ESSURE
Report
- Report Number
- 2951250-2018-03183
- Event Type
- Injury
- Date Received
- July 24, 2018
- Date of Event
- August 1, 2013
- Report Date
- December 17, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUATION/ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)") IN AN 18-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED SEIZURES, BREAST REDUCTION IN 2008, DYSMENORRHEA, ABDOMINAL CRAMPS AND IRREGULAR PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ORAL CONTRACEPTIVES: TRI-SPRINTEC; FOR AN UNREPORTED INDICATION: ANTIHISTAMINES. CONCURRENT CONDITIONS INCLUDED URINARY URGENCY, PAINFUL INTERCOURSE, NAUSEA, LOWER ABDOMINAL PAIN, BREAST TENDERNESS, URINE ANALYSIS ABNORMAL, URGENCY URINATION (SOME LEAKING OF URINE.), WEIGHT GAIN, WORN OUT, MALAISE, SLEEP DISORDER, FEELING ABNORMAL, LIGHTHEADEDNESS, UTERINE BLEEDING AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PHENTERMINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6)2012, THE PATIENT EXPERIENCED POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE FIRST EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND EMOTIONAL DISORDER ("HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2012, THE PATIENT WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND EXPERIENCED THE SECOND EPISODE OF ADNEXA UTERI PAIN ("OVARIAN PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BREAST TENDERNESS ("BREAST TENDERNESS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN MARCH 2013, THE PATIENT EXPERIENCED SKIN LESION ("LESIONS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). IN (B)(6)2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6)2014, THE PATIENT EXPERIENCED MICTURITION URGENCY ("BLADDER OR URINARY PROBLEMS OR CHANGES: CHANGES URGENCY IN URINATION/ URINARY LEAKAGE") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: URINE LEAKAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / INCREASING PAIN/CRAMPING") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH METFORMIN AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ON 8-MAY-2018). ESSURE WAS REMOVED ON 8-MAY-2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, POLYCYSTIC OVARIES, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, FATIGUE, MICTURITION URGENCY, URINARY INCONTINENCE, SKIN LESION, DYSPAREUNIA, THE LAST EPISODE OF ADNEXA UTERI PAIN, NAUSEA, BREAST TENDERNESS AND EMOTIONAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST TENDERNESS, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NAUSEA, PELVIC PAIN, POLYCYSTIC OVARIES, SKIN LESION, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ADNEXA UTERI PAIN AND THE SECOND EPISODE OF ADNEXA UTERI PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 192 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. (B)(6)2012: HYSTEROSALPINGOGRAM: SATISFACTORY LOCATION OF MICROINSERTS (STAGE II) WITH STAGE I TUBAL OCCLUSION BILATERALLY. PREGNANCY TEST UNCONFIRMED SURGICAL PATHOLOGY REPORT,PALPABLE IN THE ISTHMUS OF THE LEFT FALLOPIAN TUBE IS AN ESSURE COIL IN PLACE IN THE LUMEN. THERE IS A SMALL LEFT FALLOPIAN TUBE PARATUBAL CYST MEASURING 0.5 CM IN DIAMETER WITH A THIN TRANSLUCENT WALL AND WATERY CONTENT. THE FIMBRIA ARE MOIST AND PAPILLARY. THE AMPULLARY PORTION OF THE RIGHT FALLOPIAN TUBE HAS BEEN CUT FROM THE ISTHMUS PORTION OF THE FALLOPIAN TUBE DURING THE HYSTERECTOMY AND IS RECEIVED IN THE SAME CONTAINER WITH THE HYSTERECTOMY. THE ATTACHED ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE MEASURES 4 CM IN LENGTH. PALPABLE IN THE ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE IS THE ESSURE COIL MEASURING APPROXIMATELY 3 CM IN LENGTH. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. EXAMINING THE X-RAY SHOWS AN INTACT ESSURE COIL IN THE ISTHMUS OF EACH FALLOPIAN TUBE. THE ESSURE COILS ARE LEFT IN PLACE INTACT IN THE FALLOPIAN TUBES IN THE GROSS SPECIMEN. FINAL DIAGNOSIS: UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES (IAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) 1. ESSURE COILS IN PLACE IN THE ISTHMUS PORTION OF THE RIGHT AND LEFT FALLOPIAN TUBES. 2. SMALL PARATUBAL CYSTS, RIGHT AND LEFT FALLOPIAN TUBES. 3. UNREMARKABLE BENIGN BASALIS ENDOMETRIUM LINING THE UTERINE CAVITY (CURRENT MENSTRUATION, ENDOMETRIUM CONSISTENT WITH APPROXIMATELY DAY 2 OF MENSTRUAL CYCLE), UTERUS. 4. MILD CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, CERVIX. 5. NABOTHIAN CYSTS, CERVIX. 6. UTERINE WEIGHT: 91 GM. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2018: PFS RECEIVED EVENT " PELVIC PAIN" WAS ADDED. PATIENT AKA NAME WAS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUATION/ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)") IN AN 18-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SEIZURES, BREAST REDUCTION IN 2008, DYSMENORRHEA, ABDOMINAL CRAMPS AND IRREGULAR PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ORAL CONTRACEPTIVES: TRI-SPRINTEC; FOR AN UNREPORTED INDICATION: ANTIHISTAMINES. CONCURRENT CONDITIONS INCLUDED URINARY URGENCY, PAINFUL INTERCOURSE, NAUSEA, LOWER ABDOMINAL PAIN, BREAST TENDERNESS, URINE ANALYSIS ABNORMAL, URGENCY URINATION (SOME LEAKING OF URINE.), WEIGHT GAIN, WORN OUT, MALAISE, SLEEP DISORDER, FEELING ABNORMAL, LIGHTHEADEDNESS, UTERINE BLEEDING AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PHENTERMINE. IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE FIRST EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND EMOTIONAL DISORDER ("HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"). IN 2012, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND THE SECOND EPISODE OF ADNEXA UTERI PAIN ("OVARIES PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BREAST TENDERNESS ("BREAST TENDERNESS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED SKIN LESION ("LESIONS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2014, THE PATIENT EXPERIENCED MICTURITION URGENCY ("BLADDER OR URINARY PROBLEMS OR CHANGES: CHANGES URGENCY IN URINATION/ URINARY LEAKAGE") AND URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: URINE LEAKAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / INCREASING PAIN/CRAMPING"). THE PATIENT WAS TREATED WITH METFORMIN AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER, POLYCYSTIC OVARIES, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, FATIGUE, MICTURITION URGENCY, URINARY INCONTINENCE, SKIN LESION, DYSPAREUNIA, NAUSEA, BREAST TENDERNESS, THE LAST EPISODE OF ADNEXA UTERI PAIN AND EMOTIONAL DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST TENDERNESS, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NAUSEA, POLYCYSTIC OVARIES, SKIN LESION, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ADNEXA UTERI PAIN AND THE SECOND EPISODE OF ADNEXA UTERI PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. ON (B)(6) 2012: HYSTEROSALPINGOGRAM: SATISFACTORY LOCATION OF MICROINSERTS (STAGE II) WITH STAGE I TUBAL OCCLUSION BILATERALLY. PREGNANCY TEST UNCONFIRMED SURGICAL PATHOLOGY REPORT,PALPABLE IN THE ISTHMUS OF THE LEFT FALLOPIAN TUBE IS AN ESSURE COIL IN PLACE IN THE LUMEN. THERE IS A SMALL LEFT FALLOPIAN TUBE PARATUBAL CYST MEASURING 0.5 CM IN DIAMETER WITH A THIN TRANSLUCENT WALL AND WATERY CONTENT. THE FIMBRIA ARE MOIST AND PAPILLARY. THE AMPULLARY PORTION OF THE RIGHT FALLOPIAN TUBE HAS BEEN CUT FROM THE ISTHMUS PORTION OF THE FALLOPIAN TUBE DURING THE HYSTERECTOMY AND IS RECEIVED IN THE SAME CONTAINER WITH THE HYSTERECTOMY. THE ATTACHED ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE MEASURES 4 CM IN LENGTH. PALPABLE IN THE ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE IS THE ESSURE COIL MEASURING APPROXIMATELY 3 CM IN LENGTH. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. EXAMINING THE X-RAY SHOWS AN INTACT ESSURE COIL IN THE ISTHMUS OF EACH FALLOPIAN TUBE. THE ESSURE COILS ARE LEFT IN PLACE INTACT IN THE FALLOPIAN TUBES IN THE GROSS SPECIMEN. FINAL DIAGNOSIS: UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES (IAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) ESSURE COILS IN PLACE IN THE ISTHMUS PORTION OF THE RIGHT AND LEFT FALLOPIAN TUBES. SMALL PARATUBAL CYSTS, RIGHT AND LEFT FALLOPIAN TUBES. UNREMARKABLE BENIGN BASALIS ENDOMETRIUM LINING THE UTERINE CAVITY (CURRENT MENSTRUATION, ENDOMETRIUM CONSISTENT WITH APPROXIMATELY DAY 2 OF MENSTRUAL CYCLE), UTERUS. MILD CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, CERVIX. NABOTHIAN CYSTS, CERVIX. UTERINE WEIGHT: 91 GM. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. PATIENT¿S DEMOGRAPHIC INFORMATION UPDATED. REMOVAL DATE WAS ADDED. OUTCOME CHANGED AND UPDATED FOR EVERY EVENTS. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUATION/ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SEIZURES, BREAST REDUCTION IN 2008, DYSMENORRHEA, ABDOMINAL CRAMPS AND IRREGULAR PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ORAL CONTRACEPTIVES: TRI-SPRINTEC; FOR AN UNREPORTED INDICATION: ANTIHISTAMINES. CONCURRENT CONDITIONS INCLUDED URINARY URGENCY, PAINFUL INTERCOURSE, NAUSEA, LOWER ABDOMINAL PAIN, BREAST TENDERNESS, URINE ANALYSIS ABNORMAL, URGENCY URINATION (SOME LEAKING OF URINE.), WEIGHT GAIN, WORN OUT, MALAISE, SLEEP DISORDER, FEELING ABNORMAL, LIGHTHEADEDNESS, UTERINE BLEEDING AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PHENTERMINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE FIRST EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND EMOTIONAL DISORDER ("HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"). IN 2012, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), HEADACHE ("HEADACHES") AND THE SECOND EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES AND OVARIES PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BREAST TENDERNESS ("BREAST TENDERNESS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED SKIN LESION ("LESIONS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED MICTURITION URGENCY ("CHANGES URGENCY IN URINATION") AND URINARY INCONTINENCE ("URINE LEAKAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / INCREASING PAIN/CRAMPING") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH METFORMIN AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, POLYCYSTIC OVARIES, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, FATIGUE, MICTURITION URGENCY, URINARY INCONTINENCE, SKIN LESION, DYSPAREUNIA, NAUSEA, BREAST TENDERNESS, THE LAST EPISODE OF ADNEXA UTERI PAIN AND EMOTIONAL DISORDER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST TENDERNESS, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NAUSEA, POLYCYSTIC OVARIES, SKIN LESION, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ADNEXA UTERI PAIN AND THE SECOND EPISODE OF ADNEXA UTERI PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 27.5 KG/SQM. (B)(6) 2012: HYSTEROSALPINGOGRAM: SATISFACTORY LOCATION OF MICROINSERTS (STAGE II) WITH STAGE I TUBAL OCCLUSION BILATERALLY. PREGNANCY TEST UNCONFIRMED SURGICAL PATHOLOGY REPORT,PALPABLE IN THE ISTHMUS OF THE LEFT FALLOPIAN TUBE IS AN ESSURE COIL IN PLACE IN THE LUMEN. THERE IS A SMALL LEFT FALLOPIAN TUBE PARATUBAL CYST MEASURING 0.5 CM IN DIAMETER WITH A THIN TRANSLUCENT WALL AND WATERY CONTENT. THE FIMBRIA ARE MOIST AND PAPILLARY. THE AMPULLARY PORTION OF THE RIGHT FALLOPIAN TUBE HAS BEEN CUT FROM THE ISTHMUS PORTION OF THE FALLOPIAN TUBE DURING THE HYSTERECTOMY AND IS RECEIVED IN THE SAME CONTAINER WITH THE HYSTERECTOMY. THE ATTACHED ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE MEASURES 4 CM IN LENGTH. PALPABLE IN THE ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE IS THE ESSURE COIL MEASURING APPROXIMATELY 3 CM IN LENGTH. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. EXAMINING THE X-RAY SHOWS AN INTACT ESSURE COIL IN THE ISTHMUS OF EACH FALLOPIAN TUBE. THE ESSURE COILS ARE LEFT IN PLACE INTACT IN THE FALLOPIAN TUBES IN THE GROSS SPECIMEN. FINAL DIAGNOSIS: UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES (IAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE COILS IN PLACE IN THE ISTHMUS PORTION OF THE RIGHT AND LEFT FALLOPIAN TUBES. SMALL PARATUBAL CYSTS, RIGHT AND LEFT FALLOPIAN TUBES. UNREMARKABLE BENIGN BASALIS ENDOMETRIUM LINING THE UTERINE CAVITY (CURRENT MENSTRUATION, ENDOMETRIUM CONSISTENT WITH APPROXIMATELY DAY 2 OF MENSTRUAL CYCLE), UTERUS. MILD CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, CERVIX. NABOTHIAN CYSTS, CERVIX. UTERINE WEIGHT: 91 GM. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-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.
"NTANEOUS" CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUATION/ABNORMAL BLEEDING (MENORRHAGIA)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL) /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SEIZURES, BREAST REDUCTION IN 2008, DYSMENORRHEA, ABDOMINAL CRAMPS AND IRREGULAR PERIODS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR ORAL CONTRACEPTIVES: TRI-SPRINTEC; FOR AN UNREPORTED INDICATION: ANTIHISTAMINES. CONCURRENT CONDITIONS INCLUDED URINARY URGENCY, PAINFUL INTERCOURSE, NAUSEA, LOWER ABDOMINAL PAIN, BREAST TENDERNESS, URINE ANALYSIS ABNORMAL, URGENCY URINATION (SOME LEAKING OF URINE.), WEIGHT GAIN, WORN OUT, MALAISE, SLEEP DISORDER, FEELING ABNORMAL, LIGHTHEADEDNESS, UTERINE BLEEDING AND ENDOMETRIOSIS. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND PHENTERMINE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), POLYCYSTIC OVARIES ("POLYCYSTIC OVARIAN SYNDROME /HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), THE FIRST EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), FATIGUE ("FATIGUE") AND EMOTIONAL DISORDER ("HORMONAL CHANGES- VERY EMOTIONAL, PCOS, WEIGHT GAIN, ABNORMAL BLEEDING (EVENT SPLITTED FOR CODING)"). IN 2012, THE PATIENT EXPERIENCED HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"), HEADACHE ("HEADACHES") AND THE SECOND EPISODE OF ADNEXA UTERI PAIN ("FALLOPIAN TUBES AND OVARIES PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED BREAST TENDERNESS ("BREAST TENDERNESS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED SKIN LESION ("LESIONS"). IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING VAGINAL"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED MICTURITION URGENCY ("CHANGES URGENCY IN URINATION") AND URINARY INCONTINENCE ("URINE LEAKAGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMINAL PAIN / INCREASING PAIN/CRAMPING") AND FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH METFORMIN AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, GENITAL HAEMORRHAGE, POLYCYSTIC OVARIES, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, FEMALE SEXUAL DYSFUNCTION, MIGRAINE, HEADACHE, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, FATIGUE, MICTURITION URGENCY, URINARY INCONTINENCE, SKIN LESION, DYSPAREUNIA, NAUSEA, BREAST TENDERNESS, THE LAST EPISODE OF ADNEXA UTERI PAIN AND EMOTIONAL DISORDER OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, BREAST TENDERNESS, DYSMENORRHOEA, DYSPAREUNIA, EMOTIONAL DISORDER, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MICTURITION URGENCY, MIGRAINE, NAUSEA, POLYCYSTIC OVARIES, SKIN LESION, URINARY INCONTINENCE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, WEIGHT INCREASED, THE FIRST EPISODE OF ADNEXA UTERI PAIN AND THE SECOND EPISODE OF ADNEXA UTERI PAIN TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): (B)(6). ON (B)(6) 2012: HYSTEROSALPINGOGRAM: SATISFACTORY LOCATION OF MICROINSERTS (STAGE II) WITH STAGE I TUBAL OCCLUSION BILATERALLY. PREGNANCY TEST UNCONFIRMED SURGICAL PATHOLOGY REPORT,PALPABLE IN THE ISTHMUS OF THE LEFT FALLOPIAN TUBE IS AN ESSURE COIL IN PLACE IN THE LUMEN. THERE IS A SMALL LEFT FALLOPIAN TUBE PARATUBAL CYST MEASURING 0.5 CM IN DIAMETER WITH A THIN TRANSLUCENT WALL AND WATERY CONTENT. THE FIMBRIA ARE MOIST AND PAPILLARY. THE AMPULLARY PORTION OF THE RIGHT FALLOPIAN TUBE HAS BEEN CUT FROM THE ISTHMUS PORTION OF THE FALLOPIAN TUBE DURING THE HYSTERECTOMY AND IS RECEIVED IN THE SAME CONTAINER WITH THE HYSTERECTOMY. THE ATTACHED ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE MEASURES 4 CM IN LENGTH. PALPABLE IN THE ISTHMUS PORTION OF THE RIGHT FALLOPIAN TUBE IS THE ESSURE COIL MEASURING APPROXIMATELY 3 CM IN LENGTH. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. THE COIL APPEARS TO BE INTACT, AND IS AT LEAST 1 CM AWAY FROM THE CUT END OF THE FALLOPIAN TUBE. EXAMINING THE X-RAY SHOWS AN INTACT ESSURE COIL IN THE ISTHMUS OF EACH FALLOPIAN TUBE. THE ESSURE COILS ARE LEFT IN PLACE INTACT IN THE FALLOPIAN TUBES IN THE GROSS SPECIMEN. FINAL DIAGNOSIS: UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES (LAPAROSCOPICALLY ASSISTED TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) ESSURE COILS IN PLACE IN THE ISTHMUS PORTION OF THE RIGHT AND LEFT FALLOPIAN TUBES. SMALL PARATUBAL CYSTS, RIGHT AND LEFT FALLOPIAN TUBES. UNREMARKABLE BENIGN BASALIS ENDOMETRIUM LINING THE UTERINE CAVITY (CURRENT MENSTRUATION, ENDOMETRIUM CONSISTENT WITH APPROXIMATELY DAY 2 OF MENSTRUAL CYCLE), UTERUS. MILD CHRONIC CERVICITIS AND SQUAMOUS METAPLASIA, CERVIX. NABOTHIAN CYSTS, CERVIX. UTERINE WEIGHT: 91 GM. CONCERNING THE INJURIES IN THE CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT'S MEDICAL RECORDS: MENORRHAGIA, DYSMENORRHEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2018: MR RECEIVED: CASE BECAME INCIDENT, SURGERY: LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2018 WAS PERFORMED DUE TO MENORRHAGIA. NEW REPORTER AND CONCOMITANT DISEASE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 556674 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882184 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| PHENTERMINE| PHENTERMINE| PHENTERMINE| PHENTERMINE| PHENTERMINE| DEPO-PROVERA| PHENTERMINE |