ESSURE
Report
- Report Number
- 2951250-2016-02805
- Event Type
- Injury
- Date Received
- December 22, 2016
- Date of Event
- December 1, 2011
- Report Date
- November 16, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA /MANUF AND USER FACILITY DEVICE EXP, REFERENCE NUMBER: MW5031458) ON (B)(6) -2013. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRAGMENTS OF COILED METALLIC WIRE"), ABDOMINAL PAIN LOWER ("CRAMPING"), SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") AND UTERINE HAEMORRHAGE ("UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (09AUG200, 18APR2002, 18JUL2007 & 23FEB2009.), PRE-ECLAMPSIA, BLOOD PRESSURE HIGH AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2009 TO 2010. CONCURRENT CONDITIONS INCLUDED FATIGUE, MALAISE, HORMONAL IMBALANCE, ADENOMYOSIS AND RETROVERTED UTERUS. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SYSTEMIC LEAKAGE (SERIOUSNESS CRITERION HOSPITALIZATION) AND COMPLICATION OF DEVICE INSERTION ("THEY SAID I HAD FLUID IN ME"). IN 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/ HEADACHES (MIGRAINE PAIN, SEVERE AND DEBILITATING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("HEALTH PROBLEMS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), LIVER DISORDER ("LIVER PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("DISCHARGE"), DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL") WITH ABDOMINAL DISTENSION AND RASH, MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), UTERINE DISORDER ("UTERUS WAS DISEASED"), PELVIC PAIN ("PELVIC CRAMPING"), HEADACHE ("HEADACHE"), PAIN ("BODY ACHE") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY AND SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6)2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, SYSTEMIC LEAKAGE, COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION, SYSTEMIC LUPUS ERYTHEMATOSUS, INTERVERTEBRAL DISC DEGENERATION, SLEEP APNOEA SYNDROME, LIVER DISORDER, NAUSEA, WEIGHT INCREASED, VAGINAL DISCHARGE, DYSPAREUNIA, FATIGUE, ALOPECIA, ALLERGY TO METALS, MENTAL DISORDER AND UTERINE DISORDER OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, PELVIC PAIN AND HEADACHE HAD RESOLVED, THE FIBROMYALGIA, BACK PAIN AND FEELING ABNORMAL HAD NOT RESOLVED AND THE MIGRAINE AND PAIN WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION AND SYSTEMIC LEAKAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, INTERVERTEBRAL DISC DEGENERATION, LIVER DISORDER, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SLEEP APNOEA SYNDROME, SYSTEMIC LUPUS ERYTHEMATOSUS, UTERINE DISORDER, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROX. WEIGHT AT THE TIME OF ESSURE PLACEMENT: 180 SHE RAN TEST IN APPROXIMATELY 2012 FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE, SLEEP APNEA, LIVER PROBLEMS, NAUSEA, CRAMPING, HYSTERECTOMY AND SALPINGECTOMY IN 2016, SKIN RASHES, MIGRAINES, WEIGHT GAIN, DISCHARGE, PAINFUL SEXUAL INTERCOURSE, CRAMPING, FATIGUE, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: ESSURE CONFIRMATION TEST ON (B)(6) 2013 ABDOMEN SCAN REVEALED, TRANSABDOMINAL AND ENDOVANAL SCANNING WAS PERFORMED. THERE IS A SMALL AMOUNT OF FLUID IN THE ENDOMETRIAL CAVITY. THE ENDOMETRIAL WITH THE FLUID MEASURES 11MM. THE UTERUS IS EXTROVERTED AND HAS DIMENSIONS OF82 X 35 X 60 RUM, TRAK FREE PELVIC FLUID LIKELY PHYSIOLOGIC. THE OVARIES ARE SONOGRAPHIALLY NORMAL. THE RIGHT OVARY I 37 X 24 X. 21 NUNS AND THE LEFT OVARY IS 34 X 17 X 18 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN HEADACHE WEIGHT GAIN,HEAVY MENSTRUAL BLEEDING, DYSPAREUNIA QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)-2018: MR RECEIVED. NEW REPORTERS ADDED. CONCOMITANT CONDITION ADDED. EVENTS: DEVICE BREAKAGE ADDED. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA /MANUF AND USER FACILITY DEVICE EXP, REFERENCE NUMBER: MW5031458) ON 23-AUG-2013. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-NOV-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRAGMENTS OF COILED METALLIC WIRE"), ABDOMINAL PAIN LOWER ("CRAMPING"), SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") AND UTERINE HAEMORRHAGE ("UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: TREATMENT NONCOMPLIANCE "DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (B)(6) 2000, (B)(6) 2002, (B)(6) 2007 & (B)(6) 2009.), PRE-ECLAMPSIA, BLOOD PRESSURE HIGH AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2009 TO 2010. CONCURRENT CONDITIONS INCLUDED FATIGUE, MALAISE, HORMONAL IMBALANCE, ADENOMYOSIS AND RETROVERTED UTERUS. IN (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SYSTEMIC LEAKAGE (SERIOUSNESS CRITERION HOSPITALIZATION) AND COMPLICATION OF DEVICE INSERTION ("THEY SAID I HAD FLUID IN ME"). IN 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/ HEADACHES (MIGRAINE PAIN, SEVERE AND DEBILITATING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("HEALTH PROBLEMS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), LIVER DISORDER ("LIVER PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("DISCHARGE"), DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL") WITH ABDOMINAL DISTENSION AND RASH, MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), UTERINE DISORDER ("UTERUS WAS DISEASED"), PELVIC PAIN ("PELVIC CRAMPING"), HEADACHE ("HEADACHE"), PAIN ("BODY ACHE") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY AND SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, SYSTEMIC LEAKAGE, COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION, SYSTEMIC LUPUS ERYTHEMATOSUS, INTERVERTEBRAL DISC DEGENERATION, SLEEP APNOEA SYNDROME, LIVER DISORDER, NAUSEA, WEIGHT INCREASED, VAGINAL DISCHARGE, DYSPAREUNIA, FATIGUE, ALOPECIA, ALLERGY TO METALS, MENTAL DISORDER AND UTERINE DISORDER OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, PELVIC PAIN AND HEADACHE HAD RESOLVED, THE FIBROMYALGIA, BACK PAIN AND FEELING ABNORMAL HAD NOT RESOLVED AND THE MIGRAINE AND PAIN WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION AND SYSTEMIC LEAKAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, INTERVERTEBRAL DISC DEGENERATION, LIVER DISORDER, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SLEEP APNOEA SYNDROME, SYSTEMIC LUPUS ERYTHEMATOSUS, UTERINE DISORDER, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROX. WEIGHT AT THE TIME OF ESSURE PLACEMENT: 180 SHE RAN TEST IN APPROXIMATELY 2012 FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE, SLEEP APNEA, LIVER PROBLEMS, NAUSEA, CRAMPING, HYSTERECTOMY AND SALPINGECTOMY IN 2016, SKIN RASHES, MIGRAINES, WEIGHT GAIN, DISCHARGE, PAINFUL SEXUAL INTERCOURSE, CRAMPING, FATIGUE, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: ESSURE CONFIRMATION TEST ON (B)(6) 2013 ABDOMEN SCAN REVEALED, TRANSABDOMINAL AND ENDOVANAL SCANNING WAS PERFORMED. THERE IS A SMALL AMOUNT OF FLUID IN THE ENDOMETRIAL CAVITY. THE ENDOMETRIAL WITH THE FLUID MEASURES 11MM. THE UTERUS IS EXTROVERTED AND HAS DIMENSIONS OF82 X 35 X 60 RUM, TRAK FREE PELVIC FLUID LIKELY PHYSIOLOGIC. THE OVARIES ARE SONOGRAPHICALLY NORMAL. THE RIGHT OVARY I 37 X 24 X. 21 NUNS AND THE LEFT OVARY IS 34 X 17 X 18 MM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN HEADACHE WEIGHT GAIN,HEAVY MENSTRUAL BLEEDING, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA /MANUF AND USER FACILITY DEVICE EXP, REFERENCE NUMBER: (B)(4)) ON (B)(6)2013. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6)2018. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("CRAMPING"), SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") AND UTERINE HAEMORRHAGE ("UTERINE BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6)200, (B)(6)2002, (B)(6)2007 & (B)(6)2009.), PRE-ECLAMPSIA, BLOOD PRESSURE HIGH AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2009 TO 2010. IN JANUARY 2010, THE PATIENT HAD ESSURE INSERTED. IN DECEMBER 2011, THE PATIENT EXPERIENCED SYSTEMIC LEAKAGE (SERIOUSNESS CRITERION HOSPITALIZATION) AND COMPLICATION OF DEVICE INSERTION ("THEY SAID I HAD FLUID IN ME"). IN 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/ HEADACHES (MIGRAINE PAIN, SEVERE AND DEBILITATING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("HEALTH PROBLEMS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), LIVER DISORDER ("LIVER PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("DISCHARGE"), DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL") WITH ABDOMINAL DISTENSION AND RASH, TREATMENT NONCOMPLIANCE ("DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE: NO"), MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION"), UTERINE DISORDER ("UTERUS WAS DISEASED"), PELVIC PAIN ("PELVIC CRAMPING"), HEADACHE ("HEADACHE"), PAIN ("BODY ACHE") AND FEELING ABNORMAL ("BRAIN FOG"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY AND SALPINGECTOMY IN 2016). ESSURE WAS REMOVED IN MAY 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, UTERINE HAEMORRHAGE, PELVIC PAIN AND HEADACHE HAD RESOLVED, THE SYSTEMIC LEAKAGE, COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION, SYSTEMIC LUPUS ERYTHEMATOSUS, INTERVERTEBRAL DISC DEGENERATION, SLEEP APNOEA SYNDROME, LIVER DISORDER, NAUSEA, WEIGHT INCREASED, VAGINAL DISCHARGE, DYSPAREUNIA, FATIGUE, ALOPECIA, ALLERGY TO METALS, TREATMENT NONCOMPLIANCE, MENTAL DISORDER AND UTERINE DISORDER OUTCOME WAS UNKNOWN, THE FIBROMYALGIA, BACK PAIN AND FEELING ABNORMAL HAD NOT RESOLVED AND THE MIGRAINE AND PAIN WAS RESOLVING. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION AND SYSTEMIC LEAKAGE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, HEADACHE, INTERVERTEBRAL DISC DEGENERATION, LIVER DISORDER, MENTAL DISORDER, MIGRAINE, NAUSEA, PAIN, PELVIC PAIN, SLEEP APNOEA SYNDROME, SYSTEMIC LUPUS ERYTHEMATOSUS, TREATMENT NONCOMPLIANCE, UTERINE DISORDER, UTERINE HAEMORRHAGE, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: APPROX. WEIGHT AT THE TIME OF ESSURE PLACEMENT: 180 SHE RAN TEST IN APPROXIMATELY 2012 FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE, SLEEP APNEA, LIVER PROBLEMS, NAUSEA, CRAMPING, HYSTERECTOMY AND SALPINGECTOMY IN 2016, SKIN RASHES, MIGRAINES, WEIGHT GAIN, DISCHARGE, PAINFUL SEXUAL INTERCOURSE, CRAMPING, FATIGUE, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN MARCH 2010: ESSURE CONFIRMATION TEST QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED, EVENT ADDED IS PELVIC CRAMPING, HEAVY UTERINE BLEEDING, PRODUCT INFORMATION UPDATED. INCIDENT NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN LOWER ("CRAMPING") AND SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 200, (B)(6) 2002, (B)(6) 2007 & (B)(6) 2009.), PRE-ECLAMPSIA, BLOOD PRESSURE HIGH AND MISCARRIAGE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: MIRENA FROM 2009 TO 2010. IN 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED SYSTEMIC LEAKAGE (SERIOUSNESS CRITERION HOSPITALIZATION) AND COMPLICATION OF DEVICE INSERTION ("THEY SAID I HAD FLUID IN ME"). IN 2012, THE PATIENT EXPERIENCED FIBROMYALGIA ("FIBROMYALGIA") AND BACK PAIN ("BACK PAIN"). IN 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/ HEADACHES (MIGRAINE PAIN, SEVERE AND DEBILITATING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("HEALTH PROBLEMS"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), INTERVERTEBRAL DISC DEGENERATION ("DEGENERATIVE DISC DISEASE"), SLEEP APNOEA SYNDROME ("SLEEP APNEA"), LIVER DISORDER ("LIVER PROBLEMS"), NAUSEA ("NAUSEA"), WEIGHT INCREASED ("WEIGHT GAIN"), VAGINAL DISCHARGE ("DISCHARGE"), DYSPAREUNIA ("PAINFUL SEXUAL INTERCOURSE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("ALLERGIC TO NICKEL") WITH ABDOMINAL DISTENSION AND RASH, TREATMENT NONCOMPLIANCE ("DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE: NO"), MENTAL DISORDER ("ESSURE CAUSED OR AGGRAVATED ANY PSYCHIATRIC AND/OR PSYCHOLOGICAL CONDITION") AND UTERINE DISORDER ("UTERUS WAS DISEASED"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT HYSTERECTOMY AND SALPINGECTOMY IN 2016). ESSURE WAS REMOVED IN 2016. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN LOWER, SYSTEMIC LEAKAGE, COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION, SYSTEMIC LUPUS ERYTHEMATOSUS, INTERVERTEBRAL DISC DEGENERATION, SLEEP APNOEA SYNDROME, LIVER DISORDER, NAUSEA, WEIGHT INCREASED, VAGINAL DISCHARGE, DYSPAREUNIA, FATIGUE, ALOPECIA, ALLERGY TO METALS, TREATMENT NONCOMPLIANCE, MENTAL DISORDER AND UTERINE DISORDER OUTCOME WAS UNKNOWN AND THE FIBROMYALGIA, BACK PAIN AND MIGRAINE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, BACK PAIN, DYSPAREUNIA, FATIGUE, FIBROMYALGIA, INTERVERTEBRAL DISC DEGENERATION, LIVER DISORDER, MENTAL DISORDER, MIGRAINE, NAUSEA, SLEEP APNOEA SYNDROME, SYSTEMIC LUPUS ERYTHEMATOSUS, TREATMENT NONCOMPLIANCE, UTERINE DISORDER, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, GENERAL PHYSICAL HEALTH DETERIORATION AND SYSTEMIC LEAKAGE WITH ESSURE. THE REPORTER COMMENTED: APPROX. WEIGHT AT THE TIME OF ESSURE PLACEMENT: 180 SHE RAN TEST IN APPROXIMATELY 2012 FOR THE TREATMENT OF DEGENERATIVE DISC DISEASE, SLEEP APNEA, LIVER PROBLEMS, NAUSEA, CRAMPING, HYSTERECTOMY AND SALPINGECTOMY IN 2016, SKIN RASHES, MIGRAINES, WEIGHT GAIN, DISCHARGE, PAINFUL SEXUAL INTERCOURSE, CRAMPING, FATIGUE, HAIR LOSS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2010: ESSURE CONFIRMATION TEST. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2017: NEW REPORTERS ADDED. PATIENTS DEMOGRAPHICS UPDATED. HISTORICAL CONDITION AND DRUGS ADDED. NEW EVENTS ADDED: BACK PAIN, CRAMPING, LUPUS, DEGENERATIVE DISC DISEASE, SLEEP APNEA, FIBROMYALGIA, LIVER PROBLEMS, NAUSEA, SKIN RASHES, MIGRAINES/ HEADACHES (MIGRAINE PAIN, SEVERE AND DEBILITATING), WEIGHT GAIN, DISCHARGE, PAINFUL SEXUAL INTERCOURSE, FATIGUE, HAIR LOSS, ALLERGIC TO NICKEL, DID YOU USE BIRTH CONTROL OR CONTRACEPTION AT ANY TIME FOLLOWING YOUR ESSURE PLACEMENT PROCEDURE: NO."ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO (B)(4) AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, HER STOMACH BLEW UP LIKE SHE WAS (B)(6) PREGNANT. SHE WAS ADMITTED TO THE HOSPITAL AND THE DOCTOR HAD TO GO BACK IN AND SEE WHAT WAS GOING ON. THEY SAID SHE HAD FLUID IN HER. EVER SINCE THEN SHE HAD HEALTH PROBLEMS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EVENTS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR THE EVENTS WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF SYSTEMIC LEAKAGE ("THEY SAID I HAD FLUID IN ME") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, HER STOMACH BLEW UP LIKE SHE WAS (B)(6) PREGNANT. SHE WAS ADMITTED TO THE HOSPITAL AND THE DOCTOR HAD TO GO BACK IN AND SEE WHAT WAS GOING ON. THEY SAID SHE HAD FLUID IN HER. EVER SINCE THEN SHE HAD HEALTH PROBLEMS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EVENTS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR THE EVENTS WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED LEGAL CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED, AND ON THE SAME DAY HER STOMACH BLEW UP LIKE SHE WAS (B)(6) PREGNANT. SHE WAS HOSPITALIZED AND THEY SAID SHE HAD FLUID IN HER. THIS EVENT, REGARDED AS SYSTEMIC LEAKAGE, IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. THIS LEGAL CASE WAS REPORTED WITH LIMITED INFORMATION. NO DETAILS REGARDING THE INSERTION PROCEDURE WERE PROVIDED. HYSTEROSCOPIC TIME AND DISTENTION FLUID DEFICIT WERE NOT MENTIONED. DESPITE THE LIMITED INFORMATION, GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE PROCEDURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE REQUIRED HOSPITALIZATION. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847833 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| O| R |