ESSURE
Report
- Report Number
- 2951250-2017-02701
- Event Type
- Injury
- Date Received
- August 2, 2017
- Date of Event
- January 1, 2012
- Report Date
- July 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DISPLACED INTRAUTERINE DEVICE (SUSPICION OF) / COILS HAD MIGRATED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY"), PREMATURE SEPARATION OF PLACENTA ("PLACENTA TEARING OFF THE WALL"), PREMATURE DELIVERY ("PREMATURE DELIVERY"), PELVIC INFLAMMATORY DISEASE ("PID") AND UTERINE PERFORATION ("UTERUS PERFORATED BY IUD") IN A 33-YEAR-OLD FEMALE PATIENT (GRAVIDA 8, PARA 5) WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "UNSUCCESSFULLY ATTEMPTED TOO REMOVE ESSURE BECAUSE COILS HAD MIGRATED" AND DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2000, (B)(6) 2009, (B)(6) 2011, (B)(6) 2012) AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, ANXIETY, HYPOKALEMIA SINCE (B)(6) 2015 AND DIARRHEA SINCE(B)(6) 2015. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT ON (B)(6) 2012. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) -2011, 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("CYSTITIS") AND BACTERIAL VULVOVAGINITIS ("ACUTE BACTERIAL VAGINITIS"). IN 2011, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE-LOCATION OF DEVICE: OUTSIDE FALLOPIAN TUBES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMATURE SEPARATION OF PLACENTA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH HAEMORRHAGE IN PREGNANCY AND UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), METRONIDAZOLE (METRONIDAZOL) AND SURGERY (C-SECTION AND HYSTERECTOMY (PARTIAL)-ACCORDING TO PFS ON (B)(6) 2018). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE SEPARATION OF PLACENTA, PREMATURE DELIVERY, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VULVOVAGINITIS, NAUSEA, DEPRESSION, ANXIETY, WEIGHT DECREASED, ABDOMINAL PAIN, PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND MENSTRUAL 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) 2012. 1927G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACTERIAL VULVOVAGINITIS, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, PREMATURE SEPARATION OF PLACENTA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS:TRAILING COILS: LEFT 3 RIGHT 2. OTHER FINDINGS: MANY CERVICAL POLYPS PARTIALLY OBSCURING THE L OSTIA. ESSURE DEVICE WAS INSERTED WITH EASE. TUBAL LIGATION ON (B)(6) 2012 WAS REPORTED. PLAINTIFF IS CURRENTLY PLANNING ESSURE REMOVAL SINCE ESSURE IS GIVING RECURRING INFECTIONS, MAJOR PAIN AND HAS IMPAIRED SOME OF HER PHYSICAL ABILITIES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: THERE WAS A V SHAPED RADIO DENSITY IN THE REGION ON AN UNKNOWN DATE, CT ULTRASOUND WAS PERFORMED AND IT WAS THERE WAS A V SHAPED RADIO DENSITY IN THE REGION OF THE LEFT UTERINE FUNDUS, OF UNCERTAIN ETIOLOGY OR SIGNIFICANCE. THIS COULD BE RELATED TO PREVIOUS TUBAL LIGATION OR REPRESENT A DISPLACED INTRAUTER PATIENT PATIENT'S CURRENT WEIGHT WAS 110 LBS. (B)(6) 2012:OPERATIVE REPORT. PREOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. POSTOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. OPERATION: PRIMARY LOW TRANSVERSE CESAREAN BILATERAL TUBAL LIGATION. COMPLICATIONS: NONE. SPECIMENS: RIGHT AND LEFT FALLOPIAN TUBE SEGMENTS AND PLACENTA FINDINGS: VIABLE FEMALE INFANT 4 POUNDS 4 OUNCES WITH APGAR OF 6 AT ONE MINUTE AND 8 AT FIVE MINUTES. 50% PLACENTAL ABRUPTION (ESTIMATE), NORMAL APPEARING UTERUS, TUBES AND OVARIES. IT SHOULD BE NOTED THAT THE ESSURE COULD BE PALPATED IN THE ISTHMIC PORTION OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD CONFIRMING :ABDOMINAL PAIN,ACUTE URINARY TRACT INFECTION WITH CYSTITIS. ACUTE BACTERIAL VAGINITIS, DEPRESSION, DEVICE EXPULSION AND THE FOLLOWING ONES WERE DESCRIBED IN MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL PROBLEM ). 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.
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DISPLACED INTRAUTERINE DEVICE (SUSPICION OF) / COILS HAD MIGRATED"), UTERINE PERFORATION ("UTERUS PERFORATED BY IUD"), PELVIC INFLAMMATORY DISEASE ("PID"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY"), PREMATURE SEPARATION OF PLACENTA ("PLACENTA TEARING OFF THE WALL") AND PREMATURE DELIVERY ("PREMATURE DELIVERY") IN A 33-YEAR-OLD FEMALE PATIENT (GRAVIDA 8, PARA 5) WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "UNSUCCESSFULLY ATTEMPTED TOO REMOVE ESSURE BECAUSE COILS HAD MIGRATED" AND DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2000, (B)(6) 2009, (B)(6) 2011, (B)(6) 2012) AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, ANXIETY, HYPOKALEMIA SINCE (B)(6) 2015 AND DIARRHEA SINCE (B)(6) 2015. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT ON (B)(6) 2012. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2017. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON(B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("CYSTITIS") AND BACTERIAL VULVOVAGINITIS ("ACUTE BACTERIAL VAGINITIS"). IN 2011, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE-LOCATION OF DEVICE: OUTSIDE FALLOPIAN TUBES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PREMATURE SEPARATION OF PLACENTA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH HAEMORRHAGE IN PREGNANCY. IN 2014, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION/ RECURRENT INFECTIONS") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("IMPAIRED SOME OF MY PHYSICAL ABILITIES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), METRONIDAZOLE (METRONIDAZOL) AND SURGERY (C-SECTION AND HYSTERECTOMY (PARTIAL)-ACCORDING TO PFS ON (B)(6) 2018). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE SEPARATION OF PLACENTA, PREMATURE DELIVERY, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VULVOVAGINITIS, NAUSEA, DEPRESSION, ANXIETY, WEIGHT DECREASED, ABDOMINAL PAIN, VULVOVAGINAL MYCOTIC INFECTION AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND MENSTRUAL 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) 2012. 1927G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACTERIAL VULVOVAGINITIS, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, PREMATURE SEPARATION OF PLACENTA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS:TRAILING COILS: LEFT 3 RIGHT 2. OTHER FINDINGS: MANY CERVICAL POLYPS PARTIALLY OBSCURING THE L OSTIA. ESSURE DEVICE WAS INSERTED WITH EASE. TUBAL LIGATION ON (B)(6) 2012 WAS REPORTED. PLAINTIFF IS CURRENTLY PLANNING ESSURE REMOVAL SINCE ESSURE IS GIVING RECURRING INFECTIONS, MAJOR PAIN AND HAS IMPAIRED SOME OF HER PHYSICAL ABILITIES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: THERE WAS A V SHAPED RADIO DENSITY IN THE REGION ON AN UNKNOWN DATE, CT ULTRASOUND WAS PERFORMED AND IT WAS THERE WAS A V SHAPED RADIO DENSITY IN THE REGION OF THE LEFT UTERINE FUNDUS, OF UNCERTAIN ETIOLOGY OR SIGNIFICANCE. THIS COULD BE RELATED TO PREVIOUS TUBAL LIGATION OR REPRESENT A DISPLACED INTRAUTER PATIENT PATIENT'S CURRENT WEIGHT WAS 110 LBS. (B)(6) 2012: OPERATIVE REPORT: PREOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. POSTOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. OPERATION: PRIMARY LOW TRANSVERSE CESAREAN BILATERAL TUBAL LIGATION. COMPLICATIONS: NONE SPECIMENS: RIGHT AND LEFT FALLOPIAN TUBE SEGMENTS AND PLACENTA FINDINGS: VIABLE FEMALE INFANT 4 POUNDS 4 OUNCES WITH APGAR OF 6 AT ONE MINUTE AND 8 AT FIVE MINUTES. 50% PLACENTAL ABRUPTION (ESTIMATE), NORMAL APPEARING UTERUS, TUBES AND OVARIES. IT SHOULD BE NOTED THAT THE ESSURE COULD BE PALPATED IN THE ISTHMIC PORTION OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD CONFIRMING :ABDOMINAL PAIN,ACUTE URINARY TRACT INFECTION WITH CYSTITIS. ACUTE BACTERIAL VAGINITIS, DEPRESSION, DEVICE EXPULSION AND THE FOLLOWING ONES WERE DESCRIBED IN MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-SEP-2018: PLAINTIFF FACT SHEET RECEIVED - EVENTS INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION AND IMPAIRED SOME OF MY PHYSICAL ABILITIES 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DISPLACED INTRAUTERINE DEVICE (SUSPICION OF) / COILS HAD MIGRATED/ MIGRATION'), UTERINE PERFORATION ('UTERUS PERFORATED BY IUD'), PELVIC INFLAMMATORY DISEASE ('PID'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY'), PREMATURE SEPARATION OF PLACENTA ('PLACENTA TEARING OFF THE WALL') AND PREMATURE DELIVERY ('PREMATURE DELIVERY') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2000, (B)(6) 2009, (B)(6) 2011, (B)(6) 2012) AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED HYPOKALEMIA SINCE (B)(6) 2015, DIARRHEA SINCE (B)(6) 2015, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, BODY MASS INDEX NORMAL AND ANXIETY. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("CYSTITIS") AND BACTERIAL VULVOVAGINITIS ("ACUTE BACTERIAL VAGINITIS"), 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE. IN 2011, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE-LOCATION OF DEVICE: OUTSIDE FALLOPIAN TUBES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PREMATURE SEPARATION OF PLACENTA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH HAEMORRHAGE IN PREGNANCY AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), COMPLICATION OF DEVICE REMOVAL ("UNSUCCESSFULLY ATTEMPTED TOO REMOVE ESSURE BECAUSE COILS HAD MIGRATED"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION/ RECURRENT INFECTIONS") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("IMPAIRED SOME OF MY PHYSICAL ABILITIES"). THE PATIENT WAS TREATED WITH METRONIDAZOLE (METRONIDAZOL), PARACETAMOL (ACETAMINOPHEN) AND SURGERY (C-SECTION AND HYSTERECTOMY (PARTIAL)-ACCORDING TO PFS ON (B)(6) 2018 AND TO REMOVE ESSURE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE SEPARATION OF PLACENTA, PREMATURE DELIVERY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VULVOVAGINITIS, NAUSEA, DEPRESSION, ANXIETY, WEIGHT DECREASED, ABDOMINAL PAIN, COMPLICATION OF DEVICE REMOVAL, VULVOVAGINAL MYCOTIC INFECTION AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 5. 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 OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2012. 1927G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACTERIAL VULVOVAGINITIS, COMPLICATION OF DEVICE REMOVAL, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, PREMATURE SEPARATION OF PLACENTA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. NO FURTHER CAUSALITY ASSESSMENT WERE PROVIDED FOR THE PRODUCT. THE REPORTER COMMENTED: INSERTION DETAILS:TRAILING COILS: LEFT 3 RIGHT 2. OTHER FINDINGS: MANY CERVICAL POLYPS PARTIALLY OBSCURING THE L OSTIA. ESSURE DEVICE WAS INSERTED WITH EASE. TUBAL LIGATION ON (B)(6) 2012 WAS REPORTED. PLAINTIFF IS CURRENTLY PLANNING ESSURE REMOVAL SINCE ESSURE IS GIVING RECURRING INFECTIONS, MAJOR PAIN AND HAS IMPAIRED SOME OF HER PHYSICAL ABILITIES. PATIENT RECEIVED TREATMENT FOR: PAIN, ABNORMAL BLEEDING, MIGRATION, BLADDER/ URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: THERE WAS A V SHAPED RADIO DENSITY IN THE REGION. ON AN UNKNOWN DATE, CT ULTRASOUND WAS PERFORMED AND IT WAS THERE WAS A V SHAPED RADIO DENSITY IN THE REGION OF THE LEFT UTERINE FUNDUS, OF UNCERTAIN ETIOLOGY OR SIGNIFICANCE. THIS COULD BE RELATED TO PREVIOUS TUBAL LIGATION OR REPRESENT A DISPLACED INTRAUTERPATIENT. PATIENT'S CURRENT WEIGHT WAS 110 LBS. (B)(6) 2012:OPERATIVE REPORT. PREOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. POSTOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. OPERATION: PRIMARY LOW TRANSVERSE CESAREAN BILATERAL TUBAL LIGATION. COMPLICATIONS: NONE. SPECIMENS: RIGHT AND LEFT FALLOPIAN TUBE SEGMENTS AND PLACENTA. FINDINGS: VIABLE FEMALE INFANT 4 POUNDS 4 OUNCES WITH APGAR OF 6 AT ONE MINUTE AND 8 AT FIVE MINUTES. 50% PLACENTAL ABRUPTION (ESTIMATE), NORMAL APPEARING UTERUS, TUBES AND OVARIES. IT SHOULD BE NOTED THAT THE ESSURE COULD BE PALPATED IN THE ISTHMIC PORTION OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD CONFIRMING :ABDOMINAL PAIN,ACUTE URINARY TRACT INFECTION WITH CYSTITIS. ACUTE BACTERIAL VAGINITIS, DEPRESSION, DEVICE EXPULSION AND THE FOLLOWING ONES WERE DESCRIBED IN MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION. LOT NUMBER: 802744. MANUFACTURING DATE: 2010-11. EXPIRATION DATE: 2013-11. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-JUN-2020: QUALITY-SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DISPLACED INTRAUTERINE DEVICE (SUSPICION OF) / COILS HAD MIGRATED/ MIGRATION'), UTERINE PERFORATION ('UTERUS PERFORATED BY IUD'), PELVIC INFLAMMATORY DISEASE ('PID'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY'), PREMATURE SEPARATION OF PLACENTA ('PLACENTA TEARING OFF THE WALL') AND PREMATURE DELIVERY ('PREMATURE DELIVERY') IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2000, (B)(6) 2009, (B)(6) 2011, (B)(6) 2012) AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED HYPOKALEMIA SINCE (B)(6) 2015, DIARRHEA SINCE (B)(6) 2015, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, BODY MASS INDEX NORMAL AND ANXIETY. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2017. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("CYSTITIS") AND BACTERIAL VULVOVAGINITIS ("ACUTE BACTERIAL VAGINITIS"), 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE. IN 2011, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE-LOCATION OF DEVICE: OUTSIDE FALLOPIAN TUBES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PREMATURE SEPARATION OF PLACENTA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH HAEMORRHAGE IN PREGNANCY AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), COMPLICATION OF DEVICE REMOVAL ("UNSUCCESSFULLY ATTEMPTED TOO REMOVE ESSURE BECAUSE COILS HAD MIGRATED"), VULVOVAGINAL MYCOTIC INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: YEAST INFECTION/ RECURRENT INFECTIONS") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("IMPAIRED SOME OF MY PHYSICAL ABILITIES"). THE PATIENT WAS TREATED WITH METRONIDAZOLE (METRONIDAZOL), PARACETAMOL (ACETAMINOPHEN) AND SURGERY (C-SECTION AND HYSTERECTOMY (PARTIAL)-ACCORDING TO PFS ON (B)(6) 2018 AND TO REMOVE ESSURE). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, PELVIC INFLAMMATORY DISEASE, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE SEPARATION OF PLACENTA, PREMATURE DELIVERY, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VULVOVAGINITIS, NAUSEA, DEPRESSION, ANXIETY, WEIGHT DECREASED, ABDOMINAL PAIN, COMPLICATION OF DEVICE REMOVAL, VULVOVAGINAL MYCOTIC INFECTION AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OUTCOME WAS UNKNOWN, THE PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE MENSTRUAL DISORDER HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 8, PARA 5. 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 OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2012. 1927G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACTERIAL VULVOVAGINITIS, COMPLICATION OF DEVICE REMOVAL, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, PREMATURE SEPARATION OF PLACENTA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VULVOVAGINAL MYCOTIC INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS:TRAILING COILS: LEFT 3 RIGHT 2. OTHER FINDINGS: MANY CERVICAL POLYPS PARTIALLY OBSCURING THE L OSTIA. ESSURE DEVICE WAS INSERTED WITH EASE. TUBAL LIGATION ON (B)(6) 2012 WAS REPORTED. PLAINTIFF IS CURRENTLY PLANNING ESSURE REMOVAL SINCE ESSURE IS GIVING RECURRING INFECTIONS, MAJOR PAIN AND HAS IMPAIRED SOME OF HER PHYSICAL ABILITIES. PATIENT RECEIVED TREATMENT FOR: PAIN, ABNORMAL BLEEDING, MIGRATION, BLADDER/ URINARY PROBLEM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. ULTRASOUND SCAN - ON AN UNKNOWN DATE: RESULTS: THERE WAS A V SHAPED RADIO DENSITY IN THE REGION. ON AN UNKNOWN DATE, CT ULTRASOUND WAS PERFORMED AND IT WAS THERE WAS A V SHAPED RADIO DENSITY IN THE REGION OF THE LEFT UTERINE FUNDUS, OF UNCERTAIN ETIOLOGY OR SIGNIFICANCE. THIS COULD BE RELATED TO PREVIOUS TUBAL LIGATION OR REPRESENT A DISPLACED INTRAUTERPATIENT PATIENT'S CURRENT WEIGHT WAS 110 LBS. (B)(6) 2012:OPERATIVE REPORT. PREOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. POSTOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. OPERATION: PRIMARY LOW TRANSVERSE CESAREAN BILATERAL TUBAL LIGATION. COMPLICATIONS: NONE SPECIMENS: RIGHT AND LEFT FALLOPIAN TUBE SEGMENTS AND PLACENTA FINDINGS: VIABLE FEMALE INFANT 4 POUNDS 4 OUNCES WITH APGAR OF 6 AT ONE MINUTE AND 8 AT FIVE MINUTES. 50% PLACENTAL ABRUPTION (ESTIMATE), NORMAL APPEARING UTERUS, TUBES AND OVARIES. IT SHOULD BE NOTED THAT THE ESSURE COULD BE PALPATED IN THE ISTHMIC PORTION OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD CONFIRMING :ABDOMINAL PAIN,ACUTE URINARY TRACT INFECTION WITH CYSTITIS. ACUTE BACTERIAL VAGINITIS, DEPRESSION, DEVICE EXPULSION AND THE FOLLOWING ONES WERE DESCRIBED IN MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED. EVENT OUTCOME WERE UPDATED TO RECOVERED/ RESOLVED FOR: PAIN AND BLEEDING. PREVIOUSLY REPORTED SERIOUS EVENT PREGNANCY WITH CONTRACEPTIVE DEVICE AND PREMATURE DELIVERY UPDATED AS SERIOUS 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
SPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DISPLACED INTRAUTERINE DEVICE (SUSPICION OF) / COILS HAD MIGRATED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY"), PREMATURE SEPARATION OF PLACENTA ("PLACENTA TEARING OFF THE WALL"), PREMATURE DELIVERY ("PREMATURE DELIVERY"), PELVIC INFLAMMATORY DISEASE ("PID") AND UTERINE PERFORATION ("UTERUS PERFORATED BY IUD") IN A 33-YEAR-OLD FEMALE PATIENT (GRAVIDA 8, PARA 5) WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY" AND DEVICE DIFFICULT TO USE "UNSUCCESSFULLY ATTEMPTED TOO REMOVE ESSURE BECAUSE COILS HAD MIGRATED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 5 ((B)(6) 2000, (B)(6) 009, (B)(6) 2011, (B)(6) 2012) AND CAESAREAN SECTION. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, VAGINAL DISCHARGE SINCE (B)(6) 2011, CANDIDIASIS SINCE (B)(6) 2011, ANXIETY, HYPOKALEMIA SINCE (B)(6) 2015 AND DIARRHEA SINCE (B)(6) 2015. FAMILY HISTORY INCLUDED SICKLE CELL TRAIT ON (B)(6) 2012. CONCOMITANT PRODUCTS INCLUDED DOXYCYCLINE SINCE (B)(6) 2017. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND WEIGHT DECREASED ("WEIGHT LOSS"). ON (B)(6) 2011, 1 MONTH 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), CYSTITIS ("CYSTITIS") AND BACTERIAL VULVOVAGINITIS ("ACUTE BACTERIAL VAGINITIS"). IN 2011, THE PATIENT EXPERIENCED DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS/ MIGRATION OF ESSURE DEVICE-LOCATION OF DEVICE: OUTSIDE FALLOPIAN TUBES"), DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND NAUSEA ("NAUSEA"). IN 2012, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMATURE SEPARATION OF PLACENTA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH HAEMORRHAGE IN PREGNANCY AND UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN), METRONIDAZOLE (METRONIDAZOL) AND SURGERY (C-SECTION AND HYSTERECTOMY (PARTIAL)-ACCORDING TO PFS ON (B)(6) 2018). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE SEPARATION OF PLACENTA, PREMATURE DELIVERY, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, URINARY TRACT INFECTION, CYSTITIS, BACTERIAL VULVOVAGINITIS, NAUSEA, DEPRESSION, ANXIETY, WEIGHT DECREASED, ABDOMINAL PAIN, PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND MENSTRUAL 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) 2012. 1927G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 6 AND 8 (AT 1 AND 5 MINUTES). THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACTERIAL VULVOVAGINITIS, CYSTITIS, DEPRESSION, DEVICE DISLOCATION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, PREMATURE SEPARATION OF PLACENTA, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS:TRAILING COILS: LEFT 3 RIGHT 2. OTHER FINDINGS: MANY CERVICAL POLYPS PARTIALLY OBSCURING THE L OSTIA. ESSURE DEVICE WAS INSERTED WITH EASE. TUBAL LIGATION ON (B)(6) 2012 WAS REPORTED. PLAINTIFF IS CURRENTLY PLANNING ESSURE REMOVAL SINCE ESSURE IS GIVING RECURRING INFECTIONS, MAJOR PAIN AND HAS IMPAIRED SOME OF HER PHYSICAL ABILITIES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.1 KG/SQM. ULTRASOUND SCAN ON AN UNKNOWN DATE: THERE WAS A V SHAPED RADIO DENSITY IN THE REGION ON AN UNKNOWN DATE, CT ULTRASOUND WAS PERFORMED AND IT WAS THERE WAS A V SHAPED RADIO DENSITY IN THE REGION OF THE LEFT UTERINE FUNDUS, OF UNCERTAIN ETIOLOGY OR SIGNIFICANCE. THIS COULD BE RELATED TO PREVIOUS TUBAL LIGATION OR REPRESENT A DISPLACED INTRAUTER PATIENT PATIENT'S CURRENT WEIGHT WAS 110 LBS. (B)(6) 2012:OPERATIVE REPORT: PREOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. POSTOP DIAGNOSIS: 32 WEEK INTRAUTERINE PREGNANCY WITH PLACENTAL ABRUPTION. OPERATION: PRIMARY LOW TRANSVERSE CESAREAN BILATERAL TUBAL LIGATION. COMPLICATIONS: NONE SPECIMENS: RIGHT AND LEFT FALLOPIAN TUBE SEGMENTS AND PLACENTA FINDINGS: VIABLE FEMALE INFANT 4 POUNDS 4 OUNCES WITH APGAR OF 6 AT ONE MINUTE AND 8 AT FIVE MINUTES. 50% PLACENTAL ABRUPTION (ESTIMATE), NORMAL APPEARING UTERUS, TUBES AND OVARIES. IT SHOULD BE NOTED THAT THE ESSURE COULD BE PALPATED IN THE ISTHMIC PORTION OF THE UTERUS. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING ONE/ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORD CONFIRMING :ABDOMINAL PAIN,ACUTE URINARY TRACT INFECTION WITH CYSTITIS. ACUTE BACTERIAL VAGINITIS, DEPRESSION, DEVICE EXPULSION AND THE FOLLOWING ONES WERE DESCRIBED IN MEDICAL RECORDS: PELVIC INFLAMMATORY DISEASE AND UTERINE PERFORATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. REPORTER INFORMATION UPDATED. CONCOMITANT CONDITION, CONCOMITANT DRUG, TREATMENT DRUG WERE ADDED. LOT NUMBER ADDED. ADDED EVENT MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, PLACENTA TEARING OFF THE WALL, STARTED BLEEDING/HAD BALL BLOOD CLOTS, PREMATURE DELIVERY, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE, ACUTE URINARY TRACT INFECTION ,CYSTITIS, ACUTE BACTERIAL VAGINITIS, DEPRESSION, MENTAL ANGUISH ,WEIGHT LOSS. UPDATED ONSET DATES. FROM MEDICAL RECORDS: PID AND UTERINE PERFORATION 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 DEVICE DISLOCATION ("DISPLACED INTRAUTERINE DEVICE (SUSPICION OF)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY") IN A FEMALE PATIENT (GRAVIDA 1) WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "IT WAS DISCOVERED THAT SHE HAD A 12 WEEK INTRAUTERINE PREGNANCY". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("SEVERE PELVIC PAIN") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL TUBAL LIGATION). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND MENSTRUAL DISORDER HAD NOT RESOLVED. THE PREGNANCY OUTCOME WAS UNKNOWN TO THE REPORTER. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541106 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other| R | DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE| DOXYCYCLINE |