BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6855082 · Received September 11, 2017

    Report

    Report Number
    2951250-2017-03544
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    July 6, 2012
    Report Date
    August 8, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN, BURNING SENSATION AND UTERINE FIBROIDS. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE, ESTROGEN NOS (ESTROGEN), HYDROCODONE SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, KETOROLAC, MAGNESIUM HYDROXIDE, METFORMIN SINCE (B)(6) 2013, ONDANSETRON, PARACETAMOL (ACETAMINOPHEN) AND PROMETHAZINE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES/MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPORECTOMY/CYTOSCOPY) AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPORECTOMY/CYTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, VAGINAL DISCHARGE AND HEADACHE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING ON OR ABOUT (B)(6) 2012, PLAINTIFF WEBB SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-AUG-2018: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". IN 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)"). ON (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 (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MIGRAINE ("MIGRAINE HEADACHES/MIGRAINES / HEADACHES"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE") AND HEADACHE ("MIGRAINES / HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-"OOPHORECTOMY"/CYTOSCOPY) AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-"OOPHORECTOMY"/CYTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND HEADACHE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING ON OR ABOUT (B)(6) 2012, PLAINTIFF (B)(6) SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER ADDED. ESSURE STOP DATE UPDATED. NEW EVENTS, PELVIC PAIN, HEADACHE, PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST WERE ADDED. ON (B)(6) 2013, PATIENT "UNDERWENT" LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-"OOPHORECTOMY"/CYTOSCOPY. ESSURE LOT NUMBER 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN ("SEVERE ABDOMINAL PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 871973) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CRAMP IN LOWER ABDOMEN, BURNING SENSATION AND UTERINE FIBROIDS. CONCOMITANT PRODUCTS INCLUDED DIPHENHYDRAMINE, ESTROGEN NOS (ESTROGEN), HYDROCODONE SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, KETOROLAC, MAGNESIUM HYDROXIDE, METFORMIN SINCE (B)(6) 2013, ONDANSETRON, PARACETAMOL (ACETAMINOPHEN) AND PROMETHAZINE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES/MIGRAINES / HEADACHES") AND HEADACHE ("MIGRAINES / HEADACHES"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSMENORRHOEA ("SEVERE MENSTRUAL PAIN/DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("PAINFUL INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE/ VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPORECTOMY/CYTOSCOPY) AND SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPORECTOMY/CYTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA, MIGRAINE, VAGINAL DISCHARGE AND HEADACHE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MIGRAINE, PELVIC PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING ON OR ABOUT (B)(6) 2012, PLAINTIFF WEBB SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAY-2018: PFS RECEIVED. REPORTER ADDED. CONCOMITANT DRUG ADDED. EVENTS PAIN, HEADACHE OUTCOME AND EVENTS ONSET DATE UPDATED. 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. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, 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"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), MIGRAINE ("MIGRAINE HEADACHES") AND VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (ON OR ABOUT (B)(6) 2013, UNDERWENT TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES). ESSURE WAS REMOVED IN (B)(6) 2013. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, DYSPAREUNIA AND MIGRAINE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, MIGRAINE AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE WAS SUCCESSFULLY IMPLANTED, WITHOUT COMPLICATIONS. BEGINNING ON OR ABOUT (B)(6) 2012, PLAINTIFF WEBB SOUGHT MEDICAL TREATMENT REGARDING THE AFOREMENTIONED SYMPTOMS. BECAUSE OF THE REQUIREMENT TO UNDERGO A TOTAL HYSTERECTOMY TO REMOVE THE ESSURE DEVICES, PLAINTIFF HAS BEEN LEFT WITH ABDOMINAL DEFORMITY AND SEVERE LARGE SCARRING. SINCE THE ESSURE REMOVAL SURGERY, SHE FEELS MUCH BETTER. COMPANY CAUSALITY COMMENT: 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
    635921 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 871973

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R ACETAMINOPHEN| ACETAMINOPHEN| DIPHENHYDRAMINE| DIPHENHYDRAMINE| ESTROGEN| ESTROGEN| HYDROCODONE| HYDROCODONE| IBUPROFEN| IBUPROFEN| KETOROLAC| KETOROLAC| MAGNESIUM HYDROXIDE| MAGNESIUM HYDROXIDE| METFORMIN| METFORMIN| ONDANSETRON| ONDANSETRON| PROMETHAZINE| PROMETHAZINE