ESSURE
Report
- Report Number
- 2951250-2018-03480
- Event Type
- Injury
- Date Received
- August 10, 2018
- Date of Event
- May 1, 2011
- Report Date
- September 2, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND ENDOMETRITIS ("INFECTION (OTHER) DESCRIBE: ENDOMETRITIS") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, MULTIPLE ALLERGIES AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AZELASTINE, BUDESONIDE;FORMOTEROL FUMARATE (SYMBICORT), ERGOCALCIFEROL, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LOESTRIN FE), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), ETHINYLESTRADIOL;NORGESTIMATE (TRINESSA), MONTELUKAST, SALBUTAMOL SULFATE (PROAIR HFA), SERTACONAZOLE NITRATE (SERTALIN) AND TRAZODONE HYDROCHLORIDE (TRAZADOL). ON (B)(6)2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). IN (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /EXCESSIVE MENSTRUATION/ FREQUENT MENSTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6)2011, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6)2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED, THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN, PAIN IN EXTREMITY, ANXIETY AND NAUSEA OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DISCREPANCY NOTED : INPLANT:(B)(6)2011 , (B)(6)2010 EXPLANT: (B)(6)2012. CURRENT WEIGHT: 174 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2010: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6)2011: RESULTS: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6)2011: RESULTS: TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2018: PFS RECEIVED. REPORTERS INFORMATION UPDATED. EVENT OUTCOME FOR MENORRHAGIA UPDATED. CONCOMITANT DRUGS , MEDICAL HISTORY WERE ADDED. EXPLANTED DATE ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PERSISTENT PELVIC PAIN') AND ENDOMETRITIS ('INFECTION (OTHER) DESCRIBE: ENDOMETRITIS') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, MULTIPLE ALLERGIES AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AZELASTINE, BUDESONIDE;FORMOTEROL FUMARATE (SYMBICORT), ERGOCALCIFEROL, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LOESTRIN FE), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), ETHINYLESTRADIOL;NORGESTIMATE (TRINESSA), MONTELUKAST, SALBUTAMOL SULFATE (PROAIR HFA), SERTACONAZOLE NITRATE (SERTALIN) AND TRAZODONE HYDROCHLORIDE (TRAZADOL). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /EXCESSIVE MENSTRUATION/ FREQUENT MENSTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN, PAIN IN EXTREMITY, ANXIETY AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DISCREPANCY NOTED : INPLANT:(B)(6) 2011 , (B)(6) 2010 EXPLANT: (B)(6) 2012, CURRENT WEIGHT: 174 LBS PATIENT RECEIVED TREATMENT FOR : PAIN , ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: RESULTS: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION.. LOT NUMBER: 822365 MANUFACTURING DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-SEP-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 PELVIC PAIN ('PERSISTENT PELVIC PAIN') AND ENDOMETRITIS ('INFECTION (OTHER) DESCRIBE: ENDOMETRITIS') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, MULTIPLE ALLERGIES AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AZELASTINE, BUDESONIDE;FORMOTEROL FUMARATE (SYMBICORT), ERGOCALCIFEROL, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LOESTRIN FE), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), ETHINYLESTRADIOL;NORGESTIMATE (TRINESSA), MONTELUKAST, SALBUTAMOL SULFATE (PROAIR HFA), SERTACONAZOLE NITRATE (SERTALIN) AND TRAZODONE HYDROCHLORIDE (TRAZADOL). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /EXCESSIVE MENSTRUATION/ FREQUENT MENSTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN, PAIN IN EXTREMITY, ANXIETY AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DISCREPANCY NOTED : INPLANT:(B)(6) 2011 , (B)(6) 2010 EXPLANT: (B)(6) 2012, (B)(6) 2012. CURRENT WEIGHT: 174 LBS. PATIENT RECEIVED TREATMENT FOR : PAIN , ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: RESULTS: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. EVENT OUTCOME WERE UPDATED : PAIN , ABNORMAL BLEEDING. 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND ENDOMETRITIS ("INFECTION (OTHER) DESCRIBE: ENDOMETRITIS") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED INSOMNIA. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED ON (B)(6) 2012). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN, PAIN IN EXTREMITY, ANXIETY AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENT ADDED: NAUSEA AND MENTAL ANGUISH. INCIDENT: AT THE TIME OF REPORTING, 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 PELVIC PAIN ('PERSISTENT PELVIC PAIN') AND ENDOMETRITIS ('INFECTION (OTHER) DESCRIBE: ENDOMETRITIS') IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED BODY MASS INDEX NORMAL. CONCURRENT CONDITIONS INCLUDED INSOMNIA, MULTIPLE ALLERGIES AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED AZELASTINE, BUDESONIDE;FORMOTEROL FUMARATE (SYMBICORT), ERGOCALCIFEROL, ETHINYLESTRADIOL;FERROUS FUMARATE;NORETHISTERONE ACETATE (LOESTRIN FE), ETHINYLESTRADIOL;NORGESTIMATE (ORTHO TRI-CYCLEN), ETHINYLESTRADIOL;NORGESTIMATE (TRINESSA), MONTELUKAST, SALBUTAMOL SULFATE (PROAIR HFA), SERTACONAZOLE NITRATE (SERTALIN) AND TRAZODONE HYDROCHLORIDE (TRAZADOL). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS: MENTAL ANGUISH"). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) /EXCESSIVE MENSTRUATION/ FREQUENT MENSTRUATION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND NAUSEA ("NAUSEA") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2011, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"). IN 2012, THE PATIENT EXPERIENCED UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED AND THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN, PAIN IN EXTREMITY, ANXIETY AND NAUSEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DISCREPANCY NOTED : INPLANT:(B)(6) 2011 , (B)(6) 2010 EXPLANT: (B)(6) 2012 ,(B)(6) 2012. CURRENT WEIGHT: 174 LBS. PATIENT RECEIVED TREATMENT FOR : PAIN , ABNORMAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: RESULTS: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. EVENT OUTCOME WERE UPDATED : PAIN , ABNORMAL BLEEDING . 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN") AND ENDOMETRITIS ("INFECTION (OTHER) DESCRIBE: ENDOMETRITIS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822365) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED INSOMNIA. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"), HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES"), UTERINE ENLARGEMENT ("REPRODUCTIVE SYSTEM DISORDER OR CONDITION TYPE OF DISORDER OR CONDITION: ENLARGED UTERUS"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND PAIN IN EXTREMITY ("PAIN UPPER LEG AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUAL BLEEDING"), HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING") AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL):UTERUS AND CERVIX REMOVED ON (B)(6) 2012). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD NOT RESOLVED AND THE ENDOMETRITIS, MENSTRUAL DISORDER, HORMONE LEVEL ABNORMAL, MENORRHAGIA, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, DEPRESSION, HEADACHE, MIGRAINE, UTERINE ENLARGEMENT, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, MENOMETRORRHAGIA, ABDOMINAL PAIN AND PAIN IN EXTREMITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, FEMALE SEXUAL DYSFUNCTION, HEADACHE, HORMONE LEVEL ABNORMAL, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, PAIN IN EXTREMITY, PELVIC PAIN, UTERINE ENLARGEMENT, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PER PFS: ESSURE WAS NOT REMOVED AND SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2011: THE PROCEDURE WAS SUCCESSFUL; ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2017: CASE CORRECTION: SINCE THE PATIENT UNDERWENT HYSTERECTOMY AS TREATMENT FOR ESSURE´S RELATED COMPLAINTS, INTERVENTION REQUIRED WAS SELECTED. ON 1-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL PROBLEM UPDATE. INCIDENT: AT THE TIME OF REPORTING, 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612714 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822365 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | AZELASTINE| AZELASTINE| AZELASTINE| AZELASTINE| ERGOCALCIFEROL| ERGOCALCIFEROL| ERGOCALCIFEROL| ERGOCALCIFEROL| LOESTRIN FE| LOESTRIN FE| LOESTRIN FE| LOESTRIN FE| MONTELUKAST| MONTELUKAST| MONTELUKAST| MONTELUKAST| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| PROAIR HFA| PROAIR HFA| PROAIR HFA| PROAIR HFA| SERTALIN| SERTALIN| SERTALIN| SERTALIN| SYMBICORT| SYMBICORT| SYMBICORT| SYMBICORT| TRAZADOL| TRAZADOL| TRAZADOL| TRAZADOL| TRINESSA| TRINESSA| TRINESSA| TRINESSA| ORTHO TRI-CYCLEN |