BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6917481 · Received October 5, 2017

    Report

    Report Number
    2951250-2017-04307
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    August 1, 2012
    Report Date
    March 12, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS") AND PELVIC PAIN ("CHRONIC PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED TRAZODONE. IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED RASH GENERALISED ("RASHES /RASHES OR SKIN CONDITIONS TYPE: BODY RASH,") AND ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL"). IN (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"), ARTHRALGIA ("JOINT PAIN") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 UNDERWENT A HYSTERECTOMY AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ¿ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABDOMINAL PAIN LOWER, ARTHRALGIA, HEADACHE, AMNESIA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, WEIGHT INCREASED, ALOPECIA, RASH GENERALISED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, FATIGUE, MIGRAINE, NAUSEA, VAGINAL DISCHARGE AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH GENERALISED, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 248 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BOTH DEVICES IN PLACE AND TUBES BLOCKED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2018: PFS RECEIVED. REPORTERS INFORMATION UPDATED. LOT NO. ADDED. EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL, DYSMENORRHEA, DYSPAREUNIA, FATIGUE, HYSTERECTOMY (FULL), MIGRAINES/HEADACHES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS, NAUSEA, PAIN, PERFORATION (UTERUS), RASHES OR SKIN CONDITIONS TYPE: BODY RASH, VAGINAL DISCHARGE WERE ADDED. EVENTS OUTCOME: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), DYSMENORRHEA, DYSPAREUNIA, FATIGUE, VAGINAL DISCHARGE, PAIN, ALOPECIA, NAUSEA, MIGRAINE, RASHES WERE ADDED. CONCOMITANT DRUGS, LAB DATA WERE 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION (UTERUS)/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: FUNDUS OF THE UTERUS") AND PELVIC PAIN ("CHRONIC PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED OVERWEIGHT. CONCOMITANT PRODUCTS INCLUDED TRAZODONE. IN (B)(6) 2012, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES") AND MIGRAINE ("MIGRAINES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS") AND FATIGUE ("FATIGUE"). IN (B)(6) 2015, THE PATIENT EXPERIENCED RASH GENERALISED ("RASHES /RASHES OR SKIN CONDITIONS TYPE: BODY RASH") AND ALLERGY TO METALS ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: METAL"). IN (B)(6) 2017, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING"), ARTHRALGIA ("JOINT PAIN") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 UNDERWENT A HYSTERECTOMY AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY ¿ TOTAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, ABDOMINAL PAIN LOWER, ARTHRALGIA, HEADACHE, AMNESIA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, WEIGHT INCREASED, ALOPECIA, RASH GENERALISED, VAGINAL HAEMORRHAGE, MENORRHAGIA, DYSMENORRHOEA, FATIGUE, MIGRAINE, NAUSEA, VAGINAL DISCHARGE AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, AMNESIA, ARTHRALGIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, RASH GENERALISED, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT: 248 LBS DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BOTH DEVICES IN PLACE AND TUBES BLOCKED.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAR-2019: QUALITY SAFETY EVALUATION OF PTC. 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 LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS"), ARTHRALGIA ("JOINT PAIN"), HEADACHE ("HEADACHES"), RASH ("RASHES") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH SURGERY (ON (B)(6) 2017 UNDERWENT A HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN LOWER, WEIGHT INCREASED, ALOPECIA, ARTHRALGIA, HEADACHE, RASH AND AMNESIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, AMNESIA, ARTHRALGIA, HEADACHE, PELVIC PAIN, RASH AND WEIGHT INCREASED 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
    694557 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893037

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R TRAZODONE| TRAZODONE