BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6637262 · Received June 13, 2017

    Report

    Report Number
    2951250-2017-02091
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    January 1, 2011
    Report Date
    August 10, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)"), PELVIC PAIN ("PELVIC PAIN") AND DEVICE BREAKAGE ("DEVICE BREAKAGE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE FROM 2007 TO 2009. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA"). IN 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("EXTREME, DEBILITATING ABDOMINAL PAIN"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (RIGHT SIDED SALPINGECTOMY), SURGERY (RIGHT SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES) AND SURGERY (LEFT SIDED SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, DEVICE BREAKAGE, ABDOMINAL PAIN, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS CAUSED PATIENT TO BE ANXIOUS AND DEPRESSED AND 2011 ¿ UNILATERAL SALPINGECTOMY (LEFT), 2016 ¿ UNILATERAL SALPINGECTOMY (RIGHT) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: PERFORATION (FALLOPIAN TUBE) . AFTER IMPLANTATION OF ESSURE, PATIENT HAD A HSG TEST (RESULT NOT PROVIDED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2018: FROM PFS OUTCOME OF EVENTS " CRAMPING, PAIN DURING SEX" ARE RECOVERING/ RESOLVING. PRODUCT INFORMATION ADDED. CONCOMITANT DRUG 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 FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)"), PELVIC PAIN ("PELVIC PAIN") AND DEVICE BREAKAGE ("DEVICE BREAKAGE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE FROM 2007 TO 2009. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("EXTREME, DEBILITATING ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND ABDOMINAL PAIN LOWER ("CRAMPIG"). THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, DEVICE BREAKAGE, ABDOMINAL PAIN, DYSPAREUNIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS CAUSED PATIENT TO BE ANXIOUS AND DEPRESSED AND 2011 ¿ UNILATERAL SALPINGECTOMY (LEFT), 2016 ¿ UNILATERAL SALPINGECTOMY (RIGHT) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2011: PERFORATION (FALLOPIAN TUBE) . AFTER IMPLANTATION OF ESSURE, PATIENT HAD A HSG TEST (RESULT NOT PROVIDED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD: REPORTERS, HISTORICAL CONDITIONS AND DRUG, PATIENT DEMOGRAPHIC, ESSURE LOT NUMBER 822374 AND EVENTS (PERFORATION (FALLOPIAN TUBES), DEVICE BREAKAGE, CRAMPING) WERE 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

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)"), PELVIC PAIN ("PELVIC PAIN") AND DEVICE BREAKAGE ("DEVICE BREAKAGE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DEPRESSION AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: FLUOXETINE FROM 2007 TO 2009. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) FOR BIRTH CONTROL. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSPAREUNIA ("DYSPAREUNIA"). IN 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("EXTREME, DEBILITATING ABDOMINAL PAIN"), ANXIETY ("ANXIOUS"), DEPRESSION ("DEPRESSED") AND ABDOMINAL PAIN LOWER ("CRAMPING"). THE PATIENT WAS TREATED WITH SURGERY (RIGHT SIDED SALPINGECTOMY), SURGERY (RIGHT SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES) AND SURGERY (LEFT SIDED SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PELVIC PAIN, DEVICE BREAKAGE, ABDOMINAL PAIN, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE DYSPAREUNIA AND ABDOMINAL PAIN LOWER WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS CAUSED PATIENT TO BE ANXIOUS AND DEPRESSED AND 2011 ¿ UNILATERAL SALPINGECTOMY (LEFT), 2016 ¿ UNILATERAL SALPINGECTOMY (RIGHT) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2011: PERFORATION (FALLOPIAN TUBE) AFTER IMPLANTATION OF ESSURE, PATIENT HAD A HSG TEST (RESULT NOT PROVIDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC. 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("EXTREME, DEBILITATING ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA"), ANXIETY ("ANXIOUS") AND DEPRESSION ("DEPRESSED"). THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES.). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS CAUSED PATIENT TO BE ANXIOUS AND DEPRESSED. DIAGNOSTIC RESULTS: AFTER IMPLANTATION OF ESSURE, PATIENT HAD A HSG TEST (RESULT NOT PROVIDED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAY-2017: CORRECTION: EVENT ANXIOUS AND DEPRESSED WERE ADDED. COMPANY CAUSALITY COMMENT: 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") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("EXTREME, DEBILITATING ABDOMINAL PAIN") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (RIGHT SALPINGECTOMY AND REMOVAL OF THE ESSURE DEVICES.). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE SYMPTOMS CAUSED PATIENT TO BE ANXIOUS AND DEPRESSED. DIAGNOSTIC RESULTS: AFTER IMPLANTATION OF ESSURE, PATIENT HAD A HSG TEST (RESULT NOT PROVIDED). 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
    417779 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822374

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R DEPO-PROVERA.| DEPO-PROVERA.