BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6820456 · Received August 25, 2017

    Report

    Report Number
    2951250-2017-03175
    Event Type
    Injury
    Date Received
    August 25, 2017
    Report Date
    January 3, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT 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 MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NORETHINDRONE AND MIRENA. CONCURRENT CONDITIONS INCLUDED ANEMIA, ASTHMA, GERD, HYPERTENSION, HEADACHE, FLASHING VISION, ALLERGIC RHINITIS, FATIGUE, WHEEZING, GENERAL BODY PAIN, UTI, GENERAL BODY PAIN, BACK PAIN, RASH, UTERINE BLEEDING, CHEST PAIN, ITCHING, FOOT PAIN, KNEE PAIN, PAIN IN HEEL AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED AMLODIPINE SINCE 2012, BECLOMETASONE DIPROPIONATE (QVAR) SINCE 1990, HYDROXYZINE SINCE 2016, LISINOPRIL SINCE 2012, MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) SINCE 2002 TO (B)(6) 2015, MONTELUKAST SINCE 2016 AND OMEPRAZOLE SINCE (B)(6) 2017. IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY,SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-DEC-2018: PFS RECEIVED EVENT " SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST" WAS ADDED. HISTORICAL DRUG WAS ADDED. INCIDENT NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED ANEMIA, ASTHMA, GERD, HYPERTENSION, HEADACHE, FLASHING VISION, ALLERGIC RHINITIS, FATIGUE, WHEEZING, GENERAL BODY PAIN, UTI, GENERAL BODY PAIN, BACK PAIN, RASH, UTERINE BLEEDING, CHEST PAIN, ITCHING, FOOT PAIN, KNEE PAIN, PAIN IN HEEL AND UTERINE FIBROID. CONCOMITANT PRODUCTS INCLUDED AMLODIPINE SINCE 2012, BECLOMETASONE DIPROPIONATE (QVAR) SINCE 1990, HYDROXYZINE SINCE 2016, LISINOPRIL SINCE 2012, MEDROXYPROGESTERONE (DEPO PROVERA) SINCE 2002 TO (B)(6) 2015, MONTELUKAST SINCE 2016 AND OMEPRAZOLE SINCE (B)(6) 2017. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY,SALPINGECTOMY (BILATERAL REMOVAL OF FALLOPIAN TUBES)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN AND THE GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: NEW PFS RECEIVED- NEW EVENTS ADDED: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA) WERE ADDED.OUTCOME OF EVENT ABNORMAL BLEEDING FROM UNKNOWN TO RECOVERED/RESOLVED WAS UPDATED. 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.

    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 ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE 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
    602765 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R AMLODIPINE| AMLODIPINE| DEPO PROVERA| DEPO PROVERA| HYDROXYZINE| HYDROXYZINE| LISINOPRIL| LISINOPRIL| MONTELUKAST| MONTELUKAST| OMEPRAZOLE| OMEPRAZOLE| QVAR| QVAR