ESSURE
Report
- Report Number
- 2951250-2017-05367
- Event Type
- Injury
- Date Received
- October 24, 2017
- Date of Event
- April 1, 2012
- Report Date
- June 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785, 927073) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO" AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED VAGINAL DISCHARGE, HYPOGLYCEMIA AND PARITY 2. CONCOMITANT PRODUCTS INCLUDED VITAMIN B12 NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION ("ANAPHYLACTIC REACTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ALOPECIA ("ALOPECIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND BACK PAIN ("PAIN/LOWER BACK AREA"). 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 (UNDERWENT PARTIAL HYSTERECTOMY AND SALPINGECTOMY (ONE SIDE REMOVAL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ALOPECIA, DIZZINESS, NAUSEA, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANAPHYLACTIC REACTION, DEPRESSION, ANXIETY AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANAPHYLACTIC REACTION, ANXIETY, BACK PAIN, DEPRESSION, DIZZINESS, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER PFS, INSERTION DATE: (B)(6) 2012. LEFT VISIBLE COILS: UNABLE TO VISUALIZE AFTER INITIAL SURVEY DUE TO TUBAL SPASM. RIGHT VISIBLE COILS: 5. DIAGNOSTIC RESULTS: ON (B)(6) 2014, VISUALIZED LOWER THORAX: THERE ARE SMALL BILATERAL PLEURAL EFFUSIONS. THE VISUALIZED MEDIASTINUM IS NORMAL IN APPEARANCE WITHOUT PERICARDIAL EFFUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2018: PFS RECEIVED. NEW EVENTS ADDED-ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ANAPHYLACTIC REACTION, DEPRESSION AND MENTAL ANGUISH AND ESSURE CONFIRMATION TEST: NO. LOT NUMBER 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.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND ANAPHYLACTIC REACTION ("ANAPHYLACTIC REACTION") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785, 927073) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED VAGINAL DISCHARGE, HYPOGLYCEMIA AND PARITY 2. CONCOMITANT PRODUCTS INCLUDED VITAMIN B12 NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ALOPECIA ("ALOPECIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)") AND BACK PAIN ("PAIN/LOWER BACK AREA"). 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 (UNDERWENT PARTIAL HYSTERECTOMY AND SALPINGECTOMY (ONE SIDE REMOVAL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ANAPHYLACTIC REACTION, ALOPECIA, DIZZINESS, NAUSEA, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, ANAPHYLACTIC REACTION, ANXIETY, BACK PAIN, DEPRESSION, DIZZINESS, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER PFS, INSERTION DATE: (B)(6) 2012. LEFT VISIBLE COILS: UNABLE TO VISUALIZE AFTER INITIAL SURVEY DUE TO TUBAL SPASM. RIGHT VISIBLE COILS: 5. DIAGNOSTIC RESULTS: ON (B)(6) 2014, VISUALIZED LOWER THORAX: THERE ARE SMALL BILATERAL PLEURAL EFFUSIONS. THE VISUALIZED MEDIASTINUM IS NORMAL IN APPEARANCE WITHOUT PERICARDIAL EFFUSION. BATCH NUMBER: 925785, MANUFACTURE DATE: 2011/11, EXPIRY DATE: 2014/11. BATCH NUMBER: 927073, MANUFACTURE DATE: 2011/12, EXPIRY DATE: 2014/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN / PAIN"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), ANAPHYLACTIC REACTION ("ANAPHYLACTIC REACTION") AND PREMATURE DELIVERY ("PRETERM DELIVERY/ INTRAUTERINE PREGNANCY AT 31 WEEKS AND 0 DAYS, DELIVERED.") IN A 30-YEAR-OLD FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE (BATCH NO. 925785, 927073) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED VAGINAL DISCHARGE, HYPOGLYCEMIA, FEVER, BLURRED VISION, BREAST PAIN, MIGRAINE, NAUSEA, PHOTOPHOBIA, MULTIGRAVIDA, PARITY 3, RECURRENT ABORTION (2000, 2002 AND 2008), PREMATURE DELIVERY AND SMALL BOWEL RESECTION (DUE TO SMALL-BOWEL OBSTRUCTION AFTER GASTRIC BYPASS IN 1996.). CONCURRENT CONDITIONS INCLUDED SHORTNESS OF BREATH, CHEST PAIN, VOMITING, GERD, HYPOGLYCEMIA AND DRUG HYPERSENSITIVITY (CODEINE, SULFA, TORADOL, DILAUDID AND PCN--ANAPHYLAXIS). CONCOMITANT PRODUCTS INCLUDED VITAMIN B12 NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ALOPECIA ("ALOPECIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). IN 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACK PAIN ("PAIN/LOWER BACK AREA") AND PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). 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 SURGERY (UNDERWENT PARTIAL HYSTERECTOMY AND SALPINGECTOMY (ONE SIDE REMOVAL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ALOPECIA, DIZZINESS, NAUSEA, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, BACK PAIN AND PREMATURE DELIVERY OUTCOME WAS UNKNOWN AND THE ANAPHYLACTIC REACTION HAD RESOLVED. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A CHILD WITH HEALTH PROBLEMS. THE CAESAREAN DELIVERY OCCURRED ON (B)(6) 2014. 1830G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 4, 6 AND 8 (AT 1, 5 AND 10 MINUTES). THE REPORTER CONSIDERED ALOPECIA, ANAPHYLACTIC REACTION, ANXIETY, BACK PAIN, DEPRESSION, DIZZINESS, GENITAL HAEMORRHAGE, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER PFS, INSERTION DATE: (B)(6) 2012 (RIGHT SIDE) AND (B)(6) 2012 (LEFT SIDE).LEFT VISIBLE COILS: UNABLE TO VISUALIZE AFTER INITIAL SURVEY DUE TO TUBAL SPASM. RIGHT VISIBLE COILS: 5. PATIENT HAD AN ANAPHYLAXIS REACTION AFTER GIVEN TORADOL DURING ESSURE PROCEDURE, SHE WAS TRANSFERRED TO THE ED AND INTUBATED. AS PER MR: MATERNAL GASTRIC BYPASS STATUS COMPLICATING PREGNANCY/CHILDBIRTH/ PUERPERIUM AND PREGNANCY COMPLICATED BY RESPIRATORY DISORDERS - ANTEPARTUM CONDITION OR PRIOR COMPLICATED DELIVERY. AN ECTOPIC PREGNANCY WAS REPORTED IN PFS BUT THE INITIAL SUSPICION OF ECTOPIC PREGNANCY WAS NOT CONFIRMED AND A INTRAUTERINE VIABLE PREGNANCY DELIVERED AT 31 WEEKS WAS CONFIRMED BY MEDICAL RECORDS IN 2014,(REPORTED IN PFS AS (B)(6) 2014, (B)(6) 2016 BUT IT WAS CONFIRMED AS (B)(6) 2014). TUBAL LIGATION WAS PERFORMED AT TIME OF C-SECTION. HER BABY WAS BORN (B)(6) 2014 AT 31 WEEKS, PREMATURE DELIVERY AND WITH 1830 GRAMS (CASE (B)(4)). DIAGNOSTIC RESULTS: (B)(6) 2012 : URINE PREGNANCY TEST: NEGATIVE. (B)(6) 2013 : URINE PREGNANCY TEST RESULTS WERE POSITIVE. ULTRASOUND: QUESTIONABLE GESTATIONAL SAC VERSUS PSEUDO-GESTATIONAL SAC. THIS FLUID COLLECTION MEASURED OUT OF RANGE FOR DATING. THIS MAY REFLECT AN EARLY IUP TOO EARLY TO VISUALIZE ON ULTRASOUND, A FAILED PREGNANCY OR POTENTIALLY AN ECTOPIC PREGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY, DIZZINESS, FATIGUE, MENORRHAGIA, ALOPECIA, BACK PAIN AND GENITAL BLEEDING. BATCH NUMBER: 925785 MANUFACTURE DATE: 2011/11 EXPIRY DATE: 2014/11. BATCH NUMBER: 927073 MANUFACTURE DATE: 2011/12 EXPIRY DATE: 2014/12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-SEP-2018: PREVIOUS TERM ECTOPIC PREGNANCY UPDATED TO ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY AND CODED TO PREGNANCY WITH CONTRACEPTIVE DEVICE. INFORMATION ABOUT PREGNANCY ADDED. CONCOMITANT AND HISTORICAL CONDITION, REPORTER, LAB DATA ADDED FROM MEDICAL RECORD. ON 26-SEP-2018: PROCESSED WITH PREVIOUS FU. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN') AND PREMATURE DELIVERY ('PRETERM DELIVERY/ INTRAUTERINE PREGNANCY AT 31 WEEKS AND 0 DAYS, DELIVERED.') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785, 927073) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DISCHARGE, HYPOGLYCEMIA, FEVER, BLURRED VISION, BREAST PAIN, MIGRAINE, NAUSEA, PHOTOPHOBIA, MULTIGRAVIDA, PARITY 3, RECURRENT ABORTION (2000,2002 AND 2008), PREMATURE DELIVERY AND SMALL BOWEL RESECTION (DUE TO SMALL-BOWEL OBSTRUCTION AFTER GASTRIC BYPASS IN 1996.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: SPRINTEC FROM (B)(6) 2012 TO (B)(6) 2012, ORTHO TRI-CYLEN FROM (B)(6) 2012 TO (B)(6) 2012 AND DEPO-PROVERA FROM (B)(6) 2012 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED SHORTNESS OF BREATH, CHEST PAIN, VOMITING, GERD, HYPOGLYCEMIA AND DRUG HYPERSENSITIVITY (CODEINE, SULFA, TORADOL, DILAUDID AND PCN--ANAPHYLAXIS). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (LEVORA) FROM (B)(6) 2017 TO (B)(6) 2017 FOR BIRTH CONTROL AS WELL AS COLECALCIFEROL (VITAMIN D3), DOCUSATE SODIUM (COLACE) AND VITAMIN B12 NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION ("ANAPHYLACTIC REACTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND ALOPECIA ("ALOPECIA"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACK PAIN ("PAIN/LOWER BACK AREA"), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), IRON DEFICIENCY ANAEMIA ("ANEMIA"), DERMATITIS ALLERGIC ("ALLERGY-RASH/SKIN CONDTION") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT PARTIAL HYSTERECTOMY AND SALPINGECTOMY (ONE SIDE REMOVAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ANAPHYLACTIC REACTION, MENORRHAGIA AND DERMATITIS ALLERGIC HAD RESOLVED, THE ALOPECIA, DEPRESSION AND ANXIETY HAD NOT RESOLVED AND THE DIZZINESS, NAUSEA, MENSTRUAL DISORDER, VAGINAL HAEMORRHAGE, BACK PAIN, PREMATURE DELIVERY, IRON DEFICIENCY ANAEMIA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 7, PARA 3. 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) 2014. 1830G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 4, 6 AND 8 (AT 1, 5 AND 10 MINUTES). THE REPORTER CONSIDERED ALOPECIA, ANAPHYLACTIC REACTION, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS ALLERGIC, DIZZINESS, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER PFS, INSERTION DATE: (B)(6) 2012 (RIGHT SIDE) AND (B)(6) 2012 (LEFT SIDE).LEFT VISIBLE COILS: UNABLE TO VISUALIZE AFTER INITIAL SURVEY DUE TO TUBAL SPASM. RIGHT VISIBLE COILS: 5. PATIENT HAD AN ANAPHYLAXIS REACTION AFTER GIVEN TORADOL DURING ESSURE PROCEDURE, SHE WAS TRANSFERRED TO THE ED AND INTUBATED. AS PER MR: MATERNAL GASTRIC BYPASS STATUS COMPLICATING PREGNANCY/CHILDBIRTH/ PUERPERIUM AND PREGNANCY COMPLICATED BY RESPIRATORY DISORDERS - ANTEPARTUM CONDITION OR PRIOR COMPLICATED DELIVERY. AN ECTOPIC PREGNANCY WAS REPORTED IN PFS BUT THE INITIAL SUSPICION OF ECTOPIC PREGNANCY WAS NOT CONFIRMED AND A INTRAUTERINE VIABLE PREGNANCY DELIVERED AT 31 WEEKS WAS CONFIRMED BY MEDICAL RECORDS IN 2014,(REPORTED IN PFS AS (B)(6) 2014, (B)(6) 2016 BUT IT WAS CONFIRMED AS (B)(6) 2014). TUBAL LIGATION WAS PERFORMED AT TIME OF C-SECTION. HER BABY WAS BORN (B)(6) 2014 AT 31 WEEKS, PREMATURE DELIVERY AND WITH 1830 GRAMS (CASE (B)(4)). DATE DISCREPANCY REMOVAL (B)(6) 2014. RECEIVED TREATMENT FOR BLEEDING, ALLERGY , DIAGNOSTIC RESULTS: (B)(6) 2012 : URINE PREGNANCY TEST: NEGATIVE (B)(6) 2013 : URINE PREGNANCY TEST RESULTS WERE POSITIVE. ULTRASOUND: QUESTIONABLE GESTATIONAL SAC VERSUS PSEUDO-GESTATIONAL SAC. THIS FLUID COLLECTION MEASURED OUT OF RANGE FOR DATING. THIS MAY REFLECT AN EARLY IUP TOO EARLY TO VISUALIZE ON ULTRASOUND, A FAILED PREGNANCY OR POTENTIALLY AN ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PLAINTIFF FACT SHEET REVIVED, EVENT ANEMIA, RASH/SKIN CONDITION, ALLERGY, POST REMOVAL COMPLICATION , EVENT OUTCOME AND RCC COMMENT ADDED. SERIOUSNESS CRITERIA FOR PREVIOUSLY REPORTED EVENTS PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HEMORRHAGE AND ANAPHYLACTIC SHOCK UPDATES AS NON SERIOUS. 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 PELVIC PAIN ('SEVERE PELVIC PAIN / PAIN') AND PREMATURE DELIVERY ('PRETERM DELIVERY/ INTRAUTERINE PREGNANCY AT 31 WEEKS AND 0 DAYS, DELIVERED.') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 925785, 927073) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST: NO". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DISCHARGE, HYPOGLYCEMIA, FEVER, BLURRED VISION, BREAST PAIN, MIGRAINE, NAUSEA, PHOTOPHOBIA, MULTIGRAVIDA, PARITY 3, RECURRENT ABORTION (2000, 2002 AND 2008), PREMATURE DELIVERY AND SMALL BOWEL RESECTION (DUE TO SMALL-BOWEL OBSTRUCTION AFTER GASTRIC BYPASS IN 1996.). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR CONTRACEPTION: SPRINTEC FROM (B)(6) 2012 TO (B)(6) 2012, ORTHO TRI-CYLEN FROM (B0(6) 2012 TO (B)(6) 2012 AND DEPO-PROVERA FROM (B)(6) 2012 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED SHORTNESS OF BREATH, CHEST PAIN, VOMITING, GERD, HYPOGLYCEMIA AND DRUG HYPERSENSITIVITY (CODEINE, SULFA, TORADOL, DILAUDID AND PCN--ANAPHYLAXIS). CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;LEVONORGESTREL (LEVORA) FROM (B)(6) 2017 TO (B)(6) 2017 FOR BIRTH CONTROL AS WELL AS COLECALCIFEROL (VITAMIN D3), DOCUSATE SODIUM (COLACE) AND VITAMIN B12 NOS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED ANAPHYLACTIC REACTION ("ANAPHYLACTIC REACTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND ALOPECIA ("ALOPECIA"). ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY/ PREGNANCY (WITH COMPLICATIONS)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), BACK PAIN ("PAIN/LOWER BACK AREA"), PREMATURE DELIVERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), IRON DEFICIENCY ANAEMIA ("ANEMIA"), DERMATITIS ALLERGIC ("ALLERGY-RASH/SKIN CONDTION") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT PARTIAL HYSTERECTOMY AND SALPINGECTOMY (ONE SIDE REMOVAL)). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE, GENITAL HAEMORRHAGE, ANAPHYLACTIC REACTION, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DERMATITIS ALLERGIC HAD RESOLVED, THE ALOPECIA, DEPRESSION AND ANXIETY HAD NOT RESOLVED AND THE DIZZINESS, NAUSEA, MENSTRUAL DISORDER, BACK PAIN, PREMATURE DELIVERY, IRON DEFICIENCY ANAEMIA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 7, PARA 3. 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) 2014. 1830G WAS THE REPORTED BIRTH WEIGHT. THE APGAR SCORES WERE 4, 6 AND 8 (AT 1, 5 AND 10 MINUTES). THE REPORTER CONSIDERED ALOPECIA, ANAPHYLACTIC REACTION, ANXIETY, BACK PAIN, DEPRESSION, DERMATITIS ALLERGIC, DIZZINESS, GENITAL HAEMORRHAGE, IRON DEFICIENCY ANAEMIA, MENORRHAGIA, MENSTRUAL DISORDER, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, PREMATURE DELIVERY AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER PFS, INSERTION DATE: (B)(6) 2012 (RIGHT SIDE) AND (B)(6) 2012 (LEFT SIDE).LEFT VISIBLE COILS: UNABLE TO VISUALIZE AFTER INITIAL SURVEY DUE TO TUBAL SPASM. RIGHT VISIBLE COILS: 5. PATIENT HAD AN ANAPHYLAXIS REACTION AFTER GIVEN TORADOL DURING ESSURE PROCEDURE, SHE WAS TRANSFERRED TO THE ED AND INTUBATED. AS PER MR: MATERNAL GASTRIC BYPASS STATUS COMPLICATING PREGNANCY/CHILDBIRTH/ PUERPERIUM AND PREGNANCY COMPLICATED BY RESPIRATORY DISORDERS - ANTEPARTUM CONDITION OR PRIOR COMPLICATED DELIVERY. AN ECTOPIC PREGNANCY WAS REPORTED IN PFS BUT THE INITIAL SUSPICION OF ECTOPIC PREGNANCY WAS NOT CONFIRMED AND A INTRAUTERINE VIABLE PREGNANCY DELIVERED AT 31 WEEKS WAS CONFIRMED BY MEDICAL RECORDS IN 2014, (REPORTED IN PFS AS (B)(6) 2014, (B)(6) 2016 BUT IT WAS CONFIRMED AS (B)(6) 2014). TUBAL LIGATION WAS PERFORMED AT TIME OF C-SECTION. HER BABY WAS BORN (B)(6) 2014 AT 31 WEEKS, PREMATURE DELIVERY AND WITH 1830 GRAMS (CASE (B)(4)). DATE DECRIPENSY REMOVAL (B)(6) 2014. RECEIVED TREATMENT FOR BLEEDING, ALLERGY , DIAGNOSTIC RESULTS: (B)(6) 2012 : URINE PREGNANCY TEST: NEGATIVE. (B)(6) 2013 : URINE PREGNANCY TEST RESULTS WERE POSITIVE. ULTRASOUND: QUESTIONABLE GESTATIONAL SAC VERSUS PSEUDO-GESTATIONAL SAC. THIS FLUID COLLECTION MEASURED OUT OF RANGE FOR DATING. THIS MAY REFLECT AN EARLY IUP TOO EARLY TO VISUALIZE ON ULTRASOUND, A FAILED PREGNANCY OR POTENTIALLY AN ECTOPIC PREGNANCY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED-EVENT OUTCOME UPDATED FOR EVENT ABNORMAL BLEEDING-VAGINAL. 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 RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN") AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY / POST-IMPLANT PREGNANCY") IN A 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 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALOPECIA ("ALOPECIA"), DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA") AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). 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 (UNDERWENT HYSTERECTOMY DUE TO COMPLICATIONS FROM THE ESSURE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, ALOPECIA, DIZZINESS, NAUSEA AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, DIZZINESS, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MENSTRUAL DISORDER, NAUSEA AND PELVIC PAIN 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 |
|---|---|---|---|---|---|---|---|
| 752389 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925785, 927073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | COLACE.| COLACE.| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL].| LEVORA [ETHINYLESTRADIOL,LEVONORGESTREL].| VITAMIN B12 NOS.| VITAMIN B12 NOS.| VITAMIN B12 NOS.| VITAMIN B12 NOS.| VITAMIN B12 NOS.| VITAMIN D3.| VITAMIN D3. |