BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6939579 · Received October 11, 2017

    Report

    Report Number
    2951250-2017-04516
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    January 1, 2014
    Report Date
    August 9, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862111(INVALID)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, LIVE BIRTH IN 2001, LIVE BIRTH IN 2006 AND CYSTOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA IN 2013 AND LABETALOL. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND PRURITUS ALLERGIC ("ALLERGIC OR HYPERSENSITIVITY REACTION: ITCHING"). IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASHES OR SKIN CONDITIONS : RASHES ON ARMS , LEGS"), WEIGHT INCREASED ("WEIGHT GAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS ALLERGIC, DYSPAREUNIA, RASH, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PRURITUS ALLERGIC, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION HER CURRENT WEIGHT WAS 205 LBS. ON (B)(6) 2017, SHE HAD PATHOLOGY REPORT REPORTERS SHOWS A SMALL METAL COIL PROTRUDES FROM THE RIGHT FALLOPIAN TUBE PARTLY THROUGH THE UTERINE CORNUAL LUMEN. NO MYOMETRIAL NODULES OR OTHER ABNORMALITIES ARE NOTED. ON CUT SECTION OF THE TUBES, AN ESSURE COIL WAS PRESENT IN THE PROXIMAL THIRD OF EACH FALLOPIAN TUBE. THE COIL DOES NOT APPEAR TO EXTEND THROUGH THE EXTERIOR SEROSA. ON (B)(6) 2016, SHE HAD GYN ULTRASOUND WHICH REVELED THAT WNL. ECHOGENICITY LATERAL TO UTERUS BILATERAL MAY REPRESENT ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-2018: UPDATE OF INFORMATION (BATCH NOT VALID). 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") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A(B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 862111) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, LIVE BIRTH IN 2001, LIVE BIRTH IN 2006 AND CYSTOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO PROVERA IN 2013 AND LABETALOL. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND PRURITUS ("ALLERGIC OR HYPERSENSITIVITY REACTION: ITCHING"). IN 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), RASH ("RASHES OR SKIN CONDITIONS : RASHES ON ARMS , LEGS"), WEIGHT INCREASED ("WEIGHT GAIN") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, PRURITUS, DYSPAREUNIA, RASH, WEIGHT INCREASED AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN, PRURITUS, RASH, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 33.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION HER CURRENT WEIGHT WAS (B)(6) LBS. ON (B)(6) 2017, SHE HAD PATHOLOGY REPORT REPORTERS SHOWS A SMALL METAL COIL PROTRUDES FROM THE RIGHT FALLOPIAN TUBE PARTLY THROUGH THE UTERINE CORNUAL LUMEN. NO MYOMETRIAL NODULES OR OTHER ABNORMALITIES ARE NOTED. ON CUT SECTION OF THE TUBES, AN ESSURE COIL WAS PRESENT IN THE PROXIMAL THIRD OF EACH FALLOPIAN TUBE. THE COIL DOES NOT APPEAR TO EXTEND THROUGH THE EXTERIOR SEROSA. ON (B)(6) 2016, SHE HAD GYN ULTRASOUND WHICH REVELED THAT WNL. ECHOGENICITY LATERAL TO UTERUS BILATERAL MAY REPRESENT ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2018: REPORTERS ADDED AND UPDATED PATIENT DEMOGRAPHICS. HISTORICAL CONDITION,CONCOMITANT DISEASE AND LABORATORY DATA WERE ADDED. ESSURE LOT NUMBER WAS ADDED 862111. IN 2013, SHE HAD ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ALLERGIC OR HYPERSENSITIVITY REACTION: ITCHING. IN 2014, SHE HAD DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE); PAIN; RASHES OR SKIN CONDITIONS : RASHES ON ARMS , LEGS AND WEIGHT GAIN AND UPDATED ONSET DATE OF EVENT. 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 PELVIC PAIN ("PAIN") AND GENITAL HAEMORRHAGE ("PERSISTENT BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND GENITAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED GENITAL HAEMORRHAGE AND PELVIC PAIN 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
    721245 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 862111(INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R