BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7760874 · Received August 8, 2018

    Report

    Report Number
    2951250-2018-03369
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 15, 2010
    Report Date
    January 21, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING"), THYROID MASS ("MASS ON THYROID/ TOXIC THYROID NODULE") AND GALLBLADDER DISORDER ("GALL BLADDER") IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706579) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S MEDICAL HISTORY INCLUDED MIGRAINE IN (B)(6) , MULTI GRAVIDA, PARITY 3 (((B)(6) 2000, (B)(6) 2002,(B)(6) 2007)), VAGINAL DISCHARGE, VAGINAL EDEMA AND STRESS INCONTINENCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA FROM (B)(6) TO (B)(6) 2009; FOR AN UNREPORTED INDICATION: MIRENA IUD. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED VULVOVAGINAL PRURITUS WITH MIRENA. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED ONDANSETRON (ZOFRAN) FOR MIGRAINE AND MIGRAINE HEADACHE AS WELL AS ESTROGENS CONJUGATED (PREMARIN), SERTRALINE HYDROCHLORIDE (ZOLOFT) AND SUMATRIPTAN (IMITREX). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA BLEEDING)"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("NICKEL ALLERGY") WITH RASH AND PRURITUS, VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), IRRITABLE BOWEL SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (TYPE: IRRITABLE BOWEL SYNDROME)"), ARTHRALGIA ("SEVERE HIP PAIN"), UTERINE PAIN ("SEVERE UTERINE PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMEN PAIN/SEVERE ABDOMINAL CRAMPING"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH / METAL TASTE IN MOUTH"), NAUSEA ("NAUSEA"), BLADDER DISORDER ("BLADDER PROBLEMS") AND URINARY TRACT DISORDER ("URINARY TRACT DISORDER") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED THYROID MASS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) , THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI") AND BACTERIAL VULVOVAGINITIS ("BACTERIAL INFECTIONS IN MY VAGINA EVERY FEW MONTHS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GALLBLADDER DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL / PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL / PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH AZITHROMYCIN (AZO), CORTICOSTEROIDS, HYDROCORTISONE, IBUPROFEN, IBUPROFEN (MOTRIN), KETOROLAC TROMETHAMINE (TORADOL), METRONIDAZOLE (FLAGYL), NAPROXEN SODIUM (ALEVE), PARACETAMOL (TYLENOL) AND SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, THYROIDECTOMY ON (B)(6) 2015 AND GALL BLADDER REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, BACK PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN LOWER AND NAUSEA HAD RESOLVED, THE GENITAL HAEMORRHAGE, THYROID MASS, GALLBLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, MIGRAINE, HEADACHE, ALOPECIA, ALLERGY TO METALS AND FATIGUE HAD NOT RESOLVED AND THE DEPRESSION, ANXIETY, IRRITABLE BOWEL SYNDROME, DYSGEUSIA, URINARY TRACT INFECTION, BACTERIAL VULVOVAGINITIS, WEIGHT INCREASED, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BACTERIAL VULVOVAGINITIS, BLADDER DISORDER, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GALLBLADDER DISORDER, GENITAL HAEMORRHAGE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, THYROID MASS, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS A RESULT OF THESE SYMPTOMS, SHE HAS BEEN FORCED TO MISS WORK. SHE HAS NOT YET UNDERGONE SURGERY TO REMOVE THE ESSURE DEVICES AND STILL SUFFERS TO THIS DAY FROM THE SYMPTOMS OUTLINED ABOVE. SHE DID NOT CLAIM THAT ESSURE WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE DIDN¿T HAVE ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SHE DID NOT HAVE ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF HER ESSURE PLACEMENT PROCEDURE. SHE HAD COMMUNICATED WITH HEALTHCARE PROVIDER CONCERNING REMOVAL OF ESSURE DEVICE AND SHE WAS NOT CURRENTLY PLANNING FOR REMOVAL OF ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.3 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-JAN-2019: PFS RECEIVED. EVENT ADDED: BLADDER PROBLEMS AND URINARY TRACT DISORDER. EVENT ONSET DATE ADDED FOR SEVERE ABNORMAL MENSTRUATION PAIN. TREATMENT DRUG ADDED. CONCOMITANT MEDICATIONS 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.

    Description of Event or Problem · 1

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("SEVERE PELVIC PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL, HEAVY BLEEDING"), THYROID MASS ("MASS ON THYROID/ TOXIC THYROID NODULE") AND GALLBLADDER DISORDER ("GALL BLADDER") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 706579) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID YOU UNDERGO AN ESSURE CONFIRMATION TEST? NO". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MIGRAINE IN 2007, MULTI GRAVIDA, PARITY 3 (((B)(6) 2000, (B)(6) 2002, (B)(6) 2007)), VAGINAL DISCHARGE, VAGINAL EDEMA AND STRESS INCONTINENCE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR PREVENT PREGNANCY: MIRENA FROM 2007 TO (B)(6) 2009; FOR AN UNREPORTED INDICATION: MIRENA IUD. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED VULVOVAGINAL PRURITUS WITH MIRENA. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("PROLONGED ABNORMAL MENSES / ABNORMAL BLEEDING (MENORRHAGIA BLEEDING)"), BACK PAIN ("SEVERE BACK PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE / DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), ALOPECIA ("HAIR LOSS"), ALLERGY TO METALS ("NICKEL ALLERGY") WITH RASH AND PRURITUS, VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), IRRITABLE BOWEL SYNDROME ("GASTROINTESTINAL OR DIGESTIVE SYSTEM CONDITION (TYPE: IRRITABLE BOWEL SYNDROME)"), ARTHRALGIA ("SEVERE HIP PAIN"), UTERINE PAIN ("SEVERE UTERINE PAIN"), ABDOMINAL PAIN LOWER ("SEVERE LOWER ABDOMEN PAIN/SEVERE ABDOMINAL CRAMPING"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH / METAL TASTE IN MOUTH"), NAUSEA ("NAUSEA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON (B)(6) 2013, THE PATIENT EXPERIENCED THYROID MASS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("UTI") AND BACTERIAL VULVOVAGINITIS ("BACTERIAL INFECTIONS IN MY VAGINA EVERY FEW MONTHS"). ON (B)(6) 2015, THE PATIENT EXPERIENCED GALLBLADDER DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("PSYCHOLOGICAL / PSYCHIATRIC PROBLEMS CONDITION:DEPRESSION") AND ANXIETY ("PSYCHOLOGICAL / PSYCHIATRIC PROBLEMS CONDITION: ANXIETY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSMENORRHOEA ("SEVERE ABNORMAL MENSTRUATION PAIN"). THE PATIENT WAS TREATED WITH PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL), NAPROXEN SODIUM (ALEVE), IBUPROFEN (MOTRIN), SUMATRIPTAN (IMITREX), ONDANSETRON (ZOFRAN), KETOROLAC TROMETHAMINE (TORADOL), CORTICOSTEROIDS, HYDROCORTISONE, METRONIDAZOLE (FLAGYL), SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), SURGERY (THYROIDECTOMY ON (B)(6) 2015) AND SURGERY (GALL BLADDER REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MENORRHAGIA, BACK PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, ARTHRALGIA, UTERINE PAIN, ABDOMINAL PAIN LOWER AND NAUSEA HAD RESOLVED, THE GENITAL HAEMORRHAGE, THYROID MASS, GALLBLADDER DISORDER, DYSMENORRHOEA, DYSPAREUNIA, MIGRAINE, HEADACHE, ALOPECIA, ALLERGY TO METALS AND FATIGUE HAD NOT RESOLVED AND THE DEPRESSION, ANXIETY, IRRITABLE BOWEL SYNDROME, DYSGEUSIA, URINARY TRACT INFECTION, BACTERIAL VULVOVAGINITIS AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BACTERIAL VULVOVAGINITIS, DEPRESSION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GALLBLADDER DISORDER, GENITAL HAEMORRHAGE, HEADACHE, IRRITABLE BOWEL SYNDROME, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, THYROID MASS, URINARY TRACT INFECTION, UTERINE PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS A RESULT OF THESE SYMPTOMS, SHE HAS BEEN FORCED TO MISS WORK. SHE HAS NOT YET UNDERGONE SURGERY TO REMOVE THE ESSURE DEVICES AND STILL SUFFERS TO THIS DAY FROM THE SYMPTOMS OUTLINED ABOVE. SHE DID NOT CLAIM THAT ESSURE WORSENED A PREVIOUSLY EXISTING INJURY/CONDITION. SHE DIDN¿T HAVE ALLEGE THAT ESSURE CAUSED BIRTH DEFECTS. SHE DID NOT HAVE ANY COMPLICATIONS OR PROBLEMS THAT OCCURRED AT THE TIME OF HER ESSURE PLACEMENT PROCEDURE. SHE HAD COMMUNICATED WITH HEALTHCARE PROVIDER CONCERNING REMOVAL OF ESSURE DEVICE AND SHE WAS NOT CURRENTLY PLANNING FOR REMOVAL OF ESSURE DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 39.3 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION UPDATED. ESSURE REMOVAL DATE (B)(6) 2018 WAS ADDED. EVENTS DYSGEUSIA, NAUSEA, URINARY TRACT INFECTION, BACTERIAL VULVOVAGINITIS, WEIGHT INCREASED, THYROID MASS (PREVIOUSLY CAPTURED AS THYROIDECTOMY) WERE NEWLY ADDED. INCIDENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606963 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 706579 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R IMITREX [SUMATRIPTAN]| PREMARIN| ZOFRAN [ONDANSETRON]| ZOLOFT