BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5843696 · Received August 3, 2016

    Report

    Report Number
    2951250-2016-01236
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    January 1, 2013
    Report Date
    February 9, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. A FEMALE PATIENT WITH ENDOMETRIOSIS BACKGROUND WHO UNDERWENT SURGERY 15 YEARS AGO; AS OBSTETRIC BACKGROUND, ONE VAGINAL CHILDBIRTH AND THREE SPONTANEOUS MISCARRIAGES. ON 2012 YEAR, BILATERAL ENDOSCOPIC TUBAL LIGATION WAS PERFORMED THROUGH ESSURE DEVICES PLACEMENT, WITHOUT COMPLICATION. IT WAS VERIFIED THROUGH SIMPLE PELVIS RADIOGRAPHY THE CORRECT PLACEMENT OF THEM. AFTER ONE YEAR, PATIENT REFERRED CONSTANT PELVIC DISCOMFORTS, ITCHING ON LOWER LIMBS, AXILLARY VITILIGO AND HYPOTHYROIDISM, WHICH SHE ATTRIBUTE TO ESSURE. AFTER COMMENTING HER CASE DURING CLINICAL SESSION, IT IS DECIDED TO PERFORM EXTRACTION OF DEVICES. RESULTS: HYSTEROSCOPY WAS PERFORMED, UNDER ANESTHETIC SEDATION WITH ESSURE VISUALIZATION ON RIGHT OSTIUM, EXTRACTION OF DEVICE WITH CLAMPS. THE DEVICE WAS NOT OBSERVED ON LEFT OSTIUM, SO LAPAROSCOPIC SALPINGECTOMY WAS PERFORMED FOR ITS EXTRACTION, AND SUBSEQUENT BILATERAL TUBAL LIGATION. CONCLUSIONS: BASED ON EXISTING PUBLICATIONS IT IS NOT POSSIBLE TO CLEARLY ESTABLISH SECONDARY ADVERSE EFFECTS DUE TO ESSURE. HYSTEROSCOPY IS A SAFE METHOD IN ORDER TO REMOVE ESSURE DEVICES, RESERVING LAPAROSCOPY JUST FOR THOSE CASES IN WHICH ITS REMOVAL HAS BEEN IMPOSSIBLE THROUGH HYSTEROSCOPY WAY, OR WELL IF PATIENT DESIRES A BILATERAL SALPINGECTOMY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2017: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT RECEIVED. COMPANY CAUSALITY COMMENT: THIS MEDICAL LITERATURE CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ONE YEAR LATER, SHE REFERRED CONSTANT PELVIC DISCOMFORTS AND WAS SUBMITTED TO A HYSTEROSCOPY FOR DEVICE REMOVAL. DURING THIS PROCEDURE, THE RIGHT DEVICE WAS REMOVED. THE LEFT DEVICE WAS NOT OBSERVED ON LEFT OSTIUM (REGARDED AS DEVICE DISLOCATION INTO THE FALLOPIAN TUBE), SO LAPAROSCOPIC SALPINGECTOMY WAS PERFORMED. THESE EVENTS ARE LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES; THIS MOVEMENT INCLUDES DISLOCATION INTO THE DISTAL FALLOPIAN TUBE. ADDITIONALLY, PELVIC DISCOMFORT MAY OCCUR DURING ESSURE THERAPY. IN THIS PARTICULAR CASE, THE PATIENT HAD A PREVIOUS HISTORY OF ENDOMETRIOSIS, WHICH COULD BE AN ALTERNATIVE EXPLANATION FOR HER DISCOMFORT. HOWEVER, BASED ON EVENTS NATURE A CONTRIBUTORY ROLE OF THE SUSPECT INSERT CANNOT BE EXCLUDED. THE EVENTS ITCHING ON LOWER LIMBS, AXILLARY VITILIGO AND HYPOTHYROIDISM WERE ALSO REPORTED AND CONSIDERED AS UNRELATED TO ESSURE DUE TO THEIR NATURE AND BASED ON DEVICE SAFETY PROFILE. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS CASE REPORT FROM (B)(6) WAS DERIVED FROM MEDICAL LITERATURE ON 07-JUL-2016; ARTICLE ENTITLED "REMOVAL OF ESSURE DEVICE DUE TO LONG-TERM ADVERSE EFFECT AFTER PLACEMENT - A CASE REPORT". IT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2012 FOR TUBAL LIGATION. A FEMALE PATIENT WITH ENDOMETRIOSIS BACKGROUND WHO UNDERWENT SURGERY 15 YEARS AGO; AS OBSTETRIC BACKGROUND, ONE VAGINAL CHILDBIRTH AND THREE SPONTANEOUS MISCARRIAGES. ON 2012 YEAR, BILATERAL ENDOSCOPIC TUBAL LIGATION WAS PERFORMED THROUGH ESSURE DEVICES PLACEMENT, WITHOUT COMPLICATION. IT WAS VERIFIED THROUGH SIMPLE PELVIS RADIOGRAPHY THE CORRECT PLACEMENT OF THEM. AFTER ONE YEAR, PATIENT REFERRED CONSTANT PELVIC DISCOMFORTS, ITCHING ON LOWER LIMBS, AXILLARY VITILIGO AND HYPOTHYROIDISM, WHICH SHE ATTRIBUTE TO ESSURE. AFTER COMMENTING HER CASE DURING CLINICAL SESSION, IT IS DECIDED TO PERFORM EXTRACTION OF DEVICES. RESULTS: HYSTEROSCOPY WAS PERFORMED, UNDER ANESTHETIC SEDATION WITH ESSURE VISUALIZATION ON RIGHT OSTIUM, EXTRACTION OF DEVICE WITH CLAMPS. THE DEVICE WAS NOT OBSERVED ON LEFT OSTIUM, SO LAPAROSCOPIC SALPINGECTOMY WAS PERFORMED FOR ITS EXTRACTION, AND SUBSEQUENT BILATERAL TUBAL LIGATION. CONCLUSIONS: BASED ON EXISTING PUBLICATIONS IT IS NOT POSSIBLE TO CLEARLY ESTABLISH SECONDARY ADVERSE EFFECTS DUE TO ESSURE. HYSTEROSCOPY IS A SAFE METHOD IN ORDER TO REMOVE ESSURE DEVICES, RESERVING LAPAROSCOPY JUST FOR THOSE CASES IN WHICH ITS REMOVAL HAS BEEN IMPOSSIBLE THROUGH HYSTEROSCOPY WAY, OR WELL IF PATIENT DESIRES A BILATERAL SALPINGECTOMY. FOLLOW-UP INFORMATION RECEIVED ON 19-JUL-2016: (B)(4). COMPANY CAUSALITY COMMENT: THIS MEDICAL LITERATURE CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ONE YEAR LATER, SHE REFERRED CONSTANT PELVIC DISCOMFORTS AND WAS SUBMITTED TO A HYSTEROSCOPY FOR DEVICE REMOVAL. DURING THIS PROCEDURE, THE RIGHT DEVICE WAS REMOVED. THE LEFT DEVICE WAS NOT OBSERVED ON LEFT OSTIUM (REGARDED AS DEVICE DISLOCATION INTO THE FALLOPIAN TUBE), SO LAPAROSCOPIC SALPINGECTOMY WAS PERFORMED. THESE EVENTS ARE LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES; THIS MOVEMENT INCLUDES DISLOCATION INTO THE DISTAL FALLOPIAN TUBE. ADDITIONALLY, PELVIC DISCOMFORT MAY OCCUR DURING ESSURE THERAPY. IN THIS PARTICULAR CASE, THE PATIENT HAD A PREVIOUS HISTORY OF ENDOMETRIOSIS, WHICH COULD BE AN ALTERNATIVE EXPLANATION FOR HER DISCOMFORT. HOWEVER, BASED ON EVENTS NATURE A CONTRIBUTORY ROLE OF THE SUSPECT INSERT CANNOT BE EXCLUDED. THE EVENTS ITCHING ON LOWER LIMBS, AXILLARY VITILIGO AND HYPOTHYROIDISM WERE ALSO REPORTED AND CONSIDERED AS UNRELATED TO ESSURE DUE TO THEIR NATURE AND BASED ON DEVICE SAFETY PROFILE. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495506 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R