BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16442320 · Received February 27, 2023

    Report

    Report Number
    2951250-2023-00601
    Event Type
    Injury
    Date Received
    February 27, 2023
    Report Date
    March 17, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN, WHICH SHE PRESENTED SINCE THE ESSURE INSERTION") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF CARPAL TUNNEL SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: PREGABALIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 159 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED INSOMNIA ("INSOMNIA"). ON (B)(6) 2014 SHE EXPERIENCED DIARRHOEA ("DIARRHEA") AND VOMITING ("VOMITING"). ON (B)(6) 2014 SHE EXPERIENCED PAIN IN EXTREMITY ("PAIN AND FUNCTIONAL IMPOTENCE IN BOTH HANDS"), MUSCULOSKELETAL DISORDER ("PAIN AND FUNCTIONAL IMPOTENCE IN BOTH HANDS") AND PARAESTHESIA ("PARESTHESIA IN BOTH ARMS"). ON (B)(6) 2015 SHE EXPERIENCED VAGINAL DISORDER ("VAGINOSIS") AND VAGINITIS GARDNERELLA ("GARDNERELLA VAGINALIS INFECTION"). ON (B)(6) 2015 SHE EXPERIENCED ABDOMINAL DISCOMFORT ("DISCOMFORT IN THE HYPOGASTRIUM"). ON (B)(6) 2015 SHE EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), NECK PAIN ("NECK PAIN"), PYREXIA ("FEVER"), BACK PAIN ("LOW BACK PAIN"), DYSURIA ("DYSURIA"), POLLAKIURIA ("URINARY FREQUENCY"), RENAL PAIN ("KIDNEY PAIN"), RECTAL HAEMORRHAGE ("RECTAL BLEEDING"), BREAST PAIN ("BILATERAL MASTALGIA"), VARICOSE VEIN ("VARICOSE SYNDROME"), MEMORY IMPAIRMENT ("FORGETS EVERYDAY THINGS"), DYSARTHRIA ("DYSARTHRIA"), ARTHRALGIA ("GENERALIZED ARTHRALGIA"), MIXED ANXIETY AND DEPRESSIVE DISORDER ("ANXIOUS-DEPRESSIVE EPISODES"), MUSCULOSKELETAL STIFFNESS ("GENERALIZED MORNING STIFFNESS"), ALOPECIA ("ALOPECIA"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("PAIN IN THE LOWER ABDOMEN"), VULVOVAGINAL PRURITUS ("VULVAR ITCHING"), ALLERGY TO METALS ("ALLERGY TO NICKEL"), PRURITUS ("PRURITUS"), BONE PAIN ("GENERALIZED BONE PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA"), DYSPHONIA ("DYSPHONIA"), APATHY ("APATHY"), DECREASED APPETITE ("HYPOREXIA"), CRYING ("TENDENCY TO CRY"), MALAISE ("FEELS UNWELL"), DYSPNOEA ("DYSPNEA"), FATIGUE ("TIREDNESS"), SJOGREN'S SYNDROME ("SJÖGREN'S DISEASE"), RAYNAUD'S PHENOMENON ("RAYNAUD'S SYNDROME") AND MUSCULOSKELETAL PAIN ("ARTHROMYALGIA"). THE PATIENT WAS TREATED WITH CORTICOSTEROID NOS, NSAIDS, TRAMADOL, DOLQUINE (HYDROXYCHLOROQUINE SULFATE), PREDNISONE, NAPROXEN, OMEPRAZOLE, HEMOVAS (PENTOXIFYLLINE), PENTOXIFYLLINE, ALPRAZOLAM, DULOXETINE AND LORMETAZEPAM AS WELL AS SURGERY (LAPAROTOMIC CORNUECTOMY WITH BILATERAL SALPINGECTOMY WAS PERFORMED FOR THE REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, APATHY, ARTHRALGIA, BACK PAIN, BONE PAIN, BREAST PAIN, CRYING, DECREASED APPETITE, DIARRHOEA, DYSARTHRIA, DYSPAREUNIA, DYSPHONIA, DYSPNOEA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INSOMNIA, MALAISE, MEMORY IMPAIRMENT, MIXED ANXIETY AND DEPRESSIVE DISORDER, MUSCULOSKELETAL DISORDER, MUSCULOSKELETAL PAIN, MUSCULOSKELETAL STIFFNESS, NECK PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, POLLAKIURIA, PRURITUS, PYREXIA, RAYNAUD'S PHENOMENON, RECTAL HAEMORRHAGE, RENAL PAIN, SJOGREN'S SYNDROME, URINARY TRACT INFECTION, VAGINAL DISORDER, VAGINITIS GARDNERELLA, VARICOSE VEIN, VOMITING AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 13-MAR-2023: QUALITY-SAFETY EVALUATION OF PTC. 14-MAR-2023: HA REFERENCE NUMBER ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN, WHICH SHE PRESENTED SINCE THE ESSURE INSERTION") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF CARPAL TUNNEL SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: PREGABALIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, 159 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED INSOMNIA ("INSOMNIA"). ON (B)(6) 2014 SHE EXPERIENCED DIARRHOEA ("DIARRHEA") AND VOMITING ("VOMITING"). ON (B)(6) 2014 SHE EXPERIENCED PAIN IN EXTREMITY ("PAIN AND FUNCTIONAL IMPOTENCE IN BOTH HANDS"), MUSCULOSKELETAL DISORDER ("PAIN AND FUNCTIONAL IMPOTENCE IN BOTH HANDS") AND PARAESTHESIA ("PARESTHESIA IN BOTH ARMS"). ON (B)(6) 2015 SHE EXPERIENCED VAGINAL DISORDER ("VAGINOSIS") AND VAGINITIS GARDNERELLA ("GARDNERELLA VAGINALIS INFECTION"). ON (B)(6) 2015 SHE EXPERIENCED ABDOMINAL DISCOMFORT ("DISCOMFORT IN THE HYPOGASTRIUM"). ON (B)(6) 2015 SHE EXPERIENCED URINARY TRACT INFECTION ("URINARY TRACT INFECTION"). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), HEADACHE ("HEADACHE"), NECK PAIN ("NECK PAIN"), PYREXIA ("FEVER"), BACK PAIN ("LOW BACK PAIN"), DYSURIA ("DYSURIA"), POLLAKIURIA ("URINARY FREQUENCY"), RENAL PAIN ("KIDNEY PAIN"), RECTAL HAEMORRHAGE ("RECTAL BLEEDING"), BREAST PAIN ("BILATERAL MASTALGIA"), VARICOSE VEIN ("VARICOSE SYNDROME"), MEMORY IMPAIRMENT ("FORGETS EVERYDAY THINGS"), DYSARTHRIA ("DYSARTHRIA"), ARTHRALGIA ("GENERALIZED ARTHRALGIA"), MIXED ANXIETY AND DEPRESSIVE DISORDER ("ANXIOUS-DEPRESSIVE EPISODES"), MUSCULOSKELETAL STIFFNESS ("GENERALIZED MORNING STIFFNESS"), ALOPECIA ("ALOPECIA"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("PAIN IN THE LOWER ABDOMEN"), VULVOVAGINAL PRURITUS ("VULVAR ITCHING"), ALLERGY TO METALS ("ALLERGY TO NICKEL"), PRURITUS ("PRURITUS"), BONE PAIN ("GENERALIZED BONE PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA"), DYSPHONIA ("DYSPHONIA"), APATHY ("APATHY"), DECREASED APPETITE ("HYPOREXIA"), CRYING ("TENDENCY TO CRY"), MALAISE ("FEELS UNWELL"), DYSPNOEA ("DYSPNEA"), FATIGUE ("TIREDNESS"), SJOGREN'S SYNDROME ("SJÖGREN'S DISEASE"), RAYNAUD'S PHENOMENON ("RAYNAUD'S SYNDROME") AND MUSCULOSKELETAL PAIN ("ARTHROMYALGIA"). THE PATIENT WAS TREATED WITH CORTICOSTEROID NOS, NSAIDS, TRAMADOL, DOLQUINE (HYDROXYCHLOROQUINE SULFATE), PREDNISONE, NAPROXEN, OMEPRAZOLE, HEMOVAS (PENTOXIFYLLINE), PENTOXIFYLLINE, ALPRAZOLAM, DULOXETINE AND LORMETAZEPAM AS WELL AS SURGERY (LAPAROTOMIC CORNUECTOMY WITH BILATERAL SALPINGECTOMY WAS PERFORMED FOR THE REMOVAL OF ESSURE). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT, ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, APATHY, ARTHRALGIA, BACK PAIN, BONE PAIN, BREAST PAIN, CRYING, DECREASED APPETITE, DIARRHOEA, DYSARTHRIA, DYSPAREUNIA, DYSPHONIA, DYSPNOEA, DYSURIA, FATIGUE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INSOMNIA, MALAISE, MEMORY IMPAIRMENT, MIXED ANXIETY AND DEPRESSIVE DISORDER, MUSCULOSKELETAL DISORDER, MUSCULOSKELETAL PAIN, MUSCULOSKELETAL STIFFNESS, NECK PAIN, PAIN IN EXTREMITY, PARAESTHESIA, PELVIC PAIN, POLLAKIURIA, PRURITUS, PYREXIA, RAYNAUD'S PHENOMENON, RECTAL HAEMORRHAGE, RENAL PAIN, SJOGREN'S SYNDROME, URINARY TRACT INFECTION, VAGINAL DISORDER, VAGINITIS GARDNERELLA, VARICOSE VEIN, VOMITING AND VULVOVAGINAL PRURITUS TO BE RELATED TO ESSURE ADMINISTRATION. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753642 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention