ESSURE
Report
- Report Number
- 2951250-2017-07595
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- April 1, 2013
- Report Date
- July 25, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN") AND KIDNEY INFECTION ("KIDNEY INFECTIONS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND TRAUMA. *FOR URINARY TRACT INFECTION, URINE CULTURE AND SENSITIVITY, CHLAMYDIA/G C DNA AMP, URINE. ON (B)(6) 2016: US PELVIS TRANS VAGINAL. REASON: IRREGULAR BLEEDING. IMPRESSION: 1. ESSURE COILS ARE IN PLACE ALONG BOTH SIDES OF THE UTERUS. OTHERWISE, NORMAL EXAMINATION OF THE UTERUS AND OVARIES. 2. MINIMAL FREE FLUID IS SEEN IN THE POSTERIOR CUL-DE-SAC, LIKELY PHYSIOLOGICAL. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, DYSPAREUNIA, MEMORY LOSS, BOWEL MOVEMENT IRREGULARITY, DISCOMFORT, STRESS, MALAISE, ADHESION AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN DECEMBER 2011, THE PATIENT HAD ESSURE INSERTED. IN FEBRUARY 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING, / ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). IN MARCH 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). IN 2012, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA"). IN APRIL 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FLANK PAIN ("FLANK PAIN"). IN 2013, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). IN SEPTEMBER 2016, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("TROUBLE BALANCING HORMONES SINCE HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN /LOW BACK PAIN"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS /INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), CYSTITIS ("BLADDER INFECTIONS"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("MOOD SWINGS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL SALPINGECTOMY SINGLE OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, FLANK PAIN AND FATIGUE HAD RESOLVED, THE KIDNEY INFECTION, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, INFECTION, URINARY TRACT INFECTION, CYSTITIS, WEIGHT FLUCTUATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, ALOPECIA, MOOD SWINGS, AMNESIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FLANK PAIN, HEADACHE, HORMONE LEVEL ABNORMAL, INFECTION, KIDNEY INFECTION, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. DISCREPANCY NOTED IN DATE OF INSERTION: ON (B)(6) 2012. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- HYSTERECTOMY INSERTION DETAILS. TRAILING COILS: RIGHT:6 ESSURE COILS. LEFT:1 ESSURE COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.9 KG/SQM. ULTRASOUND SCAN VAGINA: ON (B)(6) 2016: RESULTS: ESSURE COILS SEEN. X-RAY OF PELVIS AND HIP: ON (B)(6) 2013: X-RAY - AP PELVIS. FINDINGS: ESSURE TYPE CONTRACEPTIVE DEVICE. ALIGNMENT AT SI JOINTS, SYMPHYSIS PUBIS, AND HIPS INTACT. LEFT HIP TWO VIEWS: FINDINGS: ALIGNMENT AT THE LEFT HIP IS INTACT. THE JOINT SPACE IS MAINTAINED. SOFT TISSUE PLANES INTACT. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, MENOMETRORRHAGIA, MIGRAINES". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JAN-2019: PFS+MR RECEIVED- NEW EVENT DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST WERE ADDED. LOT NUMBER, NEW REPORTER, MEDICAL HISTORY, CONCOMITANT DRUG AND 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 PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN") AND KIDNEY INFECTION ("KIDNEY INFECTIONS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENOMETRORRHAGIA ("ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA"), VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING, / ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN /LOW BACK PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS /INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), CYSTITIS ("BLADDER INFECTIONS"), KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), HEADACHE ("HEADACHES") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT REMOVAL OF THE ESSURE IMPLANT,HYSTERECTOMY(FULL),SALPINGECTOMY (BILATERAL REMOVAL)). ESSURE WAS REMOVED ON 16-SEP-2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED AND THE ABDOMINAL PAIN, BACK PAIN, MENOMETRORRHAGIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, INFECTION, URINARY TRACT INFECTION, CYSTITIS, KIDNEY INFECTION, WEIGHT FLUCTUATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, ALOPECIA AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, HEADACHE, INFECTION, KIDNEY INFECTION, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. DIAGNOSTIC RESULTS: FOR URINARY TRACT INFECTION, URINE CULTURE AND SENSITIVITY, CHLAMYDIA/G C DNA AMP, URINE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-APR-2018: PFS RECEIVED. REPORTERS WERE ADDED. PATIENT¿S DETAIL AND UNSTRUCTURED RELEVANT TESTS WERE ADDED. ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), WEIGHT GAIN / LOSS, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING AND ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA WERE ADDED AS EVENTS. 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 PELVIC PAIN ('PAIN/CHRONIC PELVIC PAIN/ SIDE/ SHARP PAINS') AND KIDNEY INFECTION ('KIDNEY INFECTIONS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND TRAUMA. *FOR URINARY TRACT INFECTION, URINE CULTURE AND SENSITIVITY, CHLAMYDIA/G C DNA AMP, URINE. ON (B)(6) 2016: US PELVIS TRANS VAGINAL. REASON: IRREGULAR BLEEDING. IMPRESSION: 1. ESSURE COILS ARE IN PLACE ALONG BOTH SIDES OF THE UTERUS. OTHERWISE, NORMAL EXAMINATION OF THE UTERUS AND OVARIES. 2. MINIMAL FREE FLUID IS SEEN IN THE POSTERIOR CUL-DE-SAC, LIKELY PHYSIOLOGICAL. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, DYSPAREUNIA, MEMORY LOSS, BOWEL MOVEMENT IRREGULARITY, DISCOMFORT, STRESS, MALAISE, ADHESION AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED DIAZEPAM (VALIUM) FROM 2016 TO 2017 AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING, / ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). IN 2012, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FLANK PAIN ("FLANK PAIN"). IN 2013, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("TROUBLE BALANCING HORMONES SINCE HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN /LOW BACK PAIN"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS /INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), CYSTITIS ("BLADDER INFECTIONS"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("MOOD SWINGS/ I'M ME AGAIN EXPECT LITTLR EMOTIONAL SOMETIME."), FATIGUE ("FATIGUE"), PYREXIA ("FEVER"), HOT FLUSH ("MY ONLY PROBLEM IS THE HOT FLASHES"), BACTERIAL VAGINOSIS ("THEY TOLD ME ABOUT BV AND GAVE ME MEDICATION FOR IT"), NAUSEA ("I WAS HUNGRY TO COULDNT HOLD ANYTHING FOR 4 DAYS I PEA BUT DID DO A BOWEL MOVEMENT TILL 1 WEEK AND A HALF") AND FLATULENCE ("GAS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL SALPINGECTOMY SINGLE OOPHERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, FLANK PAIN AND FATIGUE HAD RESOLVED, THE KIDNEY INFECTION, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, INFECTION, URINARY TRACT INFECTION, CYSTITIS, WEIGHT FLUCTUATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, ALOPECIA, MOOD SWINGS, AMNESIA, HORMONE LEVEL ABNORMAL, HOT FLUSH, BACTERIAL VAGINOSIS AND NAUSEA OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION AND PYREXIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, BACTERIAL VAGINOSIS, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FLANK PAIN, FLATULENCE, HEADACHE, HORMONE LEVEL ABNORMAL, HOT FLUSH, INFECTION, KIDNEY INFECTION, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, PYREXIA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2012. LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- HYSTERECTOMY. INSERTION DETAILS- TRAILING COILS: RIGHT:6 ESSURE COILS LEFT:1 ESSURE COIL DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2011, (B)(6) 2012 (DISCREPANCY). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.9 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: RESULTS: ESSURE COILS SEEN. X-RAY OF PELVIS AND HIP - ON (B)(6) 2013: X-RAY - AP PELVIS FINDINGS: ESSURE TYPE CONTRACEPTIVE DEVICE. ALIGNMENT AT SI JOINTS, SYMPHYSIS PUBIS, AND HIPS INTACT. LEFT HIP TWO VIEWS FINDINGS: ALIGNMENT AT THE LEFT HIP IS INTACT. THE JOINT SPACE IS MAINTAINED. SOFT TISSUE PLANES INTACT. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, MENOMETRORRHAGIA, MIGRAINES". CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES REPORTED VIA SOCIAL MEDIA : LOOSE MOTION, BACTERIAL VAGINOSIS, HOT FLASHES, FEVER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: NEW PFS+ SOCIAL MEDIA RECEIVED. NEW EVENTS: FEVER, HOT FLASHES, BACTERIAL VAGINOSIS, LOOSE MOTION WERE ADDED FROM SOCIAL MEDIA.CONCOMITANT DRUG WAS ADDED FROM PFS. 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 ("PAIN/CHRONIC PELVIC PAIN") AND KIDNEY INFECTION ("KIDNEY INFECTIONS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880435) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERWENT FOR ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND TRAUMA. *FOR URINARY TRACT INFECTION, URINE CULTURE AND SENSITIVITY, CHLAMYDIA/G C DNA AMP, URINE. ON (B)(6) 2016: US PELVIS TRANS VAGINAL. REASON: IRREGULAR BLEEDING. IMPRESSION: 1. ESSURE COILS ARE IN PLACE ALONG BOTH SIDES OF THE UTERUS. OTHERWISE, NORMAL EXAMINATION OF THE UTERUS AND OVARIES. 2. MINIMAL FREE FLUID IS SEEN IN THE POSTERIOR CUL-DE-SAC, LIKELY PHYSIOLOGICAL. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, DYSPAREUNIA, MEMORY LOSS, BOWEL MOVEMENT IRREGULARITY, DISCOMFORT, STRESS, MALAISE, ADHESION AND BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING, / ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). IN 2012, THE PATIENT EXPERIENCED MENOMETRORRHAGIA ("ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND FLANK PAIN ("FLANK PAIN"). IN 2013, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). IN (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("TROUBLE BALANCING HORMONES SINCE HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN /LOW BACK PAIN"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS /INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), CYSTITIS ("BLADDER INFECTIONS"), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("MOOD SWINGS") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL SALPINGECTOMY SINGLE OOPHERECTOMY). ESSURE WAS REMOVED ON 16-SEP-2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, FLANK PAIN AND FATIGUE HAD RESOLVED, THE KIDNEY INFECTION, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, INFECTION, URINARY TRACT INFECTION, CYSTITIS, WEIGHT FLUCTUATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, ALOPECIA, MOOD SWINGS, AMNESIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FLANK PAIN, HEADACHE, HORMONE LEVEL ABNORMAL, INFECTION, KIDNEY INFECTION, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. DISCREPANCY NOTED IN DATE OF INSERTION- (B)(6) 2012 LEAVE TAKEN FROM THIS JOB OR OTHER JOB FOR MEDICAL REASONS- HYSTERECTOMY INSERTION DETAILS- TRAILING COILS: RIGHT:6 ESSURE COILS LEFT:1 ESSURE COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 18.9 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: RESULTS: ESSURE COILS SEEN. X-RAY OF PELVIS AND HIP - ON (B)(6) 2013: X-RAY - AP PELVIS FINDINGS: ESSURE TYPE CONTRACEPTIVE DEVICE. ALIGNMENT AT SI JOINTS, SYMPHYSIS PUBIS, AND HIPS INTACT. LEFT HIP TWO VIEWS FINDINGS: ALIGNMENT AT THE LEFT HIP IS INTACT. THE JOINT SPACE IS MAINTAINED. SOFT TISSUE PLANES INTACT.. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, MENOMETRORRHAGIA, MIGRAINES". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2019: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN") AND KIDNEY INFECTION ("KIDNEY INFECTIONS") 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. CONCURRENT CONDITIONS INCLUDED FLANK PAIN, DYSPAREUNIA, MEMORY LOSS, BOWEL MOVEMENT IRREGULARITY, DISCOMFORT, STRESS, MALAISE AND ADHESION. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING, / ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)") AND MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA) (EVENT SPLITTED FOR CODING)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE /DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"). IN 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOMETRORRHAGIA ("ABNORMAL VAGINAL BLEEDING-MENOMETRORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FLANK PAIN ("FLANK PAIN"). IN 2013, THE PATIENT EXPERIENCED AMNESIA ("MEMORY LOSS"). IN (B)(6) 2016, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("TROUBLE BALANCING HORMONES SINCE HYSTERECTOMY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN /LOW BACK PAIN"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), INFECTION ("INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS /INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: URINARY TRACT INFECTIONS"), CYSTITIS ("BLADDER INFECTIONS"), KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), WEIGHT FLUCTUATION ("WEIGHT GAIN / LOSS"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("MOOD SWINGS") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL SALPINGECTOMY SINGLE OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENOMETRORRHAGIA, VAGINAL HAEMORRHAGE, MENORRHAGIA, FLANK PAIN AND FATIGUE HAD RESOLVED, THE ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, FEMALE SEXUAL DYSFUNCTION, DYSPAREUNIA, INFECTION, URINARY TRACT INFECTION, CYSTITIS, KIDNEY INFECTION, WEIGHT FLUCTUATION, WEIGHT INCREASED, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, ALOPECIA, MOOD SWINGS, AMNESIA AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, AMNESIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, FLANK PAIN, HEADACHE, HORMONE LEVEL ABNORMAL, INFECTION, KIDNEY INFECTION, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, WEIGHT FLUCTUATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: ESSURE COILS SEEN FOR URINARY TRACT INFECTION, URINE CULTURE AND SENSITIVITY, CHLAMYDIA/G C DNA AMP, URINE. ON (B)(6) 2016: US PELVIS TRANS VAGINAL. REASON: IRREGULAR BLEEDING. IMPRESSION: 1. ESSURE COILS ARE IN PLACE ALONG BOTH SIDES OF THE UTERUS. OTHERWISE, NORMAL EXAMINATION OF THE UTERUS AND OVARIES. 2. MINIMAL FREE FLUID IS SEEN IN THE POSTERIOR CUL-DE-SAC, LIKELY PHYSIOLOGICAL. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, MENOMETRORRHAGIA, MIGRAINES". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENTS MOOD SWINGS, MEMORY LOSS, FLANK PAIN , TROUBLE BALANCING HORMONES SINCE HYSTERECTOMY AND FATIGUE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN/CHRONIC PELVIC PAIN") AND KIDNEY INFECTION ("KIDNEY INFECTIONS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), ALOPECIA ("HAIR LOSS"), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VAGINAL HAEMORRHAGE ("SEVERE VAGINAL BLEEDING"), MIGRAINE ("MIGRAINES"), BACK PAIN ("BACK PAIN"), CYSTITIS ("BLADDER INFECTIONS"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS") AND KIDNEY INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT REMOVAL OF THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, INFECTION, WEIGHT INCREASED, DEPRESSION, ANXIETY, ALOPECIA, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MIGRAINE, BACK PAIN, CYSTITIS, URINARY TRACT INFECTION AND KIDNEY INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, ANXIETY, BACK PAIN, CYSTITIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, INFECTION, KIDNEY INFECTION, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE SOUGHT TREATMENT FOR HER SYMPTOMS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-NOV-2017: ESSURE INSERTION DATE WAS UPDATED (B)(6) 2012 AND WAS REMOVED ON (B)(6) 2016. EVENTS "PAINFUL MENSTRUAL CYCLES", "PAINFUL INTERCOURSE", "ABDOMINAL PAIN", "SEVERE VAGINAL BLEEDING", "MIGRAINES", "BACK PAIN", AND "URINARY TRACT INFECTIONS", "BLADDER INFECTIONS", AND "KIDNEY INFECTIONS". EVENT VERBATIM WAS UPDATED AS "PAIN/CHRONIC PELVIC PAIN". 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 PELVIC PAIN ("PAIN") 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHES"), INFECTION ("INFECTIONS"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND ALOPECIA ("HAIR LOSS"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HEADACHE, INFECTION, WEIGHT INCREASED, DEPRESSION, ANXIETY AND ALOPECIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANXIETY, DEPRESSION, HEADACHE, INFECTION, PELVIC PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 834968 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other| R | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| VALIUM |