BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17591237 · Received August 21, 2023

    Report

    Report Number
    2951250-2023-02829
    Event Type
    Injury
    Date Received
    August 21, 2023
    Date of Event
    January 1, 2006
    Report Date
    August 28, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN, PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED (LOT NO. 12274611) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DEPO-PROVERA. CONCURRENT CONDITIONS WERE LISTED AS ASTHMA, ANXIETY, LOWER ABDOMINAL PAIN AND IRREGULAR PERIODS. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005 SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ ABNORMAL BLEEDING(MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2005 SHE EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2006 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN (B)(6) 2006 SHE EXPERIENCED HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2008 SHE EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). AN UNKNOWN TIME LATER SHE EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL)") AND BACK PAIN ("LOWER BACK PAIN"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205) ADMINISTRATION. THE REPORTER COMMENTED: THE PHYSICIAN HAS RECOMMENDED THAT SHE HAVE THE DEVICE REMOVED VIA HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2005: RESULTS: TOTAL BILATERAL OCCLUSION. LOT NUMBER: 12274611. MANUFACTURE DATE: 2005-01. EXPIRATION DATE: 2006-12. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE (ESS205): 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 28-AUG-2023: 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 · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN, PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED (LOT NO. 12274611) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DEPO-PROVERA. CONCURRENT CONDITIONS WERE LISTED AS ASTHMA, ANXIETY, LOWER ABDOMINAL PAIN AND IRREGULAR PERIODS. ON (B)(6) 2005, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2005 SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("EXCESSIVE AND ABNORMAL BLEEDING DURING MENSTRUATION/ ABNORMAL BLEEDING(MENORRHAGIA)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING(VAGINAL)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2005 SHE EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2006 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN (B)(6) 2006 SHE EXPERIENCED HEADACHE ("MIGRAINES / HEADACHES"), MIGRAINE ("MIGRAINES / HEADACHES") AND NAUSEA ("NAUSEA"). IN (B)(6) 2008 SHE EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). AN UNKNOWN TIME LATER SHE EXPERIENCED GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING(GENERAL)") AND BACK PAIN ("LOWER BACK PAIN"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED BACK PAIN, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, MIGRAINE, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205) ADMINISTRATION. THE REPORTER COMMENTED: THE PHYSICIAN HAS RECOMMENDED THAT SHE HAVE THE DEVICE REMOVED VIA HYSTERECTOMY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2005: RESULTS: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE (ESS205): UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 18-AUG-2023: QUALITY SAFETY EVALUATION OF PTC. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950166 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 12274611 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other