ESSURE
Report
- Report Number
- 2951250-2018-01924
- Event Type
- Injury
- Date Received
- April 23, 2018
- Report Date
- February 7, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('XENOBIOTIC MATERIAL REMOVED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER: 915889, MANUFACTURING DATE: 2011-10, EXPIRATION DATE: 2014-10 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: REPORTER UPDATED. 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 FROM A CONSUMER VIA A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. 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), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG "), AMNESIA ("MEMORY LOSS") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, ALOPECIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, AUTOIMMUNE DISORDER, FEELING ABNORMAL, HORMONE LEVEL ABNORMAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER: 915889. MANUFACTURING DATE: 2011-10. EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2022: FOLLOW UP WAS RECEIVED VIA LAWYER: EVENTS (PREVIOUS EVENT: MEDICAL DEVICE REMOVAL) WERE SPECIFIED: (NEW:) PAIN, AUTOIMMUNE PROBLEMS, PSYCHOLOGICAL PROBLEMS, BRAIN FOG AND MEMORY LOSS, HAIR LOSS AND HORMONAL PROBLEMS 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 CONSUMER VIA A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. 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), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, ALOPECIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, AUTOIMMUNE DISORDER, FEELING ABNORMAL, HORMONE LEVEL ABNORMAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER: 915889. MANUFACTURING DATE: 2011-10. EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: TYPE OF REPORT UPDATED TO FINAL, NO NEW ADDITIONAL INFORMATION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CONSUMER VIA LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. 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), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), AMNESIA ("MEMORY LOSS") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL PROBLEMS"). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, AUTOIMMUNE DISORDER, MENTAL DISORDER, FEELING ABNORMAL, AMNESIA, ALOPECIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AMNESIA, AUTOIMMUNE DISORDER, FEELING ABNORMAL, HORMONE LEVEL ABNORMAL, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER: 915889. MANUFACTURING DATE: 2011-10. EXPIRATION DATE: 2014-10. 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. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2022: QUALITY SAFETY EVALUATION OF PTC. 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 MEDICAL DEVICE REMOVAL ('XENOBIOTIC MATERIAL REMOVED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-MAR-2020: LAWYER (NEW REPORTER) PROVIDED ESSURE LOT NUMBER. PATIENT INITIALS WERE AMENDED. 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 MEDICAL DEVICE REMOVAL ('XENOBIOTIC MATERIAL REMOVED') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 915889) INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT WAS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. LOT NUMBER: 915889, MANUFACTURING DATE: 2011-10, EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAR-2020: UPDATED QUALITY SAFETY EVALUATION OF PTC. 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 CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("XENOBIOTIC MATERIAL REMOVED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BECAUSE OF THE COMPLAINTS PATIENT IS BEING IMPEDED IN HER NORMAL DAILY FUNCTIONING AND PATIENT IS SUFFERING FROM INJURY. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 774 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. 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 |
|---|---|---|---|---|---|---|---|
| 294796 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 915889 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |