BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8752904 · Received July 2, 2019

    Report

    Report Number
    2951250-2019-03216
    Event Type
    Injury
    Date Received
    July 2, 2019
    Report Date
    July 3, 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 LITERATURE CASE DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DEVICE MIGRATION INTO THE COLON/ DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON') IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: BIANCHI EM, GOLDMAN T, ADEGBOYEGA T, SHIH S, ZHANG C, RIVADENEIRA D, COLORECTAL COMPLICATIONS ASSOCIATED WITH THE ESSURE® PERMANENT BIRTH CONTROL DEVICE: FIRST CASE REPORT AND REVIEW OF THE LITERATURE, DISEASES OF THE COLON AND RECTUM, 2019, 62:6:E252. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND GASTROINTESTINAL DISORDER ("COLONIC DISEASES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN LOWER AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION AND GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT PRESENTED A YEAR AFTER WITH MILD LOWER ABDOMINAL PAIN AND SUBSEQUENT IMAGING STUDIES DEMONSTRATED ESSURE DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON. SHE SUBSEQUENTLY UNDERWENT A LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE CASE REPORT QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 44YEAR-OLD WOMAN UNDERWENT PLACEMENT OF THE ESSURE® PERMANENT CONTRACEPTION DEVICE. THE PATIENT PRESENTED A YEAR AFTER WITH MILD LOWER ABDOMINAL PAIN AND SUBSEQUENT IMAGING STUDIES DEMONSTRATED ESSURE® DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON. SHE SUBSEQUENTLY UNDERWENT A LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE. SHE DID WELL AFTER SURGERY AND HAD RESOLUTION OF HER SYMPTOMS. RESULTS/OUTCOME(S): ALTHOUGH INTRA-ABDOMINAL COMPLICATIONS AFTER PLACEMENT OF ESSURE® ARE RARE, THE DEVICE HAS BEEN REMOVED FROM THE MARKET IN MANY COUNTRIES. THERE HAVE BEEN THIRTEEN REPORTED CASES OF ESSURE® ABDOMINAL MIGRATIONS IN THE LITERATURE, BUT THIS IS THE FIRST TO REPORT A COLON COMPLICATION RELATED TO THE DEVICE. CONCLUSIONS/DISCUSSION: IN THE MAJORITY OF CASES, THE DISPLACEMENT OF THE DEVICE IS ASYMPTOMATIC AND DOES NOT INDUCE TISSUE DAMAGE, HOWEVER WE RECOMMEND A LAPAROSCOPIC EXPLORATION AND REMOVAL OF THE DEVICE FOR THE VAST MAJORITY OF PATIENTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUL-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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. - ATTACHMENT: [LITERATURE ARTICLE_ 2019-124418.PDF]

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('DEVICE MIGRATION INTO THE COLON/ DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR CONTRACEPTION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: BIANCHI EM, GOLDMAN T, ADEGBOYEGA T, SHIH S, ZHANG C, RIVADENEIRA D, COLORECTAL COMPLICATIONS ASSOCIATED WITH THE ESSURE® PERMANENT BIRTH CONTROL DEVICE: FIRST CASE REPORT AND REVIEW OF THE LITERATURE, DISEASES OF THE COLON AND RECTUM, 2019, 62:6:E252. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND GASTROINTESTINAL DISORDER ("COLONIC DISEASES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN LOWER AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION AND GASTROINTESTINAL DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT PRESENTED A YEAR AFTER WITH MILD LOWER ABDOMINAL PAIN AND SUBSEQUENT IMAGING STUDIES DEMONSTRATED ESSURE DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON. SHE SUBSEQUENTLY UNDERWENT A LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE CASE REPORT: (B)(6) WOMAN UNDERWENT PLACEMENT OF THE ESSURE® PERMANENT CONTRACEPTION DEVICE. THE PATIENT PRESENTED A YEAR AFTER WITH MILD LOWER ABDOMINAL PAIN AND SUBSEQUENT IMAGING STUDIES DEMONSTRATED ESSURE® DEVICE MIGRATION AND IMPLANTATION INTO THE SIGMOID COLON. SHE SUBSEQUENTLY UNDERWENT A LAPAROSCOPIC EXPLORATION AND LEFT PARTIAL COLON RESECTION WITH REMOVAL OF THE MIGRATED DEVICE. SHE DID WELL AFTER SURGERY AND HAD RESOLUTION OF HER SYMPTOMS. RESULTS/OUTCOME(S): ALTHOUGH INTRA-ABDOMINAL COMPLICATIONS AFTER PLACEMENT OF ESSURE® ARE RARE, THE DEVICE HAS BEEN REMOVED FROM THE MARKET IN MANY COUNTRIES. THERE HAVE BEEN THIRTEEN REPORTED CASES OF ESSURE® ABDOMINAL MIGRATIONS IN THE LITERATURE, BUT THIS IS THE FIRST TO REPORT A COLON COMPLICATION RELATED TO THE DEVICE. CONCLUSIONS/DISCUSSION: IN THE MAJORITY OF CASES, THE DISPLACEMENT OF THE DEVICE IS ASYMPTOMATIC AND DOES NOT INDUCE TISSUE DAMAGE, HOWEVER WE RECOMMEND A LAPAROSCOPIC EXPLORATION AND REMOVAL OF THE DEVICE FOR THE VAST MAJORITY OF PATIENTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547642 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R