ESSURE
Report
- Report Number
- 2951250-2017-04204
- Event Type
- Injury
- Date Received
- October 3, 2017
- Report Date
- January 2, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANON FROM (B)(6) 2008 TO (B)(6) 2011 AND ALESSE FROM (B)(6) 2006 TO (B)(6) 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMIES HYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION WAS RESOLVING, THE HEADACHE, FATIGUE, BACK PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER, MIGRAINE, NAUSEA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY. BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE.LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.2 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: MECHANICAL COMPLICATION DUE TO INTRAUTERINEDEVICE; ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: ESSURE SYSTEM IMPLANTS ARE CORRECTLY LOCATED ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS . CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS RECEIVED, REPORTER ADDED, LOT NUMBER RECEIVED, HISTORICAL DRUG ADDED, CONCOMITANT CONDITION ADDED, EVENT ADDED AS :- INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS, MIGRAINES / HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),VAGINAL DISCHARGE, WEIGHT GAIN 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CT SCAN SHOWED IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIAL ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANON FROM 2008 TO (B)(6) 2011AND ALESSE FROM 2006 TO 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, MENORRHAGIA, MENSES IRREGULAR, UTERINE ENLARGEMENT AND CONSTIPATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINES/MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA/NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH IBUPROFEN, METRONIDAZOLE (FLAGYL), SURGERY (BILATERAL SALPINGECTOMIES HYSTERECTOMY FULL) AND ALTERNATIVE THERAPY (DIET AND EXERCISE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FATIGUE AND MIGRAINE WAS RESOLVING, THE HEADACHE, BACK PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY. BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE.LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. PELVIC PAIN IMPROVED AFTER ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: MECHANICAL COMPLICATION DUE TO INTRAUTERINEDEVICE; ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. 1. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. 2. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. 3. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS CT SCAN SHOWED MIGRATION OF ESSURE DEVICE IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUL-2018: PFS AND MR RECEIVED. OUTCOME OF THE EVENTS WERE UPDATED, PATIENT'S MEDICAL HISTORY WAS UPDATED. LABORATOTY DATA WAS 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CT SCAN SHOWED IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIAL ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANON FROM 2008 TO (B)(6) 2011 AND ALESSE FROM 2006 TO 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, MENORRHAGIA, MENSES IRREGULAR, UTERINE ENLARGEMENT AND CONSTIPATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINES/MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA/NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH IBUPROFEN, METRONIDAZOLE (FLAGYL), SURGERY (BILATERAL SALPINGECTOMIES HYSTERECTOMY FULL) AND ALTERNATIVE THERAPY (DIET AND EXERCISE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FATIGUE AND MIGRAINE WAS RESOLVING, THE HEADACHE, BACK PAIN, ABDOMINAL PAIN, MENSTRUAL DISORDER AND WEIGHT INCREASED OUTCOME WAS UNKNOWN AND THE BACTERIAL VAGINOSIS, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY. BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE. LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. PELVIC PAIN IMPROVED AFTER ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: MECHANICAL COMPLICATION DUE TO INTRAUTERINE DEVICE; ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. 1. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. 2. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. 3. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS. CT SCAN SHOWED MIGRATION OF ESSURE DEVICE IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2018: QUALITY SAFETY EVALUATION OF 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE(S)),"), DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CT SCAN SHOWED IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND UTERINE INFLAMMATION ("UTERUS INFLAMED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIAL ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANON FROM 2008 TO (B)(6) 2011 AND ALESSE FROM 2006 TO 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, MENORRHAGIA, MENSES IRREGULAR, UTERINE ENLARGEMENT AND CONSTIPATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINES/MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA/NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN LOWER BACK PAIN"), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"), URINARY TRACT INFECTION ("UTI'S"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:BACTERIAL INFECTIONS"). THE PATIENT WAS TREATED WITH IBUPROFEN, METRONIDAZOLE (FLAGYL), SURGERY (HYSTERECTOMY) AND ALTERNATIVE THERAPY (DIET AND EXERCISE). AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE INFLAMMATION, HEADACHE, MENSTRUAL DISORDER, BACTERIAL VAGINOSIS, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, THE LAST EPISODE OF ABDOMINAL PAIN AND BACTERIAL INFECTION OUTCOME WAS UNKNOWN, THE DEVICE DISLOCATION, FATIGUE, BACK PAIN AND MIGRAINE WAS RESOLVING AND THE NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND URINARY TRACT DISORDER HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE INFLAMMATION, VAGINAL DISCHARGE, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE. LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. (B)(6) 2017 HYSTERECTOMY-REMOVAL OF ONLY ONE ESSURE DEVICE (OTHER HAD MIGRATED AND UNABLE TO REMOVE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: MECHANICAL COMPLICATION DUE TO INTRAUTERINE DEVICE; ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS. CT SCAN SHOWED MIGRATION OF ESSURE DEVICE IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-OCT-2018: PFS RECEIVED. ADDED EVENT PERFORATION (FALLOPIAN TUBE(S)),BACTERIAL INFECTIONS , REPEATED UTI'S, UTERUS INFLAMED, BLADDER OR URINARY PROBLEMS OR CHANGES, DEVICE BREAKAGE, ABDOMINAL PAIN. UPDATED OUTCOME OF EVENTS(BACK PAIN, URINARY ISSUES, DYSPAREUNIA). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIANTUBE(S)),"), DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CT SCAN SHOWED IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND UTERINE INFLAMMATION ("UTERUS INFLAMED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIAL ABLATION. CURRENT WEIGHT: 160 LBS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANON FROM 2008 TO (B)(6) 2011 AND ALESSE FROM 2006 TO 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, MENORRHAGIA, MENSES IRREGULAR, UTERINE ENLARGEMENT AND CONSTIPATION. IN (B)(6) 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINES/MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA/NAUSEA") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN LOWER BACK PAIN"), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"), URINARY TRACT INFECTION ("UTI'S"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:BACTERIAL INFECTIONS"). THE PATIENT WAS TREATED WITH IBUPROFEN, METRONIDAZOLE (FLAGYL), SURGERY (HYSTERECTOMY) AND DIET AND EXERCISE. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE INFLAMMATION, HEADACHE, MENSTRUAL DISORDER, URINARY TRACT INFECTION, BLADDER DISORDER, THE LAST EPISODE OF ABDOMINAL PAIN AND BACTERIAL INFECTION OUTCOME WAS UNKNOWN, THE DEVICE DISLOCATION, FATIGUE, BACK PAIN AND MIGRAINE WAS RESOLVING AND THE BACTERIAL VAGINOSIS, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, WEIGHT INCREASED AND URINARY TRACT DISORDER HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE INFLAMMATION, VAGINAL DISCHARGE, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE. LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. (B)(6) 2017 HYSTERECTOMY-REMOVAL OF ONLY ONE ESSURE DEVICE (OTHER HAD MIGRATED AND UNABLE TO REMOVE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 24.4 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: FULL OCCLUSION OF FALLOPIAN TUBE; ON (B)(6) 2015: RESULTS: MECHANICAL COMPLICATION DUE TO INTRAUTERINEDEVICE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: RESULTS: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS. CT SCAN SHOWED MIGRATION OF ESSURE DEVICE IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2018: PFS RECEIVED. UPDATED OUTCOME OF EVENTS(BACTERIAL VAGINOSIS, WEIGHT GAIN). UPDATED ONSET DATE OF EVENTS. 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIANTUBE(S)),"), DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: CT SCAN SHOWED IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY"), DEVICE BREAKAGE ("DEVICE BREAKAGE") AND UTERINE INFLAMMATION ("UTERUS INFLAMED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822376) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ENDOMETRIAL ABLATION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IMPLANT ON FROM 2008 TO (B)(6) 2011 AND ALESSE FROM 2006 TO 2007. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, MENORRHAGIA, MENSES IRREGULAR, UTERINE ENLARGEMENT AND CONSTIPATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES/MIGRAINES / HEADACHES"), FATIGUE ("FATIGUE/FATIGUE"), MIGRAINE ("MIGRAINES/MIGRAINES / HEADACHES"), NAUSEA ("NAUSEA/NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)/DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND WEIGHT INCREASED ("WEIGHT GAIN/WEIGHT GAIN / LOSS SPECIFY WHICH ONE: WEIGHT GAIN"). IN 2015, THE PATIENT EXPERIENCED BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: BACTERIAL VAGINOSIS") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE/VAGINAL DISCHARGE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), UTERINE INFLAMMATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("BACK PAIN LOWER BACK PAIN"), THE FIRST EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"), URINARY TRACT INFECTION ("UTI'S"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES,"), THE SECOND EPISODE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") AND BACTERIAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE:BACTERIAL INFECTIONS"). THE PATIENT WAS TREATED WITH IBUPROFEN, METRONIDAZOLE (FLAGYL), SURGERY (HYSTERECTOMY), SURGERY (HYSTERECTOMY) AND ALTERNATIVE THERAPY (DIET AND EXERCISE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE INFLAMMATION, HEADACHE, MENSTRUAL DISORDER, BACTERIAL VAGINOSIS, WEIGHT INCREASED, URINARY TRACT INFECTION, BLADDER DISORDER, THE LAST EPISODE OF ABDOMINAL PAIN AND BACTERIAL INFECTION OUTCOME WAS UNKNOWN, THE DEVICE DISLOCATION, FATIGUE, BACK PAIN AND MIGRAINE WAS RESOLVING AND THE NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE AND URINARY TRACT DISORDER HAD RESOLVED. THE REPORTER CONSIDERED BACK PAIN, BACTERIAL INFECTION, BACTERIAL VAGINOSIS, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, HEADACHE, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, UTERINE INFLAMMATION, VAGINAL DISCHARGE, WEIGHT INCREASED, THE FIRST EPISODE OF ABDOMINAL PAIN AND THE SECOND EPISODE OF ABDOMINAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH FALLOPIAN TUBES APPEAR LARGELY INTACT. NO COIL IS SEE PROTRUDING FROM THE SEROSAL SURFACE. LOOPS OF SPRING VISIBLE AFTER APPLICATION, ON THE LEFT SIDE = 4. ON THE RIGHT SIDE = 3. (B)(6) 2017 HYSTERECTOMY-REMOVAL OF ONLY ONE ESSURE DEVICE (OTHER HAD MIGRATED AND UNABLE TO REMOVE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 26 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2015: MECHANICAL COMPLICATION DUE TO INTRAUTERINEDEVICE; ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE. ULTRASOUND SCAN VAGINA - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. ON (B)(6) 2015 PATIENT HAD CT ABDOMEN RESULTED IN PATIENT IS STATUS POST ESSURE OCCLUSION OF THE FALLOPIAN TUBES. RIGHT COIL APPEARS IN RIGHT ADNEXA. THERE IS A TINY MARGINAL REMNANT IN THE LEFT ADNEXA WITH REMAINDER OF THE COIL IN THE CENTRAL MESENTERY JUST INFERIOR TO THE UMBILICUS. TINY INDETERMINATE LEFT RENAL CORTICAL HYPODENSITIES, TOO SMALL TO CHARACTERIZE BUT STATISTICALLY CYSTS. MIGRATION OF THE LEFT ESSURE FALLOPIAN TUBE OCCLUSION COIL INTO THE LOWER ABDOMINAL CENTRAL MESENTERY. QUESTIONABLE HETEROGENEOUS FIBROID UTERUS. CT SCAN SHOWED MIGRATION OF ESSURE DEVICE IN LOWER ABDOMINAL CENTRAL MESENTERY; COULD NOT BE LOCATED DURING REMOVAL SURGERY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD CONFIRMING EVENT: DEVICE DISLOCATION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-OCT-2018: UPDATE OF QUALITY-SAFETY EVALUATION OF PTC( FDA CODE UPDATES). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENSTRUAL DISORDER ("EXCESSIVE MENSTRUAL CYCLES AND ABNORMAL SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMIESHYSTERECTOMY TO REMOVE ESSURE). ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, HEADACHE, FATIGUE, BACK PAIN, ABDOMINAL PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, FATIGUE, HEADACHE, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: FULL OCCLUSION OF FALLOPIAN TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-SEP-2017: EVENT EXCESSIVE MENSTRUAL CYCLES ADDED AND ACTION TAKEN WITH DRUG UPDATED TO DRUG WITHDRAWN. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED") AND 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. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), HEADACHE ("HEADACHES"), FATIGUE ("FATIGUE"), BACK PAIN ("BACK PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTERECTOMY ON (B)(6) 2017). ONE OF THE ESSURE COILS WAS ONGOING AT THE TIME OF THE REPORT. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, HEADACHE, FATIGUE, BACK PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE DISLOCATION, FATIGUE, HEADACHE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ONE OF THE COILS MIGRATED TO HER ABDOMINAL CAVITY AND HAS NOT BEEN REMOVED 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.
#1 HYSTEROSALPINGOGRAM - FULL OCCLUSION OF FALLOPIAN TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692270 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 822376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |