BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6472335 · Received April 7, 2017

    Report

    Report Number
    2951250-2017-01222
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    May 4, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PAIN ("PAINS") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF FALLOPIAN TUBES). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE CASE WAS RETRIEVED FROM A "STARTING PETITION" WEB SITE. THE PATIENT COMMENTED THAT SHE IS AN ESSURE'S VICTIM, REASON FOR WHICH SHE HAS LOST HER FALLOPIAN TUBES, AND SHE HAS SUFFERED PAINS DURING FIVE YEARS OF HER LIFE. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 13-APR-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 344 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. 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 EVENT IS A KNOWN POSSIBLE, UNDESIRABLE EVENT 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-APR-2017: QUALITY-SAFETY EVALUATION WAS RECEIVED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD PAIN IN ASSOCIATION WITH ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) THERAPY. SHE WAS SUBMITTED TO A SALPINGECTOMY. PAIN IS AN ANTICIPATED EVENT ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED VIA SOCIAL MEDIA WITH LIMITED INFORMATION. NEVERTHELESS, SINCE PAIN MAY OCCUR DURING ESSURE USE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE TECHNICAL ANALYSIS CONCLUDED, AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE, A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. NO ACTIVE FOLLOW-UP WILL BE POSSIBLE (NO PRIVATE CONTACT DETAILS AVAILABLE).

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PAIN ("PAINS") IN A FEMALE PATIENT WHO RECEIVED ESSURE. ON AN UNKNOWN DATE, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF FALLOPIAN TUBES). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE CASE WAS RETRIEVED FROM A "STARTING PETITION" WEB SITE. THE PATIENT COMMENTED THAT SHE IS AN ESSURE'S VICTIM, REASON FOR WHICH SHE HAS LOST HER FALLOPIAN TUBES, AND SHE HAS SUFFERED PAINS DURING FIVE YEARS OF HER LIFE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD PAIN IN ASSOCIATION WITH ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) THERAPY. SHE WAS SUBMITTED TO A SALPINGECTOMY. PAIN IS AN ANTICIPATED EVENT ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED VIA SOCIAL MEDIA WITH LIMITED INFORMATION. NEVERTHELESS, SINCE PAIN MAY OCCUR DURING ESSURE USE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A TECHNICAL ANALYSIS WILL BE REQUESTED. NO ACTIVE FOLLOW-UP WILL BE POSSIBLE (NO PRIVATE CONTACT DETAILS AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255432 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R