BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7297478 · Received February 26, 2018

    Report

    Report Number
    2951250-2018-00919
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    October 1, 2016
    Report Date
    September 24, 2018
    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

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ENDOMETRIAL CAVITY,") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. URS 6060132) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO NEISSERIA GONORRHOEAE ISOLATED ,NEGATIVE FOR HYPERPLASIA/MALIGNANCY. CONCURRENT CONDITIONS INCLUDED NEISSERIA GONORRHOEAE PROCTITIS, SKIN LESION, FATIGUE, HEART MURMUR, ANOGENITAL WARTS, KNEE PAIN, RENAL FAILURE, OBESITY, VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY, HIRSUTISM, HYPERTENSION, UTERINE BLEEDING, EXCESSIVE MENSTRUATION, ENDOMETRIAL BIOPSY, TRICHOMONAL VULVOVAGINITIS AND BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO CYCLEN) FROM 2001 TO 2004 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2004 TO 2006 FOR BIRTH CONTROL. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN 2010, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN,"). IN 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2016, 10 YEARS 2 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: VAGINOSIS,"), URINARY TRACT INFECTION ("UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT -HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, VAGINAL DISORDER, URINARY TRACT INFECTION, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ALOPECIA HAD RESOLVED AND THE VAGINAL DISCHARGE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, DEVICE DISLOCATION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MULTIPLE ATTEMPTS OF INSERTION OF MICRO INSERT INTO FALLOPIAN TUBE WERE UNSUCCESSFUL AS THE TUBE WAS KINKING AND APPEARED TO MEETING WITH RESISTANCE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION. ABNORMAL ULTRASOUND OF PELVIS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MR RECEIVED. NEW REPORTER, PATIENT RELEVANT INFORMATION, LAB DATA, PATIENT DEMOGRAPHIC INFORMATION, ESSURE INDICATION, LOT NUMBER, CONCOMITANT CONDITIONS AND EVENTS - ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), INFECTION (BLADDER/URINARYTRACT/VAGINAL) TYPE: VAGINOSIS, UTI, VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, HAIR LOSS WERE ADDED. MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ENDOMETRIAL CAVITY CLUBBED WITH DEVICE DISLOCATION. 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF IMPLANT/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ENDOMETRIAL CAVITY,") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A 45-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. URS 6060132-NOT VALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO NEISSERIA GONORRHOEAE ISOLATED ,NEGATIVE FOR HYPERPLASIA/MALIGNANCY. CONCURRENT CONDITIONS INCLUDED NEISSERIA GONORRHOEAE PROCTITIS, SKIN LESION, FATIGUE, HEART MURMUR, ANOGENITAL WARTS, KNEE PAIN, RENAL FAILURE, OBESITY, VITAMIN D DEFICIENCY, VITAMIN B12 DEFICIENCY, HIRSUTISM, HYPERTENSION, UTERINE BLEEDING, POLYMENORRHAGIA, ENDOMETRIAL BIOPSY, TRICHOMONAL VULVOVAGINITIS AND BREAST CANCER. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO CYCLEN) FROM 2001 TO 2004 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FROM 2004 TO 2006 FOR BIRTH CONTROL. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2007, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"). IN 2010, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN 2011, THE PATIENT EXPERIENCED WEIGHT INCREASED ("WEIGHT GAIN,"). IN 2015, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"). ON (B)(6) 2016, 10 YEARS 2 MONTHS AFTER INSERTION OF ESSURE (ESS205), THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISORDER ("INFECTION (BLADDER/URINARY TRACT/VAGINAL), TYPE: VAGINOSIS,"), URINARY TRACT INFECTION ("UTI") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT -HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, VAGINAL DISORDER, URINARY TRACT INFECTION, FATIGUE AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ALOPECIA HAD RESOLVED AND THE VAGINAL DISCHARGE WAS RESOLVING. THE REPORTER CONSIDERED ALOPECIA, DEVICE EXPULSION, FATIGUE, GENITAL HAEMORRHAGE, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL DISORDER, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: MULTIPLE ATTEMPTS OF INSERTION OF MICRO INSERT INTO FALLOPIAN TUBE WERE UNSUCCESSFUL AS THE TUBE WAS KINKING AND APPEARED TO MEETING WITH RESISTANCE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2006: TOTAL BILATERAL OCCLUSION . ABNORMAL ULTRASOUND OF PELVIS . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2018: UPDATE OF INFORMATION (BATCH IS NOT VALID). INCIDENT NO VALID 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("HEAVY BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT.). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). 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
    139329 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 URS 6060132-NOT VALID

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R DEPO-PROVERA| DEPO-PROVERA| ORTHO CYCLEN| ORTHO CYCLEN