ESSURE
Report
- Report Number
- 2951250-2020-03913
- Event Type
- Injury
- Date Received
- April 15, 2020
- Report Date
- August 18, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893038) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ADENOMYOSIS. 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) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), HYPOAESTHESIA ("HAND AND ARM NUMBNESS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"), BACTERIAL VULVOVAGINITIS ("BACTERIA VAGINITIS"), ADENOMYOSIS ("ADENOMYOSIS") AND ENDOMETRIAL HYPERPLASIA ("THEY FOUND HYPERPLASIA/UTERINE LINING THICKER"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE (FLAGYL) AND SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN, HYPOAESTHESIA, VULVOVAGINAL MYCOTIC INFECTION, BACTERIAL VULVOVAGINITIS, ADENOMYOSIS AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ARTHRALGIA, BACTERIAL VULVOVAGINITIS, ENDOMETRIAL HYPERPLASIA, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL, MUSCULOSKELETAL PAIN AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS THEN PLACED FIRST IN THE LEFT TUBAL OSTIA WITH EASE AND THERE WAS 1 COIL NOTED AT THE END OF THE PLACEMENT. A SIMILAR PROCEDURE WAS PERFORMED INTO THE RIGHT TUBAL OSTIA, WHERE 3 COILS WERE VISUALIZED AT THE END OF THE PLACEMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2020: 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 ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893038) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ADENOMYOSIS. 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) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), HYPOAESTHESIA ("HAND AND ARM NUMBNESS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"), BACTERIAL VULVOVAGINITIS ("BACTERIA VAGINITIS"), ADENOMYOSIS ("ADENOMYOSIS") AND ENDOMETRIAL HYPERPLASIA ("THEY FOUND HYPERPLASIA/UTERINE LINING THICKER"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE (FLAGYL) AND SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN, HYPOAESTHESIA, VULVOVAGINAL MYCOTIC INFECTION, BACTERIAL VULVOVAGINITIS, ADENOMYOSIS AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ARTHRALGIA, BACTERIAL VULVOVAGINITIS, ENDOMETRIAL HYPERPLASIA, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL, MUSCULOSKELETAL PAIN AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICE WAS THEN PLACED FIRST IN THE LEFT TUBAL OSTIA WITH EASE AND THERE WAS 1 COIL NOTED AT THE END OF THE PLACEMENT. A SIMILAR PROCEDURE WAS PERFORMED INTO THE RIGHT TUBAL OSTIA, WHERE 3 COILS WERE VISUALIZED AT THE END OF THE PLACEMENT. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: MR RECEIVED : REPORTER ADDED, LOT NUMBER ADDE, PATIENT DEMOGRAPHIC ADDED, MEDICAL HISTORY ADDED 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 ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), HYPOAESTHESIA ("HAND AND ARM NUMBNESS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION") AND BACTERIAL VULVOVAGINITIS ("BACTERIA VAGINITIS"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE (FLAGYL) AND SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN, HYPOAESTHESIA, VULVOVAGINAL MYCOTIC INFECTION AND BACTERIAL VULVOVAGINITIS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, BACTERIAL VULVOVAGINITIS, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL, MUSCULOSKELETAL PAIN AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: SOCIAL MEDIA REPORT RECEIVED : THE EVENTS ¿YEAST INFECTION¿ AND ¿BACTERIA VAGINITIS¿ WERE ADDED. REPORTER INFORMATION WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN") AND HYPOAESTHESIA ("HAND AND ARM NUMBNESS"). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ARTHRALGIA, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL AND MUSCULOSKELETAL PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA REPORT: REPORTER INFORMATION AND NEW EVENTS HIP PAIN, SHOULDER PAIN AND HAND AND ARM NUMBNESS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), HYPOAESTHESIA ("HAND AND ARM NUMBNESS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"), BACTERIAL VULVOVAGINITIS ("BACTERIA VAGINITIS"), ADENOMYOSIS ("ADENOMYOSIS") AND ENDOMETRIAL HYPERPLASIA ("THEY FOUND HYPERPLASIA/UTERINE LINING THICKER"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE (FLAGYL) AND SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN, HYPOAESTHESIA, VULVOVAGINAL MYCOTIC INFECTION, BACTERIAL VULVOVAGINITIS, ADENOMYOSIS AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ARTHRALGIA, BACTERIAL VULVOVAGINITIS, ENDOMETRIAL HYPERPLASIA, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL, MUSCULOSKELETAL PAIN AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: QUALITY SAFETY EVALUATION OF PTC-DUPLICATE CASE FOUND FOR SAME PATIENT. ALL THE INFORMATION, SOURCE DOCUMENT AND REFERENCES OF DELETION CASE (B)(4) TRANSFERRED INTO RETENTION CASE (B)(4) NEW EVENTS ADENOMYOSIS, THEY FOUND HYPERPLASIA/UTERINE LINING THICKER WERE ADDED AND NEW REPORTERS WERE ADDED FROM DELETION CASE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ARTHRALGIA ("HIP PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), HYPOAESTHESIA ("HAND AND ARM NUMBNESS"), VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"), BACTERIAL VULVOVAGINITIS ("BACTERIA VAGINITIS"), ADENOMYOSIS ("ADENOMYOSIS") AND ENDOMETRIAL HYPERPLASIA ("THEY FOUND HYPERPLASIA/UTERINE LINING THICKER"). THE PATIENT WAS TREATED WITH FLUCONAZOLE (DIFLUCAN), METRONIDAZOLE (FLAGYL) AND SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, ARTHRALGIA, MUSCULOSKELETAL PAIN, HYPOAESTHESIA, VULVOVAGINAL MYCOTIC INFECTION, BACTERIAL VULVOVAGINITIS, ADENOMYOSIS AND ENDOMETRIAL HYPERPLASIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ARTHRALGIA, BACTERIAL VULVOVAGINITIS, ENDOMETRIAL HYPERPLASIA, HYPOAESTHESIA, MEDICAL DEVICE REMOVAL, MUSCULOSKELETAL PAIN AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: HIP PAIN, MUSCULOSKELETAL PAIN AND HYPOAESTHESIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JUN-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('SUPRACERVICAL HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SUPRACERVICAL HYSTERECTOMY (UTERUS ONLY)). 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. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426993 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893038 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |