BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7379138 · Received March 28, 2018

    Report

    Report Number
    2951250-2018-01326
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    April 11, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("EXTREME ABDOMINAL PAIN AND CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND VISUAL IMPAIRMENT ("GRADUAL LOSS OF VISION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTITIS, GENERAL BODY PAIN, BLOATING, CHOLECYSTECTOMY AND CELLULITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: AMOX AND DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LOWER ABDOMINAL PAIN, DRUG ALLERGY, SEASONAL ALLERGY, GENERAL BODY PAIN, DYSURIA, EPIGASTRIC PAIN, CHOLELITHIASIS, VOMITING, UMBILICAL HERNIA, JOINT SWELLING, PAIN IN EXTREMITY, CHILLS, FEVER, DIARRHEA, DIARRHEA, RASH, GASTRITIS, PHOTOPHOBIA AND NECK PAIN. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS IN (B)(6)2017 FOR BLEEDING GENITAL AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM (B)(6)2012 TO (B)(6)2012 FOR VAGINAL HAEMORRHAGE, MENORRHAGIA AND MENSES IRREGULAR. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VISUAL IMPAIRMENT (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("INCREASED MENSTRUAL FLOW / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES ALL OVER"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: GSI"), ALOPECIA ("HAIR LOSS") AND PELVIC PAIN ("PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGIC REACTION TO NICKEL"), VAGINAL INFECTION ("VAGINAL INFECTION"), MALAISE ("MALAISE") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (MINILAPAROTOMY WITH BILATERAL SALPINGECTOMY ON (B)(6)2017). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, VISUAL IMPAIRMENT, ALLERGY TO METALS, DYSPAREUNIA, DYSMENORRHOEA, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL INFECTION, NAUSEA, MALAISE, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, URTICARIA, FATIGUE, GASTROINTESTINAL DISORDER, PELVIC PAIN, WEIGHT DECREASED AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, MALAISE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VISUAL IMPAIRMENT AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 106 LBS. 4 COILS WERE VISIBLE AFTER PLACEMENT ON BOTH SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 16.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION. BOTH ESSURE COILS ARE WELL POSITIONED AND BOTH FALLOPIAN TUBES ARE COMPLETELY OCCLUDED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: BACK PAIN, ABDOMINAL PAIN, URINARY TRACT INFECTION, PELVIC PAIN, MIGRAINE, HEADACHE, NAUSEA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6)2019: QUALITY-SAFETY EVALUATION OF PTC. (PRODUCT TECHNICAL COMPLAINT) INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("EXTREME ABDOMINAL PAIN AND CRAMPING"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") AND BLINDNESS ("GRADUAL LOSS OF VISION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922613) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CHOLECYSTITIS, GENERAL BODY PAIN, BLOATING, CHOLECYSTECTOMY AND CELLULITIS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: AMOX AND DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, LOWER ABDOMINAL PAIN, DRUG ALLERGY, SEASONAL ALLERGY, GENERAL BODY PAIN, DYSURIA, EPIGASTRIC PAIN, CHOLELITHIASIS, VOMITING, UMBILICAL HERNIA, JOINT SWELLING, PAIN IN EXTREMITY, CHILLS, FEVER, DIARRHEA, DIARRHEA, RASH, GASTRITIS, PHOTOPHOBIA AND NECK PAIN. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS IN JULY 2017 FOR BLEEDING GENITAL AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FOR VAGINAL HAEMORRHAGE, MENORRHAGIA AND MENSES IRREGULAR. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BLINDNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS / DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("INCREASED MENSTRUAL FLOW / ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), NAUSEA ("NAUSEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: GSI"), ALOPECIA ("HAIR LOSS") AND PELVIC PAIN ("PAIN") AND WAS FOUND TO HAVE WEIGHT DECREASED ("WEIGHT GAIN / LOSS (SPECIFY WHICH ONE) WEIGHT LOSS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGIC REACTION TO NICKEL"), VAGINAL INFECTION ("VAGINAL INFECTION"), MALAISE ("MALAISE"), MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), URTICARIA ("RASHES OR SKIN CONDITIONS TYPE: HIVES ALL OVER") AND BACK PAIN ("LOWER BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (MINILAPAROTOMY WITH BILATERAL SALPINGECTOMY ON (B)(6)2017). ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN HAD RESOLVED AND THE GENITAL HAEMORRHAGE, BLINDNESS, ALLERGY TO METALS, DYSPAREUNIA, DYSMENORRHOEA, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL INFECTION, NAUSEA, MALAISE, VAGINAL HAEMORRHAGE, BLADDER DISORDER, URINARY TRACT DISORDER, MOOD SWINGS, MIGRAINE, HEADACHE, URTICARIA, FATIGUE, GASTROINTESTINAL DISORDER, PELVIC PAIN, WEIGHT DECREASED AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ALOPECIA, BACK PAIN, BLADDER DISORDER, BLINDNESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, GENITAL HAEMORRHAGE, HEADACHE, MALAISE, MENORRHAGIA, MIGRAINE, MOOD SWINGS, NAUSEA, PELVIC PAIN, URINARY TRACT DISORDER, URINARY TRACT INFECTION, URTICARIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 106 LBS. 4 COILS WERE VISIBLE AFTER PLACEMENT ON BOTH SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 16.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2012: TOTAL BILATERAL OCCLUSION. BOTH ESSURE COILS ARE WELL POSITIONED AND BOTH FALLOPIAN TUBES ARE COMPLETELY OCCLUDED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: BACK PAIN, ABDOMINAL PAIN, URINARY TRACT INFECTION, PELVIC PAIN, MIGRAINE, HEADACHE, NAUSEA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6)2019: PFS AND MR WERE RECEIVED: REPORTERS WERE ADDED. PATIENTS DEMOGRAPHIC CONDITIONS WERE ADDED. LOT NUMBER WAS ADDED. EVENTS: GENITAL BLEEDING, VAGINAL HEMORRHAGE, BLADDER DISORDER, URINARY DISORDER, MOOD SWINGS, UTI, MIGRAINES, HEADACHES, NAUSEA, HIVES, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HAIR LOSS, PELVIC PAIN, VAGINAL DISCHARGE, LOSS OF VISION, WEIGHT LOSS, BACK PAIN WERE ADDED. EVENT ONSET DATE AND OUTCOME (ABDOMINAL PAIN) WERE UPDATED. CONCOMITANT AND HISTORICAL DRUGS WERE ADDED. REPORTER CAUSALITY COMMENT WAS ADDED. CONCOMITANT CONDITIONS WERE ADDED. LAB DATA WAS ADDED. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("EXTREME ABDOMINAL PAIN AND CRAMPING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ALLERGY TO METALS ("ALLERGIC REACTION TO NICKEL"), DYSPAREUNIA ("DYSPAREUNIA"), DYSMENORRHOEA ("SEVERE MENSTRUAL CRAMPS"), MENORRHAGIA ("INCREASED MENSTRUAL FLOW"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), VAGINAL INFECTION ("VAGINAL INFECTION"), NAUSEA ("NAUSEA") AND MALAISE ("MALAISE"). THE PATIENT WAS TREATED WITH SURGERY (MINILAPAROTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, ALLERGY TO METALS, DYSPAREUNIA, DYSMENORRHOEA, MENORRHAGIA, VAGINAL DISCHARGE, VAGINAL INFECTION, NAUSEA AND MALAISE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, MALAISE, MENORRHAGIA, NAUSEA, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221824 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R DEPO PROVERA| DEPO PROVERA| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS