ESSURE
Report
- Report Number
- 2951250-2018-00150
- Event Type
- Injury
- Date Received
- January 5, 2018
- Report Date
- September 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('COIL WAS PROTRUDING THROUGH MY FALLOPIAN TUBE OSTIA OF THE UTERUS'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 5070834-INV, 50705834) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, VOMITING AND TUBAL LIGATION. CONCURRENT CONDITIONS INCLUDED KIDNEY STONE, PHARYNGEAL CYST AND GASTROOESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), POLYMENORRHAGIA ("MENORRHAGIA/ HEAVIER AND MORE FREQUENTLY THAN NORMAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), URINARY INCONTINENCE ("URINE LEAKAGE"), COUGH ("COUGH"), SNEEZING ("SNEEZE OR MOVE DRASTICALLY"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, POLYMENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, FATIGUE, URINARY INCONTINENCE, COUGH, SNEEZING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, COUGH, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, NAUSEA, PELVIC PAIN, POLYMENORRHAGIA, SNEEZING, TOOTH DISORDER, URINARY INCONTINENCE, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. NORMAL-APPEARING OVARIES. THE ESSURE DEVICE ON THE RIGHT WAS NOT PROTRUDING FROM THE FALLOPIAN TUBE BUT DID CREATE A BULGE IN THE CORNEAL REGION OF THE UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. 2 LOT NUMBER [50705834 ] IS VALID AND [ 5070834 ] IS INVALID. LOT NUMBER:50705834 MANUFACTURING DATE: 2012-12 EXPIRATION DATE:2015-12-31. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). ON 21-SEP-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 FALLOPIAN TUBE PERFORATION ('COIL WAS PROTRUDING THROUGH MY FALLOPIAN TUBE OSTIA OF THE UTERUS'), PELVIC PAIN ('PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 5070834,50705834) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED NAUSEA, VOMITING AND TUBAL LIGATION. CONCURRENT CONDITIONS INCLUDED KIDNEY STONE, PHARYNGEAL CYST AND GASTROOESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), POLYMENORRHAGIA ("MENORRHAGIA/ HEAVIER AND MORE FREQUENTLY THAN NORMAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), URINARY INCONTINENCE ("URINE LEAKAGE"), COUGH ("COUGH"), SNEEZING ("SNEEZE OR MOVE DRASTICALLY"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, POLYMENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, FATIGUE, URINARY INCONTINENCE, COUGH, SNEEZING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, COUGH, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, NAUSEA, PELVIC PAIN, POLYMENORRHAGIA, SNEEZING, TOOTH DISORDER, URINARY INCONTINENCE, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. NORMAL-APPEARING OVARIES. THE ESSURE DEVICE ON THE RIGHT WAS NOT PROTRUDING FROM THE FALLOPIAN TUBE BUT DID CREATE A BULGE IN THE CORNEAL REGION OF THE UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2020: MR RECEIVED: LOT NUMBER WAS UPDATED. MEDICAL HISTORY WAS 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 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 FALLOPIAN TUBE PERFORATION ("COIL WAS PROTRUDING THROUGH MY FALLOPIAN TUBE OSTIA OF THE UTERUS"), PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 5070834) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NAUSEA AND VOMITING. CONCURRENT CONDITIONS INCLUDED KIDNEY STONE, PHARYNGEAL CYST AND GASTROOESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA/ HEAVIER AND MORE FREQUENTLY THAN NORMAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), URINARY INCONTINENCE ("URINE LEAKAGE"), COUGH ("COUGH"), SNEEZING ("SNEEZE OR MOVE DRASTICALLY"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, FATIGUE, URINARY INCONTINENCE, COUGH, SNEEZING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, COUGH, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, NAUSEA, PELVIC PAIN, SNEEZING, TOOTH DISORDER, URINARY INCONTINENCE, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. NORMAL-APPEARING OVARIES. THE ESSURE DEVICE ON THE RIGHT WAS NOT PROTRUDING FROM THE FALLOPIAN TUBE BUT DID CREATE A BULGE IN THE CORNEAL REGION OF THE UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PLAINTIFF FACT SHEET: EVENTS ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, NAUSEA, DENTAL PROBLEMS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, FATIGUE AND LOT NUMBER WERE 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("COIL WAS PROTRUDING THROUGH MY FALLOPIAN TUBE OSTIA OF THE UTERUS"), PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 5070834) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NAUSEA AND VOMITING. CONCURRENT CONDITIONS INCLUDED KIDNEY STONE, PHARYNGEAL CYST AND GASTROOESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED FERROUS SULFATE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), POLYMENORRHAGIA ("MENORRHAGIA/ HEAVIER AND MORE FREQUENTLY THAN NORMAL"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), FATIGUE ("FATIGUE"), URINARY INCONTINENCE ("URINE LEAKAGE"), COUGH ("COUGH"), SNEEZING ("SNEEZE OR MOVE DRASTICALLY"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN/ CRAMPING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEPRESSION, ANXIETY, VAGINAL HAEMORRHAGE, POLYMENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, NAUSEA, TOOTH DISORDER, FATIGUE, URINARY INCONTINENCE, COUGH, SNEEZING AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSPAREUNIA AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BLADDER DISORDER, COUGH, DEPRESSION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, NAUSEA, PELVIC PAIN, POLYMENORRHAGIA, SNEEZING, TOOTH DISORDER, URINARY INCONTINENCE, URINARY TRACT DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY. NORMAL-APPEARING OVARIES. THE ESSURE DEVICE ON THE RIGHT WAS NOT PROTRUDING FROM THE FALLOPIAN TUBE BUT DID CREATE A BULGE IN THE CORNEAL REGION OF THE UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD THE NEED FOR ADDITIONAL SURGERY 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 |
|---|---|---|---|---|---|---|---|
| 11926 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 5070834-INV, 50705834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE| FERROUS SULFATE |