ESSURE
Report
- Report Number
- 2951250-2021-01085
- Event Type
- Injury
- Date Received
- April 1, 2021
- Report Date
- October 1, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON (B)(6) 2021. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LUMBAR PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901336) 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 BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), STOMACH PAIN ("STOMACH PAIN"), DIARRHOEA ("DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT"), MYALGIA ("MUSCLE PAIN"), DISCOMFORT ("REPETITIVE DISCOMFORT"), MIGRAINE ("MIGRAINE"), FATIGUE ("FATIGUE"), HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS"), GASTRIC DISORDER ("MAJOR GASTRIC PROBLEM WITH DISCOMFORT") AND PAIN EPIGASTRIC ("MAJOR GASTRIC PROBLEM WITH DISCOMFORT") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (MEDICAL DEVICE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2021. AT THE TIME OF THE REPORT, THE STOMACH PAIN, DIARRHOEA, MYALGIA, DISCOMFORT, MIGRAINE, FATIGUE, WEIGHT DECREASED, HEAVY MENSTRUAL BLEEDING, GASTRIC DISORDER AND PAIN EPIGASTRIC OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BACK PAIN, DIARRHOEA, DISCOMFORT, FATIGUE, GASTRIC DISORDER, HEAVY MENSTRUAL BLEEDING, MIGRAINE, MYALGIA, STOMACH PAIN, WEIGHT DECREASED AND PAIN EPIGASTRIC WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMS ARE MORE AND MORE FREQUENT ABOUT 2 TIMES PER WEEK. ON 1 MARCH, MY GASTROENTEROLOGIST PERFORMED A COLONOSCOPY AND FIBROSCOPY TO FIND OUT THE SOURCE OF THE PAIN, FOLLOWED BY DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KGS. LOT NUMBER: 901336 MANUFACTURING DATE: 2011/09 EXPIRATION DATE: 2014/09 . 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 30-SEP-2021: THE DATE OF THE ESSURE REMOVAL REPORTED, NEW ADVERSE EVENTS ADDED: MAJOR GASTRIC PROBLEM WITH DISCOMFORT AND HAEMORRHAGIC PERIODS. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON (B)(6) 2021. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LUMBAR PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901336) 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 BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), DIARRHOEA ("DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT"), MYALGIA ("MUSCLE PAIN"), DISCOMFORT ("REPETITIVE DISCOMFORT"), MIGRAINE ("MIGRAINE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN UPPER, DIARRHOEA, MYALGIA, DISCOMFORT, MIGRAINE, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN UPPER, BACK PAIN, DIARRHOEA, DISCOMFORT, FATIGUE, MIGRAINE, MYALGIA AND WEIGHT DECREASED WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMS ARE MORE AND MORE FREQUENT ABOUT 2 TIMES PER WEEK. ON 1 MARCH, MY GASTROENTEROLOGIST PERFORMED A COLONOSCOPY AND FIBROSCOPY TO FIND OUT THE SOURCE OF THE PAIN, FOLLOWED BY DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KGS. LOT NUMBER: 901336 MANUFACTURING DATE: 2011/09 EXPIRATION DATE: 2014/09 . 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 6-APR-2021: 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4) ON 30-MAR-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('LUMBAR PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 901336) 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 BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), DIARRHOEA ("DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT"), MYALGIA ("MUSCLE PAIN"), DISCOMFORT ("REPETITIVE DISCOMFORT"), MIGRAINE ("MIGRAINE") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN UPPER, DIARRHOEA, MYALGIA, DISCOMFORT, MIGRAINE, FATIGUE AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN UPPER, BACK PAIN, DIARRHOEA, DISCOMFORT, FATIGUE, MIGRAINE, MYALGIA AND WEIGHT DECREASED WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMS ARE MORE AND MORE FREQUENT ABOUT 2 TIMES PER WEEK. ON (B)(6) 2013, MY GASTROENTEROLOGIST PERFORMED A COLONOSCOPY AND FIBROSCOPY TO FIND OUT THE SOURCE OF THE PAIN, FOLLOWED BY DIARRHOEA, WHICH WAS CAUSING ME DISCOMFORT DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6) KGS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499258 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901336 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |