BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7776164 · Received August 13, 2018

    Report

    Report Number
    2951250-2018-03491
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    May 9, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5078727) ON 10-AUG-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 07-MAY-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CONSTANT PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), FLUTICASONE FUROATE;VILANTEROL TRIFENATATE (BREO ELLIPTA), GABAPENTIN, LOSARTAN, PANTOPRAZOLE, PROMETHAZINE AND TRAMADOL. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2007, THE PATIENT EXPERIENCED DYSSTASIA ("PAINFUL TO STAND"), 27 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FIBROMYALGIA ("FIBROMYALGIA"), FATIGUE ("CHRONIC FATIGUE"), FEELING ABNORMAL ("CONSTANT BRAIN FOG THAT OFTEN MIMICS SHORT TERM MEMORY LOSS"), MENOMETRORRHAGIA ("HEAVY AND IRREGULAR PERIODS/ CLOTS SIZE OF FIFTY CENT"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("PASSING CLOTS THE SIZE OF FIFTY CENT PIECE"), BACK PAIN ("BACK PAIN") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("RASH BELIEVED TO BE RELATED TO NICKEL IN THE PRODUCT") WITH RASH AND AMNESIA ("MIMICS SHORT TERM MEMORY LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, WEIGHT INCREASED, FIBROMYALGIA, FATIGUE, FEELING ABNORMAL, MENOMETRORRHAGIA, NAUSEA, VAGINAL HAEMORRHAGE, BACK PAIN, DYSSTASIA, ABDOMINAL DISTENSION AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, AMNESIA, BACK PAIN, DYSSTASIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, MENOMETRORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: THE SERIOUSNESS CRITERION ¿DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION, OTHER SERIOUS (IMPORTANT MEDICAL EVENT)¿ WAS REPORTED, BUT NOT SPECIFIED OR ASSIGNED TO ONE OF THE EVENTS. I INTEND TO HAVE A COMPLETE HYSTERECTOMY IN THE COMING MONTHS , SOMETHING I HAD HOPED TO AVOID INITIALLY WITH THE ESSURE IMPLANTS. DATE DISCREPANCY NOTED BETWEEN DATE OF IMPLANT AND EVENT DESCRIPTION (I.E (B)(6) 2006 AND 2007). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. PATIENT INITIALS AND ESSURE INDICATION 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.

    Description of Event or Problem · 1

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5078727) ON 10-AUG-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CONSTANT PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, BREO ELLIPTA, BUPROPION (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), GABAPENTIN, LOSARTAN, PANTOPRAZOLE, PROMETHAZINE AND TRAMADOL. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2007, 27 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DYSSTASIA ("PAINFUL TO STAND"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA DISABILITY, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), WEIGHT INCREASED ("WEIGHT GAIN"), FIBROMYALGIA ("FIBROMYALGIA"), FATIGUE ("CHRONIC FATIGUE"), FEELING ABNORMAL ("CONSTANT BRAIN FOG THAT OFTEN MIMICS SHORT TERM MEMORY LOSS"), MENOMETRORRHAGIA ("HEAVY AND IRREGULAR PERIODS/ CLOTS SIZE OF FIFTY CENT"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("PASSING CLOTS THE SIZE OF FIFTY CENT PIECE"), BACK PAIN ("BACK PAIN") AND ABDOMINAL DISTENSION ("BLOATING"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS ("RASH BELIEVED TO BE RELATED TO NICKEL IN THE PRODUCT") WITH RASH AND AMNESIA ("MIMICS SHORT TERM MEMORY LOSS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ALLERGY TO METALS, WEIGHT INCREASED, FIBROMYALGIA, FATIGUE, FEELING ABNORMAL, MENOMETRORRHAGIA, NAUSEA, VAGINAL HAEMORRHAGE, BACK PAIN, DYSSTASIA, ABDOMINAL DISTENSION AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISTENSION, ALLERGY TO METALS, AMNESIA, BACK PAIN, DYSSTASIA, FATIGUE, FEELING ABNORMAL, FIBROMYALGIA, MENOMETRORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: THE SERIOUSNESS CRITERION ¿DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION, OTHER SERIOUS (IMPORTANT MEDICAL EVENT)¿ WAS REPORTED, BUT NOT SPECIFIED OR ASSIGNED TO ONE OF THE EVENTS. I INTEND TO HAVE A COMPLETE HYSTERECTOMY IN THE COMING MONTHS , SOMETHING I HAD HOPED TO AVOID INITIALLY WITH THE ESSURE IMPLANTS. DATE DISCREPANCY NOTED BETWEEN DATE OF IMPLANT AND EVENT DESCRIPTION (I.E (B)(6) 2006 AND 2007). 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
    620157 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S ATORVASTATIN| ATORVASTATIN| BREO ELLIPTA| BREO ELLIPTA| GABAPENTIN| GABAPENTIN| LOSARTAN| LOSARTAN| PANTOPRAZOLE| PANTOPRAZOLE| PROMETHAZINE| PROMETHAZINE| PROZAC| PROZAC| TRAMADOL| TRAMADOL| WELLBUTRIN| WELLBUTRIN| ATORVASTATIN| BREO ELLIPTA| GABAPENTIN| LOSARTAN| PANTOPRAZOLE| PROMETHAZINE| PROZAC| TRAMADOL| WELLBUTRIN