ESSURE
Report
- Report Number
- 2951250-2016-02473
- Event Type
- Injury
- Date Received
- November 10, 2016
- Date of Event
- December 2, 2011
- Report Date
- February 2, 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 ABDOMINAL PAIN ('PAIN ABDOMEN'), GENITAL HAEMORRHAGE ('REGULAR BLEEDINGS'), VAGINAL HAEMORRHAGE ('VAGINAL BLOOD LOSS / STILL FLOWING') AND PROCEDURAL PAIN ('MUCH PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839 (INVALID)) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD LOSS OF (NOS) IN 2009 AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. IN 2011, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("PAIN IN LEGS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), METRORRHAGIA ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), UTERINE PAIN ("PAIN IN UTERUS"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPARASCOPIC TUBECTOMY, FREEZING OF ENDOMETRIUM AND UTERUS WAS REMOVED IN 2013 AND THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PROCEDURAL PAIN, COMPLICATION OF DEVICE INSERTION, METRORRHAGIA, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT AND BACK PAIN HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, COMPLICATION OF DEVICE INSERTION, FATIGUE, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT, METRORRHAGIA, PAIN IN EXTREMITY, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE REMOVAL WAS PERFORMED BY PATIENT¿S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 0 KGS. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: PASSAGEABLE TUBAE; IN (B)(6) 2012: RESULTS: CORRECTLY IN SITU. (B)(6) 2012. TEST: ECHO. RESULT: NOT CONCLUSIVE. QUALITY-SAFETY EVALUATION OF PTC: BASED ON THE TECHNICAL ASSESSMENT, NEITHER SAMPLE NOR VALID LOT NUMBER WAS PROVIDED THEREFORE, THE QUALITY UNIT WAS UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD OR PERFORM A SAMPLE INVESTIGATION. THE QUALITY UNIT WAS UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME BECAUSE THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE INITIATED AS A VALID BATCH NUMBER OR SAMPLE WAS NOT PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-MAR-2021: NEW REPORTER LAWYER WAS ADDED AND FULL NAME PRINCIPAL'S REPORTER WAS PROVIDED. 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 ABDOMINAL PAIN ('PAIN ABDOMEN'), GENITAL HAEMORRHAGE ('REGULAR BLEEDINGS'), VAGINAL HAEMORRHAGE ('VAGINAL BLOOD LOSS / STILL FLOWING') AND PROCEDURAL PAIN ('MUCH PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD LOSS OF (NOS) IN 2009 AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. IN 2011, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("PAIN IN LEGS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), INTERMENSTRUAL BLEEDING ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), UTERINE PAIN ("PAIN IN UTERUS"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("SEVERE (CHRONIC) PAIN IN THE HIPS "), HEADACHE ("SEVERE (CHRONIC) PAIN IN THE HEAD "), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS "), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE "), HYPERSENSITIVITY ("ALLERGIC REACTIONS ") AND PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE "). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPARASCOPIC TUBECTOMY, FREEZING OF ENDOMETRIUM AND UTERUS WAS REMOVED IN 2013 AND THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PROCEDURAL PAIN, COMPLICATION OF DEVICE INSERTION, INTERMENSTRUAL BLEEDING, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT AND BACK PAIN HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE, PAIN IN EXTREMITY, ARTHRALGIA, HEADACHE, DISTURBANCE IN ATTENTION, MENSTRUAL DISORDER, HYPERSENSITIVITY AND PREMATURE MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, COMPLICATION OF DEVICE INSERTION, DISTURBANCE IN ATTENTION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, MEMORY IMPAIRMENT, MENSTRUAL DISORDER, PAIN IN EXTREMITY, PREMATURE MENOPAUSE, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE REMOVAL WAS PERFORMED BY PATIENT¿S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. AFTER REMOVAL OF THE ESSURE, IN ALL THE PLAINTIFFS (NEARLY) ALL OF THE COMPLAINTS DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: PASSAGEABLE TUBAE; IN (B)(6) 2012: RESULTS: CORRECTLY IN SITU. DIAGNOSTIC RESULTS: (B)(6) 2012. TEST: ECHO. RESULT: NOT CONCLUSIVE. 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 26-MAY-2021: NEW EVENTS: SEVERE (CHRONIC) PAIN IN THE HIPS, SEVERE (CHRONIC) PAIN IN THE HEAD, CONCENTRATION PROBLEMS, CHANGE IN MENSTRUATION CYCLE, ALLERGIC REACTIONS, PREMATURE MENOPAUSE 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 ABDOMINAL PAIN ('PAIN ABDOMEN'), GENITAL HAEMORRHAGE ('REGULAR BLEEDINGS'), VAGINAL HAEMORRHAGE ('VAGINAL BLOOD LOSS / STILL FLOWING') AND PROCEDURAL PAIN ('MUCH PAIN') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD LOSS OF (NOS) IN 2009 AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("PAIN IN LEGS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), METRORRHAGIA ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), UTERINE PAIN ("PAIN IN UTERUS"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPARASCOPIC TUBECTOMY, FREEZING OF ENDOMETRIUM AND UTERUS WAS REMOVED IN 2013 AND THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PROCEDURAL PAIN, COMPLICATION OF DEVICE INSERTION, METRORRHAGIA, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT AND BACK PAIN HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, COMPLICATION OF DEVICE INSERTION, FATIGUE, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT, METRORRHAGIA, PAIN IN EXTREMITY, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE REMOVAL WAS PERFORMED BY PATIENT¿S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: PASSAGEABLE TUBAE; IN (B)(6) 2012: RESULTS: CORRECTLY IN SITU. DIAGNOSTIC RESULTS: (B)(6) 2012. TEST: ECHO. RESULT: NOT CONCLUSIVE 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 (B)(6) 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF ESSURE'), ABDOMINAL PAIN ('PAIN ABDOMEN/ PAIN'), GENITAL HAEMORRHAGE ('REGULAR BLEEDINGS / ABNORMAL BLEEDING'), PROCEDURAL PAIN ('MUCH PAIN AT SECOND INSERTION ON RIGHT SIDE') AND BLADDER DISORDER ('BLADDER PROBLEMS') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD LOSS OF (NOS) IN 2009 AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PAIN ("PAIN IN UTERUS"), BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE"), INTERMENSTRUAL BLEEDING ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND PAIN IN EXTREMITY ("PAIN IN LEGS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERION HOSPITALIZATION). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLOOD LOSS / STILL FLOWING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEADACHE ("SEVERE (CHRONIC) PAIN IN THE HEAD"), BLADDER DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("SEVERE (CHRONIC) PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), ALOPECIA ("HAIR LOSS") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPARASCOPIC TUBECTOMY, CYSTECTOMY AND THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENSTRUAL DISORDER, HYPERSENSITIVITY, HEADACHE, BLADDER DISORDER, PAIN IN EXTREMITY, ARTHRALGIA, DISTURBANCE IN ATTENTION, PREMATURE MENOPAUSE, AUTOIMMUNE DISORDER, FEELING ABNORMAL, ALOPECIA AND AMNESIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PROCEDURAL PAIN, UTERINE PAIN, BACK PAIN, INTERMENSTRUAL BLEEDING, COMPLICATION OF DEVICE INSERTION, HORMONE LEVEL ABNORMAL, FATIGUE AND MEMORY IMPAIRMENT HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, MEMORY IMPAIRMENT, MENSTRUAL DISORDER, PAIN IN EXTREMITY, PREMATURE MENOPAUSE, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011 THE LEFT SIDE WAS PLACED, BUT THE RIGHT WAS UNSUCCESSFUL AND WAS THEN DONE ON (B)(6) 2011. BOTH WITH GREAT DIFFICULTY, ONE TOO DEEP AND THE OTHER ONE NOT DEEP ENOUGH. THE ESSURE REMOVAL WAS PERFORMED BY PATIENT¿S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. AFTER REMOVAL OF THE ESSURE, IN ALL THE PLAINTIFFS (NEARLY) ALL OF THE COMPLAINTS DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: PASSAGEABLE TUBAE; IN (B)(6) 2012: ESSURE CORRECTLY IN SITU. ULTRASOUND SCAN - IN (B)(6) 2012: NOT CONCLUSIVE. 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 27-JAN-2022: THE FOLLOWING INFORMATION WAS RECEIVED: PATIENT INITIALS UPDATED, AUTOIMMUNE DISORDER NOS, DYSPAREUNIA, FOGGY FEELING IN HEAD, MEMORY LOSS, HAIR LOSS, BLADDER DISORDER, FALLOPIAN TUBE PERFORATION/ DEVICE MIGRATION 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 FALLOPIAN TUBE PERFORATION ('PERFORATION OF THE FALLOPIAN TUBE, MIGRATION OF ESSURE'), ABDOMINAL PAIN ('PAIN ABDOMEN/ PAIN'), GENITAL HAEMORRHAGE ('REGULAR BLEEDINGS / ABNORMAL BLEEDING'), PROCEDURAL PAIN ('MUCH PAIN AT SECOND INSERTION ON RIGHT SIDE') AND BLADDER DISORDER ('BLADDER PROBLEMS') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BLOOD LOSS OF (NOS) IN 2009 AND GRAVIDA II. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PAIN ("PAIN IN UTERUS"), BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE"), INTERMENSTRUAL BLEEDING ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND PAIN IN EXTREMITY ("PAIN IN LEGS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERION HOSPITALIZATION). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("VAGINAL BLOOD LOSS / STILL FLOWING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA"), MENSTRUAL DISORDER ("CHANGE IN MENSTRUATION CYCLE"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), HEADACHE ("SEVERE (CHRONIC) PAIN IN THE HEAD"), BLADDER DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ARTHRALGIA ("SEVERE (CHRONIC) PAIN IN THE HIPS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEMS"), PREMATURE MENOPAUSE ("PREMATURE MENOPAUSE"), AUTOIMMUNE DISORDER ("AUTOIMMUNE PROBLEMS"), FEELING ABNORMAL ("BRAIN FOG"), ALOPECIA ("HAIR LOSS") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH MORPHINE AND SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPAROSCOPIC TUBECTOMY, CYSTECTOMY AND THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DYSPAREUNIA, VAGINAL HAEMORRHAGE, MENSTRUAL DISORDER, HYPERSENSITIVITY, HEADACHE, BLADDER DISORDER, PAIN IN EXTREMITY, ARTHRALGIA, DISTURBANCE IN ATTENTION, PREMATURE MENOPAUSE, AUTOIMMUNE DISORDER, FEELING ABNORMAL, ALOPECIA AND AMNESIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, PROCEDURAL PAIN, UTERINE PAIN, BACK PAIN, INTERMENSTRUAL BLEEDING, COMPLICATION OF DEVICE INSERTION, HORMONE LEVEL ABNORMAL, FATIGUE AND MEMORY IMPAIRMENT HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, AMNESIA, ARTHRALGIA, AUTOIMMUNE DISORDER, BACK PAIN, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, DISTURBANCE IN ATTENTION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERSENSITIVITY, INTERMENSTRUAL BLEEDING, MEMORY IMPAIRMENT, MENSTRUAL DISORDER, PAIN IN EXTREMITY, PREMATURE MENOPAUSE, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2011 THE LEFT SIDE WAS PLACED, BUT THE RIGHT WAS UNSUCCESSFUL AND WAS THEN DONE ON (B)(6) 2011. BOTH WITH GREAT DIFFICULTY, ONE TOO DEEP AND THE OTHER ONE NOT DEEP ENOUGH. THE ESSURE REMOVAL WAS PERFORMED BY PATIENT¿S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. AFTER REMOVAL OF THE ESSURE, IN ALL THE PLAINTIFFS (NEARLY) ALL OF THE COMPLAINTS DISAPPEARED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: PASSAGEABLE TUBAE; IN (B)(6) 2012: ESSURE CORRECTLY IN SITU. ULTRASOUND SCAN - IN (B)(6) 2012: NOT CONCLUSIVE. LOT NUMBER: 846839, MANUFACTURE DATE: 2011-04, EXPIRATION DATE: 2014-04. 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 2-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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PROCEDURAL PAIN ("MUCH PAIN"), ABDOMINAL PAIN ("PAIN ABDOMEN"), GENITAL HAEMORRHAGE ("REGULAR BLEEDINGS") AND VAGINAL HAEMORRHAGE ("VAGINAL BLOOD LOSS / STILL FLOWING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 846839 (INVALID)) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND BLOOD LOSS OF (NOS) IN 2009. CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. IN 2011, 170 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("PAIN IN LEGS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), METRORRHAGIA ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), UTERINE PAIN ("PAIN IN UTERUS"), HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH MORPHINE, SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPARASCOPIC TUBECTOMY), SURGERY (FREEZING OF ENDOMETRIUM AND UTERUS WAS REMOVED IN 2013) AND SURGERY (THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PROCEDURAL PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, COMPLICATION OF DEVICE INSERTION, METRORRHAGIA, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT AND BACK PAIN HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, COMPLICATION OF DEVICE INSERTION, FATIGUE, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MEMORY IMPAIRMENT, METRORRHAGIA, PAIN IN EXTREMITY, PROCEDURAL PAIN, UTERINE PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE REMOVAL WAS PERFORMED BY PATIENT'S REQUEST. THE PHYSICIAN REPORTED THE EVENTS COULD BE ASSOCIATED TO ESSURE DEVICES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): (B)(6). HYSTEROSALPINGOGRAM - IN (B)(6) 2012: CORRECTLY IN SITU; ON AN UNKNOWN DATE: PASSAGEABLE TUBAE (B)(6) 2012. TEST: ECHO. RESULT: NOT CONCLUSIVE . THE LIST OF DEVICE SIMILAR INCIDENTS 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 17-MAY-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: PROCEDURAL PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 177 CASES. ABDOMINAL PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1049 CASES. GENITAL HAEMORRHAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 544 CASES. VAGINAL HAEMORRHAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 62 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 PTS. QUALITY-SAFETY EVALUATION OF PTC: BASED ON THE TECHNICAL ASSESSMENT, NEITHER SAMPLE NOR VALID LOT NUMBER WAS PROVIDED THEREFORE, THE QUALITY UNIT WAS UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD OR PERFORM A SAMPLE INVESTIGATION. THE QUALITY UNIT WAS UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME BECAUSE THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. A PTC INVESTIGATION CANNOT BE INITIATED AS A VALID BATCH NUMBER OR SAMPLE WAS NOT PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-MAY-2017: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUCH PAIN DURING ESSURE INSERTION. SHE WAS HOSPITALIZED AND RECEIVED MORPHINE FOR THE PAIN. AFTER PLACEMENT, SHE EXPERIENCED REGULAR BLEEDINGS (SEEN AS GENITAL BLEEDING), PAIN ABDOMEN AND VAGINAL BLOOD LOSS / STILL FLOWING (SEEN AS VAGINAL BLEEDING). SHE WAS TREATED WITH BURNING MUCOUS MEMBRANE OF THE UTERUS, FREEZING OF ENDOMETRIUM, CURETTAGE. SHE WAS HOSPITALIZED. A REMOVAL OF UTERUS (VAGINAL UTERUS EXTIRPATION), THERMABLATE, AND ESSURE COILS REMOVED VIA LAPAROSCOPIC TUBECTOMY WERE PERFORMED. THIS CASE WAS CONSIDERED POTENTIAL LEGAL. THE EVENTS ARE CONSIDERED ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PAIN MAY OCCUR DURING AND FOLLOWING THE MICRO-INSERT PLACEMENT PROCEDURE. IN ADDITION, GENITAL BLEEDING, VAGINAL BLEEDING AND ABDOMINAL PAIN MAY ALSO OCCUR WITH ESSURE THERAPY. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE MEDICAL INTERVENTION AND DEVICE REMOVAL WERE REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL INVESTIGATION CANNOT BE INITIATED AS A VALID BATCH NUMBER OR SAMPLE WAS NOT PROVIDED THUS RESULTING IN AN UNCONFIRMED QUALITY DEFECT.
QUALITY SAFETY EVALUATION OF PTC RECEIVED ON 11-NOV-2016: PTC GLOBAL NUMBER (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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 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 MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS CASE BECAME VALID UPON RECEIPT OF FOLLOW-UP INFORMATION. THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUCH PAIN DURING ESSURE INSERTION. SHE WAS HOSPITALIZED AND RECEIVED MORPHINE FOR THE PAIN. AFTER PLACEMENT, SHE EXPERIENCED REGULAR BLEEDINGS (SEEN AS GENITAL BLEEDING) AND PAIN ABDOMEN. SHE WAS TREATED WITH BURNING MUCOUS MEMBRANE OF THE UTERUS AND CURETTAGE. SHE WAS HOSPITALIZED AND REMOVAL OF UTERUS AND ESSURE COILS WERE PERFORMED. THIS CASE WAS CONSIDERED POTENTIAL LEGAL. THE EVENTS ARE CONSIDERED ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PAIN MAY OCCUR DURING AND FOLLOWING THE MICRO-INSERT PLACEMENT PROCEDURE. IN ADDITION, GENITAL BLEEDING AND ABDOMINAL PAIN MAY ALSO OCCUR WITH ESSURE THERAPY. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE AN INTERVENTION WAS REQUIRED FOR THE PAIN (USE OF MORPHINE) AND A DEVICE REMOVAL WAS REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION HAS BEEN REQUESTED.
THE PATIENT'S PAST MEDICAL HISTORY INCLUDED VAGINAL DELIVERY AND BLOOD LOSS OF (NOS). CONCURRENT CONDITIONS INCLUDED ASTHMA AND SMOKER. ON (B)(6) 2011, THE PATIENT STARTED ESSURE. IN 2011, THE PATIENT EXPERIENCED PAIN IN EXTREMITY ("PAIN IN LEGS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), COMPLICATION OF DEVICE INSERTION ("LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE"), METRORRHAGIA ("BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS)"), UTERINE PAIN ("PAIN IN UTERUS"), HORMONE LEVEL ABNORMAL ("HORMONAL COMPLAINTS"), FATIGUE ("EXTREME FATIGUE"), MEMORY IMPAIRMENT ("EXTREME FORGETFULNESS") AND BACK PAIN ("PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE"). ON (B)(6) 2011, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH MORPHINE, SURGERY (ESSURES WERE REMOVED ON (B)(6) 2016 VIA LAPAROSCOPIC TUBECTOMY), SURGERY (FREEZING OF ENDOMETRIUM AND UTERUS WAS REMOVED IN 2013) AND SURGERY (THERMABLATE IN 2012 AND VAGINAL UTERUS EXTIRPATION ON (B)(6) 2013). AT THE TIME OF THE REPORT, THE PROCEDURAL PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, COMPLICATION OF DEVICE INSERTION, METRORRHAGIA, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT AND BACK PAIN HAD NOT RESOLVED AND THE VAGINAL HAEMORRHAGE AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PROCEDURAL PAIN, ABDOMINAL PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, COMPLICATION OF DEVICE INSERTION, METRORRHAGIA, UTERINE PAIN, HORMONE LEVEL ABNORMAL, FATIGUE, MEMORY IMPAIRMENT, BACK PAIN AND PAIN IN EXTREMITY TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IN (B)(6) 2012: HYSTEROSALPINGOGRAM RESULT WAS CORRECTLY IN SITU. ON AN UNKNOWN DATE: HYSTEROSALPINGOGRAM RESULT WAS PASSAGEABLE TUBAE. ON (B)(6) 2012. TEST: ECHO. RESULT: NOT CONCLUSIVE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-FEB-2017: ESSURE DEVICE REMOVAL QUESTIONNAIRE RECEIVED: PATIENT DETAILS, MEDICAL HISTORY, CONCURRENT CONDITIONS, LOT NUMBERS, REMOVAL METHOD WERE PROVIDED. THE EVENTS VAGINAL BLOOD LOSS / STILL FLOWING AND PAIN LEGS WERE ADDED. NO FURTHER INFORMATION WILL BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUCH PAIN DURING ESSURE INSERTION. SHE WAS HOSPITALIZED AND RECEIVED MORPHINE FOR THE PAIN. AFTER PLACEMENT, SHE EXPERIENCED REGULAR BLEEDINGS (SEEN AS GENITAL BLEEDING), PAIN ABDOMEN AND VAGINAL BLOOD LOSS / STILL FLOWING (SEEN AS VAGINAL BLEEDING). SHE WAS TREATED WITH BURNING MUCOUS MEMBRANE OF THE UTERUS, FREEZING OF ENDOMETRIUM, CURETTAGE. SHE WAS HOSPITALIZED. A REMOVAL OF UTERUS (VAGINAL UTERUS EXTIRPATION), THERMABLATE, AND ESSURE COILS REMOVED VIA LAPAROSCOPIC TUBECTOMY WERE PERFORMED. THIS CASE WAS CONSIDERED POTENTIAL LEGAL. THE EVENTS ARE CONSIDERED ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PAIN MAY OCCUR DURING AND FOLLOWING THE MICRO-INSERT PLACEMENT PROCEDURE. IN ADDITION, GENITAL BLEEDING, VAGINAL BLEEDING AND ABDOMINAL PAIN MAY ALSO OCCUR WITH ESSURE THERAPY. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE MEDICAL INTERVENTION AND DEVICE REMOVAL WERE REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. AS LOT NUMBER WAS PROVIDED, AN UPDATED PRODUCT TECHNICAL COMPLAINT IS EXPECTED.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER (VIA LETTER IN WHICH SHE HOLDS BAYER LIABLE FOR THE DAMAGE CAUSED) IN (B)(6) ON (B)(6) 2016 WHICH REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2011. THIS CASE WAS PREVIOUSLY RECEIVED FROM CONSUMER ON (B)(6) 2016 BUT IT WAS INVALID DUE TO UNSPECIFIED EVENT BUT A FOLLOW UP INFORMATION ALSO RECEIVED FROM CONSUMER ON (B)(6) 2016 THAT BECAME THIS CASE TO BE VALID. AROUND (B)(6) 2011 THE SYMPTOMS STARTED AND CONSUMER HAS NOT RECOVERED. ON (B)(6) 2011 PLACEMENT ESSURE OCCURRED, LEFT SIDE WAS SUCCESSFUL, RIGHT SIDE WAS NOT AND IT WAS DECIDED TO TRY AGAIN ON THE RIGHT SIDE ON (B)(6) 2016 (AS REPORTED, DISCREPANCY). THIS WAS SUCCESSFUL AFTER MUCH PAIN AND TROUBLE, AFTERWARDS HOSPITALIZATION WITH MORPHINE FOR THE PAIN. AFTER PLACEMENT SHE HAD BLEEDINGS AFTER DOING SPORTS (IN BETWEEN MENSTRUATIONS) AND REGULAR BLEEDINGS AND PAIN ABDOMEN/UTERUS, MANY COMPLAINTS. AFTERWARDS BURNED SLIME IN UTERUS, AFTERWARDS COMPLAINTS, NO BLEEDING, HOSPITALIZATION FOR COMPLAINTS (CURETTAGE) BECAUSE OF PERSISTENT COMPLAINTS AND DECIDED TO REMOVE THE UTERUS. SINCE PLACEMENT ESSURE, MANY HORMONAL COMPLAINTS, EXTREME FATIGUE AND EXTREME FORGETFULNESS, PAIN LOWER BACK WITH PAIN RADIATING TO LEGS, WITHOUT CAUSE. CONSUMER WAS TREATED WITH BURNING MUCOUS MEMBRANE OF THE UTERUS AND CURETTAGE, REMOVAL OF UTERUS AND REMOVAL OF ESSURE WHICH OCCURRED ON (B)(6) 2016 (AS REPORTED, DISCREPANCY). SHE WAS HOSPITALIZED. COMPANY CAUSALITY COMMENT: THIS CASE BECAME VALID UPON RECEIPT OF FOLLOW-UP INFORMATION. THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUCH PAIN DURING ESSURE INSERTION. SHE WAS HOSPITALIZED AND RECEIVED MORPHINE FOR THE PAIN. AFTER PLACEMENT, SHE EXPERIENCED REGULAR BLEEDINGS (SEEN AS GENITAL BLEEDING) AND PAIN ABDOMEN. SHE WAS TREATED WITH BURNING MUCOUS MEMBRANE OF THE UTERUS AND CURETTAGE. SHE WAS HOSPITALIZED AND REMOVAL OF UTERUS AND ESSURE COILS WERE PERFORMED. THIS CASE WAS CONSIDERED POTENTIAL LEGAL. THE EVENTS ARE CONSIDERED ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PAIN MAY OCCUR DURING AND FOLLOWING THE MICRO-INSERT PLACEMENT PROCEDURE. IN ADDITION, GENITAL BLEEDING AND ABDOMINAL PAIN MAY ALSO OCCUR WITH ESSURE THERAPY. BASED ON A COMPATIBLE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP BETWEEN THE EVENTS WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE AN INTERVENTION WAS REQUIRED FOR THE PAIN (USE OF MORPHINE) AND A DEVICE REMOVAL WAS REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. FURTHER INFORMATION AND PRODUCT TECHNICAL ANALYSIS ARE BEING SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745991 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 846839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Hospitalization| R| O |