ESSURE
Report
- Report Number
- 2951250-2020-01192
- Event Type
- Injury
- Date Received
- February 10, 2020
- Report Date
- May 1, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('A DEEPER KIND OF PAIN') 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("I HAD A CYST ON MY OVARY THAT HE DRAINED HAND REMOVED"), BLEPHAROSPASM ("EYE TWITCHING") AND POST PROCEDURAL HAEMORRHAGE ("POST OP BLOOD CLOT"). THE PATIENT WAS TREATED WITH SURGERY (OVARIES REMOVED AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, OVARIAN CYST, BLEPHAROSPASM AND POST PROCEDURAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLEPHAROSPASM, OVARIAN CYST, PELVIC PAIN AND POST PROCEDURAL HAEMORRHAGE TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: PELVIC PAIN, , OVARIAN CYST. AND ENDOMETRIOSIS PRIOR TO ESSURE . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-FEB-2020: SOCIAL MEDIA CONTENT RECEIVED: EVENT: POST OPERATIVE HAEMORRHAGE ADDED. REPORTERS WERE 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 PELVIC PAIN ('A DEEPER KIND OF PAIN'), ENDOMETRIAL ABLATION ('ABLATION 15 MONTH AFTER ESSURE') AND ARTHROPATHY ('HIP WENT BAD') 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("I HAD A CYST ON MY OVARY THAT HE DRAINED HAND REMOVED"), BLEPHAROSPASM ("EYE TWITCHING"), POST PROCEDURAL HAEMORRHAGE ("POST OP BLOOD CLOT / THEY BELIEVE BLOOD CLOT CAME FROM SURGERY SITE"), TOOTH INFECTION ("TOOTH INFECTION"), TOOTH LOSS ("TOOTH LOSS"), EPILEPSY ("DIAGNOSED WITH EPILEPSY"), ABDOMINAL PAIN LOWER ("EXCESSIVE CRAMPING / ABDOMINAL PAIN LOWER RIGHT"), SKIN DISORDER ("SKIN ISSUES"), ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BURSITIS ("BURSITIS"), ARTHRALGIA ("HIP PAIN"), HIP FRACTURE ("HIP BROKEN"), THYROID DISORDER ("NO THYROID ISSUES"), ABDOMINAL PAIN ("BELLY BUTTON PAIN"), ANAL INCONTINENCE ("LOST BOWEL CONTROL"), FEELING ABNORMAL ("FLUTTERING AND KICK LIKE FEELING"), BREAST DISCHARGE ("GETTING MILK/COLOSTRUM "), FATIGUE ("FATIGUE"), CHEST PAIN ("CHEST PAIN"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), INTERVERTEBRAL DISC PROTRUSION ("BULGING DISCS"), BACK PAIN ("CHRONIC LOWER BACK PAIN") AND GAIT INABILITY ("CAN'T WALK FOR DAYS AT A TIME"), UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE ANTICOAGULATION DRUG LEVEL DECREASED ("IN FACT HOME HEALTH NURSE DID NOT HAVE ME ON THE CORRECT LEVEL OF COUMADINE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HIP REPLACEMENT, OVARIES REMOVED AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ENDOMETRIAL ABLATION, OVARIAN CYST, BLEPHAROSPASM, POST PROCEDURAL HAEMORRHAGE, TOOTH INFECTION, TOOTH LOSS, ANTICOAGULATION DRUG LEVEL DECREASED, EPILEPSY, ABDOMINAL PAIN LOWER, SKIN DISORDER, ARTHROPATHY, BURSITIS, ARTHRALGIA, HIP FRACTURE, ABDOMINAL PAIN, ANAL INCONTINENCE, FEELING ABNORMAL, BREAST DISCHARGE, CHEST PAIN, MUSCULOSKELETAL PAIN, INTERVERTEBRAL DISC PROTRUSION, BACK PAIN AND GAIT INABILITY OUTCOME WAS UNKNOWN, THE THYROID DISORDER HAD RESOLVED AND THE FATIGUE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAL INCONTINENCE, ANTICOAGULATION DRUG LEVEL DECREASED, ARTHRALGIA, ARTHROPATHY, BACK PAIN, BLEPHAROSPASM, BREAST DISCHARGE, BURSITIS, CHEST PAIN, ENDOMETRIAL ABLATION, EPILEPSY, FATIGUE, FEELING ABNORMAL, GAIT INABILITY, HIP FRACTURE, INTERVERTEBRAL DISC PROTRUSION, MUSCULOSKELETAL PAIN, OVARIAN CYST, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, SKIN DISORDER, THYROID DISORDER, TOOTH INFECTION AND TOOTH LOSS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: PELVIC PAIN, OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: CONTENT FROM SOCIAL MEDIA RECEIVED: NEW EVENTS BULGING DISCS, CHRONIC LOWER BACK PAIN AND CAN'T WALK FOR DAYS AT A TIME WERE ADDED. REPORTER 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 PELVIC PAIN ('A DEEPER KIND OF PAIN'), ENDOMETRIAL ABLATION ('ABLATION 15 MONTH AFTER ESSURE') AND ARTHROPATHY ('HIP WENT BAD') 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("I HAD A CYST ON MY OVARY THAT HE DRAINED HAND REMOVED"), BLEPHAROSPASM ("EYE TWITCHING"), POST PROCEDURAL HAEMORRHAGE ("POST OP BLOOD CLOT / THEY BELIEVE BLOOD CLOT CAME FROM SURGERY SITE"), TOOTH INFECTION ("TOOTH INFECTION"), TOOTH LOSS ("TOOTH LOSS"), EPILEPSY ("DIAGNOSED WITH EPILEPSY"), ABDOMINAL PAIN LOWER ("EXCESSIVE CRAMPING / ABDOMINAL PAIN LOWER RIGHT"), SKIN DISORDER ("SKIN ISSUES"), ARTHROPATHY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BURSITIS ("BURSITIS"), ARTHRALGIA ("HIP PAIN"), HIP FRACTURE ("HIP BROKEN"), THYROID DISORDER ("NO THYROID ISSUES"), ABDOMINAL PAIN ("BELLY BUTTON PAIN"), ANAL INCONTINENCE ("LOST BOWEL CONTROL"), FEELING ABNORMAL ("FLUTTERING AND KICK LIKE FEELING"), BREAST DISCHARGE ("GETTING MILK/COLOSTRUM "), FATIGUE ("FATIGUE"), CHEST PAIN ("CHEST PAIN") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND WAS FOUND TO HAVE ANTICOAGULATION DRUG LEVEL DECREASED ("IN FACT HOME HEALTH NURSE DID NOT HAVE ME ON THE CORRECT LEVEL OF COUMADINE"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HIP REPLACEMENT, OVARIES REMOVED AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ENDOMETRIAL ABLATION, OVARIAN CYST, BLEPHAROSPASM, POST PROCEDURAL HAEMORRHAGE, TOOTH INFECTION, TOOTH LOSS, ANTICOAGULATION DRUG LEVEL DECREASED, EPILEPSY, ABDOMINAL PAIN LOWER, SKIN DISORDER, ARTHROPATHY, BURSITIS, ARTHRALGIA, HIP FRACTURE, ABDOMINAL PAIN, ANAL INCONTINENCE, FEELING ABNORMAL, BREAST DISCHARGE, CHEST PAIN AND MUSCULOSKELETAL PAIN OUTCOME WAS UNKNOWN, THE THYROID DISORDER HAD RESOLVED AND THE FATIGUE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAL INCONTINENCE, ANTICOAGULATION DRUG LEVEL DECREASED, ARTHRALGIA, ARTHROPATHY, BLEPHAROSPASM, BREAST DISCHARGE, BURSITIS, CHEST PAIN, ENDOMETRIAL ABLATION, EPILEPSY, FATIGUE, FEELING ABNORMAL, HIP FRACTURE, MUSCULOSKELETAL PAIN, OVARIAN CYST, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, SKIN DISORDER, THYROID DISORDER, TOOTH INFECTION AND TOOTH LOSS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: PELVIC PAIN, OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED : EVENT "IN FACT HOME HEALTH NURSE DID NOT HAVE ME ON THE CORRECT LEVEL OF COUMADIN" ADDED. REPORTER ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENTS "EPILEPSY" ADDED. NEW REPORTERS WERE ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA RECEIVED : FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA RECEIVED: EVENT "EXCESSIVE CRAMPING" AND "SKIN ISSUE" ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA RECEIVED : EVENT "BELLY BUTTON PAIN" AND "LOST CONTROL OF BOWEL" ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 20-MAR-2020: SOCIAL MEDIA RECEIVED : EVENT "HIP WENT BAD", "HIP BROKEN", "BURSITIS", "SHOCKS OF PAIN HIP RIGHT" ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 23-MAR-2020: SOCIAL MEDIA RECEIVED- NEW EVENTS FLUTTERING AND KICK LIKE FEELING, GETTING MILK / COLOSTRUM, FATIGUE, THYROID ISSUES WERE ADDED. NEW REPORTERS WERE ADDED FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. ON 23-MAR-2020: SOCIAL MEDIA RECEIVED : EVENT "CHEST PAIN" AND "SHOULDER PAIN" ADDED. FOLLOW UP 9, 10, 11, 12, 13, 14, 15, 16 PROCESSED TOGETHER. 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 PELVIC PAIN ('A DEEPER KIND OF PAIN') 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("I HAD A CYST ON MY OVARY THAT HE DRAINED HAND REMOVED"), BLEPHAROSPASM ("EYE TWITCHING"), POST PROCEDURAL HAEMORRHAGE ("POST OP BLOOD CLOT"), TOOTH INFECTION ("TOOTH INFECTION") AND TOOTH LOSS ("TOOTH LOSS"). THE PATIENT WAS TREATED WITH SURGERY (OVARIES REMOVED AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, OVARIAN CYST, BLEPHAROSPASM, POST PROCEDURAL HAEMORRHAGE, TOOTH INFECTION AND TOOTH LOSS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLEPHAROSPASM, OVARIAN CYST, PELVIC PAIN, POST PROCEDURAL HAEMORRHAGE, TOOTH INFECTION AND TOOTH LOSS TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: PELVIC PAIN, OVARIAN CYST. AND ENDOMETRIOSIS PRIOR TO ESSURE . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA CONTENT RECEIVED: EVENT TOOTH INFECTION & TOOTH LOSS WERE ADDED. PRODUCT PATIENT & REPORTER INFORMATION UPDATED. FU 08 & 09 PROCESSED TOGETHER. 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 PELVIC PAIN ('A DEEPER KIND OF PAIN') 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN CYST ("I HAD A CYST ON MY OVARY THAT HE DRAINED HAND REMOVED") AND BLEPHAROSPASM ("EYE TWITCHING"). THE PATIENT WAS TREATED WITH SURGERY (OVARIES REMOVED AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, OVARIAN CYST AND BLEPHAROSPASM OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLEPHAROSPASM, OVARIAN CYST AND PELVIC PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: PELVIC PAIN, , OVARIAN CYST. AND ENDOMETRIOSIS PRIOR TO ESSURE . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: ALL THE INFORMATION FROM DELETION CASE 2019-221724 WAS TRANSFERRED TO THIS CASE. NEW REPORTER, REMOVAL DETAIL, AND REFERENCE SECTION WAS ADDED. LEGACY DEVICE REPORT NUMBER 2951250-2019-12084. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153877 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |