ESSURE
Report
- Report Number
- 2951250-2017-05771
- Event Type
- Injury
- Date Received
- October 30, 2017
- Date of Event
- April 1, 2012
- Report Date
- April 9, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THE SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION BY DEVICE") AND GENITAL HAEMORRHAGE ("HEMORRHAGING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MISCARRIAGE AND PARITY 4. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (PLAINTIFF HAD UNDERWENT A PARTIAL HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUL-2018: PFS AND MEDICAL RECORD RECEIVED: THE EVENT ABNORMAL VAGINAL BLEEDING, MENORRHAGIA, DEPRESSION, MENTAL ANGUISH, DYSMENORRHEA, WEIGHT GAIN ADDED. REPORTERS AND LOT NUMBER ADDED. 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.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS") AND GENITAL HAEMORRHAGE ("HEMORRHAGING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA"), WEIGHT INCREASED ("WEIGHT GAIN"), URINARY TRACT INFECTION ("UTI"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), ANAEMIA ("ANEMIA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN") AND MOOD SWINGS ("MOOD SWINGS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND MEDICAL RECORD RECEIVED:EVENT UTI, BLADDER PROBLEMS, URINARY TRACT DISORDER, MIGRAINES, HEADACHES, PARTIAL EXPULSION OF IUD, NAUSEA, ANEMIA, LEFT LOWER SIDE PAIN ADDED. PRODUCT STOP DATE CHANGED 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 UTERINE PERFORATION ("PERFORATION BY DEVICE") AND GENITAL HAEMORRHAGE ("HEMORRHAGING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), MENORRHAGIA ("MENORRHAGIA"), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), DYSMENORRHOEA ("DYSMENORRHEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (PLAINTIFF HAD UNDERWENT A PARTIAL HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PELVIC PAIN, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, DYSMENORRHOEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-AUG-2018: QUALITY SAFETY EVALUATION OF PTC. 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 UTERINE PERFORATION ('PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS') AND MENORRHAGIA ('MENORRHAGIA') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, VAGINAL PROLAPSE, URETHRAL PROLAPSE AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE (B)(6) 2017 FOR HYPERTENSION AS WELL AS ESOMEPRAZOLE MAGNESIUM;NAPROXEN (VIMOVO) (B)(6) 2013 TO (B)(6) 2013, FERROUS SULFATE (FEOSOL), IBUPROFEN FROM (B)(6) 2013 TO (B)(6) 2013, OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) FROM (B)(6) 2018 TO (B)(6) 2018, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2018 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"), 1 MONTH 31 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN ("PAIN:ABDOMINAL AREA"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE:") AND BLADDER DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BLADDER PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("OTHER INJURY(IES) OR COMPLICATION-PLEASE DESCRIBE: ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEMORRHAGING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN"), MOOD SWINGS ("MOOD SWINGS"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA"), DERMATITIS ALLERGIC ("ALLEGRY - RASH /SKIN CONDITION") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, DILATATION AND CURETTAGE AND HYSTERECTOMY (FULL) DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, METRORRHAGIA AND DERMATITIS ALLERGIC HAD RESOLVED, THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA, MOOD SWINGS, BACK PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 AND (B)(6) 2018 UNILATERAL SALPINGO-OOPHERECTOMY - LEFT SIDE HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY - RIGHT SIDE RECEIVED TREATMENT FOR PAIN, BLEEDING, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011 (AS REPORTED). LOT NUMBER: 863566 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-MAY-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 UTERINE PERFORATION ('PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS'), MENORRHAGIA ('MENORRHAGIA') AND ENDOMETRITIS ('CHRONIC ENDOMETRITIS') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION, PARITY 4, STRESS URINARY INCONTINENCE AND MENOMETRORRHAGIA. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, VAGINAL PROLAPSE, URETHRAL PROLAPSE, MORBID OBESITY, ENDOMETRIAL DISORDER, PARATUBAL CYST AND ENDOMETRIAL POLYP. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE (B)(6) 2017 FOR HYPERTENSION AS WELL AS ESOMEPRAZOLE MAGNESIUM;NAPROXEN (VIMOVO) (B)(6) 2013 TO (B)(6) 2013, FERROUS SULFATE (FEOSOL), IBUPROFEN FROM (B)(6) 2013 TO (B)(6) 2013, OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) FROM (B)(6) 2018 TO (B)(6) 2018, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2018 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"), 1 MONTH 31 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN ("PAIN:ABDOMINAL AREA"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE:") AND BLADDER DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BLADDER PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("OTHER INJURY(IES) OR COMPLICATION-PLEASE DESCRIBE: ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEMORRHAGING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN"), MOOD SWINGS ("MOOD SWINGS"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA"), DERMATITIS ALLERGIC ("ALLERGY - RASH /SKIN CONDITION"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, DILATATION AND CURETTAGE AND HYSTERECTOMY (FULL) DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, METRORRHAGIA, DERMATITIS ALLERGIC AND HYPERSENSITIVITY HAD RESOLVED, THE ENDOMETRITIS, MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA, MOOD SWINGS, BACK PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, ENDOMETRITIS, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 AND (B)(6) 2018 UNILATERAL SALPINGO-OOPHORECTOMY - LEFT SIDE HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY - RIGHT SIDE RECEIVED TREATMENT FOR PAIN, BLEEDING , MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: SUCCESSFUL ESSURE PROCEDURE. IMAGING PROCEDURE - ON (B)(6) 2012: NOT PROVIDED. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011 (AS REPORTED).. LOT NUMBER: 863566 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-APR-2021: MR RECEIVED. REPORTER'S INFORMATION ADDED. LAB DATA ADDED. EVENT:CHRONIC ENDOMETRITIS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS') AND MENORRHAGIA ('MENORRHAGIA') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, VAGINAL PROLAPSE, URETHRAL PROLAPSE AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE (B)(6) 2017 FOR HYPERTENSION AS WELL AS ESOMEPRAZOLE MAGNESIUM;NAPROXEN (VIMOVO)14-JUN-2013 TO (B)(6) 2013, FERROUS SULFATE (FEOSOL), IBUPROFEN FROM (B)(6) 2013 TO (B)(6) 2013, OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) FROM 31-MAY-2018 TO 17-JUL-2018, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2018 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"), 1 MONTH 31 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN ("PAIN:ABDOMINAL AREA"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE:") AND BLADDER DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BLADDER PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("OTHER INJURY(IES) OR COMPLICATION-PLEASE DESCRIBE: ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEMORRHAGING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN"), MOOD SWINGS ("MOOD SWINGS"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA"), DERMATITIS ALLERGIC ("ALLEGRY - RASH /SKIN CONDITION"), POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION") AND HYPERSENSITIVITY ("ALLERGIC REACTION"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, DILATATION AND CURETTAGE AND HYSTERECTOMY (FULL) DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, METRORRHAGIA, DERMATITIS ALLERGIC AND HYPERSENSITIVITY HAD RESOLVED, THE MENSTRUAL DISORDER, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA, MOOD SWINGS, BACK PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 AND (B)(6) 2018 UNILATERAL SALPINGO-OOPHERECTOMY - LEFT SIDE HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY - RIGHT SIDE RECEIVED TREATMENT FOR PAIN, BLEEDING , MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. IMAGING PROCEDURE - ON (B)(6) 2012: NOT PROVIDED. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011 (AS REPORTED).. LOT NUMBER: 863566 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED. REPORTER INFORMATION ADDED. EVENT OUTCOME WERE UPDATED. EVENT: ALLERGIC REACTION ADDED. ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT 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 UTERINE PERFORATION ('PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS') AND MENORRHAGIA ('MENORRHAGIA') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, VAGINAL PROLAPSE, URETHRAL PROLAPSE AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE (B)(6) 2017 FOR HYPERTENSION AS WELL AS ESOMEPRAZOLE MAGNESIUM;NAPROXEN (VIMOVO) (B)(6) 2013 TO (B)(6) 2013, FERROUS SULFATE (FEOSOL), IBUPROFEN FROM (B)(6) 2013 TO (B)(6) 2013, OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) FROM (B)(6) 2018 TO (B)(6) 2018, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2018 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"), 1 MONTH 31 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN ("PAIN:ABDOMINAL AREA"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE:") AND BLADDER DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BLADDER PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("OTHER INJURY(IES) OR COMPLICATION-PLEASE DESCRIBE: ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("HEMORRHAGING"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN"), MOOD SWINGS ("MOOD SWINGS"), BACK PAIN ("BACK PAIN"), METRORRHAGIA ("METRORRHAGIA"), DERMATITIS ALLERGIC ("ALLEGRY - RASH /SKIN CONDITION") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, DILATATION AND CURETTAGE AND HYSTERECTOMY (FULL) DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, PELVIC PAIN, METRORRHAGIA AND DERMATITIS ALLERGIC HAD RESOLVED, THE MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA, MOOD SWINGS, BACK PAIN AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BACK PAIN, BLADDER DISORDER, DEPRESSION, DERMATITIS ALLERGIC, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 AND (B)(6) 2018 UNILATERAL SALPINGO-OOPHERECTOMY - LEFT SIDE HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY - RIGHT SIDE RECEIVED TREATMENT FOR PAIN, BLEEDING , MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011 (AS REPORTED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PLAINTIFF FACT SHEET REVIVED, NEW REPORTER, EVENT BACK PAIN, METRORRHAGIA , ALLERGY, COMPLICATION OF DEVICE REMOVAL AND OUTCOME OF THE EVENT ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION BY DEVICE/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: WIRE EXTRUDING FROM LEFT SIDE OF UTERUS"), MENORRHAGIA ("MENORRHAGIA") AND GENITAL HAEMORRHAGE ("HEMORRHAGING") IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863566) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RECURRENT ABORTION AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, VAGINAL PROLAPSE, URETHRAL PROLAPSE AND MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED LOSARTAN SINCE (B)(6) 2017 FOR HYPERTENSION AS WELL AS ESOMEPRAZOLE MAGNESIUM;NAPROXEN (VIMOVO) (B)(6) 2013 TO (B)(6) 2013, FERROUS SULFATE (FEOSOL), IBUPROFEN FROM (B)(6) 2013 TO (B)(6) 2013, OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) FROM (B)(6) 2018 TO (B)(6) 2018, PARACETAMOL (ACETAMINOPHEN) FROM (B)(6) 2012 TO (B)(6) 2018 AND VITAMIN D NOS (VITAMIN D) FROM (B)(6) 2013 TO (B)(6) 2013. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"), 1 MONTH 31 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL VAGINAL BLEEDING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: DEPRESSION"), ANXIETY ("PSYCHOLOGICAL OR PSYCHAITRIC PROBLEMS-CONDITION: MENTAL ANGUISH") AND ABDOMINAL PAIN ("PAIN:ABDOMINAL AREA"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/LOSS (SPECIFY WHICH ONE) WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE") AND BLADDER DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BLADDER PROBLEMS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ANAEMIA ("OTHER INJURY(IES) OR COMPLICATION-PLEASE DESCRIBE: ANEMIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), NAUSEA ("NAUSEA"), ABDOMINAL PAIN LOWER ("LEFT LOWER SIDE PAIN") AND MOOD SWINGS ("MOOD SWINGS"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION, DILATATION AND CURETTAGE AND HYSTERECTOMY (FULL) DUE TO COMPLICATIONS FROM THE ESSURE DEVICE/). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, MENORRHAGIA, GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, DEPRESSION, ANXIETY, DYSMENORRHOEA, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, ANAEMIA AND MOOD SWINGS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANAEMIA, ANXIETY, BLADDER DISORDER, DEPRESSION, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 AND (B)(6) 2018 UNILATERAL SALPINGO-OOPHORECTOMY LEFT SIDE HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY RIGHT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.7 KG/SQM. HYSTEROSALPINGOGRAM ON (B)(6) 2012: RESULTS: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION ON (B)(6) 2011 (AS REPORTED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-APR-2019: PFS RECEIVED. REPORTER'S INFORMATION WAS ADDED. ADDED EVENT ABDOMINAL PAIN. UPDATED OUTCOME OF EVENT: ABDOMINAL PAIN. UPDATED EVENT ONSET DATE. CONCOMITANT CONDITION, CONCOMITANT DRUG, LAB DATA WERE 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 UTERINE PERFORATION ("PERFORATION BY DEVICE") AND GENITAL HAEMORRHAGE ("HEMORRHAGING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (PLAINTIFF HAD UNDERWENT A PARTIAL HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, MENSTRUAL DISORDER, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. COMPANY CAUSALITY COMMENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768156 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| FEOSOL| FEOSOL| FEOSOL| FEOSOL| FEOSOL| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| LOSARTAN| LOSARTAN| LOSARTAN| LOSARTAN| LOSARTAN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| VIMOVO| VIMOVO| VIMOVO| VIMOVO| VIMOVO| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS] |