ESSURE
Report
- Report Number
- 2951250-2016-01150
- Event Type
- Injury
- Date Received
- July 20, 2016
- Date of Event
- April 1, 2012
- Report Date
- April 23, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS"), DEVICE BREAKAGE ("BROKEN RIGHT ESSURE DEVICE"), GASTROINTESTINAL INJURY ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATION"), PELVIC PAIN ("SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)"), MENORRHAGIA ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS"), GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE"), PERFORATION ("PERFORATION"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY"), IMMUNE THROMBOCYTOPENIC PURPURA ("IDIOPATHIC THROMBOCYTOPENIC PURPURA WORSENED") AND CAESAREAN SECTION ("LARGE BABY REQUIRING C-SECTION") IN A 30-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 4) WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 (B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003 AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN APRIL 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ACHING WHOLE BODY"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN"). IN 2012, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLINF OUT / DENTAL ISSUES") AND BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN JULY 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("WORSENED DEPRESSION"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG") AND INFLAMMATION ("INFLAMMATION"). THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. IN JANUARY 2015, THE TOOTH LOSS HAD RESOLVED. IN APRIL 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, PELVIC INFLAMMATORY DISEASE, MENORRHAGIA, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA, DEPRESSION, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, BACK PAIN, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, DEHYDRATION, DEPRESSION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, MENORRHAGIA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED TUBAL OCCLUSION PREGNANCY TEST - ON (B)(6) 2012: NEGATIVE ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: BOTH FALLOPIAN TUBES WERE OCCLUDED. (B)(6) 2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." 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 UTERINE PERFORATION ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS"), DEVICE BREAKAGE ("BROKEN RIGHT ESSURE DEVICE"), GASTROINTESTINAL INJURY ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATION"), PELVIC PAIN ("SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)"), MENORRHAGIA ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS"), GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE"), PERFORATION ("PERFORATION"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)"), IMMUNE THROMBOCYTOPENIC PURPURA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: IDIOPATHIC THROMBOCYTOPENIC PURPURA") AND CAESAREAN SECTION ("LARGE BABY REQUIRING C-SECTION") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753,904763) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012, DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 (27AUG2003, (B)(6) 2011), C-SECTION, SCAR, FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003 AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("ACHING WHOLE BODY/ PAIN"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN 2012, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLINF OUT / DENTAL ISSUES") AND WAS FOUND TO HAVE BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), LASTING 56 DAYS. IN (B)(6) 2012, THE PATIENT EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), KIDNEY INFECTION ("INFECTION (OTHER) DESCRIBE: KIDNEY") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("WORSENED DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). IN NOVEMBER 2012, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN APRIL 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). IN (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG"), INFLAMMATION ("INFLAMMATION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES FREQUENCY") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES") AND WAS FOUND TO HAVE BLOOD OESTROGEN ABNORMAL ("HORMONAL CHANGES DESCRIBE: ESTROGEN LEVELS WERE ABNORMAL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND FULL HYSTERECTOMY) AND TEETH EXTRACTIONS. ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN APRIL 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, PELVIC INFLAMMATORY DISEASE, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN, INFLAMMATION, BLOOD OESTROGEN ABNORMAL, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, VISUAL IMPAIRMENT, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, CYSTITIS, KIDNEY INFECTION, ANXIETY, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 4. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLOOD OESTROGEN ABNORMAL, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, CYSTITIS, DEHYDRATION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, TOOTH LOSS, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DISCREPANCY IN DATE OF INSERTION , (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED TUBAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: RESULTS: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: BOTH FALLOPIAN TUBES WERE OCCLUDED. (B)(6) 2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2019: PFS RECEIVED. LOT NUMBER ADDED. EVENTS : HORMONAL CHANGES DESCRIBE: ESTROGEN LEVELS WERE ABNORMAL, ABNORMAL BLEEDING (VAGINAL), INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), INFECTION (OTHER) DESCRIBE: KIDNEY, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, RASHES OR SKIN CONDITIONS TYPE: RASHES, BLADDER OR URINARY PROBLEMS OR CHANGES FREQUENCY, MIGRAINES, HEADACHES, NAUSEA, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VISION/EYE PROBLEMS TYPE: VISION DETERIORATED, FATIGUE, WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN, DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BROKEN RIGHT ESSURE DEVICE'), PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), UTERINE PERFORATION ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS'), EMBEDDED DEVICE ('LEFT IS EMBEDDED IN MY BOWEL'), PELVIC PAIN ('SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)/ SHARP STABBING PAIN'), PERFORATION ('PERFORATION'), GASTROINTESTINAL INJURY ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL'), MENORRHAGIA ('BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS/ CONSTANT HEAVY PERIODS'), IMMUNE THROMBOCYTOPENIC PURPURA ('AUTOIMMUNE DISORDER TYPE OF DISORDER: IDIOPATHIC THROMBOCYTOPENIC PURPURA') AND CAESAREAN SECTION ('LARGE BABY REQUIRING C-SECTION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753,904763-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012, DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003, HYPERTHYROIDISM FROM 2003 TO 2016, PARITY 3 ((B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, MULTIGRAVIDA, ANAPHYLACTIC REACTION TO DRUG, THROAT SWELLING, NERVOUS SYSTEM DISORDER, PULMONARY FAILURE, KIDNEY DYSFUNCTION, HEPATOBILIARY DISEASE, THROMBOEMBOLIC EVENT, HEMORRHAGIC DISORDER, ANEMIA, VIRAL INFECTION, BACTERIAL INFECTION, ALLERGIC REACTION TO ANALGESICS, NAUSEA, CONSTIPATION, URINARY RETENTION, FOGGY FEELING IN HEAD AND LOSS OF TEETH. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION AS WELL AS LEVOTHYROXINE SODIUM (SYNTHROID) FROM 2003 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("ACHING BACK PAIN / BACKACHE"), PAIN ("ACHING WHOLE BODY/ PAIN"), BONE PAIN ("ACHING BONE") AND ARTHRALGIA ("ACHING JOINTS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND EXPERIENCED GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE"), LASTING 56 DAYS. IN 2012, THE PATIENT WAS FOUND TO HAVE BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE BLOOD OESTROGEN ABNORMAL ("HORMONAL CHANGES DESCRIBE: ESTROGEN LEVELS WERE ABNORMAL") AND EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), KIDNEY INFECTION ("INFECTION (OTHER) DESCRIBE: KIDNEY") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("WORSENED DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLING OUT / DENTAL ISSUES") AND TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL"), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG"), INFLAMMATION ("INFLAMMATION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES FREQUENCY"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), PARAESTHESIA ("TINGLING SENSATION OF HAND AND LEGS"), OVARIAN CYST ("OVARIAN CYST "), MUSCLE TWITCHING ("MUSCLE TWITCHING") AND PANCYTOPENIA ("PANCYTOPENIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)) AND TEETH EXTRACTIONS. ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, BACK PAIN AND ARTHRALGIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC INFLAMMATORY DISEASE, UTERINE PERFORATION, EMBEDDED DEVICE, PERFORATION, GASTROINTESTINAL INJURY, DYSMENORRHOEA, ALLERGY TO METALS, ABDOMINAL DISTENSION, ALOPECIA, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN, INFLAMMATION, BLOOD OESTROGEN ABNORMAL, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, VISUAL IMPAIRMENT, FATIGUE, PARAESTHESIA, OVARIAN CYST, MUSCLE TWITCHING AND PANCYTOPENIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, GENITAL HAEMORRHAGE, DEPRESSION, CYSTITIS, KIDNEY INFECTION, ANXIETY, HEADACHE AND DYSPAREUNIA HAD RESOLVED, THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 4. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. 4081.5G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLOOD OESTROGEN ABNORMAL, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, CYSTITIS, DEHYDRATION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, OBSESSIVE-COMPULSIVE DISORDER, OVARIAN CYST, PAIN, PANCYTOPENIA, PARAESTHESIA, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, TOOTH LOSS, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4)). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DISCREPANCY IN DATE OF INSERTION , (B)(6) 2012 AND (B)(6) 2012. DISCREPANCY NOTED AS PREGNANCY (NO COMPLICATION) WITH OUT COME OF PREGNANCY: LIVE BIRTH WITHOUT COMPLICATION WAS REPORTED IN PFS DATED (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED TUBAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: RESULTS: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: BOTH FALLOPIAN TUBES WERE OCCLUDED. 05-NOV-2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." LOT NUMBER: 904753, MANUFACTURE DATE: 2011-10, EXPIRATION DATE: 2014-10 . LOT NUMBER REPORTED 904763 IS NOT VALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: LEFT IS EMBEDDED IN MY BOWEL, HEADACHE, TINGLING SENSATION OF HAND AND LEGS, MUSCLE TWITCHING, ALLERGY TO NICKEL, PANCYTOPENIA AND OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED. REPORTER'S INFORMATION ADDED. EVENTS: LEFT IS EMBEDDED IN MY BOWEL, TINGLING SENSATION OF HAND AND LEGS, MUSCLE TWITCHING, ALLERGY TO NICKEL, PANCYTOPENIA AND OVARIAN CYST WERE ADDED. EVENTS OF PREGNANCY AND GENITAL HEMORRHAGE DOWNGRADED TO NON-SERIOUS. OUTCOME OF THE EVENTS UPDATED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('BROKEN RIGHT ESSURE DEVICE'), PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), UTERINE PERFORATION ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS'), DEVICE DISLOCATION ('LEFT IS EMBEDDED IN MY BOWEL'), PELVIC PAIN ('SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)/ SHARP STABBING PAIN'), PERFORATION ('PERFORATION'), GASTROINTESTINAL INJURY ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL'), MENORRHAGIA ('BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS/ CONSTANT HEAVY PERIODS'), IMMUNE THROMBOCYTOPENIC PURPURA ('AUTOIMMUNE DISORDER TYPE OF DISORDER: IDIOPATHIC THROMBOCYTOPENIC PURPURA') AND CAESAREAN SECTION ('LARGE BABY REQUIRING C-SECTION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753,904763-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012, DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003, HYPERTHYROIDISM FROM 2003 TO 2016, PARITY 3 (B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, MULTIGRAVIDA, ANAPHYLACTIC REACTION TO DRUG, THROAT SWELLING, NERVOUS SYSTEM DISORDER, PULMONARY FAILURE, KIDNEY DYSFUNCTION, HEPATOBILIARY DISEASE, THROMBOEMBOLIC EVENT, HEMORRHAGIC DISORDER, ANEMIA, VIRAL INFECTION, BACTERIAL INFECTION, ALLERGIC REACTION TO ANALGESICS, NAUSEA, CONSTIPATION, URINARY RETENTION, FOGGY FEELING IN HEAD AND LOSS OF TEETH. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION AS WELL AS LEVOTHYROXINE SODIUM (SYNTHROID) FROM 2003 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("ACHING BACK PAIN / BACKACHE"), PAIN ("ACHING WHOLE BODY/ PAIN"), BONE PAIN ("ACHING BONE") AND ARTHRALGIA ("ACHING JOINTS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND VAGINAL HEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND EXPERIENCED GENITAL HEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE"), LASTING 56 DAYS. IN 2012, THE PATIENT WAS FOUND TO HAVE BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE BLOOD OESTROGEN ABNORMAL ("HORMONAL CHANGES DESCRIBE: ESTROGEN LEVELS WERE ABNORMAL") AND EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), KIDNEY INFECTION ("INFECTION (OTHER) DESCRIBE: KIDNEY") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("WORSENED DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLING OUT / DENTAL ISSUES") AND TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGY TO NICKEL"), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG"), INFLAMMATION ("INFLAMMATION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES FREQUENCY"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), PARAESTHESIA ("TINGLING SENSATION OF HAND AND LEGS"), OVARIAN CYST ("OVARIAN CYST "), MUSCLE TWITCHING ("MUSCLE TWITCHING") AND PANCYTOPENIA ("PANCYTOPENIA"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND TEETH EXTRACTIONS. ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, BACK PAIN AND ARTHRALGIA HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC INFLAMMATORY DISEASE, UTERINE PERFORATION, DEVICE DISLOCATION, PERFORATION, GASTROINTESTINAL INJURY, DYSMENORRHOEA, ALLERGY TO METALS, ABDOMINAL DISTENSION, ALOPECIA, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN, INFLAMMATION, BLOOD OESTROGEN ABNORMAL, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, VISUAL IMPAIRMENT, FATIGUE, PARAESTHESIA, OVARIAN CYST, MUSCLE TWITCHING AND PANCYTOPENIA OUTCOME WAS UNKNOWN, THE MENORRHAGIA, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HEMORRHAGE, GENITAL HEMORRHAGE, DEPRESSION, CYSTITIS, KIDNEY INFECTION, ANXIETY, HEADACHE AND DYSPAREUNIA HAD RESOLVED, THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED AND THE WEIGHT INCREASED WAS RESOLVING. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 4. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS 3-JUL-2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. 4081.5G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLOOD OESTROGEN ABNORMAL, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, CYSTITIS, DEHYDRATION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GENITAL HEMORRHAGE, HEADACHE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, MUSCLE TWITCHING, NAUSEA, OBSESSIVE-COMPULSIVE DISORDER, OVARIAN CYST, PAIN, PANCYTOPENIA, PARAESTHESIA, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, TOOTH LOSS, URINARY TRACT DISORDER, VAGINAL HEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DISCREPANCY IN DATE OF INSERTION , (B)(6) 2012 AND (B)(6) 2012. DISCREPANCY NOTED AS PREGNANCY (NO COMPLICATION) WITH OUT COME OF PREGNANCY: LIVE BIRTH WITHOUT COMPLICATION WAS REPORTED IN PFS DATED 17-MAY-2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED TUBAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: RESULTS: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: BOTH FALLOPIAN TUBES WERE OCCLUDED. (B)(6) 2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." LOT NUMBER: 904753, MANUFACTURE DATE: 2011-10, EXPIRATION DATE: 2014-10. LOT NUMBER REPORTED 904763 IS NOT VALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: LEFT IS EMBEDDED IN MY BOWEL, HEADACHE, TINGLING SENSATION OF HAND AND LEGS, MUSCLE TWITCHING, ALLERGY TO NICKEL, PANCYTOPENIA AND OVARIAN CYST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-APR-2020: FU 26 & 27 WERE PROCESSED TOGETHER. QUALITY SAFETY EVALUATION OF PTC. ON 20-MAR-2020: FU 26 & 27 WERE PROCESSED TOGETHER. SOCIAL MEDIA RECEIVED: REPORTER INFORMATION WAS ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)"), MENORRHAGIA ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS"), GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING"), PERFORATION ("PERFORATION"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATION"), IMMUNE THROMBOCYTOPENIC PURPURA ("IDIOPATHIC THROMBOCYTOPENIC PURPURA WORSENED") AND CAESAREAN SECTION ("LARGE BABY REQUIRING C-SECTION ") IN A 30-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 4) WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003 AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("ACHING WHOLE BODY"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN "). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). IN (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLINF OUT / DENTAL ISSUES"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("WORSENED DEPRESSION"), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG") AND INFLAMMATION ("INFLAMMATION"). THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA, DEPRESSION, PELVIC INFLAMMATORY DISEASE, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, BACK PAIN, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, DEHYDRATION, DEPRESSION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, MENORRHAGIA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4)). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: BOTH FALLOPIAN TUBES WERE OCCLUDED. 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 UTERINE PERFORATION ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS'), DEVICE BREAKAGE ('BROKEN RIGHT ESSURE DEVICE'), GASTROINTESTINAL INJURY ('LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL'), PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATION'), PELVIC PAIN ('SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)'), MENORRHAGIA ('BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS'), GENITAL HAEMORRHAGE ('CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE'), PERFORATION ('PERFORATION'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY/UNINTENDED PREGNANCY / PREGNANCY (NO COMPLICATIONS)'), IMMUNE THROMBOCYTOPENIC PURPURA ('AUTOIMMUNE DISORDER TYPE OF DISORDER: IDIOPATHIC THROMBOCYTOPENIC PURPURA') AND CAESAREAN SECTION ('LARGE BABY REQUIRING C-SECTION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753,904763-INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012, DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003, HYPERTHYROIDISM FROM 2003 TO 2016, PARITY 3 ((B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, MULTIGRAVIDA, ANAPHYLACTIC REACTION TO DRUG, THROAT SWELLING, NERVOUS SYSTEM DISORDER, PULMONARY FAILURE, KIDNEY DYSFUNCTION, HEPATOBILIARY DISEASE, THROMBOEMBOLIC EVENT, HEMORRHAGIC DISORDER, ANEMIA, VIRAL INFECTION, BACTERIAL INFECTION, ALLERGIC REACTION TO ANALGESICS, NAUSEA, CONSTIPATION, URINARY RETENTION, FOGGY FEELING IN HEAD AND LOSS OF TEETH. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION AS WELL AS LEVOTHYROXINE SODIUM (SYNTHROID) FROM 2003 TO 2016. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("ACHING WHOLE BODY/ PAIN"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), LASTING 56 DAYS. IN 2012, THE PATIENT WAS FOUND TO HAVE BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE BLOOD OESTROGEN ABNORMAL ("HORMONAL CHANGES DESCRIBE: ESTROGEN LEVELS WERE ABNORMAL") AND EXPERIENCED CYSTITIS ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BLADDER"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), KIDNEY INFECTION ("INFECTION (OTHER) DESCRIBE: KIDNEY") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED RASH ("RASHES OR SKIN CONDITIONS TYPE: RASHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("WORSENED DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VISUAL IMPAIRMENT ("VISION/EYE PROBLEMS TYPE: VISION DETERIORATED"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLINF OUT / DENTAL ISSUES") AND TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). ON (B)(6) 2014, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG"), INFLAMMATION ("INFLAMMATION"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES FREQUENCY") AND URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL),SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES) AND FULL HYSTERECTOMY) AND TEETH EXTRACTIONS. ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, PELVIC INFLAMMATORY DISEASE, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN, INFLAMMATION, BLOOD OESTROGEN ABNORMAL, FEMALE SEXUAL DYSFUNCTION, RASH, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, DYSMENORRHOEA, VISUAL IMPAIRMENT, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE MENORRHAGIA, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, DEPRESSION, VAGINAL HAEMORRHAGE, CYSTITIS, KIDNEY INFECTION, ANXIETY, HEADACHE AND DYSPAREUNIA HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 4, PARA 4. LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BLADDER DISORDER, BLOOD OESTROGEN ABNORMAL, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, CYSTITIS, DEHYDRATION, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HEADACHE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, KIDNEY INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, TOOTH LOSS, URINARY TRACT DISORDER, VAGINAL HAEMORRHAGE, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4)). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DISCREPANCY IN DATE OF INSERTION , (B)(6) 2012. DISCREPANCY NOTED AS PREGNANCY (NO COMPLICATION) WITH OUT COME OF PREGNANCY: LIVE BIRTH WITHOUT COMPLICATION WAS REPORTED IN PFS DATED (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: CONFIRMED TUBAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2012: RESULTS: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RESULTS: BOTH FALLOPIAN TUBES WERE OCCLUDED.. (B)(6) 2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." LOT NUMBER: 904753 MANUFACTURE DATE: 2011-10 EXPIRATION DATE: 2014-10 . LOT NUMBER REPORTED 904763 IS INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT WE RECEIVED A LOT NUMBER. 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.
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS"), DEVICE BREAKAGE ("BROKEN RIGHT ESSURE DEVICE"), GASTROINTESTINAL INJURY ("LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATION"), PERFORATION ("PERFORATION"), PELVIC PAIN ("SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)"), MENORRHAGIA ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS"), GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING FOUR MONTHS AFTER PLACEMENT OF ESSURE DEVICE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY"), IMMUNE THROMBOCYTOPENIC PURPURA ("IDIOPATHIC THROMBOCYTOPENIC PURPURA WORSENED") AND CAESAREAN SECTION ("LARGE BABY REQUIRING C-SECTION") IN A 30-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 4) WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, FALLOPIAN TUBE PERFORATION (DURING CESAREAN SECTION) IN 2003 AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY, DEPRESSION AND UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) SINCE 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PAIN ("ACHING WHOLE BODY"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN "). IN 2012, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLINF OUT / DENTAL ISSUES") AND BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("WORSENED DEPRESSION"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG") AND INFLAMMATION ("INFLAMMATION"). THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY), SURGERY (FULL HYSTERECTOMY), SURGERY (FULL HYSTERECTOMY), SURGERY (FULL HYSTERECTOMY), SURGERY (FULL HYSTERECTOMY) AND SURGERY (FULL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, DEVICE BREAKAGE, GASTROINTESTINAL INJURY, PELVIC INFLAMMATORY DISEASE, PERFORATION, MENORRHAGIA, ABDOMINAL DISTENSION, ALOPECIA, DEPRESSION, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE, GASTROINTESTINAL INJURY AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, BACK PAIN, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, DEHYDRATION, DEPRESSION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, MENORRHAGIA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4) ). PER MEDICAL RECORD: STARTING ON THE PATIENT¿S RIGHT SIDE, AN ESSURE MICROINSERT WAS DEPLOYED LEAVING FOUR TRAILING COILS. A SIMILAR PROCEDURE WAS REPEATED ON THE LEFT SIDE LEAVING THREE TRAILING COILS. INITIALLY ON DEPLOYMENT OF THE LEFT INSERT THE DEVICE DID SPIRAL INTO THE OSTIUM LEAVING ONE TRAILING COIL; THEREFORE, A HYSTEROSCOPIC GRASPER WAS USED TO PROVIDE GENTLE TRACTION ON THIS TO LEAVE THREE INTRACAVITY COILS. ON (B)(6) 2016, AN ULTRASOUND AND PREVIOUS X-RAY SHOWED WHAT THEY THOUGHT WAS A BROKEN RIGHT ESSURE DEVICE AND THE LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: CONFIRMED TUBAL OCCLUSION PREGNANCY TEST - ON (B)(6) 2012: NEGATIVE. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: BOTH FALLOPIAN TUBES WERE OCCLUDED. (B)(6) 2014: PREGNANCY WAS CONFIRMED. ON (B)(6) 2016, SURGICAL PATHOLOGY REPORT REVEALED UTERUS, MORSELIZED HYSTERECTOMY. NO PATHOLOGICAL DIAGNOSIS. NO EVIDENCE OF HYPERPLASIA OR MALIGNANCY. FALLOPIAN TUBES, RIGHT AND LEFT, EXCISION. PARATUBAL CYST. BILATERAL ESSURE DEVICES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PERFORATION, PELVIC PAIN, MENORRHAGIA,IDIOPATHIC THROMBOCYTOPENIC PURPURA, PELVIC ADHESION, CESAREAN SECTION, BRAIN FOG, TEETH LOSS AND PREGNANCY WITH CONTRACEPTIVE DEVICE." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUL-2018: REPORTER INFORMATION WAS UPDATED. THIS CASE IS MEDICALLY CONFIRMED. HER CONCURRENT CONDITIONS WERE ADDED. PER MEDICAL RECORD FOLLOWING EVENTS: LEFT DEVICE MAY HAVE PERFORATED THE UTERUS, BROKEN RIGHT ESSURE DEVICE AND LEFT DEVICE MAY HAVE PERFORATED THE UTERUS AND WAS WITHIN THE BOWEL WERE ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE AND PERSISTENT PAIN / PELVIA PAIN (CONSTANT)"), MENORRHAGIA ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS / HEAVY CLOTTING PERIODS"), GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING"), PERFORATION ("PERFORATION"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY"), PELVIC INFLAMMATORY DISEASE ("PELVIC INFLAMMATION "), IMMUNE THROMBOCYTOPENIC PURPURA ("IDIOPATHIC THROMBOCYTOPENIC PURPURA WORSENED ") AND CAESAREAN SECTION ("LARGE BABY REQUIRING C-SECTION ") IN A (B)(6) YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 4) WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT" ON (B)(6) 2012 AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3 ((B)(6) 2003, (B)(6) 2007, (B)(6) 2011), C-SECTION, SCAR, GENITAL INJURY (DURING CESAREAN SECTION) IN 2003 AND MULTIGRAVIDA. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA, NICKEL SENSITIVITY AND DEPRESSION. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN 2012 FOR CONTRACEPTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("ACHING WHOLE BODY"), BONE PAIN ("ACHING BONE"), ARTHRALGIA ("ACHING JOINTS") AND BACK PAIN ("ACHING BACK PAIN "). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND OBSESSIVE-COMPULSIVE DISORDER ("OCD - OBSESSIVE COMPULSIVE DISORDER"). IN (B)(6) 2014, THE PATIENT EXPERIENCED TOOTH LOSS ("TOOTH LOSS / HAVE LOST ALL MY TEETH / TEETH FALLING OUT / DENTAL ISSUES"). ON (B)(6) 2015, THE PATIENT UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("WORSENED DEPRESSION"), PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BONE DENSITY DECREASED ("BONES DETERIORATED / BONE DENSITY LOSS"), IMMUNE THROMBOCYTOPENIC PURPURA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC ADHESIONS ("PELVIC ADHESIONS"), DEHYDRATION ("DEHYDRATION"), FEELING ABNORMAL ("BRAIN FOG ") AND INFLAMMATION ("INFLAMMATION"). THE PATIENT'S LAST MENSTRUAL PERIOD WAS ON AN UNKNOWN DATE AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2015. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. IN (B)(6) 2015, THE TOOTH LOSS HAD RESOLVED. IN (B)(6) 2015, THE PELVIC PAIN, ARTHRALGIA AND BACK PAIN HAD RESOLVED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA, DEPRESSION, PELVIC INFLAMMATORY DISEASE, BONE DENSITY DECREASED, PELVIC ADHESIONS, DEHYDRATION, CAESAREAN SECTION, FEELING ABNORMAL, PAIN, BONE PAIN AND INFLAMMATION OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE AND PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED AND THE IMMUNE THROMBOCYTOPENIC PURPURA AND OBSESSIVE-COMPULSIVE DISORDER HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2015. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, BACK PAIN, BONE DENSITY DECREASED, BONE PAIN, CAESAREAN SECTION, DEHYDRATION, DEPRESSION, FEELING ABNORMAL, GENITAL HAEMORRHAGE, IMMUNE THROMBOCYTOPENIC PURPURA, INFLAMMATION, MENORRHAGIA, OBSESSIVE-COMPULSIVE DISORDER, PAIN, PELVIC ADHESIONS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TOOTH LOSS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT STATED THAT HER SON HAD NO TEETH LEFT (BABY CASE# (B)(4)). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 21.5 KG/SQM. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: BOTH FALLOPIAN TUBES WERE OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE KNOWN, POSSIBLE, UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE LACK OF EFFICACY AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-NOV-2017: DELIVERY INFORMATION PROVIDED. MEDICAL HISTORY UPDATED. ESSURE WAS INSERTED ON (B)(6) 2012, LOT NUMBER 904753. CONCOMITANT MEDICATION PROVIDED. EVENTS ADDED: PELVIC INFLAMMATION, BONES DETERIORATED / BONE DENSITY LOSS, IDIOPATHIC THROMBOCYTOPENIC PURPURA WORSENED, PELVIC ADHESIONS, DEHYDRATION, LARGE BABY REQUIRING C-SECTION, BRAIN FOG, ACHING WHOLE BODY, ACHING BONE, ACHING JOINTS, ACHING BACK PAIN, LEFT FALLOPIAN TUBE WAS CUT DURING FIRST CESAREAN SECTION IN 2003, WHICH MADE PLACEMENT OF ESSURE COIL DIFFICULT, INFLAMMATION, OCD - OBSESSIVE COMPULSIVE DISORDER. 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 PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), THE FIRST EPISODE OF GENITAL HAEMORRHAGE ("BLEEDING CAME BACK, BLEEDING FOR 20 DAYS A MONTH/HEAVY PERIODS"), THE SECOND EPISODE OF GENITAL HAEMORRHAGE ("CONTINUOUS BLEEDING/SEVERE BLEEDING,") AND PERFORATION ("PERFORATION") IN A (B)(6) YEAR-OLD 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" IN 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED PARITY 3, C-SECTION AND SCAR. CONCURRENT CONDITIONS INCLUDED IDIOPATHIC THROMBOCYTOPENIC PURPURA AND NICKEL SENSITIVITY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY/UNINTENDED PREGNANCY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), THE FIRST EPISODE OF GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), THE SECOND EPISODE OF GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR MONTHS PREGNANT"), ALOPECIA ("HAIR LOSS"), TOOTH LOSS ("TOOTH LOSS") AND DEPRESSION ("DEPRESSION"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PERFORATION, ABDOMINAL DISTENSION, ALOPECIA AND TOOTH LOSS OUTCOME WAS UNKNOWN AND THE LAST EPISODE OF GENITAL HAEMORRHAGE HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, DEPRESSION, PELVIC PAIN, PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH LOSS, THE FIRST EPISODE OF GENITAL HAEMORRHAGE AND THE SECOND EPISODE OF GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE KNOWN, POSSIBLE, UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE LACK OF EFFICACY AND A QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: POTENTIAL LEGAL SUMMON DOCUMENT RECEIVED. NEW REPORTER, PRODUCT STOP DATE AND THE FOLLOWING EVENTS WERE ADDED: PERFORATION, HAIR AND TOOTH LOSS, DEPRESSION AND PAIN. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM (B)(6), 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. 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.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER IN UNITED STATES ON 10-NOV-2014 AND ADDITIONAL INFORMATION RECEIVED ON THE SAME DAY. IT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2012 FOR PERMANENT STERILIZATION AND GOT PREGNANT. ON (B)(6) 2014 PREGNANCY (DEVICE INEFFECTIVE) WAS CONFIRMED AT DOCTOR'S OFFICE. THE CONSUMER STATED THAT SHE WAS IN A STUDY, FOR THE TRANSVAGINAL ULTRASOUND CONFIRMATION TEST. THIS TEST WAS DONE 90 DAYS AFTER PROCEDURE AND SHE WAS TOLD THAT BOTH FALLOPIAN TUBES WERE OCCLUDED. ESSURE WAS NOT REMOVED. THE OUTCOME OF THE EVENT PREGNANCY CONFIRMED WAS REPORTED AS ONGOING (NOT RECOVERED/ NOT RESOLVED). FOLLOW-UP INFORMATION WAS RECEIVED ON 08-DEC-2014: NO RESPONSE TO DATE. ADDITIONALLY, PTC INVESTIGATION RESULT WAS RECEIVED ON 08-DEC-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A LACK OF EFFICACY. A CONTRACEPTIVE FAILURE MAY OCCUR UNDER THE USE OF ANY CONTRACEPTIVE AND IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FOLLOW-UP RECEIVED ON 20-MAY-2015: CONSUMER REPORTED THAT SHE IS READY TO DELIVER HER BABY NEXT MONTH AND STATES THAT SHE HAS NOT HAD ANY PROBLEMS WITH THIS PREGNANCY. FOLLOW UP 04-AUG-2015: THE REQUIRED NUMBER OF FOLLOW UP ATTEMPTS HAVE BEEN COMPLETED, WITHOUT RESPONSE TO DATE. NO NEW INFORMATION WAS PROVIDED. CASE CLOSED. FOLLOW UP INFORMATION RECEIVED FROM THE CONSUMER VIA SOCIAL MEDIA ON 08-SEP-2015. CONSUMER MENTIONED THAT SHE WAS MOTHER OF FOUR BOYS, THE MOST RECENT BEING JUST FOUR WEEKS OLD AND THAT SHE TRIED TWICE TO HAVE HER TUBES TIED WHEN SHE HAD HER C-SECTIONS BUT THEY WERE UNSUCCESSFUL DUE TO LARGE AMOUNTS OF SCAR TISSUE. SO, HER LAST DOCTOR RECOMMENDED HER ESSURE AS A PERMANENT BIRTH CONTROL. CONSUMER ALSO MENTIONED THAT SHE BEGAN PARTICIPATING IN THE STUDY IN (B)(6) 2012 WHICH THEY WERE VERIFYING PROPER PLACEMENT BY ULTRASOUND. SHE REPORTED THAT ESSURE IS STILL IN HER AND SHE HAS TO SEE A SPECIALIST ABOUT HAVING A HYSTERECTOMY TO HAVE IT REMOVED. SHE STATED THAT AFTER IT (ESSURE) WAS PUT IN, SHE HAD CONTINUOUS BLEEDING FOR ABOUT EIGHT WEEKS, WENT TO SEE HER DOCTOR WHO SAID TO HER THAT IT COULD BE A SIDE EFFECT OF HER BODY ADJUSTING TO IT. AT 12 WEEKS, THE CONSUMER SAID HER DOCTOR PUT HER ON SOME HORMONAL MEDICINE TO TRY TO GET HER BLEEDING REGULATED. THE MEDICINE WORKED WHILE SHE WAS TAKING IT, BUT AS SOON AS SHE STOPPED, THE BLEEDING CAME BACK. SHE HAD BLOATING THAT MADE HER LOOKED LIKE SHE WAS FOUR-MONTHS PREGNANT, BUT SHE DID NOT HAVE ANY PAIN. HER DOCTORS TOLD HER THAT HER PROBLEMS WERE NOT COMING FROM ESSURE. SHE SAID THAT HER BODY WAS NOT RIGHT. SHE COMPLAINED THAT SHE JUST STARTED DEALING WITH IT, BLEEDING, FOR 20 DAYS A MONTH. IN ADDITION, THE CONSUMER HAD IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) AS CONCOMITANT CONDITION AND AN ALLERGY TO NICKEL, WHICH SHE SAID THAT SHE KNEW ABOUT PRIOR TO HAVING THE ESSURE IMPLANTED. PTC INVESTIGATION RESULT WAS RECEIVED ON 02-OCT-2015. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE KNOWN, POSSIBLE, UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE LACK OF EFFICACY AND A QUALITY DEFECT. FOLLOW-UP INFORMATION RECEIVED ON 22-JUN-2016: LAWYERS WERE ADDED AS REPORTERS AND THE CASE BECAME A LEGAL CASE UPON RECEIPT OF THE LEGAL CLAIM. PLAINTIFF HAD THE DEVICE REMOVED DUE TO COMPLICATIONS. NO FURTHER INFORMATION WAS REPORTED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS LEGAL CASE REPORT REFERS TO A (B)(6) FEMALE PLAINTIFF WHO BECAME PREGNANT AND DELIVERED A MALE BABY AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ADDITIONALLY, SHE HAD CONTINUOUS BLEEDING FOR 8 WEEKS, WHICH CAME BACK AFTER TREATMENT WITH HORMONAL THERAPY. SHE STATED SHE HAD BLEEDING FOR 20 DAYS A MONTH. ACCORDING TO ADDITIONAL INFORMATION RECEIVED VIA LEGAL CLAIM, ESSURE DEVICES WERE REMOVED. ALL EVENTS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE, WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST TO DETERMINE IF THE INSERTS ARE IN THE CORRECT LOCATION AND TUBAL OCCLUSION IS PRESENT. IN THIS PARTICULAR CASE, CONSUMER UNDERWENT A TEST 90 DAYS AFTER ESSURE INSERTION WHICH SHOWED BOTH FALLOPIAN TUBES OCCLUDED. CONSIDERING THIS INFORMATION AN ESSURE CONTRACEPTIVE FAILURE CANNOT BE EXCLUDED. REGARDING CONSUMER'S BLEEDING; AFTER ESSURE INSERTION ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS CASE; CONSUMER HAD IDIOPATHIC THROMBOCYTOPENIC PURPURA; THIS CONDITION COULD BE AN ALTERNATIVE EXPLANATION FOR HER BLEEDING. HOWEVER, AS THIS EVENT STARTED IN CLOSE ASSOCIATION WITH ESSURE INSERTION, A CONTRIBUTORY ROLE OF THE SUSPECT DEVICE CANNOT BE EXCLUDED. UPON RECEIPT OF FOLLOW UP INFORMATION, THIS CASE WAS THEN CLASSIFIED AS INCIDENT SINCE DEVICE REMOVAL WAS REQUIRED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461841 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 904753,904763-INV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| SYNTHROID| SYNTHROID| SYNTHROID |