ESSURE
Report
- Report Number
- 2951250-2016-00969
- Event Type
- Injury
- Date Received
- June 28, 2016
- Date of Event
- October 21, 2014
- Report Date
- September 4, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("ACUTE PELVIC INFLAMMATORY DISEASE"), OVARIAN ABSCESS ("OVARIAN ABSCESS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), STAPHYLOCOCCAL INFECTION ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499/ C03089) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6) 2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6) 2015, MISCARRIAGE, PSYCHOLOGICAL DISORDER NOS, UTERINE CONTRACTIONS ABNORMAL, FETAL MOVEMENTS DECREASED, URINARY TRACT INFECTION, SCOLIOSIS, CARPAL TUNNEL SYNDROME, ASTHMA, LIGAMENT TEAR, MUSCLE STRAIN, HEMATURIA, BREAST LUMP, FLANK PAIN, LEUKOCYTOSIS, CHEST PAIN, MASTITIS, BREAST OPERATION, NAUSEA, GALLBLADDER OPERATION, MULTIGRAVIDA, PARITY 2, COUGH, NASAL CONGESTION, RHINORRHEA, SHORTNESS OF BREATH, VIRAL UPPER RESPIRATORY TRACT INFECTION, HEART MURMUR, FLU-LIKE ILLNESS, GASTROENTERITIS, ATOPIC DERMATITIS, CELLULITIS, HEMORRHOIDS, RECTAL PAIN, HEADACHE, BREAST BIOPSY, PLEURITIC PAIN, OVARIAN CYST, BREAST LUMP REMOVAL, TACHYCARDIA, BREAST ABSCESS AND ARTHRITIS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014, BUTALBLTAL-ACETAMINOPHEN-CAFFEINE, CYCLOBENZAPRINE, VITAMINS, ACETAMINOPHEN, NAPROXEN, OXYCODONE, ALBUTEROL SULFATE AND HYDROCODONE. CONCURRENT CONDITIONS INCLUDED INFECTION MRSA, SMOKER (0.5 PACKS/DAY), COSTOCHONDRITIS, RECTAL BLEEDING, BRONCHITIS, DIARRHEA, PNEUMONIA, LUMBAGO, ANKLE INJURY, ABRASION NOS, CONTUSION, FRACTURE, BENIGN NEOPLASM OF CORPUS UTERI, LOOSE STOOLS, VAGINAL DISCHARGE, MUSCULOSKELETAL PAIN AND BACTERIAL VAGINOSIS. FAMILY HISTORY INCLUDED STROKE (FATHER,DECEASED), ANEURYSM CEREBRAL, DIABETES MELLITUS (PATERNAL GRANDMOTHER, MATERNAL GRANDFATHER) AND COLON CANCER (GRANDPARENT). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) SINCE 2013 FOR ANXIETY, DEPRESSION AND HEADACHE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) FROM 2013 TO 2015 AND VICODIN (NORCO) FROM 2013 TO 2015 FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA) AND IBUPROFEN. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2016, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN ABSCESS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), STAPHYLOCOCCAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING)HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, OVARIAN ABSCESS, DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, STAPHYLOCOCCAL INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, OVARIAN ABSCESS, RHEUMATOID ARTHRITIS, STAPHYLOCOCCAL INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SE WAS SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND ON (B)(6) 2015, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND TOLD THAT THE INTRAOPERATIVE CHOLANGIOGRAM WAS ABNORMAL AND WAS SHOWING IMPACTED GALLSTONES IN THE DISTAL COMMON BILE DUCT. SHE WAS TRANSFERRED HERE FOR ERCP. THE PATIENT REPORTS SOME UPPER ABDOMINAL PAIN. SHE SAID SHE HAS VOMITED ONCE SINCE THE SURGERY. SHE HAS BEEN PASSING GAS AND HAS NOT HAD A BOWEL MOVEMENT SINCE SURGERY. LABS FROM 01/13, SHOWING A BILIRUBIN OF 2.7, AST OF 328, ALT OF 856, ALKALINE PHOSPHATASE OF 334, AND LIPASE OF 68. HER BILIRUBIN IS 3.4, AST 117, ALT 319, AND ALKALINE PHOSPHATASE 269. PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY, HAD ABNORMAL INTRAOPERATIVE CHOLANGIOGRAM WITH CHOLEDOCHOLITHIASIS AND TRANSFERRED HERE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ON (B)(6) 2013 PATIENT UNDERWENT ULTRASOUND SCAN RESULTED IN BREAST ABSCESS 2.5X1.2X1.4 CM UNDERSURFACE OF THE NIPPLE AREOLA WITH ASSOCIATED EDEMA OF SUBCUE TISSUE. PT WILL BE STARTED ON IV VANCOMYCIN SURGICAL CONSULT OBTAINED. SMALL SUBAREOLAR BREAST ABSCESS. ON (B)(6) 2015 PATIENT UNDERWENT ABDOMINAL ULTRASOUND - RIGHT UPPER QUADRANT RESULTED IN NUMEROUS SMALL GALLSTONES IN AN OTHERWISE NORMAL-APPEARING GALLBLADDER. NO DEMONSTRATED BILE DUCT DILATATION. ON (B)(6) 2015 PATIENT UNDERWENT X-RAY ABDOMEN RESULTED IN INITIAL IMAGES DEMONSTRATE A FILLING DEFECT WITHIN THE COMMON BILE DUCT. UNCLEAR THIS REPRESENTS A STONE, BALLOON, AIR, OR OTHER. ON (B)(6) 2015 PATIENT UNDERWENT CT ABDOMEN AND PELVIS W CONT RESULTED IN SMALL AREA OF MILD, AIRSPACE DISEASE IN THE PERIPHERAL ASPECT OF THE RIGHT UPPER LOBE AS ABOVE. THIS CAN REPRESENT FOCAL AREA OF PNEUMONITIS. ON (B)(6) 2015 PATIENT UNDERWENT LUMBAR SPINE THREE VIEWS RESULTED IN POSSIBLE MILD SCOLIOSIS. ON (B)(6) 2015 PATIENT UNDERWENT US TRANSVAGINAL NON OBSTETRIC RESULTED IN RIGHT CORPUS LUTEAL CYST WITH SMALL AMOUNT OF ADJACENT FREE FLUID LIKELY REPRESENTING A RIGHT HEMORRHAGIC OVARIAN CYST. ON (B)(6) 2017 AND (B)(6) 2015 PATIENT UNDERWENT TRANSVAGINAL PELVIC ULTRASOUND RESULTED IN THE PELVIC ULTRASOUND IS GROSSLY NORMAL IN APPEARANCE. THE PATIENT HAS BILATERAL TUBAL OCCLUSION COILS, THAT APPEAR TO BE IN GOOD POSITION ALTHOUGH THEY ARE NOT FULLY VISUALIZED AND THE ENDOMETRIUM IS SOMEWHAT THICKENED AND IRREGULAR, PROBABLY DUE TO BEING IN THE PROLIFERATIVE STAGE. IT WAS NORMAL ON THE PREVIOUS ULTRASOUND DONE ON (B)(6) 2014. ON (B)(6) 2015 UNDERWENT US BREAST LIMITED ULTRASOUND RESULTED IN LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT WAS PERFORMED. THE RE IS A 14 X 8 X 12 MM COM PLEX HYPOECHOIC COLLECTION WITH IN THE SKIN OF THE RIGHT BREAST AT THE 5:00 POSITION. THIS IS NEW FROM THE PRIOR ULTRASOUND. THERE IS SURROUNDING DOPPLER FLOW. AT THE 5:30 POSITION, THERE IS A SMALL OVAL HYPOECHOIC COLLECTION AGAIN WITHIN THE SKIN OF THE BREAST. THESE MEASURES 13 X 4 X 16 MM AN D IS SIMILAR IN APPEARANCE TO THE PRIOR EXAM. IMPRESSION-LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT. THERE ARE TWO SMALL ABSCESSES WITHIN THE SKIN/ SUPERFICIAL SOFT TISSUES OVERLYING THE RIGHT BREAST AS ABOVE. ON (B)(6) 2017 PATIENT UNDERWENT ULTRASOUND, TRANSVAGINAL RESULTED IN LARGE CYST RIGHT OVARY. DUE TO ITS LARGE SIZE, IT SHOULD BE FOLLOWED TO ASSURE RESOLUTION WITH REPEAT ULTRASOUND IN 8-10 WEEKS LOT NUMBER: B97499, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 02-DEC-2013. LOT NUMBER: C03089, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 03-DEC-2013. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2018: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT :AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
CUTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("ACUTE PELVIC INFLAMMATORY DISEASE"), OVARIAN ABSCESS ("OVARIAN ABSCESS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), STAPHYLOCOCCAL INFECTION ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499/ C03089) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6) 2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6) 2015, MISCARRIAGE, PSYCHOLOGICAL DISORDER NOS, UTERINE CONTRACTIONS ABNORMAL, FETAL MOVEMENTS DECREASED, URINARY TRACT INFECTION, SCOLIOSIS, CARPAL TUNNEL SYNDROME, ASTHMA, LIGAMENT TEAR, MUSCLE STRAIN, HEMATURIA, BREAST LUMP, FLANK PAIN, LEUKOCYTOSIS, CHEST PAIN, MASTITIS, BREAST OPERATION, NAUSEA, GALLBLADDER OPERATION, MULTIGRAVIDA, PARITY 2, COUGH, NASAL CONGESTION, RHINORRHEA, SHORTNESS OF BREATH, VIRAL UPPER RESPIRATORY TRACT INFECTION, HEART MURMUR, FLU-LIKE ILLNESS, GASTROENTERITIS, ATOPIC DERMATITIS, CELLULITIS, HEMORRHOIDS, RECTAL PAIN, HEADACHE, BREAST BIOPSY, PLEURITIC PAIN, OVARIAN CYST, BREAST LUMP REMOVAL, TACHYCARDIA, BREAST ABSCESS AND ARTHRITIS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014, BUTALBLTAL-ACETAMINOPHEN-CAFFEINE, CYCLOBENZAPRINE, VITAMINS, ACETAMINOPHEN, NAPROXEN, OXYCODONE, ALBUTEROL SULFATE AND HYDROCODONE. CONCURRENT CONDITIONS INCLUDED INFECTION MRSA, SMOKER (0.5 PACKS/DAY), COSTOCHONDRITIS, RECTAL BLEEDING, BRONCHITIS, DIARRHEA, PNEUMONIA, LUMBAGO, ANKLE INJURY, ABRASION NOS, CONTUSION, FRACTURE, BENIGN NEOPLASM OF CORPUS UTERI, LOOSE STOOLS, VAGINAL DISCHARGE, MUSCULOSKELETAL PAIN AND BACTERIAL VAGINOSIS. FAMILY HISTORY INCLUDED STROKE (FATHER,DECEASED), ANEURYSM CEREBRAL, DIABETES MELLITUS (PATERNAL GRANDMOTHER, MATERNAL GRANDFATHER) AND COLON CANCER (GRANDPARENT). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) SINCE 2013 FOR ANXIETY, DEPRESSION AND HEADACHE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) FROM 2013 TO 2015 AND VICODIN (NORCO) FROM 2013 TO 2015 FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA) AND IBUPROFEN. IN 2014, THE PATIENT EXPERIENCED MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). ON (B)(6) 2014, 15 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON (B)(6) 2015, THE PATIENT EXPERIENCED ALOPECIA ("INCREASED HAIR LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), STAPHYLOCOCCAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING)HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, OVARIAN ABSCESS, DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, STAPHYLOCOCCAL INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED, COMPLICATION OF DEVICE INSERTION AND ALOPECIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, OVARIAN ABSCESS, RHEUMATOID ARTHRITIS, STAPHYLOCOCCAL INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SE WAS SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. THE PATIENT TOLERATED THE PROCEDURE WELL. INJURY/CONDITION, WHETHER YOU HAD RECOVERED FROM THAT INJURY/CONDITION BEFORE YOUR ESSURE PLACEMENT, AND IF SO, THE DATE YOU RECOVERED FROM THE INJURY/CONDITION: ABDOMINAL PAIN, BLEEDING; DEPRESSION, FATIGUE, MIGRAINES NOT RECOVERED BEFORE IMPLANT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS. PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND ON (B)(6) 2015, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND TOLD THAT THE INTRAOPERATIVE CHOLANGIOGRAM WAS ABNORMAL AND WAS SHOWING IMPACTED GALLSTONES IN THE DISTAL COMMON BILE DUCT. SHE WAS TRANSFERRED HERE FOR ERCP. THE PATIENT REPORTS SOME UPPER ABDOMINAL PAIN. SHE SAID SHE HAS VOMITED ONCE SINCE THE SURGERY. SHE HAS BEEN PASSING GAS AND HAS NOT HAD A BOWEL MOVEMENT SINCE SURGERY. LABS FROM 01/13, SHOWING A BILIRUBIN OF 2.7, AST OF 328, ALT OF 856, ALKALINE PHOSPHATASE OF 334, AND LIPASE OF 68. HER BILIRUBIN IS 3.4, AST 117, ALT 319, AND ALKALINE PHOSPHATASE 269. PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY, HAD ABNORMAL INTRAOPERATIVE CHOLANGIOGRAM WITH CHOLEDOCHOLITHIASIS AND TRANSFERRED HERE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ON (B)(6) 2013 PATIENT UNDERWENT ULTRASOUND SCAN RESULTED IN BREAST ABSCESS 2.5X1.2X1.4 CM UNDERSURFACE OF THE NIPPLE AREOLA WITH ASSOCIATED EDEMA OF SUBCUE TISSUE. PT WILL BE STARTED ON IV VANCOMYCIN SURGICAL CONSULT OBTAINED. SMALL SUBAREOLAR BREAST ABSCESS. ON (B)(6) 2015 PATIENT UNDERWENT ABDOMINAL ULTRASOUND - RIGHT UPPER QUADRANT RESULTED IN NUMEROUS SMALL GALLSTONES IN AN OTHERWISE NORMAL-APPEARING GALLBLADDER. NO DEMONSTRATED BILE DUCT DILATATION. ON (B)(6) 2015 PATIENT UNDERWENT X-RAY ABDOMEN RESULTED IN INITIAL IMAGES DEMONSTRATE A FILLING DEFECT WITHIN THE COMMON BILE DUCT. UNCLEAR THIS REPRESENTS A STONE, BALLOON, AIR, OR OTHER. ON (B)(6) 2015 PATIENT UNDERWENT CT ABDOMEN AND PELVIS W CONT RESULTED IN SMALL AREA OF MILD, AIRSPACE DISEASE IN THE PERIPHERAL ASPECT OF THE RIGHT UPPER LOBE AS ABOVE. THIS CAN REPRESENT FOCAL AREA OF PNEUMONITIS. ON (B)(6) 2015 PATIENT UNDERWENT LUMBAR SPINE THREE VIEWS RESULTED IN POSSIBLE MILD SCOLIOSIS. ON (B)(6) 2015 PATIENT UNDERWENT US TRANSVAGINAL NON OBSTETRIC RESULTED IN RIGHT CORPUS LUTEAL CYST WITH SMALL AMOUNT OF ADJACENT FREE FLUID LIKELY REPRESENTING A RIGHT HEMORRHAGIC OVARIAN CYST. ON (B)(6) 2017 AND (B)(6) 2015 PATIENT UNDERWENT TRANSVAGINAL PELVIC ULTRASOUND RESULTED IN THE PELVIC ULTRASOUND IS GROSSLY NORMAL IN APPEARANCE. THE PATIENT HAS BILATERAL TUBAL OCCLUSION COILS, THAT APPEAR TO BE IN GOOD POSITION ALTHOUGH THEY ARE NOT FULLY VISUALIZED AND THE ENDOMETRIUM IS SOMEWHAT THICKENED AND IRREGULAR, PROBABLY DUE TO BEING IN THE PROLIFERATIVE STAGE. IT WAS NORMAL ON THE PREVIOUS ULTRASOUND DONE ON (B)(6) 2014. ON (B)(6) 2015 UNDERWENT US BREAST LIMITED ULTRASOUND RESULTED IN LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT WAS PERFORMED. THE RE IS A 14 X 8 X 12 MM COM PLEX HYPOECHOIC COLLECTION WITH IN THE SKIN OF THE RIGHT BREAST AT THE 5:00 POSITION. THIS IS NEW FROM THE PRIOR ULTRASOUND. THERE IS SURROUNDING DOPPLER FLOW. AT THE 5:30 POSITION, THERE IS A SMALL OVAL HYPOECHOIC COLLECTION AGAIN WITHIN THE SKIN OF THE BREAST. THESE MEASURES 13 X 4 X 16 MM AN D IS SIMILAR IN APPEARANCE TO THE PRIOR EXAM. IMPRESSION-LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT. THERE ARE TWO SMALL ABSCESSES WITHIN THE SKIN/ SUPERFACIAL SOFT TISSUES OVERLYING THE RIGHT BREAST AS ABOVE. ON (B)(6) 2017 PATIENT UNDERWENT ULTRASOUND, TRANSVAGINAL RESULTED IN LARGE CYST RIGHT OVARY. DUE TO ITS LARGE SIZE, IT SHOULD BE FOLLOWED TO ASSURE RESOLUTION WITH REPEAT ULTRASOUND IN 8-10 WEEKS LOT NUMBER: B97499, EXPIRATION DATE: (B)(6) 2016, MFR DATE: (B)(6) 2013. LOT NUMBER: C03089, EXPIRATION DATE: (B)(6) 2016, MFR DATE: (B)(6) 2013. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS ADDED FROM PFS- INCREASED HAIR LOSS. ONSET DATE OF EVENT ABDOMINAL PAIN, RHEUMATOID ARTHRITIS, GENITAL HAEMORRHAGE WERE UPDATE. 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 PELVIC INFLAMMATORY DISEASE ("ACUTE PELVIC INFLAMMATORY DISEASE"), OVARIAN ABSCESS ("OVARIAN ABSCESS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), STAPHYLOCOCCAL INFECTION ("(B)(6) MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER (B)(6) BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499,C03089) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6)-2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6)-2015, MISCARRIAGE, PSYCHOLOGICAL DISORDER NOS, UTERINE CONTRACTIONS ABNORMAL, FETAL MOVEMENTS DECREASED, URINARY TRACT INFECTION, SCOLIOSIS, CARPAL TUNNEL SYNDROME, ASTHMA, LIGAMENT TEAR, MUSCLE STRAIN, HEMATURIA, BREAST LUMP, FLANK PAIN, LEUKOCYTOSIS, CHEST PAIN, MASTITIS, STSI, BREAST OPERATION, NAUSEA, GALLBLADDER OPERATION, GRAVIDA II, PARITY 2, COUGH, NASAL CONGESTION, RHINORRHEA, SHORTNESS OF BREATH, VIRAL UPPER RESPIRATORY TRACT INFECTION, HEART MURMUR, FLU-LIKE ILLNESS, GASTROENTERITIS, ATOPIC DERMATITIS, CELLULITIS, HEMORRHOIDS, RECTAL PAIN, HEADACHE, BREAST BIOPSY, PLEURITIC PAIN, OVARIAN CYST, BREAST LUMP REMOVAL, TACHYCARDIA, BREAST ABSCESS AND ARTHRITIS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014, BUTALBLTAL-ACETAMINOPHEN-CAFFEINE, CYCLOBENZAPRINE, VITAMINS, ACETAMINOPHEN, NAPROXEN, OXYCODONE, ALBUTEROL SULFATE AND HYDROCODONE. CONCURRENT CONDITIONS INCLUDED INFECTION (B)(6), SMOKER (0.5 PACKS/DAY), COSTOCHONDRITIS, RECTAL BLEEDING, BRONCHITIS, DIARRHEA, PNEUMONIA, LUMBAGO, ANKLE INJURY, ABRASION NOS, CONTUSION, FRACTURE, BENIGN NEOPLASM OF CORPUS UTERI, LOOSE STOOLS, VAGINAL DISCHARGE, MUSCULOSKELETAL PAIN AND BACTERIAL VAGINOSIS. FAMILY HISTORY INCLUDED STROKE (FATHER,DECEASED), ANEURYSM CEREBRAL, DIABETES MELLITUS (PATERNAL GRANDMOTHER, MATERNAL GRANDFATHER) AND COLON CANCER (GRANDPARENT). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) IN 2013 FOR ANXIETY, DEPRESSION AND HEADACHE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) IN 2013 AND VICODIN (NORCO) IN 2013 FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA) AND IBUPROFEN. IN 2014, 113 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6)-2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2016, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), STAPHYLOCOCCAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING)HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("(B)(6) MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER (B)(6) BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, OVARIAN ABSCESS, DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, STAPHYLOCOCCAL INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, OVARIAN ABSCESS, RHEUMATOID ARTHRITIS, STAPHYLOCOCCAL INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SE WAS SCHEDULED FOR A YSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED.ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND ON (B)(6) 2015, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND TOLD THAT THE INTRAOPERATIVE CHOLANGIOGRAM WAS ABNORMAL AND WAS SHOWING IMPACTED GALLSTONES IN THE DISTAL COMMON BILE DUCT. SHE WAS TRANSFERRED HERE FOR ERCP. THE PATIENT REPORTS SOME UPPER ABDOMINAL PAIN. SHE SAID SHE HAS VOMITED ONCE SINCE THE SURGERY. SHE HAS BEEN PASSING GAS AND HAS NOT HAD A BOWEL MOVEMENT SINCE SURGERY. LABS FROM (B)(6), SHOWING A BILIRUBIN OF 2.7, AST OF 328, ALT OF 856, ALKALINE PHOSPHATASE OF 334, AND LIPASE OF 68.HER BILIRUBIN IS 3.4, AST 117, ALT 319, AND ALKALINE PHOSPHATASE 269.PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY, HAD ABNORMAL INTRAOPERATIVE CHOLANGIOGRAM WITH CHOLEDOCHOLITHIASIS AND TRANSFERRED HERE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ON (B)(6) 2013 PATIENT UNDERWENT ULTRASOUND SCAN RESULTED IN BREAST ABSCESS 2.5X1.2X1.4 CM UNDERSURFACE OF THE NIPPLE AREOLA WITH ASSOCIATED EDEMA OF SUBCUE TISSUE. PT WILL BE STARTED ON IV VANCOMYCIN SURGICAL CONSULT OBTAINED.SMALL SUBAREOLAR BREAST ABSCESS. ON (B)(6) 2015 PATIENT UNDEWENT ABDOMINAL ULTRASOUND - RIGHT UPPER QUADRANT RESULTED IN NUMEROUS SMALL GALLSTONES IN AN OTHERWISE NORMAL-APPEARING GALLBLADDER. NO DEMONSTRATED BILE DUCT DILATATION. ON (B)(6) 2015 PATIENT UNDERWENT X-RAY ABDOMEN RESULTED IN INITIAL IMAGES DEMONSTRATE A FILLING DEFECT WITHIN THE COMMON BILE DUCT. UNCLEAR THIS REPRESENTS A STONE, BALLOON, AIR, OR OTHER. ON (B)(6) 2015 PATIENT UNDERWENT CT ABDOMEN AND PELVIS W CONT RESULTED IN SMALL AREA OF MILD, AIRSPACE DISEASE IN THE PERIPHERAL ASPECT OF THE RIGHT UPPER LOBE AS ABOVE. THIS CAN REPRESENT FOCAL AREA OF PNEUMONITIS. ON (B)(6) 2015 PATIENT UNDERWENT LUMBAR SPINE THREE VIEWS RESULTED IN POSSIBLE MILD SCOLIOSIS. ON (B)(6) 2015 PATIENT UNDERWENT US TRANSVAGINAL NON OBSTETRIC RESULTED IN RIGHT CORPUS LUTEAL CYST WITH SMALL AMOUNT OF ADJACENT FREE FLUID LIKELY REPRESENTING A RIGHT HEMORRHAGIC OVARIAN CYST. ON (B)(6) 2017 AND (B)(6) 2015 PATIENT UNDERWENT TRANSVAGINAL PELVIC ULTRASOUND RESULTED IN THE PELVIC ULTRASOUND IS GROSSLY NORMAL IN APPEARANCE. THE PATIENT HAS BILATERAL TUBAL OCCLUSION COILS, THAT APPEAR TO BE IN GOOD POSITION ALTHOUGH THEY ARE NOT FULLY VISUALIZED AND THE ENDOMETRIUM IS SOMEWHAT THICKENED AND IRREGULAR, PROBABLY DUE TO BEING IN THE PROLIFERATIVE STAGE. IT WAS NORMAL ON THE PREVIOUS ULTRASOUND DONE ON (B)(6) 2014. ON (B)(6) 2015 UNDERWENT US BREAST LIMITED ULTRASOUND RESULTED IN LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT WAS PERFORMED. THE RE IS A 14 X 8 X 12 MM COM PLEX HYPOECHOIC COLLECTION N WITH IN THE SKIN OF THE RIGHT BREAST AT THE 5:00 POSITION. THIS IS NEW FROM THE PRIOR ULTRASOUND. THERE IS SURROUNDING DOPPLER FLOW. AT THE 5:30 POSITION, THERE IS A SMALL OVAL HYPOECHOIC COLLECTION AGAIN WITHIN THE SKIN OF THE BREAST. THESE MEASURES 13 X 4 X 16 MM AN D IS SIMILAR IN APPEARANCE TO THE PRIOR EXAM. - IMPRESSION-LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT. THERE ARE TWO SMALL ABSCESSES WITHIN THE SKIN/ SUPERFACIAL SOFT TISSUES OVERLYING THE RIGHT BREAST AS ABOVE. ON (B)(6) 2017 PATIENT UNDERWENT ULTRASOUND, TRANSVAGINAL RESULTED IN LARGE CYST RIGHT OVARY. DUE TO ITS LARGE SIZE, IT SHOULD BE FOLLOWED TO ASSURE RESOLUTION WITH REPEAT ULTRASOUND IN 8-10 WEEKS MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-DEC-2017: PFS RECEIVED; MEDICALL CONFIRMED REPORTER ADDED, PATIENT HISTORICAL CONDITION, CONCOMITANT CONDITION HISTORICAL AND CONCOMIATNT DRUG ADDED, FROM MR EVENT EXTRACTED AS FOLLOWS:- PELVIC INFLAMMATORY DISEASE AND OVARIAN ABSCESS 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 PELVIC INFLAMMATORY DISEASE ("ACUTE PELVIC INFLAMMATORY DISEASE"), OVARIAN ABSCESS ("OVARIAN ABSCESS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), STAPHYLOCOCCAL INFECTION ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499/ C03089) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6) 2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6) 2015, MISCARRIAGE, PSYCHOLOGICAL DISORDER NOS, UTERINE CONTRACTIONS ABNORMAL, FETAL MOVEMENTS DECREASED, URINARY TRACT INFECTION, SCOLIOSIS, CARPAL TUNNEL SYNDROME, ASTHMA, LIGAMENT TEAR, MUSCLE STRAIN, HEMATURIA, BREAST LUMP, FLANK PAIN, LEUKOCYTOSIS, CHEST PAIN, MASTITIS, BREAST OPERATION, NAUSEA, GALLBLADDER OPERATION, MULTIGRAVIDA, PARITY 2, COUGH, NASAL CONGESTION, RHINORRHEA, SHORTNESS OF BREATH, VIRAL UPPER RESPIRATORY TRACT INFECTION, HEART MURMUR, FLU-LIKE ILLNESS, GASTROENTERITIS, ATOPIC DERMATITIS, CELLULITIS, HEMORRHOIDS, RECTAL PAIN, HEADACHE, BREAST BIOPSY, PLEURITIC PAIN, OVARIAN CYST, BREAST LUMP REMOVAL, TACHYCARDIA, BREAST ABSCESS AND ARTHRITIS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014, BUTALBITAL-ACETAMINOPHEN-CAFFEINE, CYCLOBENZAPRINE, VITAMINS, ACETAMINOPHEN, NAPROXEN, OXYCODONE, ALBUTEROL SULFATE AND HYDROCODONE. CONCURRENT CONDITIONS INCLUDED INFECTION MRSA, SMOKER (0.5 PACKS/DAY), COSTOCHONDRITIS, RECTAL BLEEDING, BRONCHITIS, DIARRHEA, PNEUMONIA, LUMBAGO, ANKLE INJURY, ABRASION NOS, CONTUSION, FRACTURE, BENIGN NEOPLASM OF CORPUS UTERI, LOOSE STOOLS, VAGINAL DISCHARGE, MUSCULOSKELETAL PAIN AND BACTERIAL VAGINOSIS. FAMILY HISTORY INCLUDED STROKE (FATHER,DECEASED), ANEURYSM CEREBRAL, DIABETES MELLITUS (PATERNAL GRANDMOTHER, MATERNAL GRANDFATHER) AND COLON CANCER (GRANDPARENT). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) SINCE 2013 FOR ANXIETY, DEPRESSION AND HEADACHE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) FROM 2013 TO 2015 AND VICODIN (NORCO) FROM 2013 TO 2015 FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA) AND IBUPROFEN. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2016, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), STAPHYLOCOCCAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING)HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, OVARIAN ABSCESS, DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, STAPHYLOCOCCAL INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, OVARIAN ABSCESS, RHEUMATOID ARTHRITIS, STAPHYLOCOCCAL INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SE WAS SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS. PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND ON (B)(6) 2015, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND TOLD THAT THE INTRAOPERATIVE CHOLANGIOGRAM WAS ABNORMAL AND WAS SHOWING IMPACTED GALLSTONES IN THE DISTAL COMMON BILE DUCT. SHE WAS TRANSFERRED HERE FOR ERCP. THE PATIENT REPORTS SOME UPPER ABDOMINAL PAIN. SHE SAID SHE HAS VOMITED ONCE SINCE THE SURGERY. SHE HAS BEEN PASSING GAS AND HAS NOT HAD A BOWEL MOVEMENT SINCE SURGERY. LABS FROM (B)(6) , SHOWING A BILIRUBIN OF 2.7, AST OF 328, ALT OF 856, ALKALINE PHOSPHATASE OF 334, AND LIPASE OF 68. HER BILIRUBIN IS 3.4, AST 117, ALT 319, AND ALKALINE PHOSPHATASE 269. PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY, HAD ABNORMAL INTRAOPERATIVE CHOLANGIOGRAM WITH CHOLEDOCHOLITHIASIS AND TRANSFERRED HERE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ON (B)(6) 2013 PATIENT UNDERWENT ULTRASOUND SCAN RESULTED IN BREAST ABSCESS 2.5X1.2X1.4 CM UNDERSURFACE OF THE NIPPLE AREOLA WITH ASSOCIATED EDEMA OF SUBCUT TISSUE. PT WILL BE STARTED ON IV VANCOMYCIN SURGICAL CONSULT OBTAINED. SMALL SUBAREOLAR BREAST ABSCESS. ON (B)(6) 2015 PATIENT UNDERWENT ABDOMINAL ULTRASOUND - RIGHT UPPER QUADRANT RESULTED IN NUMEROUS SMALL GALLSTONES IN AN OTHERWISE NORMAL-APPEARING GALLBLADDER. NO DEMONSTRATED BILE DUCT DILATATION. ON (B)(6) 2015 PATIENT UNDERWENT X-RAY ABDOMEN RESULTED IN INITIAL IMAGES DEMONSTRATE A FILLING DEFECT WITHIN THE COMMON BILE DUCT. UNCLEAR THIS REPRESENTS A STONE, BALLOON, AIR, OR OTHER. ON (B)(6) 2015 PATIENT UNDERWENT CT ABDOMEN AND PELVIS W CONT RESULTED IN SMALL AREA OF MILD, AIRSPACE DISEASE IN THE PERIPHERAL ASPECT OF THE RIGHT UPPER LOBE AS ABOVE. THIS CAN REPRESENT FOCAL AREA OF PNEUMONITIS. ON (B)(6) 2015 PATIENT UNDERWENT LUMBAR SPINE THREE VIEWS RESULTED IN POSSIBLE MILD SCOLIOSIS. ON (B)(6) 2015 PATIENT UNDERWENT US TRANSVAGINAL NON OBSTETRIC RESULTED IN RIGHT CORPUS LUTEAL CYST WITH SMALL AMOUNT OF ADJACENT FREE FLUID LIKELY REPRESENTING A RIGHT HEMORRHAGIC OVARIAN CYST. ON (B)(6) 2017 AND (B)(6) 2015 PATIENT UNDERWENT TRANSVAGINAL PELVIC ULTRASOUND RESULTED IN THE PELVIC ULTRASOUND IS GROSSLY NORMAL IN APPEARANCE. THE PATIENT HAS BILATERAL TUBAL OCCLUSION COILS, THAT APPEAR TO BE IN GOOD POSITION ALTHOUGH THEY ARE NOT FULLY VISUALIZED AND THE ENDOMETRIUM IS SOMEWHAT THICKENED AND IRREGULAR, PROBABLY DUE TO BEING IN THE PROLIFERATIVE STAGE. IT WAS NORMAL ON THE PREVIOUS ULTRASOUND DONE ON (B)(6) 2014. ON (B)(6) 2015 UNDERWENT US BREAST LIMITED ULTRASOUND RESULTED IN LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT WAS PERFORMED. THE RE IS A 14 X 8 X 12 MM COM PLEX HYPOECHOIC COLLECTION N WITH IN THE SKIN OF THE RIGHT BREAST AT THE 5:00 POSITION. THIS IS NEW FROM THE PRIOR ULTRASOUND. THERE IS SURROUNDING DOPPLER FLOW. AT THE 5:30 POSITION, THERE IS A SMALL OVAL HYPOECHOIC COLLECTION AGAIN WITHIN THE SKIN OF THE BREAST. THESE MEASURES 13 X 4 X 16 MM AN D IS SIMILAR IN APPEARANCE TO THE PRIOR EXAM. IMPRESSION-LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT. THERE ARE TWO SMALL ABSCESSES WITHIN THE SKIN/ SUPERFICIAL SOFT TISSUES OVERLYING THE RIGHT BREAST AS ABOVE. ON (B)(6) 2017 PATIENT UNDERWENT ULTRASOUND, TRANSVAGINAL RESULTED IN LARGE CYST RIGHT OVARY. DUE TO ITS LARGE SIZE, IT SHOULD BE FOLLOWED TO ASSURE RESOLUTION WITH REPEAT ULTRASOUND IN 8-10 WEEKS. LOT NUMBER: B97499, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 02-DEC-2013. LOT NUMBER: C03089, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 03-DEC-2013 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: 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 PELVIC INFLAMMATORY DISEASE ("ACUTE PELVIC INFLAMMATORY DISEASE"), OVARIAN ABSCESS ("OVARIAN ABSCESS"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), STAPHYLOCOCCAL INFECTION ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499/ C03089) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6) 2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6) 2015, MISCARRIAGE, PSYCHOLOGICAL DISORDER NOS, UTERINE CONTRACTIONS ABNORMAL, FETAL MOVEMENTS DECREASED, URINARY TRACT INFECTION, SCOLIOSIS, CARPAL TUNNEL SYNDROME, ASTHMA, LIGAMENT TEAR, MUSCLE STRAIN, HEMATURIA, BREAST LUMP, FLANK PAIN, LEUKOCYTOSIS, CHEST PAIN, MASTITIS, BREAST OPERATION, NAUSEA, GALLBLADDER OPERATION, MULTIGRAVIDA, PARITY 2, COUGH, NASAL CONGESTION, RHINORRHEA, SHORTNESS OF BREATH, VIRAL UPPER RESPIRATORY TRACT INFECTION, HEART MURMUR, FLU-LIKE ILLNESS, GASTROENTERITIS, ATOPIC DERMATITIS, CELLULITIS, HEMORRHOIDS, RECTAL PAIN, HEADACHE, BREAST BIOPSY, PLEURITIC PAIN, OVARIAN CYST, BREAST LUMP REMOVAL, TACHYCARDIA, BREAST ABSCESS AND ARTHRITIS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014, BUTALBLTAL-ACETAMINOPHEN-CAFFEINE, CYCLOBENZAPRINE, VITAMINS, ACETAMINOPHEN, NAPROXEN, OXYCODONE, ALBUTEROL SULFATE AND HYDROCODONE. CONCURRENT CONDITIONS INCLUDED INFECTION MRSA, SMOKER (0.5 PACKS/DAY), COSTOCHONDRITIS, RECTAL BLEEDING, BRONCHITIS, DIARRHEA, PNEUMONIA, LUMBAGO, ANKLE INJURY, ABRASION NOS, CONTUSION, FRACTURE, BENIGN NEOPLASM OF CORPUS UTERI, LOOSE STOOLS, VAGINAL DISCHARGE, MUSCULOSKELETAL PAIN AND BACTERIAL VAGINOSIS. FAMILY HISTORY INCLUDED STROKE (FATHER,DECEASED), ANEURYSM CEREBRAL, DIABETES MELLITUS (PATERNAL GRANDMOTHER, MATERNAL GRANDFATHER) AND COLON CANCER (GRANDPARENT). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) SINCE 2013 FOR ANXIETY, DEPRESSION AND HEADACHE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) FROM 2013 TO 2015 AND VICODIN (NORCO) FROM 2013 TO 2015 FOR PAIN AS WELL AS ANAESTHETICS (ANESTHESIA) AND IBUPROFEN. IN 2014, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN OCTOBER 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2016, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), STAPHYLOCOCCAL INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING)HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("MRSA MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER MRSA BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, OVARIAN ABSCESS, DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, STAPHYLOCOCCAL INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN HAD RESOLVED AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, OVARIAN ABSCESS, RHEUMATOID ARTHRITIS, STAPHYLOCOCCAL INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SE WAS SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. THE PATIENT TOLERATED THE PROCEDURE WELL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND ON (B)(6) 2015, SHE UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND TOLD THAT THE INTRAOPERATIVE CHOLANGIOGRAM WAS ABNORMAL AND WAS SHOWING IMPACTED GALLSTONES IN THE DISTAL COMMON BILE DUCT. SHE WAS TRANSFERRED HERE FOR ERCP. THE PATIENT REPORTS SOME UPPER ABDOMINAL PAIN. SHE SAID SHE HAS VOMITED ONCE SINCE THE SURGERY. SHE HAS BEEN PASSING GAS AND HAS NOT HAD A BOWEL MOVEMENT SINCE SURGERY. LABS FROM 01/13, SHOWING A BILIRUBIN OF 2.7, AST OF 328, ALT OF 856, ALKALINE PHOSPHATASE OF 334, AND LIPASE OF 68. HER BILIRUBIN IS 3.4, AST 117, ALT 319, AND ALKALINE PHOSPHATASE 269. PATIENT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY, HAD ABNORMAL INTRAOPERATIVE CHOLANGIOGRAM WITH CHOLEDOCHOLITHIASIS AND TRANSFERRED HERE FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. ON (B)(6) 2013 PATIENT UNDERWENT ULTRASOUND SCAN RESULTED IN BREAST ABSCESS 2.5X1.2X1.4 CM UNDERSURFACE OF THE NIPPLE AREOLA WITH ASSOCIATED EDEMA OF SUBCUE TISSUE. PT WILL BE STARTED ON IV VANCOMYCIN SURGICAL CONSULT OBTAINED. SMALL SUBAREOLAR BREAST ABSCESS. ON (B)(6) 2015 PATIENT UNDERWENT ABDOMINAL ULTRASOUND - RIGHT UPPER QUADRANT RESULTED IN NUMEROUS SMALL GALLSTONES IN AN OTHERWISE NORMAL-APPEARING GALLBLADDER. NO DEMONSTRATED BILE DUCT DILATATION. ON (B)(6) 2015 PATIENT UNDERWENT X-RAY ABDOMEN RESULTED IN INITIAL IMAGES DEMONSTRATE A FILLING DEFECT WITHIN THE COMMON BILE DUCT. UNCLEAR THIS REPRESENTS A STONE, BALLOON, AIR, OR OTHER. ON (B)(6) 2015 PATIENT UNDERWENT CT ABDOMEN AND PELVIS W CONT RESULTED IN SMALL AREA OF MILD, AIRSPACE DISEASE IN THE PERIPHERAL ASPECT OF THE RIGHT UPPER LOBE AS ABOVE. THIS CAN REPRESENT FOCAL AREA OF PNEUMONITIS. ON (B)(6) 2015 PATIENT UNDERWENT LUMBAR SPINE THREE VIEWS RESULTED IN POSSIBLE MILD SCOLIOSIS. ON (B)(6) 2015 PATIENT UNDERWENT US TRANSVAGINAL NON OBSTETRIC RESULTED IN RIGHT CORPUS LUTEAL CYST WITH SMALL AMOUNT OF ADJACENT FREE FLUID LIKELY REPRESENTING A RIGHT HEMORRHAGIC OVARIAN CYST. ON (B)(6) 2017 AND (B)(6) 2015 PATIENT UNDERWENT TRANSVAGINAL PELVIC ULTRASOUND RESULTED IN THE PELVIC ULTRASOUND IS GROSSLY NORMAL IN APPEARANCE. THE PATIENT HAS BILATERAL TUBAL OCCLUSION COILS, THAT APPEAR TO BE IN GOOD POSITION ALTHOUGH THEY ARE NOT FULLY VISUALIZED AND THE ENDOMETRIUM IS SOMEWHAT THICKENED AND IRREGULAR, PROBABLY DUE TO BEING IN THE PROLIFERATIVE STAGE. IT WAS NORMAL ON THE PREVIOUS ULTRASOUND DONE ON SEP2014. ON (B)(6) 2015 UNDERWENT US BREAST LIMITED ULTRASOUND RESULTED IN LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT WAS PERFORMED. THE RE IS A 14 X 8 X 12 MM COM PLEX HYPOECHOIC COLLECTION N WITH IN THE SKIN OF THE RIGHT BREAST AT THE 5:00 POSITION. THIS IS NEW FROM THE PRIOR ULTRASOUND. THERE IS SURROUNDING DOPPLER FLOW. AT THE 5:30 POSITION, THERE IS A SMALL OVAL HYPOECHOIC COLLECTION AGAIN WITHIN THE SKIN OF THE BREAST. THESE MEASURES 13 X 4 X 16 MM AN D IS SIMILAR IN APPEARANCE TO THE PRIOR EXAM. - IMPRESSION-LIMITED ULTRASOUND EXAM OF THE RIGHT BREAST WITHOUT A RADIOLOGIST PRESENT. THERE ARE TWO SMALL ABSCESSES WITHIN THE SKIN/ SUPERFICIAL SOFT TISSUES OVERLYING THE RIGHT BREAST AS ABOVE. ON (B)(6) 2017 PATIENT UNDERWENT ULTRASOUND, TRANSVAGINAL RESULTED IN LARGE CYST RIGHT OVARY. DUE TO ITS LARGE SIZE, IT SHOULD BE FOLLOWED TO ASSURE RESOLUTION WITH REPEAT ULTRASOUND IN 8-10 WEEKS LOT NUMBER: B97499, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 02-DEC-2013. LOT NUMBER: C03089, EXPIRATION DATE: 31-DEC-2016, MFR DATE: 03-DEC-2013 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 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN"), DEVICE DISLOCATION ("LOCATION OF THE LEFT COIL COULD NOT BE DETERMINE / DEVICE MIGRATION"), UTERINE PERFORATION ("ESSURE PERFORATED UTERUS"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING"), SUBCUTANEOUS ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), BREAST ABSCESS ("RECURRING BREAST AND BUTTOCK ABSCESSES"), (B)(6) INFECTION ("(B)(6) MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER (B)(6) BOILS") AND RHEUMATOID ARTHRITIS ("RHEUMATOID ARTHRITIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B97499,C03089) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (2009, 2010, 2014), ABORTION, BILE DUCT OBSTRUCTION (LAPAROSCOPIC CHOLECYSTECTOMY) ON (B)(6) 2015, INFLAMMATION GALLBLADDER (ERCP) ON (B)(6) 2015, SPONTANEOUS ABORTION AND PSYCHOLOGICAL DISORDER NOS. SHE DID NOT CLAIMED THAT SHE IS ALLERGIC AND SHE EXPERIENCED A HYPERSENSITIVITY REACTION TO NICKEL OR ANY OTHER COMPONENT OF ESSURE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NUVA RING IN 2014. CONCURRENT CONDITIONS INCLUDED INFECTION (B)(6). CONCOMITANT PRODUCTS INCLUDED CLONAZEPAM (KLONOPIN), FLUOXETINE HYDROCHLORIDE (PROZAC) AND SERTRALINE (ZOLOFT) IN 2013 FOR ANXIETY, DEPRESSION AND HEADACHE AND CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL) IN 2013 AND VICODIN (NORCO) IN 2013 FOR PAIN. IN 2014, 113 DAYS BEFORE INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MIGRAINE ("SEVERE MIGRAINES/MORE SEVERE SINCE ESSURE PROCEDURE"), FATIGUE ("FATIGUE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE") AND WEIGHT FLUCTUATION ("WEIGHT FLUCTUATIONS"). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"). IN 2015, THE PATIENT EXPERIENCED BACK PAIN ("SEVERE BACK PAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). IN 2016, THE PATIENT EXPERIENCED RHEUMATOID ARTHRITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN, SUBCUTANEOUS ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BREAST ABSCESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), (B)(6) INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HEADACHE ("HEADACHES/ HEAD STABBING; THROBBING) HEADACHES INCREASED AFTER IMPLANT"), FURUNCLE ("(B)(6) MORE SEVERE/ER ANYWHERE FROM FIVE TO EIGHT TIMES A MONTH IN ORDER TO TREAT HER (B)(6) BOILS"), ABDOMINAL PAIN LOWER ("CRAMPING"), LIBIDO DECREASED ("SEXUAL INTIMACY SHARPLY DECLINED") AND COMPLICATION OF DEVICE INSERTION ("R COIL BENT UPON INSERTION AND A NEW KIT WAS OPENED AND USED FOR THE R TUBE"). THE PATIENT WAS TREATED WITH HYDROCODONE, VICODIN (LORTAB), TRAMADOL, BACLOFEN, AXOTAL (FIORICET) AND CIPROFLOXACIN BETAIN (CIPRO). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN HAD RESOLVED, THE DEVICE DISLOCATION, UTERINE PERFORATION, GENITAL HAEMORRHAGE, SUBCUTANEOUS ABSCESS, BREAST ABSCESS, (B)(6) INFECTION, RHEUMATOID ARTHRITIS, MIGRAINE, DYSMENORRHOEA, BACK PAIN, FATIGUE, DYSPAREUNIA, HEADACHE, WEIGHT FLUCTUATION, FURUNCLE, ABDOMINAL PAIN LOWER, LIBIDO DECREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE DEPRESSION AND ANXIETY HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, BREAST ABSCESS, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FURUNCLE, GENITAL HAEMORRHAGE, HEADACHE, LIBIDO DECREASED, MIGRAINE, RHEUMATOID ARTHRITIS, (B)(6) INFECTION, SUBCUTANEOUS ABSCESS, UTERINE PERFORATION AND WEIGHT FLUCTUATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE WAS SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2015 BUT COULD NOT GO FORWARD DUE TO RECURRING BREAST AND BUTTOCK ABSCESSES. DIAGNOSTIC RESULTS: HSG: LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. ON AN UNSPECIFIED DARE, ESSURE WAS CONFIRMED BY HSG AND MULTIPLE ULTRASOUNDS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2017: PLAINTIFF FACT SHEET RECEIVED-ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND TREATMENT DRUG WERE ADDED. LOT NUMBER, EVENTS MENSTRUAL PAIN; ABDOMINAL PAIN; BACK PAIN; DEPRESSION; FATIGUE; HEAVY BLEEDING; PAIN DURING INTERCOURSE. ALL SYMPTOMS BEGAN SHORTLY AFTER IMPLANT, RECURRING BREAST AND BUTTOCK ABSCESSES, ESSURE PERFORATED UTERUS WERE ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF FAMILY IN UNITED STATES ON 03-JUN-2016 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2014 FOR PERMANENT STERILIZATION. SHORTLY AFTER PROCEDURE, SHE BEGAN TO SUFFER SEVERE MENSTRUAL PAIN, ABDOMINAL AND BACK PAIN. SHE ALSO HAD DEPRESSION, FATIGUE, HEAVY BLEEDING, PAIN DURING INTERCOURSE, SEVERE MIGRAINES (WHICH BECAME MORE SEVERE SINCE PROCEDURE) AND ABDOMINAL PAIN WHICH CAUSED SEVERAL HOSPITALIZATIONS. FURTHERMORE, CONSUMER'S (B)(6) WHICH WAS DIAGNOSED WHEN SHE WAS (B)(6) BECAME MORE SEVERE. SHE WENT TO ER SEVERAL TIMES TO TREAT HER (B)(6) AND SHE RECEIVED CIPRO. IT WAS REPORTED THAT DURING HSG, IT WAS DETERMINED THAT ONLY RIGHT ESUSRE COILS WAS IN PLACE. LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. SHE RECEIVED HYDROCODONE, LORTAB, TRAMADOL AND BACLOFEN TO TREAT CHRONIC PAIN. FOR MIGRAINES, SHE WAS TREATED WITH FIORCET. IT WAS INFORMED THAT PLAINTIFF WOULD LIKELY HAVE TO ENDURE SURGICAL REMOVAL OF THE DEVICES BY UNDERGOING HYSTERECTOMY. QUALITY-SAFETY EVALUATION ((B)(4)) RECEIVED ON 17-JUN-2016: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A LAWYER ON BEHALF OF A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SHORTLY AFTER THE PROCEDURE, BEGAN TO SUFFER SEVERE ABDOMINAL PAIN. IT WAS REPORTED THAT DURING HSG ONLY RIGHT ESSURE COILS WAS IN PLACE. LEFT COILS COULD NOT BE LOCATED; DEVICE MIGRATED. FURTHERMORE, CONSUMER'S (B)(6) WHICH WAS DIAGNOSED WHEN SHE WAS (B)(6) BECAME MORE SEVERE. THESE EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT (B)(6) WHICH IS UNLISTED. ABDOMINAL PAIN MAY OCCUR DURING ESSURE USE. IN ADDITION, THE DEVICE MAY DISLOCATE TOWARDS ABDOMINAL CAVITY. THUS, GIVEN THE ABSENCE OF ALTERNATIVE EXPLANATION AND THE EVENTS NATURE PER SE, CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND ESSURE USE CANNOT BE EXCLUDED. IN REGARDS OF WORSENING OF MHRA, THE DISEASE ALREADY HAD BEEN DIAGNOSED IN THE PATIENT SEVERAL YEARS BEFORE ESSURE IMPLANTATION. BESIDES, CONSIDERING THAT THE MICRO-INSERTS ACT LOCALLY IN FALLOPIAN TUBES, CAUSAL RELATIONSHIP BETWEEN THIS INFECTION AND ESSURE USE IS VERY UNLIKELY. SINCE EVENTS LED HER TO BE HOSPITALIZED SEVERAL TIMES, THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE INFORMED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE; A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409985 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B97499/ C03089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization| O| R | ANESTHESIA| ANESTHESIA| ANESTHESIA| ANESTHESIA| ANESTHESIA| FLEXERIL| FLEXERIL| FLEXERIL| FLEXERIL| FLEXERIL| FLEXERIL| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| KLONOPIN| NORCO| NORCO| NORCO| NORCO| NORCO| NORCO| PROZAC| PROZAC| PROZAC| PROZAC| PROZAC| PROZAC| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT| ZOLOFT |