CYSTITIS ("INFECTION(BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH,"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE,"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE,") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN/ SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL) WITH BILATERAL SALPINGECTOMY ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, DEVICE EXPULSION, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENORRHAGIA, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON UNSPECIFIED PATIENT HAD BEEN TAKEN DIABETES MEDICATION AND ON (B)(6) 2017 SHE HAD BEEN SURGICAL REMOVAL OF COIL(S))( HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. MOST OF SYMPTOMS IMPROVED FOLLOWING ESSURE REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.3 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET, NEW REPORTER, PATIENT DEMOGRAPHIC INFORMATION,ESSURE INDICATION PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES, LOT NUMBER 841531,NEW EVENTS HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION, INFECTION(BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), RASHES OR SKIN CONDITIONS TYPE: RASH, BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), EXPULSION OF ESSURE DEVICE, VAGINAL DISCHARGE, FATIGUE. THE EVENT PAIN CLUBBED WITH PREVIOUS EVENT. 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 BREAKAGE ("DEVICE BREAKAGE"), PELVIC PAIN ("PELVIC PAIN/PAIN,") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841531) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA. CONCURRENT CONDITIONS INCLUDED UTERINE ADENOMYOMA. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE 2017. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION,"), CYSTITIS ("INFECTION(BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), RASH ("RASHES OR SKIN CONDITIONS TYPE: RASH,"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE,"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE,") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN/ SEVERE CRAMPING") AND VULVOVAGINAL PAIN ("VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTICALLY ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, VULVOVAGINAL PAIN, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, HYPERSENSITIVITY, CYSTITIS, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, DEVICE EXPULSION, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, MENORRHAGIA, NAUSEA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VULVOVAGINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON UNSPECIFIED PATIENT HAD BEEN TAKEN DIABETES MEDICATION AND ON (B)(6) 2017 SHE HAD BEEN SURGICAL REMOVAL OF COIL(S))( HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. MOST OF SYMPTOMS IMPROVED FOLLOWING ESSURE REMOVED. DATE(S) OF REMOVAL: (B)(6) 2017 CHANGE TO DATE(S) OF REMOVAL: (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.3 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT'S MEDICAL RECORDS: DYSMENORRHOEA, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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 PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN/ SEVERE CRAMPING"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ONE OR MORE OF THE COILS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, VULVOVAGINAL PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, 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 |
|---|---|---|---|---|---|---|---|
| 291916 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | LOSARTAN| LOSARTAN |