BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4101958 · Received September 19, 2014

    Report

    Report Number
    2951250-2014-00390
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    June 19, 2014
    Report Date
    November 25, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY FDA MAUDE (CASE# MW5037057) IN UNITED STATES ON 15-AUG-2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2014. CONSUMER REPORTED THAT SHE FOLLOWED HER DOCTOR'S OPINION AND ALLOWED HIM TO IMPLANT THE ESSURE, SIMPLY BECAUSE THEY STATED THERE WAS NO DOWN TIME, SHE WOULD BE ABLE TO RETURN TO WORK RIGHT AWAY. OVER A WEEK LATER AND SHE WAS BACK TO THE DOCTOR ALMOST EVERY OTHER DAY AND HE HAS MADE HER TAKE NUMEROUS TESTS AND PLACED HER ON VARIOUS ANTIBIOTICS AND SHE HAS STILL FELT HORRIBLE. HER BODY WAS WEAK; SHE HAD MIGRAINE HEADACHES WHICH SHE HAS NEVER HAD BEFORE. HER KNEE STARTED HURTING ON (B)(6) 2014, HER LOWER BACK AND FRONT OF HER STOMACH WAS IN SO MUCH PAIN THAT IT WAS HARD FOR HER TO SIT, DRIVE AND LAY DOWN FLAT. DISABILITY OR PERMANENT DAMAGE WAS MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. ON (B)(6) 2014 SHE WENT TO HER DOCTOR PLEADING THAT SOMETHING WAS WRONG WITH THE ESSURE BECAUSE SHE WAS HEALTHY BEFORE AND HE STATED THAT HE NEEDED TO DO FURTHER TESTING BECAUSE THE SURGERY WENT WELL, AND ONLY OPTION SHE HAD WAS A HYSTERECTOMY. CONSUMER REPORTED THAT NOTHING WAS WRONG WITH HER FEMALE ORGANS AND BECAUSE FOLLOWING HIS ADVICE SHE HAD TO REMOVE THEM. SHE DID NOT GO IN HIS OFFICE FOR AN ESSURE AND HE RECOMMENDED SHE TIE HER TUBES AND CHOSE THAT PROCEDURE. FOLLOW-UP INFORMATION WAS RECEIVED ON 22-AUG-2014 VIA CONSUMER QUESTIONNAIRE. CASE WAS UPGRADED TO INCIDENT DUE TO LAPAROSCOPIC REMOVAL OF ESSURE AND TUBES. CONSUMER'S DATE OF BIRTH, WEIGHT AND HEIGHT WERE PROVIDED. THIS REPORT REFERS TO A (B)(6) FEMALE CONSUMER. CONCOMITANT CONDITION INCLUDED OBESITY (BMI (B)(6)). SHE DENIED ANY PREVIOUS GYNECOLOGICAL PROBLEMS OR PROCEDURES, RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2014 ESSURE WAS IMPLANTED. SHE WAS ON POSTPARTUM STATE (HER SON WAS BORN IN (B)(6) 2014). THE NEXT DAY AFTER INSERTION SHE STARTED EXPERIENCING MIGRAINES, VISION WAS BLURRY, WEAKNESS, COULDN'T SIT DOWN, GAINED A LOT OF WEIGHT, BACK HURT, KNEE WAS SWOLLEN, STOMACH CRAMPS, BLED BLACK TAR MATERIAL. SHE WAS TREATED WITH PAIN KILLERS. NO HOSPITALIZATION WAS REQUIRED. BETWEEN (B)(6) 2014 SHE HAD A MILLION TESTS, X-RAYS, BLOOD WORK AND NONE OF THEM SHOWED ANYTHING TO HER KNOWLEDGE. HSG (HYSTEROSALPINGOGRAM) TEST WAS NOT PERFORMED. ON (B)(6) 2014 SHE UNDERWENT A LAPAROSCOPIC REMOVAL OF ESSURE AND TUBES. THE PHYSICIAN TOLD HER THAT ESSURE WAS IN THE TUBES AND WERE BOTH PULLED OUT. SHE RECOVERED FROM THE ESSURE REMOVAL PROCEDURE. SHE STATED THAT EVERYTHING STOPPED SINCE SHE HAD ESSURE REMOVED. SHE BELIEVES THE CONDITION WAS CAUSED BY THE ESSURE BECAUSE SHE FELT HORRIBLE WHILE SHE HAD THEM IN AND FELT MUCH BETTER SINCE THEY WERE REMOVED. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION WAS RECEIVED ON 28-AUG-2014 VIA ESSURE HEALTH CARE PROVIDER UTERINE/TUBAL PERFORATION QUESTIONNAIRE (FROM PHYSICIAN WHO PERFORMED THE REMOVAL). THIS CASE IS NOW MEDICALLY CONFIRMED. SHE DENIED ANY PREVIOUS GYNECOLOGICAL INTERVENTIONS. MEDICAL HISTORY INCLUDED ABNORMAL PAP. SHE HAD 04 PREGNANCIES, 03 LIVE BIRTHS AND 01 SPONTANEOUS ABORTION. SHE WAS NOT PREGNANT. NO IMAGING TESTS OR HSG (HYSTEROSALPINGOGRAM) WERE PERFORMED TO CONFIRM ESSURE PLACEMENT. ON UNSPECIFIED DATE SHE EXPERIENCED FATIGUE, JOINT PAIN AND CRAMPS. NO ORGAN OR INTRA-ABDOMINAL STRUCTURE WAS PERFORATED. NO PERFORATION OCCURRED DURING SOUNDING, CERVICAL DILATION OR HYSTEROSCOPY PRIOR TO ESSURE INSERTION. ON (B)(6) 2014 ESSURE WAS REMOVED. BILATERAL SALPINGECTOMY WAS PERFORMED AND BOTH DEVICES WERE INTACT IN CORNEAL REGION. THERE WERE NO SIGNS AND SYMPTOMS OF INFECTION. THE REMOVAL WAS MEDICALLY NECESSARY AND THE PATIENT REQUESTED. THE PATIENT RECOVERED FROM THE ESSURE REMOVAL PROCEDURE AND THE SYMPTOMS/PAIN RESOLVED AFTER SURGERY. THE CONDITION WAS CAUSED BY ESSURE DEVICES BECAUSE APPARENT NICKEL ALLERGY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION WAS RECEIVED ON 08-SEP-2014 VIA PHYSICIAN'S QUESTIONNAIRE (FROM PHYSICIAN WHO PERFORMED THE INSERTION). SHE DENIED ANY PREVIOUS CERVICAL CONIZATION, PREVIOUS IUD/IUS, MYOMECTOMY AND ADNEXAL SURGERY. MEDICAL HISTORY INCLUDED 03 C-SECTIONS AND 01 SUCTION DC. ON (B)(6) 2014 THE PATIENT HAD PERIPHERAL BLOOD SMEAR THAT REVEALED SEVERE LEUKOPENIA SECONDARY TO NEUTROPENIA WITH NO CIRCULATION BLAST IDENTIFIED. ON (B)(6) 2014 ESSURE WAS EASILY IMPLANTED. ANALGESIA (IV SEDATION) WAS APPLIED DURING ESSURE INSERTION. CERVICAL DILATATION AND SOUNDING WERE DENIED. THE VISUALIZATION OF THE TUBAL OSTIUM WAS EASY. FLUID LOSS DURING HYSTEROSCOPY WAS LESS THAN 1500CC AND THE PROCEDURE TOOK MORE THAN 20 MINUTES. IMAGING TESTS TO CONFIRM ESSURE PLACEMENT WERE NOT PERFORMED. DEPO WAS USED AS BACK-UP CONTRACEPTION. ON (B)(6) 2014 ABDOMINAL ULTRASOUND, PELVIC ULTRASOUND, X-RAY LUMBAR SPINE AND IUP (INTERPRETED AS INTRAUTERINE PESSARY) WERE PERFORMED AND SHOWED NORMAL LIMITS. HOSPITALIZATION WAS NOT REQUIRED. THE REPORTER DID NOT KNOW IF ESSURE WAS REMOVED OR REMOVAL WAS PLANNED BECAUSE PATIENT HAS FOLLOWED UP WITH ANOTHER DOCTOR. NO FURTHER INFORMATION WAS PROVIDED. RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON 18-SEP-2014: (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH EVALUATION NOR A BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE AND THE MAJORITY OF EVENTS WAS CONSIDERED AS UNRELATED TO THE PRODUCT BY COMPANY. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THE AVAILABLE INFORMATION. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT RECEIVED VIA REGULATORY AUTHORITY REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED FRONT OF STOMACH WAS IN SO MUCH PAIN THAT IT WAS HARD FOR HER TO SIT, DRIVE AND LAY DOWN FLAT AND BLED BLACK TAR MATERIAL. EVENT FRONT OF STOMACH WAS IN SO MUCH PAIN THAT IT WAS HARD FOR HER TO SIT, DRIVE AND LAY DOWN FLAT IS SERIOUS DUE TO DISABILITY REPORTED AND IT IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. GIVEN THE NATURE OF THIS EVENT, IT WAS ASSESSED AS UNRELATED TO ESSURE AND NON-INCIDENT. BLED BLACK TAR MATERIAL IS SERIOUS DUE TO MEDICAL SIGNIFICANCE, IT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, AND WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (CONSUMER HAD A LAPAROSCOPIC REMOVAL OF THE TUBES). DURING ESSURE MICRO-INSERT THERAPY ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR; THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE EVENT BLED BLACK TAR MATERIAL AND ESSURE CANNOT BE EXCLUDED. ALSO, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL COMPLAIN (PTC) INVESTIGATION WAS PERFORMED AND ACCORDING TO INVESTIGATION RESULTS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN REPORTED EVENTS AND A POTENTIAL PRODUCT QUALITY DEFICIT. NO FURTHER INFORMATION IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582211 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 B97498

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R| S DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA (MEDROXYPROGESTERONE ACETATE)