BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6569080 · Received May 16, 2017

    Report

    Report Number
    2951250-2017-01928
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    August 1, 2015
    Report Date
    June 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(6) (REFERENCE NUMBER: (B)(4)) ON (B)(6) 2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-JUN-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF GROIN PAIN ("PAIN IN RIGHT GROIN MAKING IT DIFFICULT TO WALK") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C49137) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED GROIN PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PELVIC PAIN"), BACK PAIN ("LOWER BACK PAIN"), PAIN IN EXTREMITY ("PAIN IN RIGHT LEG MAKING IT DIFFICULT TO WALK"), DYSPAREUNIA ("PAIN ON SEXUAL INTERCOURSE AT TIMES"), DEPRESSION ("DEPRESSION") WITH IRRITABILITY AND FATIGUE, MENSTRUATION IRREGULAR ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS"), DYSMENORRHOEA ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS") AND AMENORRHOEA ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS"). AT THE TIME OF THE REPORT, THE GROIN PAIN, PELVIC PAIN, BACK PAIN, PAIN IN EXTREMITY, DYSPAREUNIA, DEPRESSION, MENSTRUATION IRREGULAR, DYSMENORRHOEA AND AMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMENORRHOEA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GROIN PAIN, MENSTRUATION IRREGULAR, PAIN IN EXTREMITY AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: SHE SAW A NUMBER OF SPECIALISTS, BUT FOUND NO EXPLANATION FOR THE PAIN, WHICH STARTED WITH PAIN IN THE GROIN A FEW DAYS AFTER PLACEMENT OF THE INSERTS AND THAT HAVE BEEN EXHAUSTING FOR HER IN THE PAST YEAR AND A HALF, WITH NO MEDICAL SUPPORT. DIAGNOSTIC RESULTS: SHE UNDERWENT A NUMBER OF TESTS TO TRY TO FIND THE CAUSE OF THE PAIN: PELVIC AND LUMBAR SPINAL MRI, X-RAY OF HIPS. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: GROIN PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 09 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. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: DEVICE EVALUATION RECEIVED COMPANY CAUSALITY COMMENT: AT THE TIME OF REPORTING, 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.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(4) ON 28-APR-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF GROIN PAIN ("PAIN IN RIGHT GROIN MAKING IT DIFFICULT TO WALK") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C49137) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED GROIN PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("CHRONIC PELVIC PAIN"), BACK PAIN ("LOWER BACK PAIN"), PAIN IN EXTREMITY ("PAIN IN RIGHT LEG MAKING IT DIFFICULT TO WALK"), DYSPAREUNIA ("PAIN ON SEXUAL INTERCOURSE AT TIMES"), DEPRESSION ("DEPRESSION") WITH IRRITABILITY AND FATIGUE, MENSTRUATION IRREGULAR ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS"), DYSMENORRHOEA ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS") AND AMENORRHOEA ("IRREGULAR PAINFUL MENSTRUAL PERIODS OR ABSENCE OF PERIODS"). AT THE TIME OF THE REPORT, THE GROIN PAIN, PELVIC PAIN, BACK PAIN, PAIN IN EXTREMITY, DYSPAREUNIA, DEPRESSION, MENSTRUATION IRREGULAR, DYSMENORRHOEA AND AMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMENORRHOEA, BACK PAIN, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, GROIN PAIN, MENSTRUATION IRREGULAR, PAIN IN EXTREMITY AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: SHE SAW A NUMBER OF SPECIALISTS, BUT FOUND NO EXPLANATION FOR THE PAIN, WHICH STARTED WITH PAIN IN THE GROIN A FEW DAYS AFTER PLACEMENT OF THE INSERTS AND THAT HAVE BEEN EXHAUSTING FOR HER IN THE PAST YEAR AND A HALF, WITH NO MEDICAL SUPPORT. DIAGNOSTIC RESULTS: SHE UNDERWENT A NUMBER OF TESTS TO TRY TO FIND THE CAUSE OF THE PAIN: PELVIC AND LUMBAR SPINAL MRI, X-RAY OF HIPS. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED CASE REPORT RECEIVED FROM THE REGULATORY AUTHORITY REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PAIN IN RIGHT GROIN MAKING IT DIFFICULT TO WALK AMONGST OTHER NON-SERIOUS EVENTS. THE EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, ALTHOUGH HISTORICAL AND CONCOMITANT MEDICAL CONDITIONS WERE NOT INFORMED, THE CONSUMER REFERS THAT THE GROIN PAIN STARTED A FEW DAYS AFTER INSERTION. PAIN, INCLUDING GROIN, PELVIC, ABDOMINAL AND BACK PAIN OF VARYING INTENSITY AND LENGTH OF TIME MAY OCCUR AND PERSIST FOLLOWING ESSURE PLACEMENT. IN THIS CASE, CONSIDERING THE NATURE OF THE EVENT, THE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED (RELATED). THIS CASE WAS REGARDED AS INCIDENT IN LINE WITH THE REGULATORY AUTHORITY, SINCE ACCORDING TO THE CONSUMER'S REPORT; MEDICAL INTERVENTION (SEVERAL SPECIALISTS VISITS AND TESTS) WAS REQUIRED FOR PAIN TREATMENT. A PRODUCT TECHNICAL ANALYSIS IS AWAITED. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350246 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C49137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R