BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9223743 · Received October 23, 2019

    Report

    Report Number
    2951250-2019-10665
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    October 1, 2013
    Report Date
    July 4, 2025
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/ PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840018) 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 "PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 AND MENSTRUATION IRREGULAR. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, PAINFUL INTERCOURSE, UTI AND INADEQUATE LUBRICATION. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR PAINFUL PERIODS. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION / ABNORMAL BLEEDING (MENORRHAGIA)"), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VISUAL IMPAIRMENT ("VISION PROBLEMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS") AND EXPERIENCED RASH ("RASHES"), DEPRESSION ("DEPRESSION"), PARAESTHESIA ("TINGLING IN HER HANDS AND FEET"), VULVOVAGINAL PAIN ("VAGINAL PAIN") AND ADNEXA UTERI PAIN ("OVARIAN PAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENORRHAGIA, ALOPECIA, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, VAGINAL DISCHARGE, VISUAL IMPAIRMENT AND VULVOVAGINAL PAIN HAD NOT RESOLVED AND THE WEIGHT INCREASED, RASH, DEPRESSION, PARAESTHESIA, WEIGHT DECREASED AND ADNEXA UTERI PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADNEXA UTERI PAIN, ALOPECIA, BLADDER DISORDER, CYSTITIS, DEPRESSION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PARAESTHESIA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINAL PAIN, WEIGHT DECREASED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CURRENTLY HAS NO HEALTH INSURANCE TO UNDERGO REMOVAL OF THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-OCT-2019: PFS RECEIVED: EVENT OVARIAN PAIN WAS ADDED. EVENT OUTCOME OF ALL EVENTS UPDATED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/ PAIN') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 840018) 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 "PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 3 AND MENSTRUATION IRREGULAR. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA, PAINFUL INTERCOURSE, UTI AND INADEQUATE LUBRICATION. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR PAINFUL PERIODS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALOPECIA ("HAIR LOSS"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), MIGRAINE ("MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND VISUAL IMPAIRMENT ("VISION PROBLEMS") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL FLOW EXCESSIVE ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION"), RASH ("RASHES"), DEPRESSION ("DEPRESSION"), PARAESTHESIA ("TINGLING IN HER HANDS AND FEET") AND VULVOVAGINAL PAIN ("VAGINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, MENSTRUAL FLOW EXCESSIVE, WEIGHT INCREASED, ALOPECIA, RASH, DEPRESSION, PARAESTHESIA, HORMONE LEVEL ABNORMAL, VAGINAL HAEMORRHAGE, MENORRHAGIA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, NAUSEA, TOOTH DISORDER, VAGINAL DISCHARGE, WEIGHT DECREASED, VISUAL IMPAIRMENT AND VULVOVAGINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BLADDER DISORDER, CYSTITIS, DEPRESSION, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, NAUSEA, PARAESTHESIA, PELVIC PAIN, RASH, TOOTH DISORDER, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT, VULVOVAGINAL PAIN, WEIGHT DECREASED, WEIGHT INCREASED AND MENSTRUAL FLOW EXCESSIVE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE CURRENTLY HAS NO HEALTH INSURANCE TO UNDERGO REMOVAL OF THE ESSURE DEVICE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26.5 KG/SQM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: VAGINAL BLEEDING, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-OCT-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORDS WERE RECEIVED. EVENTS PER PFS: ABNORMAL BLEEDING (GENERAL), HORMONAL CHANGES, ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING (MENORRHAGIA), BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE), BLADDER PROBLEMS, URINARY PROBLEMS, MIGRAINES / HEADACHES, NAUSEA, DENTAL PROBLEMS, VAGINAL DISCHARGE, WEIGHT LOSS, VISION PROBLEMS, VAGINAL PAIN AND PLAINTIFF DID NOT UNDERGO CONFIRMATION TEST. LOT NUMBER ADDED. ON 8-OCT-2019: FU4 & FU5 WERE PROCESSED TOGETHER. MEDICAL RECORDS RECEIVED. CONCURRENT CONDITION AND CONCOMITANT MEDICATION 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 NON-CONFORMANCE DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016924 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B40015 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention| O MIRENA| MIRENA| MIRENA (LEVONORGESTREL),| MIRENA (LEVONORGESTREL),