ESSURE
Report
- Report Number
- 2951250-2017-08571
- Event Type
- Injury
- Date Received
- November 23, 2017
- Date of Event
- January 20, 2016
- Report Date
- May 31, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ OUTSIDE OF FALLOPIAN TUBE"), UTERINE PERFORATION ("PERFORATION (UTERUS)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN UTERUS"), OVARIAN PERFORATION ("PERFORATION: RIGHT OVARY/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN RIGHT OVARY"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), INTESTINAL PERFORATION ("BOWEL WAS PERFORATED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND HABITUAL ABORTION ("MISCARRIAGES") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA ((B)(6) 2004, (B)(6) 2007, (B)(6) 2011), PARITY 3, HIGH RISK PREGNANCY, PRETERM LABOR, FIRST-DEGREE PERINEAL LACERATION DURING DELIVERY, RECURRENT ABORTION AND POST ABORTION HEMORRHAGE. US OB TRANSABDOMINAL, FETAL MATERNAL W DETAILED FETAL EXAM, SINGLE GESTATION, IN CLINIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED MENSTRUAL CRAMPS, NICKEL SENSITIVITY, CHRONIC MIGRAINE, ASTHMA, CHARCOT-MARIE-TOOTH DISEASE, MUSCULAR DYSTROPHY, FIBROCYSTIC BREAST DISEASE, CERVICALGIA, LOW BACK PAIN, ARTHRALGIA, MIGRAINE WITH AURA, STRABISMUS, DIPLOPIA, TENSION HEADACHE, ABDOMINAL PAIN, COUGHING, DEPRESSION (MOTHER), LIGHT PERIODS AND MENSES LACK OF. THE PATIENT ALSO HAD A FAMILY HISTORY OF DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING), HYDROCODONE, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), MUPIROCIN, NITROFURANTOIN MONOHYDRATE, NYSTATIN, PARACETAMOL (ACETAMINOPHEN) AND SALBUTAMOL SULFATE (PROAIR HFA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), NEUROSIS ("UNSPECIFIED NEUROLOGICAL") AND TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE. IN FEBRUARY 2016, THE PATIENT EXPERIENCED HABITUAL ABORTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTESTINAL PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY (FULL), OOPHORECTOMY (ONE SIDE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, OVARIAN PERFORATION, DEVICE BREAKAGE, INTESTINAL PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, NEUROSIS, TOOTH DISORDER, ALLERGY TO METALS, DYSPAREUNIA, FATIGUE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, HABITUAL ABORTION, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS PARA 3. 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 SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HABITUAL ABORTION, INTESTINAL PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, NEUROSIS, OVARIAN PERFORATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF REMOVAL : (B)(6) 2016, (B)(6) 2016 : HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: NORMAL AND ESSURE DEVICES IN PLACE. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2016: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : VAGINAL HAEMORRHAGE BATCH NUMBER: 910512 MANUFACTURE DATE: 2011-10 EXPIRATION DATE:2014-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-MAR-2019: QUALITY-SAFETY EVALUATION OF PTC. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE(S)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ OUTSIDE OF FALLOPIAN TUBE'), UTERINE PERFORATION ('PERFORATION (UTERUS)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN UTERUS'), OVARIAN PERFORATION ('PERFORATION: RIGHT OVARY/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN RIGHT OVARY'), DEVICE BREAKAGE ('DEVICE BREAKAGE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING'), INTESTINAL PERFORATION ('BOWEL WAS PERFORATED, BOWEL WAS PERFORATED DURING THE HYSTERECTOMY.'), PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY'), HABITUAL ABORTION ('MISCARRIAGES') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISORDER- TYPE OF DISORDER UNSPECIFIED NEUROGICAL') IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA ((B)(6) 2004, (B)(6) 2007, (B)(6) 2011), PARITY 3, HIGH RISK PREGNANCY, PRETERM LABOR, FIRST-DEGREE PERINEAL LACERATION DURING DELIVERY, RECURRENT ABORTION, POST ABORTION HEMORRHAGE AND RECURRENT ABORTION. US OB TRANSABDOMINAL, FETAL MATERNAL W DETAILED FETAL EXAM, SINGLE GESTATION, IN CLINIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED MENSTRUAL CRAMPS, NICKEL SENSITIVITY, CHRONIC MIGRAINE, ASTHMA, CHARCOT-MARIE-TOOTH DISEASE, MUSCULAR DYSTROPHY, FIBROCYSTIC BREAST DISEASE, CERVICALGIA, LOW BACK PAIN, ARTHRALGIA, MIGRAINE WITH AURA, STRABISMUS, DIPLOPIA, TENSION HEADACHE, ABDOMINAL PAIN, COUGHING, DEPRESSION (MOTHER), LIGHT PERIODS AND MENSES LACK OF. THE PATIENT ALSO HAD A FAMILY HISTORY OF DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING), HYDROCODONE, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), MUPIROCIN, NITROFURANTOIN MONOHYDRATE, NYSTATIN, PARACETAMOL (ACETAMINOPHEN) AND SALBUTAMOL SULFATE (PROAIR HFA). IN (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/PELVIC AREA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"). IN 2012, THE PATIENT EXPERIENCED NEUROSIS ("UNSPECIFIED NEUROLOGICAL"). IN (B)(6) 2015, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2015, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2016, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS AFTER INSERTION OF ESSURE. ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2016, THE PATIENT EXPERIENCED HABITUAL ABORTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND OVARIAN PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTESTINAL PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TOOTH DISORDER ("DENTAL PROBLEMS") AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, UNILATERAL OOPHERECTOMY AND SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY (FULL), OOPHORECTOMY (ONE SIDE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, OVARIAN PERFORATION, DEVICE BREAKAGE, INTESTINAL PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, NEUROSIS, TOOTH DISORDER, ALLERGY TO METALS, DYSPAREUNIA, FATIGUE, MENSTRUAL DISORDER AND AUTOIMMUNE DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, HABITUAL ABORTION, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS PARA 3. 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 SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, AUTOIMMUNE DISORDER, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HABITUAL ABORTION, INTESTINAL PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, NEUROSIS, OVARIAN PERFORATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF REMOVAL : (B)(6) 2016, (B)(6) 2016 : HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, UNILATERAL OOPHORECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: NORMAL AND ESSURE DEVICES IN PLACE. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2016: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : VAGINAL HAEMORRHAGE BATCH NUMBER: 910512 MANUFACTURE DATE: 2011-10 EXPIRATION DATE:2014-10 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAY-2019: PFS RECEIVED. REPORTER AND PATIENT DEMOGRAPHICS WERE ADDED. MEDICAL HISTORY WERE ADDED. EVENT AUTOIMMUNE DISORDER- TYPE OF DISORDER UNSPECIFIED NEUROGICAL 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 FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ OUTSIDE OF FALLOPIAN TUBE"), UTERINE PERFORATION ("PERFORATION (UTERUS)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN UTERUS"), OVARIAN PERFORATION ("PERFORATION: RIGHT OVARY/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN RIGHT OVARY"), DEVICE BREAKAGE ("DEVICE BREAKAGE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), INTESTINAL PERFORATION ("BOWEL WAS PERFORATED"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND ABORTION SPONTANEOUS ("MISCARRIAGES") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910512) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (B)(6) 2004,(B)(6) 2007, (B)(6) 2011), PARITY 3, HIGH RISK PREGNANCY, PRETERM LABOR, FIRST-DEGREE PERINEAL LACERATION DURING DELIVERY, RECURRENT ABORTION AND POST ABORTION HEMORRHAGE. US OB TRANSABDOMINAL, FETAL MATERNAL W DETAILED FETAL EXAM, SINGLE GESTATION, IN CLINIC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA IUD. CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA, NICKEL SENSITIVITY, CHRONIC MIGRAINE, ASTHMA, CHARCOT-MARIE-TOOTH DISEASE, MUSCULAR DYSTROPHY, FIBROCYSTIC BREAST DISEASE, CERVICALGIA, LOW BACK PAIN, ARTHRALGIA, MIGRAINE WITH AURA, STRABISMUS, DIPLOPIA, TENSION HEADACHE, ABDOMINAL PAIN, COUGHING, DEPRESSION (MOTHER), LIGHT PERIODS AND MENSES LACK OF. THE PATIENT ALSO HAD A FAMILY HISTORY OF DEPRESSION. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING), HYDROCODONE, MEDROXYPROGESTERONE ACETATE (DEPOPROVERA), MUPIROCIN, NITROFURANTOIN MONOHYDRATE, NYSTATIN, PARACETAMOL (ACETAMINOPHEN) AND SALBUTAMOL SULFATE (PROAIR HFA). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED ANXIETY ("ANXIETY"), NEUROSIS ("UNSPECIFIED NEUROLOGICAL") AND TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2015, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2016, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABORTION SPONTANEOUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), OVARIAN PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), INTESTINAL PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALLERGY TO METALS ("NICKEL ALLERGY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), FATIGUE ("FATIGUE") AND MENSTRUAL DISORDER ("MENSTRUAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES), HYSTERECTOMY (FULL), OOPHORECTOMY (ONE SIDE). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, OVARIAN PERFORATION, DEVICE BREAKAGE, INTESTINAL PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY, NEUROSIS, TOOTH DISORDER, ALLERGY TO METALS, DYSPAREUNIA, FATIGUE AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE, ABORTION SPONTANEOUS, PELVIC PAIN AND DYSMENORRHOEA HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS PARA 3. 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 SPONTANEOUS ABORTION. THE REPORTER CONSIDERED ABORTION SPONTANEOUS, ALLERGY TO METALS, ANXIETY, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, INTESTINAL PERFORATION, MENORRHAGIA, MENSTRUAL DISORDER, NEUROSIS, OVARIAN PERFORATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE OF REMOVAL : (B)(6) 2016, (B)(6) 2016 : HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, UNILATERAL. OOPHORECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: NORMAL AND ESSURE DEVICES IN PLACE. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST - ON (B)(6) 2016: POSITIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS : VAGINAL HAEMORRHAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-FEB-2019: PFS AND MR RECEIVED. REPORTER INFORMATION WERE ADDED AND UPDATED. DATE OF INSERTION AND DATE OF REMOVAL WERE UPDATED. LOT NUMBER WERE ADDED. MEDICAL HISTORY, LAB DATA AND CONCOMITANT DRUG WERE ADDED. EVENT VERBATIM WERE UPDATED AS PAIN/PELVIC AREA. PREGNANCY OUTCOME WERE UPDATED. OUTCOME OF THE EVENT PAIN WERE UPDATED. EVENT : ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, ANXIETY, UNSPECIFIED NEUROLOGICAL, DENTAL PROBLEMS, NICKEL ALLERGY, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PERFORATION: RIGHT OVARY/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN RIGHT OVARY, PERFORATION (UTERUS)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ IN UTERUS, FATIGUE, MISCARRIAGES, MENSTRUAL ISSUES, BOWEL WAS PERFORATED AND EVENT PERFORATION WERE REPLACED WITH PERFORATION (FALLOPIAN TUBE(S)/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE/ OUTSIDE OF FALLOPIAN TUBE WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PREGNANCY". IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE, PELVIC PAIN, PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 835282 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| DEPOPROVERA| DEPOPROVERA| DEPOPROVERA| HYDROCODONE| HYDROCODONE| HYDROCODONE| MUPIROCIN| MUPIROCIN| MUPIROCIN| NITROFURANTOIN MONOHYDRATE| NITROFURANTOIN MONOHYDRATE| NITROFURANTOIN MONOHYDRATE| NUVARING| NUVARING| NUVARING| NYSTATIN| NYSTATIN| NYSTATIN| PROAIR HFA| PROAIR HFA| PROAIR HFA |