BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7531545 · Received May 22, 2018

    Report

    Report Number
    2951250-2018-02313
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    February 1, 2004
    Report Date
    May 16, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC INFLAMMATORY DISEASE ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PELVIC INFLAMMATION"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12246180,12246180) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED URINARY INCONTINENCE AND GRAND MULTIPARITY. CONCURRENT CONDITIONS INCLUDED HYPERKERATOSIS. CONCOMITANT PRODUCTS INCLUDED DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID (OMEGA 3), MAGNESIUM, PROBIOTICS [UMBRELLA TERM], VITAMIN D NOS (VITAMIN D) AND ZINC. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2004, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2004, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE,DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2004, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2005, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IBS"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN / JOINT PAIN"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2007, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("AUTOIMMUNE DISORDER TYPE OF DISORDER: INTERSTITIAL CYSTITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY AND REMOVAL OF THE DEVICE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSPAREUNIA, ARTHRALGIA, ALOPECIA, FATIGUE, MOOD SWINGS, DYSMENORRHOEA, IRRITABLE BOWEL SYNDROME, MIGRAINE, DEPRESSION AND ANXIETY HAD RESOLVED AND THE CYSTITIS INTERSTITIAL AND URINARY INCONTINENCE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, CYSTITIS INTERSTITIAL, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URINARY INCONTINENCE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 IS PROVIDED IN FOLLOW-UP. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2004: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JAN-2019: PFS RECEIVED. LOT NUMBER ADDED. LAB DATA ADDED. CONCOMITANT MEDICATION, DRUG AND HISTORICAL CONDITION ADDED. EVENTS: ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, AUTOIMMUNE DISORDER TYPE OF DISORDER: INTERSTITIAL CYSTITIS, BLADDER OR URINARY PROBLEMS OR CHANGES, DYSMENORRHEA (CRAMPING), GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IBS, MIGRAINES, HEADACHES, NICKEL ALLERGY, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, ANXIETY 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 PELVIC INFLAMMATORY DISEASE ("ALLERGIC OR HYPERSENSITIVITY REACTION TYPE: PELVIC INFLAMMATION"), PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 12246180) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED URINARY INCONTINENCE AND GRAND MULTIPARITY. CONCURRENT CONDITIONS INCLUDED HYPERKERATOSIS. CONCOMITANT PRODUCTS INCLUDED MAGNESIUM, PROBIOTICS [UMBRELLA TERM], VITAMIN D NOS (VITAMIN D) AND ZINC. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN (B)(6) 2004, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2004, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES"). IN (B)(6) 2004, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2004, THE PATIENT EXPERIENCED MOOD SWINGS ("HORMONAL CHANGES DESCRIBE: MOOD SWINGS"). IN (B)(6) 2005, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION TYPE: IBS"), MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2005, THE PATIENT EXPERIENCED PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ARTHRALGIA ("HIP PAIN / JOINT PAIN"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). IN (B)(6) 2007, THE PATIENT EXPERIENCED ALOPECIA ("HAIR LOSS"). IN (B)(6) 2008, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED CYSTITIS INTERSTITIAL ("AUTOIMMUNE DISORDER TYPE OF DISORDER: INTERSTITIAL CYSTITIS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION : ANXIETY"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY AND REMOVAL OF THE DEVICE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC INFLAMMATORY DISEASE, GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, HEADACHE AND ALLERGY TO METALS OUTCOME WAS UNKNOWN, THE PELVIC PAIN, DYSPAREUNIA, ARTHRALGIA, ALOPECIA, FATIGUE, MOOD SWINGS, DYSMENORRHOEA, IRRITABLE BOWEL SYNDROME, MIGRAINE, DEPRESSION AND ANXIETY HAD RESOLVED AND THE CYSTITIS INTERSTITIAL AND URINARY INCONTINENCE HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, CYSTITIS INTERSTITIAL, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, MOOD SWINGS, PELVIC INFLAMMATORY DISEASE, PELVIC PAIN, URINARY INCONTINENCE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2014 IS PROVIDED IN FOLLOW-UP . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2004: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-MAY-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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL DISTENSION ("BLOATING"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ARTHRALGIA ("HIP PAIN / JOINT PAIN"), ALOPECIA ("HAIR LOSS") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE DEVICE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL DISTENSION, DYSPAREUNIA, ARTHRALGIA, ALOPECIA AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUL-2018: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") AND GENITAL HAEMORRHAGE ("EXCESSIVE AND ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2004, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("BLOATING"), ARTHRALGIA ("HIP PAIN / JOINT PAIN"), ALOPECIA ("HAIR LOSS"), FATIGUE ("FATIGUE"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF THE DEVICE). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL DISTENSION, ARTHRALGIA, ALOPECIA, FATIGUE, GENITAL HAEMORRHAGE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ALOPECIA, ARTHRALGIA, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). 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
    376960 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 12246180

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R MAGNESIUM| MAGNESIUM| PROBIOTICS [UMBRELLA TERM]| PROBIOTICS [UMBRELLA TERM]| VITAMIN D [VITAMIN D NOS]| VITAMIN D [VITAMIN D NOS]| ZINC| ZINC