BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11618406 · Received April 6, 2021

    Report

    Report Number
    2951250-2021-01118
    Event Type
    Injury
    Date Received
    April 6, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') AND DIABETES MELLITUS ('BLOOD OR HEART DISORDER/CONDITION TYPE: DIABETES') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904748) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPLE CESAREAN SECTIONS, PELVIC ADHESIONS, ABDOMINAL ADHESIONS, ELEVATED BP, UNINTENDED PREGNANCY, PAP SMEAR ABNORMAL, VAGINAL BURNING SENSATION, DYSPLASIA, CHRONIC CERVICITIS, MICROCYTIC ANEMIA AND HYPOKALEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, ANEMIA, COLPOSCOPY, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION, VAGINAL PAIN, VAGINAL DISCHARGE, YEAST INFECTION, ACUTE VAGINITIS, VAGINAL ITCHING, BLEEDING GENITAL, ACUTE PANCREATITIS, PYELONEPHRITIS, TYPE 2 DIABETES MELLITUS, UTERINE BLEEDING, NABOTHIAN CYST, CERVICAL HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION, ADENOMYOSIS AND LEIOMYOMA OF UTERUS, UNSPECIFIED. CONCOMITANT PRODUCTS INCLUDED METFORMIN HYDROCHLORIDE (FORTAMET) FROM (B)(6) 2016 TO (B)(6) 2017 FOR DIABETES, NSAIDS SINCE (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE 1-FEB-2012 FOR PELVIC PAIN AS WELL AS ATORVASTATIN CALCIUM FROM (2016 TO 2-MAY-2017, FERROUS SULFATE FROM 19-SEP-2016 TO 24-JUN-2017, FLUOXETINE HYDROCHLORIDE (PROZAC) FROM 28-MAR-2017 TO 2-MAY-2017, GABAPENTIN FROM 13-DEC-2016 TO 5-APR-2017, HYDROXYZINE HYDROCHLORIDE FROM 14-SEP-2016 TO 3-AUG-2017, LISINOPRIL FROM 14-SEP-2016 TO 24-JUN-2017, LORAZEPAM, METFORMIN AND OSELTAMIVIR PHOSPHATE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DIABETES MELLITUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN/ PAIN PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL INFECTION") WITH VAGINAL DISCHARGE, DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION/PSYCH INJURY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH/PSYCH INJURY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 5 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERY ¿ OTHER") AND VAGINAL INFECTION NOS (" VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE), IBUPROFEN AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY ROBOTIC, CONVERTED TO OPEN SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON 1-OCT-2018. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DIABETES MELLITUS, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL INFECTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY AND VAGINAL INFECTION NOS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DIABETES MELLITUS, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VAGINAL INFECTION NOS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2012. SHE WAS PLANNING FOR ESSURE REMOVAL. RECEIVED TREATMENT FOR PAIN, BLEEDING, AUTOIMMUNE, PSYCH INJURY, BLADDER/URINARY, OTHER INJURIES/SYMPT : YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFTTLLY OCCLUDED OBSTRUCTED BOTH FALLOPIAN TUBES, DEVICE ESSURE, WITHOUT EVIDENCE OF FALLOPIAN TUBE FREE SPILL. LOT NUMBER: 904748 MANUFACTURE DATE: 2011-09 EXPIRATION DATE: 2014-09. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') AND DIABETES MELLITUS ('BLOOD OR HEART DISORDER/CONDITION TYPE: DIABETES') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904748) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPLE CESAREAN SECTIONS, PELVIC ADHESIONS, ABDOMINAL ADHESIONS, ELEVATED BP, UNINTENDED PREGNANCY, PAP SMEAR ABNORMAL, VAGINAL BURNING SENSATION, DYSPLASIA, CHRONIC CERVICITIS, MICROCYTIC ANEMIA AND HYPOKALEMIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIRENA. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, ANEMIA, COLPOSCOPY, HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION, VAGINAL PAIN, VAGINAL DISCHARGE, YEAST INFECTION, ACUTE VAGINITIS, VAGINAL ITCHING, BLEEDING GENITAL, ACUTE PANCREATITIS, PYELONEPHRITIS, TYPE 2 DIABETES MELLITUS, UTERINE BLEEDING, NABOTHIAN CYST, DYSPLASIA OF CERVIX (UTERI), ADENOMYOSIS AND LEIOMYOMA OF UTERUS, UNSPECIFIED. CONCOMITANT PRODUCTS INCLUDED METFORMIN HYDROCHLORIDE (FORTAMET) FROM (B)(6) 2016 TO (B)(6) 2017 FOR DIABETES, NSAIDS SINCE (B)(6) 2012 AND PARACETAMOL (ACETAMINOPHEN) SINCE (B)(6) 2012 FOR PELVIC PAIN AS WELL AS ATORVASTATIN CALCIUM FROM (B)(6) 2016 TO (B)(6) 2017, FERROUS SULFATE FROM (B)(6) 2016 TO (B)(6) 2017, FLUOXETINE HYDROCHLORIDE (PROZAC) FROM (B)(6) 2017 TO (B)(6) 2017, GABAPENTIN FROM (B)(6) 2016 TO (B)(6) 2017, HYDROXYZINE HYDROCHLORIDE FROM (B)(6) 2016 TO (B)(6) 2017, LISINOPRIL FROM (B)(6) 2016 TO (B)(6) 2017, LORAZEPAM, METFORMIN AND OSELTAMIVIR PHOSPHATE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED DIABETES MELLITUS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PHYSICAL PAIN/ PAIN PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL INFECTION") WITH VAGINAL DISCHARGE, DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION/PSYCH INJURY"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: MENTAL ANGUISH/PSYCH INJURY"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), 5 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), HYPERSENSITIVITY ("ALLERGY  OTHER") AND VAGINAL INFECTION NOS (" VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE), IBUPROFEN AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY ROBOTIC, CONVERTED TO OPEN SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DIABETES MELLITUS, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL INFECTION, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, HYPERSENSITIVITY AND VAGINAL INFECTION NOS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, BACK PAIN, DEPRESSION, DIABETES MELLITUS, DYSMENORRHOEA, GENITAL HAEMORRHAGE, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VAGINAL INFECTION NOS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: DATE(S) OF INSERTION: (B)(6) 2012, (B)(6) 2013. SHE WAS PLANNING FOR ESSURE REMOVAL. RECEIVED TREATMENT FOR PAIN, BLEEDING, AUTOIMMUNE, PSYCH INJURY, BLADDER/URINARY, OTHER INJURIES/SYMPTOM : YES DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED OBSTRUCTED BOTH FALLOPIAN TUBES, DEVICE ESSURE, WITHOUT EVIDENCE OF FALLOPIAN TUBE FREE SPILL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAR-2021: MR RECEIVED. REPORTER INFORMATION, MEDICAL HISTORY AND REMOVAL DETAILS (DATE EXPLANTED) WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520397 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 904748 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| ATORVASTATIN CALCIUM| ATORVASTATIN CALCIUM| FERROUS SULFATE| FERROUS SULFATE| FORTAMET| FORTAMET| GABAPENTIN| GABAPENTIN| HYDROXYZINE HYDROCHLORIDE| HYDROXYZINE HYDROCHLORIDE| LISINOPRIL| LISINOPRIL| LORAZEPAM| LORAZEPAM| METFORMIN| METFORMIN| NSAIDS| NSAIDS| OSELTAMIVIR PHOSPHATE| OSELTAMIVIR PHOSPHATE| PROZAC| PROZAC