ESSURE
Report
- Report Number
- 2951250-2019-10047
- Event Type
- Injury
- Date Received
- October 11, 2019
- Date of Event
- August 8, 2011
- Report Date
- November 8, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ('MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS/ LEFT COIL PERFORATING LEFT UTERINE FUNDUS'), EMBEDDED DEVICE ('HE LEFT AND RIGHT SILVER METALLIC COILS ARE LEFT EMBEDDED WITHIN THE LEFT AND RIGHT MYOMETRIUM/MIGRATED AND PUSHED INTO UTERUS,'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION/ PREGNANCY (WITH COMPLICATIONS),') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ ABNORMAL BLEEDING (GENERAL)') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY AND OVARIAN CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("HORMONAL CHANGES/ HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), RASH ("SKIN BREAKOUT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPEPSIA ("HEARTBURN") AND ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/ LEFT SIDE PAIN"). ON (B)(6) 2011, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS: WEAKENED TEETH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES/ OCULAR MIGRANES"), PALPITATIONS ("BLOOD OR HEART DISORDER : HEART PALPITATIONS"), ARTHRALGIA ("JOINT PAIN") AND CHEST PAIN ("CHEST PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), ANXIETY ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND ALLERGY TO SYNTHETIC FABRIC ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN SENSITIVITY TO FABRICS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBE)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ALLERGY TO METALS, VAGINAL DISCHARGE, ANXIETY, ALLERGY TO SYNTHETIC FABRIC, DYSPEPSIA, ABDOMINAL PAIN LOWER, ARTHRALGIA AND CHEST PAIN OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ABDOMINAL DISTENSION, ALOPECIA, TOOTH DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, VISUAL IMPAIRMENT, PALPITATIONS, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE RASH WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. 4417G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALLERGY TO SYNTHETIC FABRIC, ALOPECIA, ANXIETY, ARTHRALGIA, CHEST PAIN, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PALPITATIONS, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR EVENTS DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BLOOD/HEART DISORDER, GENERAL ABNORMAL BLEEDING, PSYCH INJURY, PERFORATION: FALLOPIAN TUBES/ MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS. HORMONAL CHANGES, MIGRAINE, HEADACHES, VISION PROBLEMS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-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 UTERINE PERFORATION ('MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS/ LEFT COIL PERFORATING LEFT UTERINE FUNDUS/MALPOSITION OF ESSURE DEVICE'), FALLOPIAN TUBE PERFORATION ('MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS/ LEFT COIL PERFORATING LEFT UTERINE FUNDUS/MALPOSITION OF ESSURE DEVICE'), EMBEDDED DEVICE ('THE LEFT AND RIGHT SILVER METALLIC COILS ARE LEFT EMBEDDED WITHIN THE LEFT AND RIGHT MYOMETRIUM/MIGRATED AND PUSHED INTO UTERUS,'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION/ PREGNANCY (WITH COMPLICATIONS),'), GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ ABNORMAL BLEEDING (GENERAL)') AND CAESAREAN SECTION ('CAESAREAN SECTION') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY AND OVARIAN CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/ LEFT SIDE PAIN"), ABDOMINAL DISTENSION ("GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("HORMONAL CHANGES/ HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), RASH ("SKIN BREAKOUT") AND DYSPEPSIA ("HEARTBURN"). ON (B)(6) 2011, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS: WEAKENED TEETH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES/ OCULAR MIGRANES"), PALPITATIONS ("BLOOD OR HEART DISORDER : HEART PALPITATIONS"), ARTHRALGIA ("JOINT PAIN") AND CHEST PAIN ("CHEST PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), ANXIETY ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND ALLERGY TO SYNTHETIC FABRIC ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN SENSITIVITY TO FABRICS") AND UNDERWENT CAESAREAN SECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBE)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE, CAESAREAN SECTION, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, VAGINAL DISCHARGE, ANXIETY, ALLERGY TO SYNTHETIC FABRIC, DYSPEPSIA, ARTHRALGIA AND CHEST PAIN OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, ALOPECIA, TOOTH DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, VISUAL IMPAIRMENT AND PALPITATIONS HAD RESOLVED AND THE RASH WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2012. 4417G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALLERGY TO SYNTHETIC FABRIC, ALOPECIA, ANXIETY, ARTHRALGIA, CAESAREAN SECTION, CHEST PAIN, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PALPITATIONS, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR EVENTS DYSMENNORHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BLOOD/HEART DISORDER, GENERAL ABNORMAL BLEEDING, PSYCH INJURY, PERFORATION: FALLOPIAN TUBES/ MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS. HORMONAL CHANGES, MIGRAINE, HEADACHES, VISION PROBLEMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: SMALL AMOUNT OF SPILLAGE NOTED ON LEFT.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2019: PFS RECEIVED. EVENT: CAESAREAN SECTION ADDED. LAB DATA ADDED. EVENT: MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS/ LEFT COIL PERFORATING LEFT UTERINE FUNDUS/MALPOSITION OF ESSURE DEVICE SPLIT AND NEW EVENT ADDED: FALLOPIAN TUBE PERFORATION. 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 UTERINE PERFORATION ('MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS/ LEFT COIL PERFORATING LEFT UTERINE FUNDUS'), EMBEDDED DEVICE ('HE LEFT AND RIGHT SILVER METALLIC COILS ARE LEFT EMBEDDED WITHIN THE LEFT AND RIGHT MYOMETRIUM/MIGRATED AND PUSHED INTO UTERUS,'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY: BIRTH - NO COMPLICATION/ PREGNANCY (WITH COMPLICATIONS),') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING/ ABNORMAL BLEEDING (GENERAL)') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822372) 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". THE PATIENT'S MEDICAL HISTORY INCLUDED NICKEL SENSITIVITY AND OVARIAN CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ABDOMINAL DISTENSION ("GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING"), ALOPECIA ("HAIR LOSS"), MOOD SWINGS ("HORMONAL CHANGES/ HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), RASH ("SKIN BREAKOUT"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), DYSPEPSIA ("HEARTBURN") AND ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/ LEFT SIDE PAIN"). ON (B)(6) 2011, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 3 MONTHS 27 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2013, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS: WEAKENED TEETH"). IN (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE/ MIGRAINES / HEADACHES/ OCULAR MIGRANES"), PALPITATIONS ("BLOOD OR HEART DISORDER : HEART PALPITATIONS"), ARTHRALGIA ("JOINT PAIN") AND CHEST PAIN ("CHEST PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), HEADACHE ("HEADACHES"), VISUAL IMPAIRMENT ("VISION PROBLEMS"), ANXIETY ("PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY") AND ALLERGY TO SYNTHETIC FABRIC ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN SENSITIVITY TO FABRICS"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD HYSTERECTOMY (FULL) AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBE)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE, ALLERGY TO METALS, VAGINAL DISCHARGE, ANXIETY, ALLERGY TO SYNTHETIC FABRIC, DYSPEPSIA, ABDOMINAL PAIN LOWER, ARTHRALGIA AND CHEST PAIN OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, FATIGUE, ABDOMINAL DISTENSION, ALOPECIA, TOOTH DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, VISUAL IMPAIRMENT, PALPITATIONS, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE RASH WAS RESOLVING. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. (B)(6)G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALLERGY TO SYNTHETIC FABRIC, ALOPECIA, ANXIETY, ARTHRALGIA, CHEST PAIN, DYSMENORRHOEA, DYSPAREUNIA, DYSPEPSIA, EMBEDDED DEVICE, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PALPITATIONS, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, RASH, TOOTH DISORDER, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE RECEIVED TREATMENT FOR EVENTS DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BLOOD/HEART DISORDER, GENERAL ABNORMAL BLEEDING, PSYCH INJURY, PERFORATION: FALLOPIAN TUBES/ MIGRATION, BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HAIR LOSS, DENTAL PROBLEMS. HORMONAL CHANGES, MIGRAINE, HEADACHES, VISION PROBLEMS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: REPORTERS DETAILS UPDATED AND PATIENT DEMOGRAPHICS, LABORATORY DATA WERE ADDED. ESSURE INDICATION UPDATED. ON (B)(6) 2012, SHE EXPLANTED ESSURE. INJURY EVENT WAS UPDATED TO DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PELVIC PAIN, ABDOMINAL PAIN, BLOOD OR HEART DISORDER : HEART PALPITATIONS, GENERAL ABNORMAL BLEEDING/ ABNORMAL BLEEDING (GENERAL), NICKEL ALLERGY, PSYCH INJURY/ PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY, PREGNANCY: BIRTH - NO COMPLICATION/ PREGNANCY (WITH COMPLICATIONS), MIGRATION/ PERFORATION: FALLOPIAN TUBES/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : UTERUS/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE : MIGRATED AND PUSHED INTO UTERUS, BLADDER/URINARY PROBLEMS: VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS/ GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: BLOATING, HAIR LOSS, DENTAL PROBLEMS: WEAKENED TEETH, HORMONAL CHANGES/ HORMONAL CHANGES DESCRIBE: MOOD SWINGS, MIGRAINE/ MIGRAINES / HEADACHES, HEADACHES, VISION PROBLEMS. ON (B)(6) 2019: REPORTERS, PATIENT DEMOGRAPHICS, LABORATORY DATA WERE ADDED. ADDED LOT NUMBER. ON (B)(6) 2016, SHE EXPLANTED ESSURE. ADDED EVENTS SKIN BREAKOUTS, ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: SKIN SENSITIVITY TO FABRICS, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), HEARTBURN, RIGHT LOWER QUADRANT PAIN/ LEFT SIDE PAIN, JOINT PAIN, CHEST PAIN. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972324 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822372 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |