ESSURE
Report
- Report Number
- 2951250-2019-04353
- Event Type
- Injury
- Date Received
- August 5, 2019
- Report Date
- May 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('A BIOPSY WAS DONE TODAY CO RULE OUT A LOWGRADE ENDOMETRITIS'), DEVICE EXPULSION ('SHE MIGHT STILL HAVE THE PROXIMAL COIL LEFT IN THE UTERUS') AND SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626221) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE INJURY, BACK INJURY, CRAMP IN LOWER ABDOMEN, VAGINAL DISCHARGE ABNORMALITY, SWELLING OF HANDS, LEG EDEMA, INSOMNIA, VAGINAL ITCHING, ALLERGIC RHINITIS, CANDIDIASIS, VAGINAL INFECTION, VAGINAL BURNING SENSATION, VAGINAL IRRITATION, AMENORRHEA AND OBESITY. CURRENT WEIGHT 251 LBS. CONCURRENT CONDITIONS INCLUDED GERD, GENITAL BLEEDING, ANEMIC, ABDOMINAL PAIN, APPETITE LOST, VOMITING, LOOSE STOOLS, DIZZINESS, THALASSEMIA, STOMACH PAIN, HEADACHE, STRESS, LIGHT HEADEDNESS, MENSES IRREGULAR, PANIC ATTACKS, CHLAMYDIAL INFECTION, VAGINAL PAIN AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS, BIFIDOBACTERIUM BIFIDUM, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE JANUARY 2009, CAFFEINE, CLONAZEPAM (KLONOPIN) SINCE JANUARY 2009, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM APRIL 2008 TO OCTOBER 2008, OMEPRAZOLE MAGNESIUM (PRILOSEC), RANITIDINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE JANUARY 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PHYSICAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, DEVICE EXPULSION, SALPINGITIS, VAGINAL INFECTION, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS GIVEN SEP-2008 INITIALLY, BUT IN CURRENT PFS (B)(6) 2008 GIVEN CURRENT WEIGHT 251 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.1 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION (AS PER PFS). PATHOLOGY TEST - ON (B)(6) 2009: ACUTE AND CHRONIC SALPINGITIS WITH TIBROPLASTIN AND GLANT CELL REACTION BENIGN SECRETORY ENDOMETRIUM CHRONIC CERVIOTIS NABOTHIAN CYSTS. ULTRASOUND SCAN - ON (B)(6) 2009: BOTH ESSURE DEVICES SEEN TRAILING INTO CORNUAL PORTION OF FUNDUS WITH 2-3 COILS WITHIN ENDOMETRIUM NORMAL RETROVERTED UTERUS, NORMAL LEFT TUBE AND OVARY. RT TUBE NOT SEEN. MODERATE AMOUNT OF CDS FLUID, EARLY LUTEAL PHASE.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TRANSVAGINAL SCAN SHOWS NORMAL SIZE RETROVERTED UTERUS WITH SYMMETRIC APPEARING ENDOMETRIAL STRIPE. THE TIPS OF EACH COIL COULD BE VISIBLE IN THE UPPER CORNUAL AREA AND I COULD TRACE THE COILS BACKWARD BILATERALLY AND THEY SEEMED TO BE LYING ON THE POSTERIOR WALL OF THE UTERUS FOR A SHORT DISTANCE AND THEN LOST THEM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: MENORRHAGIA, NAUSEA, PELVIC PAIN, FATIGUE, DYSPAREUNIA QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT) WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('A BIOPSY WAS DONE TODAY CO RULE OUT A LOWGRADE ENDOMETRITIS'), DEVICE EXPULSION ('SHE MIGHT STILL HAVE THE PROXIMAL COIL LEFT IN THE UTERUS'), SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626221) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE INJURY, BACK INJURY, CRAMP IN LOWER ABDOMEN, VAGINAL DISCHARGE ABNORMALITY, SWELLING OF HANDS, LEG EDEMA, INSOMNIA, VAGINAL ITCHING, ALLERGIC RHINITIS, CANDIDIASIS, VAGINAL INFECTION, VAGINAL BURNING SENSATION, VAGINAL IRRITATION, AMENORRHEA AND OBESITY. CURRENT WEIGHT 251 LBS. CONCURRENT CONDITIONS INCLUDED GERD, GENITAL BLEEDING, ANEMIC, ABDOMINAL PAIN, APPETITE LOST, VOMITING, LOOSE STOOLS, DIZZINESS, THALASSEMIA, STOMACH PAIN, HEADACHE, STRESS, LIGHT HEADEDNESS, MENSES IRREGULAR, PANIC ATTACKS, CHLAMYDIAL INFECTION, VAGINAL PAIN AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS, BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM INFANTIS;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS (WALGREENS 4 STRAIN PROBIOTIC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2009, CAFFEINE, CLONAZEPAM (KLONOPIN) SINCE (B)(6) 2009, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2008 TO (B)(6) 2008, OMEPRAZOLE MAGNESIUM (PRILOSEC), RANITIDINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ANAEMIA ("ANEMIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), RASH ("RASH") AND SKIN DISORDER ("SKIN CONDITION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, DEVICE EXPULSION, SALPINGITIS, DEPRESSION, ANXIETY, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND SKIN DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, NAUSEA, FATIGUE, ABDOMINAL PAIN, ANAEMIA AND ALLERGY TO METALS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, SALPINGITIS, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS GIVEN (B)(6) 2008 INITIALLY, BUT IN CURRENT PFS (B)(6) 2008 GIVEN CURRENT WEIGHT 251 LBS, PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, ALLERGY, PSYCH INJURY, BLADDER/URINARY PROBLEMS, FATIGUE, NAUSEA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.1 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION (AS PER PFS). PATHOLOGY TEST - ON (B)(6) 2009: ACUTE AND CHRONIC SALPINGITIS WITH TIBROPLASTIN AND GLANT CELL REACTION. BENIGN SECRETORY ENDOMETRIUM CHRONIC CERVIOTIS NABOTHIAN CYSTS. ULTRASOUND SCAN - ON (B)(6) 2009: BOTH ESSURE DEVICES SEEN TRAILING INTO CORNUAL PORTION OF FUNDUS WITH 2-3 COILS WITHIN ENDOMETRIUM. NORMAL RETROVERTED UTERUS, NORMAL LEFT TUBE AND OVARY. RT TUBE NOT SEEN. MODERATE AMOUNT OF CDS FLUID, EARLY LUTEAL PHASE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TRANSVAGINAL SCAN SHOWS NORMAL SIZE RETROVERTED UTERUS WITH SYMMETRIC APPEARING ENDOMETRIAL STRIPE. THE TIPS OF EACH COIL COULD BE VISIBLE IN THE UPPER CORNUAL AREA AND I COULD TRACE THE COILS BACKWARD BILATERALLY AND THEY SEEMED TO BE LYING ON THE POSTERIOR WALL OF THE UTERUS FOR A SHORT DISTANCE AND THEN LOST THEM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: MENORRHAGIA, NAUSEA, PELVIC PAIN, FATIGUE, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED: NEW EVENTS ABDOMINAL PAIN, ANEMIA, GENERAL ABNORMAL BLEEDING, NICKEL ALLERGY, RASH, SKIN CONDITION WERE ADDED AND EVENT PELVIC PAIN, MENORRHAGIA, VAGINAL INFECTION, FATIGUE, NAUSEA OUTCOME UPDATED RECOVERED/RESOLVED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('A BIOPSY WAS DONE TODAY CO RULE OUT A LOWGRADE ENDOMETRITIS'), DEVICE EXPULSION ('SHE MIGHT STILL HAVE THE PROXIMAL COIL LEFT IN THE UTERUS'), SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626221) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE INJURY, BACK INJURY, CRAMP IN LOWER ABDOMEN, VAGINAL DISCHARGE ABNORMALITY, SWELLING OF HANDS, LEG EDEMA, INSOMNIA, VAGINAL ITCHING, ALLERGIC RHINITIS, CANDIDIASIS, VAGINAL INFECTION, VAGINAL BURNING SENSATION, VAGINAL IRRITATION, AMENORRHEA AND OBESITY. CURRENT WEIGHT 251 LBS. CONCURRENT CONDITIONS INCLUDED GERD, GENITAL BLEEDING, ANEMIC, ABDOMINAL PAIN, APPETITE LOST, VOMITING, LOOSE STOOLS, DIZZINESS, THALASSEMIA, STOMACH PAIN, HEADACHE, STRESS, LIGHT HEADEDNESS, MENSES IRREGULAR, PANIC ATTACKS, CHLAMYDIAL INFECTION, VAGINAL PAIN AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS, BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM INFANTIS;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS (WALGREENS 4 STRAIN PROBIOTIC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2009, CAFFEINE, CLONAZEPAM (KLONOPIN) SINCE (B)(6) 2009, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2008 TO (B)(6) 2008, OMEPRAZOLE MAGNESIUM (PRILOSEC), RANITIDINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ANAEMIA ("ANEMIA"), ALLERGY TO METALS ("NICKEL ALLERGY"), RASH ("RASH") AND SKIN DISORDER ("SKIN CONDITION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, DEVICE EXPULSION, SALPINGITIS, DEPRESSION, ANXIETY, MIGRAINE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND SKIN DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, PELVIC PAIN, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, NAUSEA, FATIGUE, ABDOMINAL PAIN, ANAEMIA AND ALLERGY TO METALS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANAEMIA, ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH, SALPINGITIS, SKIN DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS GIVEN (B)(6) 2008 INITIALLY, BUT IN CURRENT PFS (B)(6) 2008 GIVEN CURRENT WEIGHT 251 LBS. PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING, ALLERGY, PSYCH INJURY, BLADDER/URINARY PROBLEMS, FATIGUE, NAUSEA . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.1 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION (AS PER PFS). PATHOLOGY TEST - ON (B)(6) 2009: ACUTE AND CHRONIC SALPINGITIS WITH TIBROPLASTIN AND GLANT CELL REACTION BENIGN SECRETORY ENDOMETRIUM CHRONIC CERVIOTIS NABOTHIAN CYSTS. ULTRASOUND SCAN - ON (B)(6) 2009: BOTH ESSURE DEVICES SEEN TRAILING INTO CORNUAL PORTION OF FUNDUS WITH 2-3 COILS WITHIN ENDOMETRIUM NORMAL RETROVERTED UTERUS, NORMAL LEFT TUBE AND OVARY. RT TUBE NOT SEEN. MODERATE AMOUNT OF CDS FLUID, EARLY LUTEAL PHASE.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TRANSVAGINAL SCAN SHOWS NORMAL SIZE RETROVERTED UTERUS WITH SYMMETRIC APPEARING ENDOMETRIAL STRIPE. THE TIPS OF EACH COIL COULD BE VISIBLE IN THE UPPER CORNUAL AREA AND I COULD TRACE THE COILS BACKWARD BILATERALLY AND THEY SEEMED TO BE LYING ON THE POSTERIOR WALL OF THE UTERUS FOR A SHORT DISTANCE AND THEN LOST THEM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: MENORRHAGIA, NAUSEA, PELVIC PAIN, FATIGUE, DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED: NEW EVENTS ABDOMINAL PAIN, ANEMIA, GENERAL ABNORMAL BLEEDING, NICKEL ALLERGY, RASH, SKIN CONDITION WERE ADDED AND EVENT PELVIC PAIN, MENORRHAGIA, VAGINAL INFECTION, FATIGUE, NAUSEA OUTCOME UPDATED RECOVERED/RESOLVED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ENDOMETRITIS ('A BIOPSY WAS DONE TODAY CO RULE OUT A LOWGRADE ENDOMETRITIS'), DEVICE EXPULSION ('SHE MIGHT STILL HAVE THE PROXIMAL COIL LEFT IN THE UTERUS') AND SALPINGITIS ('ACUTE AND CHRONIC SALPINGITIS') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 626221) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE INJURY, BACK INJURY, LOWER ABDOMINAL PAIN, VAGINAL DISCHARGE ABNORMALITY, SWELLING OF HANDS, LEG EDEMA, INSOMNIA, VAGINAL ITCHING, ALLERGIC RHINITIS, CANDIDIASIS, VAGINAL INFECTION, VAGINAL BURNING SENSATION, VAGINAL IRRITATION, AMENORRHEA AND MORBID OBESITY. CURRENT WEIGHT (B)(6). CONCURRENT CONDITIONS INCLUDED GERD, GENITAL BLEEDING, ANEMIC, ABDOMINAL PAIN, APPETITE LOST, VOMITING, LOOSE STOOLS, DIZZINESS, THALASSEMIA, STOMACH PAIN, HEADACHE, STRESS, LIGHT HEADEDNESS, MENSES IRREGULAR, PANIC ATTACKS, (B)(6) INFECTION, VAGINAL PAIN AND NABOTHIAN CYST. CONCOMITANT PRODUCTS INCLUDED BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM INFANTIS;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS ((B)(6) 4 STRAIN PROBIOTIC), BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2009, CAFFEINE, CLONAZEPAM (KLONOPIN) SINCE (B)(6) 2009, CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), HYDROCORTISONE; NEOMYCIN SULFATE;POLYMYXIN B SULFATE (ANTIBIOTIC HC), IBUPROFEN, KETOROLAC TROMETHAMINE (TORADOL), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D ALLERGY), MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6) 2008 TO (B)(6) 2008, OMEPRAZOLE MAGNESIUM (PRILOSEC), RANITIDINE AND SERTRALINE HYDROCHLORIDE (ZOLOFT) SINCE (B)(6) 2009. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2008, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), 16 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2008, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, DEPRESSION & MENTAL ANGUISH"). ON (B)(6) 2008, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2008, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2008, THE PATIENT EXPERIENCED MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2009, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("PHYSICAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2009. AT THE TIME OF THE REPORT, THE ENDOMETRITIS, DEVICE EXPULSION, SALPINGITIS, VAGINAL INFECTION, DEPRESSION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE PELVIC PAIN WAS RESOLVING AND THE MENORRHAGIA AND VAGINAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRITIS, FATIGUE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, SALPINGITIS, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE WAS GIVEN (B)(6) 2008 INITIALLY, BUT IN CURRENT PFS (B)(6) 2008 GIVEN. CURRENT WEIGHT (B)(6). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 35.1 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2008: TOTAL BILATERAL OCCLUSION (AS PER PFS). PATHOLOGY TEST - ON (B)(6) 2009: ACUTE AND CHRONIC SALPINGITIS WITH TIBROPLASTIN AND GIANT CELL REACTION BENIGN SECRETORY ENDOMETRIUM CHRONIC CERVIOTIS NABOTHIAN CYSTS. ULTRASOUND SCAN - ON (B)(6) 2009: BOTH ESSURE DEVICES SEEN TRAILING INTO CORNUAL PORTION OF FUNDUS WITH 2-3 COILS WITHIN ENDOMETRIUM NORMAL RETROVERTED UTERUS, NORMAL LEFT TUBE AND OVARY. RT TUBE NOT SEEN. MODERATE AMOUNT OF CDS FLUID, EARLY LUTEAL PHASE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2009: TRANSVAGINAL SCAN SHOWS NORMAL SIZE RETROVERTED UTERUS WITH SYMMETRIC APPEARING ENDOMETRIAL STRIPE. THE TIPS OF EACH COIL COULD BE VISIBLE IN THE UPPER CORNUAL AREA AND I COULD TRACE THE COILS BACKWARD BILATERALLY AND THEY SEEMED TO BE LYING ON THE POSTERIOR WALL OF THE UTERUS FOR A SHORT DISTANCE AND THEN LOST THEM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: MENORRHAGIA, NAUSEA, PELVIC PAIN, FATIGUE, DYSPAREUNIA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUL-2019: PFS & MR RECEIVED: CASE BECAME INCIDENT. NEW EVENTS- CHRONIC SALPINGITIS, ENDOMETRITIS, SHE MIGHT STILL HAVE THE PROXIMAL COIL LEFT IN THE UTERUS, MENORRHAGIA, VAGINAL BLEEDING, VAGINAL INFECTION, ANXIETY, DEPRESSION, MIGRAINES/HEADACHES, NAUSEA, DYSMENORRHEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, PELVIC PAIN. LOT NUMBER AND EVENT ONSET DATE WERE ADDED. UPDATED OUTCOME OF EVENT PELVIC PAIN TO RECOVERING/RESOLVING, MENORRHAGIA AND VAGINAL BLEEDING TO RECOVERED/RESOLVED. REPORTERS INFORMATION, PATIENTS DOB, DEMOGRAPHICS, RACE, DATE OF REMOVAL, LAB DATA, MEDICAL HISTORY, CONCOMITANT CONDITION AND DRUGS WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653560 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 626221 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| ANTIBIOTICS| BIFIDOBACTERIUM BIFIDUM| BIFIDOBACTERIUM BIFIDUM| CAFFEINE| CAFFEINE| CAFFEINE| CAFFEINE| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| CLARITIN-D ALLERGY| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| PRILOSEC [OMEPRAZOLE MAGNESIUM]| RANITIDINE| RANITIDINE| RANITIDINE| RANITIDINE| TORADOL| TORADOL| TORADOL| TORADOL| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3| WALGREENS 4 STRAIN PROBIOTIC| WALGREENS 4 STRAIN PROBIOTIC| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |