ESSURE
Report
- Report Number
- 2951250-2017-01147
- Event Type
- Injury
- Date Received
- March 29, 2017
- Date of Event
- November 9, 2015
- Report Date
- July 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION FALLOPIAN TUBE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY"), RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL),") AND BIPOLAR DISORDER ("BI-POLAR/PSYCHOLOGICAL PROBLEMS") IN A 28-YEAR-OLD FEMALE PATIENT (GRAVIDA 6, PARA 3) WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (G5), PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: ((B)(6) 2007, (B)(6) 2008, (B)(6) 2009) IN (B)(6) 2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. (B)(6) 2009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), VAGINAL DELIVERY IN 2007, SMOKER (THE PATIENT SMOKENE PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES) IN 2006, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER FEMALE, CANCER, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, RAPE VICTIM IN (B)(6) 2017, EXPOSURE TO COMMUNICABLE DISEASE, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN JANUARY), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL (GENERAL ANESTHESIA) AND CARBAZOCHROME SODIUM SULFONATE (ADONA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015, 4 YEARS 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE,"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH METHOTREXATE, METRONIDAZOLE (FLAGYL), SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015), SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015) AND SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. (B)(4) CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. (B)(4) CASE CREATED FOR PREGNANCY (TERMINATION). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY - ON AN UNKNOWN DATE: NEGATIVE. HEPATITIS VIRAL TEST - ON AN UNKNOWN DATE: NEGATIVE. HUMAN CHORIONIC GONADOTROPIN - ON AN UNKNOWN DATE: POSITIVE. PREGNANCY TEST - ON AN UNKNOWN DATE: POSITIVE. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: NEGATIVE. LAST MENSTRUAL PERIOD (B)(6) 2007. (B)(6) 2011: HYSTEROSCOPY: FINDINGS: THE UTERUS WAS FOUND ANT EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM. THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESSIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. (B)(6) 2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND: FINDINGS TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND:FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM. THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. (B)(6) 2015, SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. (B)(6) 2015, TRANSABDOMINAL OB ULTRASOUND: FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ANXIETY, LT ECTOPIC PREGNANCY, VAGINITIS, SUSPECTED RUPTURED ECTOPIC PREGNANCY LT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION FALLOPIAN TUBE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY"), RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL),") AND BIPOLAR DISORDER ("BI-POLAR/PSYCHOLOGICAL PROBLEMS") IN A 24-YEAR-OLD FEMALE PATIENT (GRAVIDA 6, PARA 3) WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (G5), PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: ((B)(6) 2007,(B)(6) 2008,(B)(6) 2009) IN26FEB2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. (B)(6) 009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), VAGINAL DELIVERY IN 2007, SMOKER (THE PATIENT SMOKENE PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES) IN 2006, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER FEMALE, CANCER, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, RAPE VICTIM IN JUNE 2017, EXPOSURE TO COMMUNICABLE DISEASE, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN JANUARY), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL (GENERAL ANESTHESIA) AND CARBAZOCHROME SODIUM SULFONATE (ADONA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"). IN (B)(6) THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE,"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH METHOTREXATE, METRONIDAZOLE (FLAGYL), SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED, THE GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND BACTERIAL VAGINOSIS WAS RESOLVING AND THE DEPRESSION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACTERIAL VAGINOSIS, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. 2017-043573 CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. 2018-050923 CASE CREATED FOR PREGNANCY (TERMINATION). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY - ON AN UNKNOWN DATE: NEGATIVE HEPATITIS VIRAL TEST - ON AN UNKNOWN DATE: NEGATIVE HUMAN CHORIONIC GONADOTROPIN - ON AN UNKNOWN DATE: POSITIVE PREGNANCY TEST - ON AN UNKNOWN DATE: POSITIVE PREGNANCY TEST URINE - ON AN UNKNOWN DATE: NEGATIVE LAST MENSTRUAL PERIOD 15-MAY-2007. 18-AUG-2011:HYSTEROSCOPY: FINDINGS: THE UTERUS WAS FOUND ANT EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. 30-SEP-2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND: FINDINGS TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND:FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. (B)(6) 2015, SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. 09NOV2015, TRANSABDOMINAL OB ULTRASOUND: FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ANXIETY, LT ECTOPIC PREGNANCY, VAGINITIS, SUSPECTED RUPTURED ECTOPIC PREGNANCY LT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2018: PLAINTIFF FACT SHEET RECEIVED: EVENTS (BACTERIAL VAGINOSIS, DYSMENORRHEA, DEPRESSION) WERE ADDED AND EVENTS OUTCOME UPDATED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE- RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBE'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('LEFT ECTOPIC PREGNANCY'), RUPTURED ECTOPIC PREGNANCY ('RUPTURED LEFT ECTOPIC PREGNANCY'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING(GENERAL)') AND BIPOLAR DISORDER ('BI-POLAR/PSYCHOLOGICAL PROBLEMS') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED RAPE VICTIM IN (B)(6) 2017, VAGINAL DELIVERY IN 2007, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES) IN 2006, TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, MULTI GRAVIDA (G5), PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: ((B)(6) 2007,(B)(6) 2008,(B)(6) 2009) IN (B)(6) 2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. (B)(6) 2009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), SMOKER (THE PATIENT SMOKENE PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER FEMALE, CANCER, EXPOSURE TO COMMUNICABLE DISEASE, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN JANUARY), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL AND CARBAZOCHROME SODIUM SULFONATE (ADONA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"), 5 YEARS 1 MONTH AFTER INSERTION OF ESSURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ANXIETY ("ANXIETY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND VULVOVAGINAL CANDIDIASIS ("CANDIDAL VAGINOSIS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, METHOTREXATE AND SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, RUPTURED ECTOPIC PREGNANCY, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, BACTERIAL VAGINOSIS AND VULVOVAGINAL CANDIDIASIS HAD RESOLVED, THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION WAS RESOLVING AND THE DEPRESSION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ANXIETY, BACTERIAL VAGINOSIS, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. (B)(4) CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. (B)(4) CASE CREATED FOR PREGNANCY (TERMINATION). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. HEPATITIS VIRAL TEST - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. HUMAN CHORIONIC GONADOTROPIN - ON AN UNKNOWN DATE: RESULTS: POSITIVE. PREGNANCY TEST - ON AN UNKNOWN DATE: RESULTS: POSITIVE. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. DIAGNOSTIC RESULTS: LAST MENSTRUAL PERIOD (B)(6) 2007. (B)(6) 2011:HYSTEROSCOPY: FINDINGS: THE UTERUS WAS FOUND ANT EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. (B)(6) 2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND: FINDINGS TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND:FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. (B)(6) 2015, SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. (B)(6) 2015, TRANSABDOMINAL OB ULTRASOUND: FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ANXIETY, LT ECTOPIC PREGNANCY, VAGINITIS, SUSPECTED RUPTURED ECTOPIC PREGNANCY LT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED: EVENT CANDIDA VAGINOSIS ADDED. EVENT OUTCOME , LAWYER UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION FALLOPIAN TUBE'), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('LEFT ECTOPIC PREGNANCY'), RUPTURED ECTOPIC PREGNANCY ('RUPTURED LEFT ECTOPIC PREGNANCY'), GENITAL HEMORRHAGE ('ABNORMAL BLEEDING(GENERAL)') AND BIPOLAR DISORDER ('BI-POLAR/PSYCHOLOGICAL PROBLEMS') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED RAPE VICTIM IN (B)(6) 2017, VAGINAL DELIVERY IN 2007, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES) IN 2006, TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, MULTI GRAVIDA (G5), PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009) IN (B)(6) 2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. (B)(6) 2009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), SMOKER (THE PATIENT SMOKENE PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER FEMALE, CANCER, EXPOSURE TO COMMUNICABLE DISEASE, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN (B)(6)), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL AND CARBAZOCHROME SODIUM SULFONATE (ADONA). IN 2008, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION,PSYCH INJURY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015 THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND ANXIETY ("ANXIETY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE") AND NAUSEA ("NAUSEA,"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE ("FATIGUE,"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND VULVOVAGINAL CANDIDIASIS ("CANDIDAL VAGINOSIS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"). THE PATIENT WAS TREATED WITH ANTIBIOTICS, METHOTREXATE AND SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, RUPTURED ECTOPIC PREGNANCY, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HEMORRHAGE, BACTERIAL VAGINOSIS AND VULVOVAGINAL CANDIDIASIS HAD RESOLVED, THE MENORRHAGIA, VAGINAL HEMORRHAGE AND VAGINAL INFECTION WAS RESOLVING AND THE DEPRESSION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 6, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ANXIETY, BACTERIAL VAGINOSIS, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HEMORRHAGE, VAGINAL INFECTION, VULVOVAGINAL CANDIDIASIS AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. (B)(4) CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. (B)(4) CASE CREATED FOR PREGNANCY (TERMINATION). PLAINTIFF REVIVED TREATMENT FOR PAIN, BLEEDING, BLADDER, URINARY PROBLEM ADDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. HEPATITIS VIRAL TEST - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. HUMAN CHORIONIC GONADOTROPIN - ON AN UNKNOWN DATE: RESULTS: POSITIVE. PREGNANCY TEST - ON AN UNKNOWN DATE: RESULTS: POSITIVE. PREGNANCY TEST URINE - ON AN UNKNOWN DATE: RESULTS: NEGATIVE. DIAGNOSTIC RESULTS: LAST MENSTRUAL PERIOD (B)(6) 2007. (B)(6) 2011:HYSTEROSCOPY: FINDINGS: THE UTERUS WAS FOUND ANT EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. (B)(6) 2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND: FINDINGS. TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND:FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. (B)(6) 2015, SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. (B)(6) 2015, TRANSABDOMINAL OB ULTRASOUND: FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2020: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION FALLOPIAN TUBE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY"), RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL),") IN A 28-YEAR-OLD FEMALE PATIENT (GRAVIDA 6, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA (G5), PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: ((B)(6) 2007,(B)(6) 2008,(B)(6) 2009). IN (B)(6) 2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. ON (B)(6) 2009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), VAGINAL DELIVERY IN 2007, SMOKER (THE PATIENT SMOKENE PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES IN 2006, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER, CANCER, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, RAPE VICTIM IN JUNE 2017, HEPATITIS, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN JANUARY), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL (GENERAL ANESTHESIA) AND CARBAZOCHROME SODIUM SULFONATE (ADONA). IN 2011, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015, 4 YEARS 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER ("BI-POLAR") AND ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE"), NAUSEA ("NAUSEA,"), FATIGUE ("FATIGUE,"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH METHOTREXATE, METRONIDAZOLE (FLAGYL), SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. (B)(4) CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. (B)(4) CASE CREATED FOR PREGNANCY (TERMINATION). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY - ON AN UNKNOWN DATE: NEGATIVE HEPATITIS VIRAL TEST - ON AN UNKNOWN DATE: NEGATIVE HUMAN CHORIONIC GONADOTROPIN - ON AN UNKNOWN DATE: POSITIVE PREGNANCY TEST - ON AN UNKNOWN DATE: POSITIVE PREGNANCY TEST URINE - ON AN UNKNOWN DATE: NEGATIVE LAST MENSTRUAL PERIOD (B)(6) 2007. (B)(6) 2011:HYSTEROSCOPY: FINDINGS: THE UTERUS WAS FOUND ANT EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. (B)(6) 2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND: FINDINGS TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND:FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM.THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. (B)(6) 2015, SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. (B)(6) 2015, TRANSABDOMINAL OB ULTRASOUND: FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ANXIETY, LT ECTOPIC PREGNANCY, VAGINITIS, SUSPECTED RUPTURED ECTOPIC PREGNANCY LT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-FEB-2018: PFS AND MEDICAL RECORDS RECEIVED: REPORTERS DETAILS ADDED. AKA NAMES ADDED. CASE MEDICALLY CONFIRMED. EVENT SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST, LOWER ABDOMINAL AREA, ABNORMAL BLEEDING(GENERAL),ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA), MULTIPLE CASES OF VAGINITIS, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS-ANXIETY AND BI-POLAR, BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRAINES / HEADACHES, NAUSEA,DENTAL PROBLEMS, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, VAGINAL DISCHARGE, PERFORATION (FALLOPIAN TUBE), FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: GALLBLADDER STONE. HISTORICAL, CONCOMITANT CONDITION AND RELEVANT LAB DATA WERE ADDED. CONCOMITANT, HISTORICAL DRUGS AND TREATMENT DRUGS WERE 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION FALLOPIAN TUBE"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY"), RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL),") IN A 28-YEAR-OLD FEMALE PATIENT (GRAVIDA 6, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (LIVE BIRTHS:3 DATE OF BIRTH: ((B)(6) 2007,(B)(6) 2008, AND (B)(6)2009). IN (B)(6) 2007 AT 40 WEEKS THE PATIENT DELIVERED 6 POUNDS 8 OUNCE MALE INFANT BY SPONTANEOUS VAGINAL DELIVERY. IN (B)(6) 2009 AT 40 WEEKS, THE PATIENT DELIVERED 6 POUNDS 8 OUNCES FEMALE INFANT.), TRACHEOSTOMY IN 2004, AUTOMOBILE ACCIDENT (MVA AT AGE 16, BRAIN INJURY) IN 2004, MENARCHE (AT 12 YEARS OLD, REGULAR CYCLE), VAGINAL DELIVERY IN 2007, SMOKER (THE PATIENT SMOKED A PACK PER DAY, TOBACCO USE, SMOKING FOR 7 YEARS, CURRENT EVERY DAY SMOKER), MARIJUANA USE (LAST USE AT 13 YEARS OLD.), CRANIOTOMY, DISORDER PERSONALITY, ABORTION SPONTANEOUS COMPLETE (ABORTIONS - WHICH DID NOT REQUIRE D AND C. MISCARRIAGES) IN 2006, COMA (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), CAFFEINE CONSUMPTION, LOW BACK PAIN (VA AT AGE 16 COMA X 2 WEEKS NO LONG TERM MEMORY (BEFORE AGE 16)), ARTHRITIS, ASTHMA, OTHER DISORDERS OF INTESTINE, BREAST DISORDER FEMALE, CANCER, BRAIN OPERATION (MVA AT AGE 16, BRAIN INJURY , AUTOMOBILE ACCIDENT, HEAD INJURY FEEDING TUBE) IN 2004, RAPE VICTIM IN JUNE 2017, EXPOSURE TO COMMUNICABLE DISEASE, OVARIAN CYST, LATEX ALLERGY (EXTERNAL VULVLLR SWELLING WHEN SHE USES CONDOMS) AND THREATENED ABORTION. SOCIAL HISTORY DOES NOT INCLUDE ALCOHOL USE OR ILLICIT DRUG USE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVES. CONCURRENT CONDITIONS INCLUDED PENICILLIN ALLERGY, UTERINE BLEEDING (BLOOD CLOTS), BACTERIAL VAGINOSIS (VAGINAL ODOR, BV/TRICHY, BV AND C ALBICANS IN JANUARY), TOBACCO USER, EXTERNAL HEMORRHOIDS, ANXIETY DISORDER, DEPRESSION, VAGINAL HEMATOMA, INSOMNIA AND BLOOD PRESSURE HIGH. FAMILY HISTORY INCLUDED CANCER, HEART DISEASE, UNSPECIFIED, HYPERTENSION, PASSENGER IN MOTOR VEHICLE ACCIDENT (FATHER DECEASED MVA), DIABETES MELLITUS (MOTHER) AND MENTAL DISORDER (MOTHER). CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011, ANESTHETICS, GENERAL (GENERAL ANESTHESIA) AND CARBAZOCHROME SODIUM SULFONATE (ADONA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED IN 2011, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN 2015, THE PATIENT EXPERIENCED VAGINAL INFECTION ("MULTIPLE CASES OF VAGINITIS") WITH VAGINAL DISCHARGE. ON (B)(6) 2015, 4 YEARS 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2016, THE PATIENT EXPERIENCED BIPOLAR DISORDER ("BI-POLAR") AND ANXIETY ("ANXIETY"). ON (B)(6) 2016, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND ABDOMINAL PAIN LOWER, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("MIGRAINES / HEADACHES"), HEADACHE ("MIGRAINES / HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), CHOLELITHIASIS ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE:GALLBLADDER STONE"), NAUSEA ("NAUSEA,"), FATIGUE ("FATIGUE,"), WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE:WEIGHT GAIN"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH METHOTREXATE, METRONIDAZOLE (FLAGYL), SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015) AND SURGERY (OPERATIVE LAPAROSCOPY AND LEFT SALPINGECTOMY ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY, GENITAL HAEMORRHAGE, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, BIPOLAR DISORDER, ANXIETY, TOOTH DISORDER, MIGRAINE, HEADACHE, DYSPAREUNIA, CHOLELITHIASIS, NAUSEA, FATIGUE, WEIGHT INCREASED, URINARY TRACT DISORDER AND BLADDER DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ANXIETY, BIPOLAR DISORDER, BLADDER DISORDER, CHOLELITHIASIS, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, RUPTURED ECTOPIC PREGNANCY, TOOTH DISORDER, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: NO COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF ESSURE PLACEMENT PROCEDURE. ESSURE DEVICE WAS INSERTED AND PLACED FIRST ON THE LEFT TUBE. THREE COILS WERE LEFT OUTSIDE OF THE OSTIUM. IT WAS A LITTLE DIFFICULT TO INSERT IN THE RIGHT TUBE, PERHAPS WITH ADHESION IN THAT TUBE, BUT FINALLY IT WAS INSERTED AND AFTER THE INSERTION IT WAS NOT ABLE TO PULL BACK, SO THE DEVICE WAS RELEASED AND NO COIL WAS NOTED OUTSIDE OF THE OSTIUM. (B)(4) CASE CREATED FOR PREGNANCY (STILLBIRTH OR MISCARRIAGE) AND PREGNANCY (WITH COMPLICATIONS. (B)(4) CASE CREATED FOR PREGNANCY (TERMINATION). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HIV ANTIBODY: ON AN UNKNOWN DATE: NEGATIVE. HEPATITIS VIRAL TEST: ON AN UNKNOWN DATE: NEGATIVE. HUMAN CHORIONIC GONADOTROPIN: ON AN UNKNOWN DATE: POSITIVE. PREGNANCY TEST: ON AN UNKNOWN DATE: POSITIVE. PREGNANCY TEST URINE: ON AN UNKNOWN DATE: NEGATIVE. LAST MENSTRUAL PERIOD (B)(6) 2007. IN (B)(6) 2011: HYSTEROSCOPY FINDINGS: THE UTERUS WAS FOUND AND EVERTED. IT WAS SOUNDED TO 8 CM. TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND: THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA. IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM. THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX. AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS. FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ULTRASOUND FINDINGS: TRANSVERSE EXAM WAS PERFORMED TO PROVIDED BEST ANATOMIC DEFINITION OF UTERUS ENDOMETRIUM AND EVALUATED ADNEXAL STRUCTURE. COMPARED TO THE PREVIOUS EXAM THE CURRENT STUDY SHOW NO CYSTS /ADNEXAL MASS IN RIGHT OVARY. PREVIOUS COMPLEX CYST MAY REPRESENT A CORPUS LUTEUM CYST THAT HAS SINCE DECOMPOSED OR RUPTURE .THERE IS A LEFT ADNEXAL MASS SUSPICIOUS FOR ECTOPIC PREGNANCY WITH SMALL AMOUNT OF FREE FLUID PRESENT IN BOTH RIGHT AND LEFT ADNEXAL AREAS IMPRESSIONS:CURRENTS EXAM CONFIRMS A LEFT ADNEXAL MASS MEASURING SUSPICIOUS FOR ECTOPIC PREGNANCY. ULTRASOUND OBSTETRIC, TRANSVAGINAL: FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY IS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM. SIMPLE CYST MEASURES 2.00 X 1.81 X 1.84 CM LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM. COMPLEX CYST MEASURES 1.83 X 1.12. THERE IS VASCULAR FLOW SEEN IN EACH OVARY ON DOPPLER IMAGING IMPRESSION: NO INTRAUTERINE PREGNANCY IS IDENTIFIED., SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY., ECTOPIC PREGNANCY NOT EXCLUDED, FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 LO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. IN (B)(6) 2016, TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND. FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION THERE IS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER IS APPROXIMATELY 1.5 CM THERE IS NO FREE FLUID SEEN IN THE CUL-DE-SAC. ON (B)(6) 2015, TRANSVAGINAL OBSTETRIC PELVIC ULTRASOUND FINDINGS: TRANCE VAGINAL EXAM WAS PERFORM TO PROVIDE BEST ANATOMIC DEFINITIONS OF UTERUS ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURE .THE UTERUS APPEARS MIDDLE WITH CERVICAL LENGTH 3.10CM THERE IS NO INTRAUTERINE PREGNANCY THERE IS COMPLEX CYST VERSUS ECTOPIC PREGNANCY SEEN IN THE RIGHT ADNEXA IMPRESSION: UTERUS IS IN MIDLINE ENDOMETRIAL DIAMETER APPROXIMATELY 4MM. THERE IS AN ABNORMALITY IN THE RIGHT ADNEXA THERE IS A COMPLEX AREA OF ECHOGENICITY WITH CYSTIC AND SOLID COMPONENTS .FINDING ARE CONCERTING FOR ECTOPIC PREGNANCY CONSIDERING BETA HCG LEVEL 7228>LESS LIKELY THIS REPRESENTED HEMORRHAGIC CYST. ON (B)(6) 2015 SURGICAL PATHOLOGY REPORT: FINAL DIAGNOSIS: LEFT FALLOPIAN TUBE: PORTIONS OF FALLOPIAN TUBE SHOWING INTRALUMINAL CHORIONIC VILLLAND DECIDUALIZATION CONSISTENT WITH TUBAL ECTOPIC PREGNANCY. ON (B)(6) 2015, TRANSABDOMINAL OB ULTRASOUND FINDINGS: THE B-HCG IS REPORTED TO BE 501. THE UTERUS MEASURES 3.2 X 2.2 X 3.6 CM. A SMALL ANECHOIC FOCUS IS SEEN NEAR THE ENDOMETRIUM MEASURING 4 X 4 X 5 MM. NO YOLK SAC OR FETAL POLE IS SEEN. THE RIGHT OVARY MEASURES 3.2 X 2.2 X 3.6 CM. THE LEFT OVARY MEASURES 2.1 X 2.3 X 2.6 CM. DOPPLER FLOW TO THE OVARIES IS SEEN. SHADOWING ECHOGENIC FOCI ARE SEEN POSTERIOR TO THE UTERUS. NO FREE FLUID IS SEEN. IMPRESSION: 5 MM FOCUS IN THE ENDOMETRIUM WHICH COULD REPRESENT A GESTATIONAL SAC OR PSEUDOGESTATIONAL SAC. SHADOWING ECHOGENIC FOCI POSTERIOR THE UTERUS LIKELY REPRESENTS BOWEL GAS. THE B-HCG IS LIKELY NOT ELEVATED ENOUGH FOR THIS TO REPRESENT FETAL OSSEOUS STRUCTURES IN THE SETTING OF AN ABDOMINAL ECTOPIC PREGNANCY. CONCERNING INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT MEDICAL RECORDS: IT CONFIRMS EVENTS AS ANXIETY, LT ECTOPIC PREGNANCY, VAGINITIS, SUSPECTED RUPTURED ECTOPIC PREGNANCY LT. 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 PTC. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY") AND RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 4 YEARS 2 MONTHS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO TREAT ECTOPIC PREGNANCY ON (B)(6) 2015). AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY AND PELVIC PAIN OUTCOME WAS UNKNOWN. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT IS UNDER LITIGATION AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND EXPERIENCED A RUPTURED LEFT ECTOPIC PREGNANCY. SHE HAD A SURGERY TO TREAT THIS ECTOPIC PREGNANCY. ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE AND ITS RUPTURE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN A PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE ESSURE IN PLACE, DUE TO THE TUBAL OCCLUSION AND TISSUE IN-GROWTH MECHANISM OF ACTION OF ESSURE MICRO-INSERTS. CONSIDERING THIS AND AS ECTOPIC PREGNANCY OCCURRED AFTER ESSURE INSERTION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. RUPTURES OF ECTOPIC PREGNANCIES ARE OFTEN SEEN WITH PROGRESSING GESTATIONAL AGE. CONSIDERING THIS IS A COMPLICATION OF ECTOPIC PREGNANCY, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO THE SURGICAL INTERVENTION REQUIRED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS OR LACK OF EFFICACY CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS AND LACK OF EFFICACY ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT ECTOPIC PREGNANCY") AND RUPTURED ECTOPIC PREGNANCY ("RUPTURED LEFT ECTOPIC PREGNANCY") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2011, THE PATIENT STARTED ESSURE. THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS ON AN UNKNOWN DATE. ON (B)(6) 2015, 1544 DAYS AFTER STARTING ESSURE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND RUPTURED ECTOPIC PREGNANCY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("SEVERE PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (TO TREAT ECTOPIC PREGNANCY ON (B)(6) 2015). AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, RUPTURED ECTOPIC PREGNANCY AND PELVIC PAIN TO BE RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT IS UNDER LITIGATION AND REFERS TO A FEMALE CONSUMER WHO HAD ESSURE INSERTED AND EXPERIENCED A RUPTURED LEFT ECTOPIC PREGNANCY. SHE HAD A SURGERY TO TREAT THIS ECTOPIC PREGNANCY. ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE AND ITS RUPTURE ARE ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN A PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE ESSURE IN PLACE, DUE TO THE TUBAL OCCLUSION AND TISSUE IN-GROWTH MECHANISM OF ACTION OF ESSURE MICRO-INSERTS. CONSIDERING THIS AND AS ECTOPIC PREGNANCY OCCURRED AFTER ESSURE INSERTION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. RUPTURES OF ECTOPIC PREGNANCIES ARE OFTEN SEEN WITH PROGRESSING GESTATIONAL AGE. CONSIDERING THIS IS A COMPLICATION OF ECTOPIC PREGNANCY, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, DUE TO THE SURGICAL INTERVENTION REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224708 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | ADONA| ADONA| ADONA| ADONA| ADONA [CARBAZOCHROME SODIUM SULFONATE]| ADONA [CARBAZOCHROME SODIUM SULFONATE]| ANESTHETICS, GENERAL| ANESTHETICS, GENERAL| GENERAL ANESTHESIA| GENERAL ANESTHESIA| GENERAL ANESTHESIA| GENERAL ANESTHESIA| XANAX| XANAX| XANAX| XANAX| XANAX| XANAX |