ESSURE
Report
- Report Number
- 2951250-2021-00626
- Event Type
- Injury
- Date Received
- March 5, 2021
- Report Date
- January 28, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("LOCALISED PAIN") AND DEVICE BREAKAGE ("DEVICE BREAKAGE DURING REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863580). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT HAD A MEDICAL HISTORY OF CAESAREAN SECTION, LOW BACK PAIN AND PARITY 2. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY/ABNORMAL BLEEDING"), URINARY TRACT DISORDER ("URINARY PROBLEM"), GASTROINTESTINAL DISORDER ("BOWEL PROBLEM"), DEVICE INTOLERANCE ("INABILITY TO TOLERATE THE DEVICE"), DYSPAREUNIA ("DYSPAREUNIA"), DEVICE DISLOCATION ("MOVEMENT OF ESSURE IUD"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), BLADDER DISORDER ("BLADDER PROBLEM"), MENTAL DISORDER ("PSYCHOLOGICAL ISSUES"), FOOD INTOLERANCE ("FOOD INTOLERANCE"), BACK PAIN ("BACK PAIN") AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY SALPINGECTOMY AND ADHESIOLYSIS). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE OUTCOMES FOR DEVICE INTOLERANCE, DYSPAREUNIA, HYPERSENSITIVITY, BLADDER DISORDER, BACK PAIN AND PAIN IN EXTREMITY WERE UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE INTOLERANCE, DYSPAREUNIA, FOOD INTOLERANCE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENTAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: NO DEVICE MIGRATION. AS PER FOLLOW UP OF 26-MAR-2021: DISCREPANCY IN PATIENT INITIALS (B)(6). REMOVAL DETAILS: FINAL DIAGNOSIS: LAPAROSCOPIC BILATERAL SALPINGECTOMY. CLINICAL SUMMARY: ELECTIVE ADMISSION FOR BILATERAL SALPINGECTOMY. FINDING: NORMAL UTERUS, OVARIES, FALLOPIAN TUBES X 1 BAND OF OMENTAL ADHESION- FREE. SURGICAL PATHOLOGY: SPECIMEN: BILATERAL FALLOPIAN TUBES. CLINICAL HISTORY: ESSURE DEVICE. PAIN- BILATERAL SALPINGECTOMY. HISTORY OF ALLERGIC TO NICKEL. GROSS DESCRIPTION: 2 FALLOPIAN TUBES WITH BOTH FIMBRIAE ENDS. THERE IS METAL WIRE PROTRUDING FROM SURGICAL CUT END. THIS IS EMBEDDED WITH FIBROUS TISSUE AND VERY DIFFICULT TO REMOVE 12 MM LONG. OTHER TUBE HAS A PROTRUDING METAL WIRE AT THE SURGICAL CUT END 6MM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2022: NO CONTRAST MEDIUM DEFINED THE FALLOPIAN TUBES BUT THE UTERUS LOOKS NORMAL. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2012: OWS A DEGENERATIVE DISC AT L4/5 AND L5/S1. THERE IS AN ESSENTIAL DISC BULGE AT L5/S1 WHICH IS NOT REALLY COMPRESSING EITHER S1 NERVE ROOTS. LOT NUMBER: 863580. MANUFACTURING DATE: 2011/05. EXPIRATION DATE: 2014/05. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:GENITAL HAEMORRHAGE AND PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-DEC-2023: MEDICAL RECORD RECEIVED. EVENTS BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE INTOLERANCE, DYSPAREUNIA, FOOD INTOLERANCE, GASTROINTESTINAL DISORDER, , HYPERSENSITIVITY, MENTAL DISORDER, PAIN IN EXTREMITY, AND URINARY TRACT DISORDER ARE ADDED. MEDICAL HISTORY, LAB DATA & REPORTER INFORMATION UPDATED. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("LOCALISED PAIN") AND DEVICE BREAKAGE ("DEVICE BREAKAGE DURING REMOVAL") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863580). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT HAD A MEDICAL HISTORY OF CAESAREAN SECTION, LOW BACK PAIN AND PARITY 2. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2019. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEAVY / ABNORMAL BLEEDING"), URINARY TRACT DISORDER ("URINARY PROBLEM"), GASTROINTESTINAL DISORDER ("BOWEL PROBLEM"), DEVICE INTOLERANCE ("INABILITY TO TOLERATE THE DEVICE"), DYSPAREUNIA ("DYSPAREUNIA"), DEVICE DISLOCATION ("MOVEMENT OF ESSURE IUD"), HYPERSENSITIVITY ("ALLERGIC OR HYPERSENSITIVITY REACTION"), BLADDER DISORDER ("BLADDER PROBLEM"), MENTAL DISORDER ("PSYCHOLOGICAL ISSUES"), FOOD INTOLERANCE ("FOOD INTOLERANCE"), BACK PAIN ("BACK PAIN") AND PAIN IN EXTREMITY ("LEG PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY SALPINGECTOMY & ADHESIOLYSIS). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE OUTCOMES FOR DEVICE INTOLERANCE, DYSPAREUNIA, HYPERSENSITIVITY, BLADDER DISORDER, BACK PAIN AND PAIN IN EXTREMITY WERE UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE INTOLERANCE, DYSPAREUNIA, FOOD INTOLERANCE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, MENTAL DISORDER, PAIN IN EXTREMITY, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: NO DEVICE MIGRATION AS PER FOLLOW UP OF (B)(6) 2021: DISCREPANCY IN PATIENT INITIALS (RB- RAB) REMOVAL DETAILS: FINAL DIAGNOSIS: LAPAROSCOPIC BILATERAL SALPINGECTOMY CLINICAL SUMMARY: ELECTIVE ADMISSION FOR BILATERAL SALPINGECTOMY FINDING: NORMAL UTERUS, OVARIES, FALLOPIAN TUBES X 1 BAND OF OMENTAL ADHESION- FREE SURGICAL PATHOLOGY: SPECIMEN: BILATERAL FALLOPIAN TUBES CLINICAL HISTORY: ESSURE DEVICE PAIN- BILATERAL SALPINGECTOMY HISTORY OF ALLERGIC TO NICKEL GROSS: 2 FALLOPIAN TUBES WITH BOTH FIMBRIAE ENDS. THERE IS METAL WIRE PROTRUDING FROM SURGICAL CUT END. THIS IS EMBEDDED WITH FIBROUS TISSUE AND VERY DIFFICULT TO REMOVE 12 MM LONG. OTHER TUBE HAS A PROTRUDING METAL WIRE AT THE SURGICAL CUT END 6MM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2022: NO CONTRAST MEDIUM DEFINED THE FALLOPIAN TUBES BUT THE UTERUS LOOKS NORMAL. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2012: OWS A DEGENERATIVE DISC AT L4/5 AND L5/S1. THERE IS AN ESSENTIAL DISC BULGE AT L5/S1 WHICH IS NOT REALLY COMPRESSING EITHER S1 NERVE ROOTS. LOT NUMBER: 863580 MANUFACTURING DATE: 2011/05 EXPIRATION DATE: 2014/05 CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS:GENITAL HAEMORRHAGE AND PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-JAN-2024: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('LOCALISED PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863580) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE ("HEAVY / ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO DEVICE MIGRATION. LOT NUMBER: 863580 MANUFACTURING DATE: 2011/05 EXPIRATION DATE: 2014/05. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-MAR-2021: QUALITY SAFETY EVALUATION OF PTC. 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 PELVIC PAIN ('LOCALISED PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863580) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE ("HEAVY / ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO DEVICE MIGRATION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: LAWYER REPORTED NEW EVENT: HEAVY / ABNORMAL BLEEDING. ESSURE WAS REMOVED BY SALPINGECTOMY. NO DEVICE MIGRATION. EVENTS RESOLVED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321228 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863580 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |