BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056353 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08031
    Event Type
    Injury
    Date Received
    November 23, 2017
    Report Date
    September 21, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 956215) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENSES IRREGULAR, OVARIAN CYST, NABOTHIAN CYST, CERVICITIS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED LOTRISONE, PANADEINE CO (TYLENOL #3) AND QUERCUS SPP. BARK EXTRACT (TRAXATON). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FUNGAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): YEAST INFECTION"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: BLOATING"), ALOPECIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: HAIR LOSS"), MOOD SWINGS ("HORMONAL CHANGES"), COMPLICATION OF DEVICE INSERTION ("DEVICE INSERTION FAILED") AND HOT FLUSH ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED, MOOD SWINGS AND HOT FLUSH HAD RESOLVED AND THE FUNGAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, CONSTIPATION, ALOPECIA AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, CONSTIPATION, FUNGAL INFECTION, HOT FLUSH, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PLAINTIFF FACT SHEET & MEDICAL RECORD RECEIVED. ABDOMINAL DISTENSION, ALOPECIA, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, CONSTIPATION, FUNGAL INFECTION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED. LOT NUMBER & LAB DATA, CONCOMITANT, HISTORICAL CONDITIONS DRUGS WERE ADDED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. 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 PELVIC PAIN ("PAIN") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 956215- INVALID) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HEADACHE. CONCURRENT CONDITIONS INCLUDED OBESITY, MENSES IRREGULAR, OVARIAN CYST, NABOTHIAN CYST, CERVICITIS AND ADENOMYOSIS. CONCOMITANT PRODUCTS INCLUDED LOTRISONE, PANADEINE CO (TYLENOL #3) AND QUERCUS SPP. BARK EXTRACT (TRAXATON). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED CONSTIPATION ("CONSTIPATION"). IN (B)(6) 2013, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES "), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEM OR CHANGES ") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), FUNGAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL): YEAST INFECTION"), ABDOMINAL DISTENSION ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION: BLOATING"), ALOPECIA ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION:HAIR LOSS"), MOOD SWINGS ("HORMONAL CHANGES"), COMPLICATION OF DEVICE INSERTION ("DEVICE INSERTION FAILED") AND HOT FLUSH ("HORMONAL CHANGES"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED, MOOD SWINGS AND HOT FLUSH HAD RESOLVED AND THE FUNGAL INFECTION, BLADDER DISORDER, URINARY TRACT DISORDER, VAGINAL DISCHARGE, ABDOMINAL DISTENSION, CONSTIPATION, ALOPECIA AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, BLADDER DISORDER, COMPLICATION OF DEVICE INSERTION, CONSTIPATION, FUNGAL INFECTION, HOT FLUSH, MENORRHAGIA, MOOD SWINGS, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.5 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. LOT NUMBER 956215- INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: UPDATE OF INFORMATION (BATCH WAS 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 PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED 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
    835152 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 956215- INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R LOTRISONE| LOTRISONE| TRAXATON| TRAXATON| TYLENOL #3| TYLENOL #3