Description of Event or Problem · 1
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. LITERATURE REFERENCE: CAMARA S; DE CASTRO COELHO F; FREITAS C; REMESSO L, ESSURE® PRESENT CONTROVERSIES AND 5 YEARS? LEARNED LESSONS: A RETROSPECTIVE STUDY WITH SHORT- AND LONG-TERM FOLLOW-UP, ESSURE® PRESENT CONTROVERSIES AND 5 YEARS? LEARNED LESSONS: A RETROSPECTIVE STUD, 2017, 14:1:ARTICLE NUMBER: 20. MEDICAL CONDITIONS: PATIENT HAS NO HISTORY OF ALLERGY TO METALS BEFORE ESSURE. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ECZEMA. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ALLERGY TO METALS WITH ESSURE. THE REPORTER COMMENTED: INVESTIGATION ABOUT WHETHER SOME WOMEN STILL HAVE PATENT TUBES AT THE 3-MONTH FOLLOW-UP COULD LEAD TO PROTOCOL IMPROVEMENT. IT IS IMPORTANT THAT CLINICIANS LOOK FOR SECOND CAUSES FOR ADVERSE EFFECTS RELATED TO ESSURE® AND AVOID THE ERRONEOUS INDICATION FOR IMPLANT REMOVAL. LONG FOLLOW-UP ALLOWED FOR BOTH INTERNAL QUALITY EVALUATION AND CLARIFICATION OF MISCONCEPTION; IT COULD POSSIBLY ALSO HAVE CONTRIBUTED TO PATIENT SATISFACTION. 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 14-DEC-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ALLERGY TO METALS THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 350 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. DIAGNOSTIC RESULTS: NICKEL ALLERGY CONFIRMED BY IMMUNOALLERGOLOGY PATCH TEST BACKGROUND: THE RISK-BENEFIT OF CONTRACEPTION WITH ESSURE® IS BEING READDRESSED DUE TO AN INCREASE OF REPORTS OF ADVERSE EFFECTS WITH THIS DEVICE. OUR AIM WAS TO PROCEED TO AN INTERNAL QUALITY EVALUATION AND TO IDENTIFY OPPORTUNITIES FOR PROTOCOL IMPROVEMENT. WE PROCEEDED TO A ONE-CENTER, RETROSPECTIVE CONSECUTIVE CASE SERIES OF WOMEN ADMITTED FOR ESSURE PLACEMENT, FROM 1 JANUARY 2012 UNTIL 31 DECEMBER 2016 (5 YEARS). RESULTS: IN A TOTAL OF 274 WOMEN, TECHNICAL DIFFICULTIES WERE MAINLY UNILATERAL, WITH NO ACUTE OR SHORT-TERM SEVERE COMPLICATIONS. THE PROCEDURE WAS BRIEF (MEDIAN 3.2 MIN, IQR 2.5-5.2) AND MODERATELY PAINFUL (MEDIAN OF 4 IN A 0-10 SCALE; IQR 3-5). AT 3 MONTHS, THE FAILURE RATE WAS 2%, WITH NO PREGNANCIES. SECOND SURGERY INDICATION (< 1%) RESUMED TO A CASE OF NICKEL HYPERSENSITIVITY. AT 1 YEAR, PREGNANCY RATE WAS 1%. NINETY-EIGHT PERCENT OF THE PATIENTS WOULD RECOMMEND THE METHOD. CONCLUSIONS: WE IDENTIFIED HIGH PATIENT SATISFACTION AND LOW FAILURE RATES, BOTH AT SHORT AND LONG TERM. INVESTIGATION ABOUT WHETHER SOME WOMEN STILL HAVE PATENT TUBES AT THE 3-MONTH FOLLOW-UP COULD LEAD TO PROTOCOL IMPROVEMENT. IT IS IMPORTANT THAT CLINICIANS LOOK FOR SECOND CAUSES FOR ADVERSE EFFECTS RELATED TO ESSURE AND AVOID THE ERRONEOUS INDICATION FOR IMPLANT REMOVAL. LONG FOLLOW-UP ALLOWED FOR BOTH INTERNAL QUALITY EVALUATION AND CLARIFICATION OF MISCONCEPTION; IT COULD POSSIBLY ALSO HAVE CONTRIBUTED TO PATIENT SATISFACTION. KEYWORDS: HYSTEROSCOPY, STERILIZATION, COUNSELING, PATIENT SATISFACTION, PELVIC PAIN. 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.