BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6968663 · Received October 23, 2017

    Report

    Report Number
    2951250-2017-05281
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE CORRECTION: THIS CASE WAS REPORTED AS AN INITIAL REPORT WITH THE INCORRECT MFR # OF 2951250-2017-05281. IT WAS DETERMINED TO BE A FOLLOW UP # 4 TO MFR # 2951250-2014-00023. PLEASE DISREGARD AS THE REPORT HAS BEEN SUBMITTED TO THE CORRECT MFR # 2951250-2014-00023.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# MW5032674) IN UNITED STATES ON (B)(6) 2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED BREAKING OUT IN A RASH QUICKLY SPREAD TO ENTIRE BODY, RASH WAS IN HER THROAT AND DOCTORS FEARED IT WAS CLOSING HER THROAT, EAR PAIN, NECK ARTHRITIS, DRY MOUTH, DRY EYES, DRY SKIN, FACIAL REDNESS/ROSACEA, SCALY RED BODY RASH, BODY ITCHY, FATIGUE, DERMATOGRAPHIC URTICARIA, CHRONIC URTICARIA, HEAD INDUCED URTICARIA, JOINT PAIN OF SHOULDERS AND ANKLES, HAIR LOSS, SWELLING OF HANDS AND FEET, LARGE WEIGHT LOSS, LOSS OF APPETITE, LOSS OF SEXUAL DRIVE, BRUISING, SLOW HEALING CUTS, CHRONIC CONSTIPATION WITH OVERFLOW FOLLOWED BY FULL CONSTIPATION, ULCERS IN MOUTH, NAUSEA, AND HYSTERECTOMY REMOVING MY UTERUS AND TUBES CONTAINING COILS. NO INFORMATION WAS GIVEN ON CONSUMER'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATION. ON (B)(6) 2011 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, LOT NUMBER 810881. ON (B)(6) 2011 CONSUMER HAD THE ESSURE BIRTH CONTROL DEVICE IMPLANTED. WITHIN A FEW MONTHS SHE STARTED BREAKING OUT IN A RASH. THIS QUICKLY SPREAD TO HER ENTIRE BODY AND WENT ON FOR ALMOST A YEAR AND A HALF. AT FIRST, THE RASH WAS SO BAD SHE WAS TREATED WITH STEROIDS. THE RASH WAS IN HER THROAT AND DOCTORS FEARED IT WAS CLOSING HER THROAT. IN THE YEAR AFTER THE PROCEDURE, HER BODY COMPLETELY FELL APART. CONSUMER STATES THAT SHE EXPERIENCED EAR PAIN (DEEP STABBING), NECK ARTHRITIS, DRY MOUTH, DRY EYES, DRY SKIN, FACIAL REDNESS/ROSACEA, SCALY RED BODY RASH - BODY ITCHY, FATIGUE, DERMATOGRAPHIC URTICARIA, CHRONIC URTICARIA, HEAT INDUCED URTICARIA1, JOINT PAIN OF SHOULDERS AND ANKLES, HAIR LOSS, SWELLING OF HANDS AND FEET, LARGE WEIGHT LOSS, LOSS OF APPETITE, LOSS OF SEXUAL DRIVE, BRUISING, SLOW HEALING CUTS, CHRONIC CONSTIPATION WITH OVERFLOW FOLLOWED BY FULL CONSTIPATION, ULCERS IN MOUTH, AND NAUSEA. CONSUMER STATES THAT SHE WAS A HEALTHY WOMAN WHEN THIS WAS DONE AND SHE ENDED UP HAVING A HYSTERECTOMY IN (B)(6) 2013 REMOVING HER UTERUS, AND TUBES CONTAINING COILS. SHE IS NOW SYMPTOM FREE AND HAS NO HIVES. SHE LOST SEVERAL JOBS AND MUCH TIME WITH HER FAMILY DUE TO ESSURE. ADDITIONALLY CONSUMER REPORTED THAT SHE WAS NEVER TOLD IT CONTAINED NICKEL AND NEITHER ABOUT THOSE POSSIBLE COMPLICATIONS. REPORTER CAUSALITY WAS NOT REPORTED. FOLLOW-UP RECEIVED ON (B)(6) 2014: PRODUCT TECHNICAL COMPLAINT GLOBAL ((B)(4)) AND LOCAL ((B)(4)) NUMBER WERE RECEIVED. FOLLOW UP RECEIVED ON 24-JAN-2014 WITH THE FINAL PTC INVESTIGATION RESULT: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS:(B)(4). FINAL ASSESSMENT NO LOT NUMBER PROVIDED; THEREFORE, NO LOT HISTORY RECORD (LHR) REVIEW COULD BE DONE. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. NO CAPA INVESTIGATION IS REQUIRED PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN (B)(4)." FDA EVALUATION CODES: (B)(4) MEDICAL ASSESSMENT THE MEDICAL EVENTS REPORTED ARE NOT INDICATIVE FOR A QUALITY DEFECT PER SE. THE MEDICAL EVENTS WERE REPORTED WITH AN OCCURRENCE OVER A PERIOD OF 2,5 YEARS AND ARE OF BROAD NATURE. 3 FURTHER AE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH 810881, BUT NONE OF THOSE CASES REFER ALSO TO SIMILAR ADVERSE TYPES OF EVENTS. NO BATCH SIGNAL COULD BE IDENTIFIED. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE REVIEW OF THE LOT HISTORY RECORDS FOUND THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, BASED ON THE AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT QUALITY DEFECT. FOLLOW UP INFORMATION RECEIVED ON 03-FEB-2014 CONSUMER QUESTIONNAIRE RECEIVED PATIENT INFORMATION UPDATED. REPORTER AND EVENTS ADDED. SHE IS (B)(6) FEMALE, BORN ON (B)(6) 1971. WEIGHT AND HEIGHT ADDED. AT THE TIME OF ESSURE INSERTION SHE HAD A UTERINE ABLATION FOR HEAVY MENSTRUATION AND IN 1990 SHE HAD A LAPAROSCOPIC PROCEDURE FOR ENDOMETRIOSIS. NO OTHER RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. SHE UNDERWENT A FULL ALLERGY TEST FOR FOOD AND ENVIRONMENTAL ALLERGENS, NO METAL TESTING WAS DONE, SKIN BIOPSY WAS DONE, ALL WAS OK. ON (B)(6) 2012 A PELVIC ULTRASOUND WAS PERFORMED AND SHOWED NOTHING ABNORMAL, BUT ON THE PATHOLOGY REPORT THE DOCTOR STATED A COUPLE OF FIBROIDS WERE NOTED. SHE DID NOT PERFORMED A NICKEL ALLERGY TEST. ESSURE WAS NOT INSERTED AFTER A PREGNANCY. HER HUSBAND DID A VASECTOMY, AND THAT WAS THE BACK UP CONTRACEPTION USED. SHE DID NOT GET A HYSTEROSALPINGOGRAM DONE BECAUSE SHE HEARD IT WAS A VERY PAINFUL PROCEDURE. ALL THE EVENTS STARTED A COUPLE OF WEEKS AFTER ESSURE INSERTION, THE MOST TROUBLING WAS A SKIN RASH, THAT STARTED OFF WITH COUPLE OF BUMPS AND THEN SPREADED TO HER WHOLE BODY. SHE WENT TO A NEW OBGYN AND A DERMATOLOGIST CONCERNING THESE SYMPTOMS AND NO PARTICULAR DIAGNOSIS WAS GIVEN. SHE WAS TREATED WITH STEROIDS FOR WHOLE BODY HIVES, AND DEVELOPED ADRENAL FATIGUE AND GAINED 60 POUNDS DUE TO THE STEROIDS. IN (B)(6) 2013, SHE UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. SHE STAYED HOSPITALIZED OVERNIGHT TO GET THE PROCEDURE DONE. IT WAS MEDICALLY NECESSARY, AFTER 2 YEARS AND HALF OF GOING THROUGH THE SYMPTOMS, IT WAS THE ONLY OPTION LEFT. IT WAS DONE ALONG WITH ESSURE COIL REMOVAL, TUBES HAD TO GO OFF AND SHE KEPT HER OVARIES. SHE IS RECOVERED FROM THE PROCEDURE AND IS NOT AWARE OF ANY SYMPTOMS OF INFECTION. THE PATHOLOGY RESULTS AND HOSPITAL RECORDS ARE WITH HER DOCTOR. ALL HER SYMPTOMS WENT AWAY DURING 6 WEEKS RECOVERY PERIOD. SHE FEELS GOOD NOW, ALL HER PAIN SYMPTOMS WENT AWAY. SHE IS A HUNDRED PERCENT SURE THAT ALL THE EVENTS ARE DUE TO ESSURE. CORRECTION BASED ON INFORMATION RECEIVED ON (B)(6) 2014 AFTER A COMPANY INTERNAL REVIEW: PTC FINAL ASSESSMENT WAS: LOT HISTORY RECORD (LHR) REVIEWED. PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2015: THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING TAKING PLACE IN SEPTEMBER 2015 (CASE # (B)(4), AWARENESS DATE (B)(6) 2015). THE CONSUMER REPORTED THAT WITHIN 2 MONTHS SHE HAD FULL BODY URTICARIAL PAINFUL AND BURNING; LED TO HASHIMOTOS, POLYGLANDULAR TYPE II, IBD (UNDERSTOOD AS IRRITABLE BOWEL DISEASE), FIBRO (UNDERSTOOD AS FIBROMYALGIA), REYNOUDS, RLS (UNDERSTOOD AS RESTLESS LEGS SYNDROME), INSOMNIA, MAJOR DEPRESSIVE DISORDER, HAIR LOSS, SKIN THINNING, BRUISING, TURNING COLORS, FLUSHING, HEART PALPITATIONS. SHE STATED THE DEVICE RUINED HER LIFE, INCLUDING A FULL HYSTO (UNDERSTOOD AS HYSTERECTOMY). FOLLOW-UP INFORMATION RECEIVED ON 03-NOV-2015. THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING WHICH TOOK PLACE IN SEPTEMBER 2015 (CASE # (B)(4)). CONSUMER ALSO EXPERIENCED ANGER AND DEPRESSION. FOLLOW-UP INFORMATION RECEIVED ON 25-SEP-2017 REPORTER ADDED. ON (B)(6) 2011, ESSURE WAS INSERTED FOR PERMANENT BIRTH CONTROL. ON AN UNSPECIFIED DATE, PATIENT EXPERIENCED SEVERE ABDOMINAL CRAMPING; SEVERE PELVIC (INTERVENTION REQUIRED AND MEDICALLY SIGNIFICANT), AND LOWER ABDOMINAL PAIN; MIGRAINES; HEADACHES; WORSENING OF HER DEPRESSION; WORSENING OF HER ANXIETY; RASHES; SKIN REDNESS; SKIN BUMPS; PATCHES OF SKIN RESEMBLING BURN MARKS; HIVES; BLISTERS; ITCHING; OTHER SKIN CONDITIONS; ALLERGY TO NICKEL; VISION PROBLEMS; HALLUCINATIONS, ADRENAL DISORDER. ALL THE EVENTS OUTCOME WERE UNKNOWN. ON (B)(6) 2013, (SHE UNDERWENT A TOTAL HYSTERECTOMY AND BILATERAL AND SALPINGECTOMY DURING WHICH HER UTERUS, CERVIX, AND BOTH FALLOPIAN TUBES WERE ALL REMOVED. REPORTER CAUSALITY BETWEEN ESSURE AND EVENTS WAS RELATED. 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
    748448 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 810881

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R