BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7056583 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08248
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 1, 2009
    Report Date
    August 21, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 646631-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TUBAL PREGNANCY, ABDOMINAL PAIN, VOMITING, D & C, TUBAL LIGATION AND BREAST REDUCTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA AND DEPO PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED EMBEDDED DEVICE WITH MIRENA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, UTERINE FIBROID, IRREGULAR PERIODS, MENOMETRORRHAGIA, ALLERGY (NKDA), GARDNERELLA VAGINALIS VAGINITIS, FEVER, DYSURIA, POSTOPERATIVE PAIN, GAS, RETROVERTED UTERUS, VULVOVAGINITIS, LOW BACK PAIN AND ESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE / VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PANADEINE CO (TYLENOL #3), METRONIDAZOLE (FLAGYL), SURGERY (UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY), AND SURGERY (ON (B)(6) 2010 UNDERWENT ABLATION). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, NAUSEA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: UPON INFORMATION AND BELIEF, BEGINNING ON OR ABOUT AUG- 2010, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. MR-MENOMETRORRHAGIA TREATED WITH ENDOMETRIAL ABLATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. HYSTEROSALPINGOGRAM - ON 25-JAN-2011: OCCLUDED.; IN SEPTEMBER 2010: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: CONFIRMING- PELVIC PAIN, DYSMENORRHEA" MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. FU PTC DECLINED BY QA (NO VALID BATCH, NO NEW PTC INFORMATION) INCIDENT NO VALID 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") AND MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES / ABNORMAL BLEEDING (MENORRHAGIA)") IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 646631) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TUBAL PREGNANCY, ABDOMINAL PAIN, VOMITING, D & C, TUBAL LIGATION AND BREAST REDUCTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA AND DEPO PROVERA. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED EMBEDDED DEVICE WITH MIRENA. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, UTERINE FIBROID, IRREGULAR PERIODS, MENOMETRORRHAGIA, ALLERGY (NKDA), GARDNERELLA VAGINALIS VAGINITIS, FEVER, DYSURIA, POSTOPERATIVE PAIN, GAS, RETROVERTED UTERUS, VULVOVAGINITIS, LOW BACK PAIN AND ESOPHAGEAL REFLUX. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN / DYSMENORRHEA (CRAMPING)"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE / VAGINAL DISCHARGE"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), NAUSEA ("NAUSEA") AND FATIGUE ("FATIGUE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH PANADEINE CO (TYLENOL #3), METRONIDAZOLE (FLAGYL), SURGERY (UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (ON (B)(6) 2010 UNDERWENT ABLATION). ESSURE WAS REMOVED ON (B)(6) 2011. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, NAUSEA, FATIGUE AND ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, MENORRHAGIA, NAUSEA, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: UPON INFORMATION AND BELIEF, BEGINNING ON OR ABOUT (B)(6) 2010, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. MR-MENOMETRORRHAGIA TREATED WITH ENDOMETRIAL ABLATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.9 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: OCCLUDED.; IN (B)(6) 2010: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: CONFIRMING- PELVIC PAIN, DYSMENORRHEA" MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED. EVENTS- "ABNORMAL BLEEDING (VAGINAL), NAUSEA, PAIN, FATIGUE, LOWER ABDOMINAL PAIN", REPORTER ADDED FROM PFS. HISTORICAL, CONCOMITTANT CONDITION, CONCOMITTANT DRUG, LAB DATA ADDED FROM MEDICAL RECORD. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("SEVERE ABDOMINAL 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) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN"), MENORRHAGIA ("ABNORMAL MENSTRUAL BLEEDING / PROLONGED MENSES"), DYSPAREUNIA ("PAINFUL INTERCOURSE") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2012. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: UPON INFORMATION AND BELIEF, BEGINNING ON OR ABOUT (B)(6) 2010, PLAINTIFF SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, PLAINTIFF HAS REPORTED THAT ALL HER SYMPTOMS HAVE RESOLVED AND THAT SHE FEELS MUCH BETTER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2010: FALLOPIAN TUBES WERE BILATERALLY OCCLUDED. 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
    836124 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 646631-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R IBUPROFEN| IBUPROFEN