ESSURE
Report
- Report Number
- 2951250-2016-02848
- Event Type
- Injury
- Date Received
- December 30, 2016
- Report Date
- May 6, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE IMPLANT/ MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6)2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING"), RASH ("SKIN RASH"), VISUAL IMPAIRMENT ("VISION ISSUES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("LOSS OF TEETH"), ANXIETY ("ANXIETY"), HYPOAESTHESIA ("NUMBNESS FEELING ON HANDS/ NUMBNESS IS MY FEET, HANDS AND ARMS"), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("LONG PERIODS"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE"), PARAESTHESIA ("TINGLING HANDS"), TOOTH DISORDER ("DENTAL ISSUES"), BACK PAIN ("SEVERE BACK PAIN"), FEELING ABNORMAL ("BRAIN FOG"), FATIGUE ("FATIGUE"), MUSCLE SPASMS ("LEG CRAMPS") AND POLYMENORRHOEA ("2 ND PERIOD IN LESS THAN 20 DAYS") AND WAS FOUND TO HAVE BLOOD GLUCOSE DECREASED ("LOW BLOOD SUGAR") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH ESSURE REMOVAL ON (B)(6)2016). ESSURE WAS REMOVED ON (B)(6)2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION, PARAESTHESIA, TOOTH DISORDER, BACK PAIN, FEELING ABNORMAL, FATIGUE, MUSCLE SPASMS AND POLYMENORRHOEA OUTCOME WAS UNKNOWN AND THE RASH HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACK PAIN, BLOOD GLUCOSE DECREASED, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HYPOAESTHESIA, MENORRHAGIA, MUSCLE SPASMS, PARAESTHESIA, PELVIC PAIN, POLYMENORRHOEA, RASH, TOOTH DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NOT GOT PREGNANT ON ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: FATIGUE, FEELING ABNORMAL, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. NEW EVENT LEG CRAMP AND 2ND PERIOD IN LESS THAN 20 DAYS ADDED. NEW REPORTER ADDED. FU 7 & 8 PROCESS TOGETHER. ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. EVENT "RASH "OUTCOME ADDED. NEW REPORTER ADDED. FU 7 & 8 PROCESS TOGETHER. INCIDENT: 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 DEVICE DISLOCATION ('MIGRATION OF THE IMPLANT/ MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING"), RASH ("SKIN RASH"), VISUAL IMPAIRMENT ("VISION ISSUES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("LOSS OF TEETH"), ANXIETY ("ANXIETY"), HYPOAESTHESIA ("NUMBNESS FEELING ON HANDS/ NUMBNESS IS MY FEET, HANDS AND ARMS"), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("LONG PERIODS"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE"), PARAESTHESIA ("TINGLING HANDS"), TOOTH DISORDER ("DENTAL ISSUES"), BACK PAIN ("SEVERE BACK PAIN"), FEELING ABNORMAL ("BRAIN FOG"), FATIGUE ("FATIGUE"), MUSCLE SPASMS ("LEG CRAMPS") AND POLYMENORRHOEA ("2 ND PERIOD IN LESS THAN 20 DAYS") AND WAS FOUND TO HAVE BLOOD GLUCOSE DECREASED ("LOW BLOOD SUGAR") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH ESSURE REMOVAL ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION, PARAESTHESIA, TOOTH DISORDER, BACK PAIN, FEELING ABNORMAL, FATIGUE, MUSCLE SPASMS AND POLYMENORRHOEA OUTCOME WAS UNKNOWN AND THE RASH HAD RESOLVED. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACK PAIN, BLOOD GLUCOSE DECREASED, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HYPOAESTHESIA, MENORRHAGIA, MUSCLE SPASMS, PARAESTHESIA, PELVIC PAIN, POLYMENORRHOEA, RASH, TOOTH DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NOT GOT PREGNANT ON ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: FATIGUE, FEELING ABNORMAL, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-APR-2020: QUALITY-SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ("MIGRATION OF THE IMPLANT/ MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("SKIN RASH"), VISUAL IMPAIRMENT ("VISION ISSUES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("LOSS OF TEETH"), ANXIETY ("ANXIETY"), HYPOAESTHESIA ("NUMBNESS FEELING ON HANDS/ NUMBNESS IS MY FEET, HANDS AND ARMS"), BLOOD GLUCOSE DECREASED ("LOW BLOOD SUGAR"), WEIGHT INCREASED ("WEIGHT GAIN"), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("LONG PERIODS"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE"), PARAESTHESIA ("TINGLING HANDS"), TOOTH DISORDER ("DENTAL ISSUES"), BACK PAIN ("SEVERE BACK PAIN"), FEELING ABNORMAL ("BRAIN FOG") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH ESSURE REMOVAL ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, RASH, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION, PARAESTHESIA, TOOTH DISORDER, BACK PAIN, FEELING ABNORMAL AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BACK PAIN, BLOOD GLUCOSE DECREASED, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HYPOAESTHESIA, MENORRHAGIA, PARAESTHESIA, PELVIC PAIN, RASH, TOOTH DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE HAD NOT GOT PREGNANT ON ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE REPORTED VIA SOCIAL MEDIA: FATIGUE, FEELING ABNORMAL, BACK PAIN. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUN-2018: INFORMATION RECEIVED FROM SOCIAL MEDIA: REPORTER INFORMATION UPDATED. EVENT NUMBNESS IS MY FEET, HANDS AND ARMS WAS CLUBBED WITH PREVIOUSLY REPORTED EVENT. EVENTS FATIGUE, FEELING ABNORMAL, BACK PAIN WERE NEWLY ADDED. 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.
QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JAN-2017: AFTER INTERNAL REVIEW THE FDA EVALUATION CODES WERE CORRECTED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MIGRATION OF THE IMPLANT AND HEAVY BLEEDING AMONGST NON SERIOUS EVENTS. ALMOST SEVEN YEARS AFTER THE INSERTION, PLAINTIFF UNDERWENT A HYSTERECTOMY WITH REMOVAL OF IMPLANTS. THE EVENTS, REGARDED AS GENITAL HAEMORRHAGE AND DEVICE DISLOCATION, ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING THE ESSURE THERAPY, A DEVICE DISLOCATION MAY OCCUR. CONSIDERING THE INFORMATION PROVIDED AND THE NATURE OF REPORTED EVENT, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. ALSO ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. GIVEN THE TEMPORAL RELATIONSHIP AND THE LACK OF ALTERNATIVE EXPLANATION, GENITAL HAEMORRHAGE WAS CONSIDERED RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT, AS A SURGICAL INTERVENTION WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE IMPLANT/ MIGRATION") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("SKIN RASH"), VISUAL IMPAIRMENT ("VISION ISSUES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("LOSS OF TEETH"), ANXIETY ("ANXIETY"), HYPOAESTHESIA ("NUMBNESS FEELING ON HANDS"), BLOOD GLUCOSE DECREASED ("LOW BLOOD SUGAR"), WEIGHT INCREASED ("WEIGHT GAIN"), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("LONG PERIODS"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE"), PARAESTHESIA ("TINGLING HANDS") AND TOOTH DISORDER ("DENTAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH ESSURE REMOVAL ON (B)(6) 2016). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, RASH, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION, PARAESTHESIA AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, BLOOD GLUCOSE DECREASED, DEVICE DISLOCATION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, GENITAL HAEMORRHAGE, HYPOAESTHESIA, MENORRHAGIA, PARAESTHESIA, PELVIC PAIN, RASH, TOOTH DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-NOV-2017: EVENT DENTAL ISSUES WAS ADDED AND PAIN WAS RECODED TO PELVIC PAIN FEMALE AND CONSIDERED AS SYMPTOM OF MIGRATION. EVENTS ABNORMAL BLEEDING, MIGRATION, SKIN RASHES, HAIR LOSS, DENTAL ISSUES, PAINFUL INTERCOURSE, WEIGHT GAIN, ANXIETY, PAIN WAS CLUBBED WITH PREVIOUSLY REPORTED EVENT.ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA AG, (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE IMPLANT") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2009, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUS CRITERION MEDICALLY SIGNIFICANT), PAIN ("PAIN"), RASH ("SKIN RASH"), VISUAL IMPAIRMENT ("VISION ISSUES"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("LOSS OF TEETH"), ANXIETY ("ANXIETY"), HYPOAESTHESIA ("NUMBNESS FEELING ON HANDS"), BLOOD GLUCOSE DECREASED ("LOW BLOOD SUGAR"), WEIGHT INCREASED ("WEIGHT GAIN"), PELVIC PAIN ("PELVIC PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MENORRHAGIA ("LONG PERIODS"), DISTURBANCE IN ATTENTION ("INABILITY TO CONCENTRATE") AND PARAESTHESIA ("TINGLING HANDS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH ESSURE REMOVAL ON (B)(6) 2016). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PAIN, RASH, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION AND PARAESTHESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PAIN, RASH, VISUAL IMPAIRMENT, ALOPECIA, TOOTH LOSS, ANXIETY, HYPOAESTHESIA, BLOOD GLUCOSE DECREASED, WEIGHT INCREASED, PELVIC PAIN, DYSPAREUNIA, MENORRHAGIA, DISTURBANCE IN ATTENTION AND PARAESTHESIA TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MIGRATION OF THE IMPLANT AND HEAVY BLEEDING AMONGST NON SERIOUS EVENTS. ALMOST SEVEN YEARS AFTER THE INSERTION, PLAINTIFF UNDERWENT A HYSTERECTOMY WITH REMOVAL OF IMPLANTS. THE EVENTS, REGARDED AS GENITAL HAEMORRHAGE AND DEVICE DISLOCATION, ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING THE ESSURE THERAPY, A DEVICE DISLOCATION MAY OCCUR. CONSIDERING THE INFORMATION PROVIDED AND THE NATURE OF REPORTED EVENT, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. ALSO ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. GIVEN THE TEMPORAL RELATIONSHIP AND THE LACK OF ALTERNATIVE EXPLANATION, GENITAL HAEMORRHAGE WAS CONSIDERED RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT, AS A SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865823 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |