ESSURE
Report
- Report Number
- 2951250-2017-02475
- Event Type
- Injury
- Date Received
- July 11, 2017
- Date of Event
- September 1, 2009
- Report Date
- September 20, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), PELVIC INFLAMMATORY DISEASE ("PID"), UTERINE HAEMORRHAGE ("UTERINE BLEEDING"), TOOTH DISORDER ("DENTAL PROBLEMS"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM INSERTED FOR UTERINE BLEEDING. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "MIRENA USED FOR UNAPPROVED INDICATION" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 2001; (B)(6) 2004; (B)(6) 2006; (B)(6) 2008), ANXIETY, DEPRESSION AND VAGINAL DELIVERY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM (B)(6) 2008 TO (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VISION BLURRED ("BLURRY VISION"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / BLEEDING EVERY 2 WEEKS") AND PRURITUS ("ITCHY SKIN"). ON (B)(6)2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSGEUSIA ("METAL TASTE IN MOUTH"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). ON (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTIONS / BI-WEEKLY VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT HAD MIRENA INSERTED (INTRA-UTERINE) 52 MG, RELEASING PRODUCT AT 20 MCG/24HR CONTINUOUSLY. ON (B)(6) 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH ESTROGENS CONJUGATED (PREMARIN), CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN (MOTRIN), VICODIN, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), VICODIN (NORCO), PANADEINE CO (TYLENOL W/CODEINE NO. 2), CHOLECALCIFEROL (VITAMIN D), METRONIDAZOLE (FLAGYL), MICONAZOLE NITRATE (MONISTAT), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), SURGERY (10 TEETH REMOVED) AND SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE VAGINAL INFECTION HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, UTERINE HAEMORRHAGE, TOOTH DISORDER, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, PRURITUS, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, VISION BLURRED AND CONSTIPATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE AND MIRENA. THE REPORTER COMMENTED: PATIENT UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DURING WHICH HER CERVIX, UTERUS, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAD MOSTLY RESOLVED, THOUGH SOME REMAIN. SHE WAS NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.3 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2008: NEGATIVE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: NO VISUALIZATION OF THE LEFT OVARY MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: SIGNIFICANT CASE CORRECTION: CODING CORRECTION PERFORMED ON REQUEST OF GPV-CASE PROCESSING WHC TEAM. PID ABBREVIATION WAS EXPANDED. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), PELVIC INFLAMMATORY DISEASE ("PID"), UTERINE HAEMORRHAGE ("UTERINE BLEEDING"), TOOTH DISORDER ("DENTAL PROBLEMS"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM INSERTED FOR UTERINE BLEEDING. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "MIRENA USED FOR UNAPPROVED INDICATION" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 ((B)(6) 2001; (B)(6) 2004; (B)(6) 2006; (B)(6) 2008), ANXIETY, DEPRESSION AND VAGINAL DELIVERY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM (B)(6) 2008 TO(B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VISION BLURRED ("BLURRY VISION"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / BLEEDING EVERY 2 WEEKS") AND PRURITUS ("ITCHY SKIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSGEUSIA ("METAL TASTE IN MOUTH"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). ON (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTIONS / BI-WEEKLY VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2010, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT HAD MIRENA INSERTED (INTRA-UTERINE) 52 MG, RELEASING PRODUCT AT 20 MCG/24HR CONTINUOUSLY. ON (B)(6) 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH ESTROGENS CONJUGATED (PREMARIN), CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN (MOTRIN), VICODIN, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), VICODIN (NORCO), PANADEINE CO (TYLENOL W/CODEINE NO. 2), COLECALCIFEROL (VITAMIN D), METRONIDAZOLE (FLAGYL), MICONAZOLE NITRATE (MONISTAT), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), SURGERY (10 TEETH REMOVED) AND SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE VAGINAL INFECTION HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, UTERINE HAEMORRHAGE, TOOTH DISORDER, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, PRURITUS, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, VISION BLURRED AND CONSTIPATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA AND BACK PAIN WAS RESOLVING AND THE GENITAL HAEMORRHAGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE AND MIRENA. THE REPORTER COMMENTED: PATIENT UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DURING WHICH HER CERVIX, UTERUS, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAD MOSTLY RESOLVED, THOUGH SOME REMAIN. SHE WAS NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.3 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2008: NEGATIVE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: NO VISUALIZATION OF THE LEFT OVARY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-SEP-2018: INTERNAL CORRECTION: PRODUCT TAB 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), PELVIC INFLAMMATORY DISEASE ("PID"), UTERINE HAEMORRHAGE ("UTERINE BLEEDING"), TOOTH DISORDER ("DENTAL PROBLEMS"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM INSERTED FOR UTERINE BLEEDING. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "MIRENA USED FOR UNAPPROVED INDICATION" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4 (B)(6) 2001; (B)(6) 2004; (B)(6) 2006; (B)(6) 2008), ANXIETY, DEPRESSION AND VAGINAL DELIVERY. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM (B)(6) 2008 TO (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VISION BLURRED ("BLURRY VISION"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / BLEEDING EVERY 2 WEEKS") AND PRURITUS ("ITCHY SKIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSGEUSIA ("METAL TASTE IN MOUTH"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). ON (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTIONS / BI-WEEKLY VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2010, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT HAD MIRENA INSERTED (INTRA-UTERINE) 52 MG, RELEASING PRODUCT AT 20 MCG/24HR CONTINUOUSLY. ON (B)(6) 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH ESTROGENS CONJUGATED (PREMARIN), CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN (MOTRIN), VICODIN, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), VICODIN (NORCO), PANADEINE CO (TYLENOL W/CODEINE NO. 2), CHOLECALCIFEROL (VITAMIN D), METRONIDAZOLE (FLAGYL), MICONAZOLE NITRATE (MONISTAT), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), SURGERY (10 TEETH REMOVED) AND SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE VAGINAL INFECTION HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, UTERINE HAEMORRHAGE, TOOTH DISORDER, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, PRURITUS, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, VISION BLURRED AND CONSTIPATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA AND BACK PAIN WAS RESOLVING AND THE GENITAL HAEMORRHAGE, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA, MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE AND MIRENA. THE REPORTER COMMENTED: PATIENT UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DURING WHICH HER CERVIX, UTERUS, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAD MOSTLY RESOLVED, THOUGH SOME REMAIN. SHE WAS NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.3 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2008: NEGATIVE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: NO VISUALIZATION OF THE LEFT OVARY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-AUG-2018: EVENT OUTCOME UPDATED FOR EVENTS ABNORMAL BLEEDING FROM RECOVERING / RESOLVING TO RECOVERED / RESOLVED. 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 UTERINE PERFORATION ("PERFORATION (UTERUS)"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE"), PELVIC INFLAMMATORY DISEASE ("PID"), UTERINE HAEMORRHAGE ("UTERINE BLEEDING"), TOOTH DISORDER ("DENTAL PROBLEMS"), PELVIC PAIN ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A 22-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED MIRENA INTRAUTERINE DELIVERY SYSTEM INSERTED FOR UTERINE BLEEDING. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "MIRENA USED FOR UNAPPROVED INDICATION" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND PARITY 4 ((B)(6) 2001; (B)(6) 2004; (B)(6) 2006; (B)(6) 2008). CONCURRENT CONDITIONS INCLUDED MORBID OBESITY. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM (B)(6) 2008 TO (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED VISION BLURRED ("BLURRY VISION"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("PROLONGED MENSES/ ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / BLEEDING EVERY 2 WEEKS") AND PRURITUS ("ITCHY SKIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) "), DYSGEUSIA ("METAL TASTE IN MOUTH"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). ON (B)(6) 2008, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). ON (B)(6) 2009, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("SEVERE BACK PAIN / BACK PAIN") AND VAGINAL INFECTION ("VAGINAL INFECTIONS / BI-WEEKLY VAGINAL INFECTIONS") WITH VAGINAL DISCHARGE. ON (B)(6) 2010, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2014, THE PATIENT HAD MIRENA INSERTED (INTRA-UTERINE) 52 MG, RELEASING PRODUCT AT 20 MCG/24HR CONTINUOUSLY. ON (B)(6) 2014, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN LOWER, PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TOOTH DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION") AND ACNE ("ACNE"). THE PATIENT WAS TREATED WITH ESTROGENS CONJUGATED (PREMARIN), CO-TRIMOXAZOLE (BACTRIM), IBUPROFEN (MOTRIN), VICODIN, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL), VICODIN (NORCO), PANADEINE CO (TYLENOL W/CODEINE NO. 2), COLECALCIFEROL (VITAMIN D), METRONIDAZOLE (FLAGYL), MICONAZOLE NITRATE (MONISTAT), SURGERY (FULL HYSTERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND SURGERY (10 TEETH REMOVED). ESSURE WAS REMOVED ON (B)(6) 2016. ON (B)(6) 2016, THE VAGINAL INFECTION HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE DISLOCATION, PELVIC INFLAMMATORY DISEASE, UTERINE HAEMORRHAGE, TOOTH DISORDER, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, PRURITUS, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, VISION BLURRED AND CONSTIPATION OUTCOME WAS UNKNOWN, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN, MENORRHAGIA AND VAGINAL HAEMORRHAGE WAS RESOLVING AND THE FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION AND ALOPECIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ACNE, ALOPECIA, ANXIETY, BACK PAIN, BLADDER DISORDER, CONSTIPATION, DEPRESSION, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PRURITUS, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE HAEMORRHAGE, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE AND MIRENA. THE REPORTER COMMENTED: PATIENT UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DURING WHICH HER CERVIX, UTERUS, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAD MOSTLY RESOLVED, THOUGH SOME REMAIN. SHE WAS NOT ADVISED OF ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF YOUR ESSURE PLACEMENT PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 48.3 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PFS RECEIVED, REPORTER ADDED, PATIENT HISTORICAL AND CONCOMITANT CONDITION ADDED, CONCOMITANT DRUG AND CO-SUSPECT (MIRENA) ADDED, EVENTS ADDED AS FOLLOWS:-UTERINE PERFORATION, DEVICE DISLOCATION, TOOTH DISORDER, BLURRY VISION,VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, DYSGEUSIA, FEMALE SEXUAL DYSFUNCTION, ANXIETY, DEPRESSION, PRURITIS, BLADDER DISORDER, URINARY TRACT DISORDER,MIGRAINES, HEADACHES, CONSTIPATION, WEIGHT INCREASED, UTERINE HAEMORRHAGE, DEVICE MONITORING PROCEDURE NOT PERFORMAED, ACNE, PELVIC INPLAMMATORY DISEASE, DEVICE USE ISSUE. 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 ("SEVERE PELVIC PAIN") AND GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("SEVERE ABDOMINAL PAIN/ SEVERE CRAMPING"), BACK PAIN ("SEVERE BACK PAIN"), VAGINAL INFECTION ("VAGINAL INFECTIONS"), FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), ABDOMINAL DISTENSION ("BLOATING"), ALOPECIA ("HAIR LOSS") AND MENORRHAGIA ("PROLONGED MENSES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN LOWER, BACK PAIN, VAGINAL INFECTION, FATIGUE, WEIGHT INCREASED, ABDOMINAL DISTENSION, ALOPECIA AND MENORRHAGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, ALOPECIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, DURING WHICH HER CERVIX, UTERUS, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. SINCE HER REMOVAL SURGERY, PATIENT'S SYMPTOMS HAD MOSTLY RESOLVED, THOUGH SOME REMAIN. COMPANY CAUSALITY COMMENT: 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 |
|---|---|---|---|---|---|---|---|
| 481098 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other| R | ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS |