ESSURE
Report
- Report Number
- 2951250-2017-07058
- Event Type
- Injury
- Date Received
- November 23, 2017
- Report Date
- October 24, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), FALLOPIAN TUBE PERFORATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERFORATED FROM MY FALLOPIAN TUBE"), MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: MULTIPLE SCLEROSIS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NUMBNESS AND HEMORRHAGIC CYST. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION,"), HEADACHE ("HEADACHES,"), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: JOINT PAIN"), MIGRAINE ("MIGRAINES"), NEUROPATHY PERIPHERAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: NEUROPATHY"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, FALLOPIAN TUBE PERFORATION, MULTIPLE SCLEROSIS, FATIGUE, ALOPECIA, DEPRESSION, HEADACHE, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, URINARY TRACT INFECTION, ARTHRALGIA, MIGRAINE, NEUROPATHY PERIPHERAL, DYSMENORRHOEA, VAGINAL DISCHARGE AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MULTIPLE SCLEROSIS, NEUROPATHY PERIPHERAL, PERFORATION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2012: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS+MR RECEIVED: NEW EVENTS: GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, URINARY TRACT INFECTION, MIGRAINE, HEADACHE, NEUROPATHY PERIPHERAL, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, ABDOMINAL PAIN LOWER WERE ADDED AND PREVIOUSLY REPORTED EVENTS DEVICE DISLOCATION AND AUTOIMMUNE DISORDER WERE UPDATED TO FALLOPIAN TUBE PERFORATION AND MULTIPLE SCLEROSIS, RESPECTIVELY. REPORTER, PATIENT DEMOGRAPHIC INFORMATION, CONCOMITANT DISEASES, PRODUCT LOT NUMBER, LAB DATA 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.
CONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), FALLOPIAN TUBE PERFORATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERFORATED FROM MY FALLOPIAN TUBE"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING (GENERAL)"), NEUROPATHY PERIPHERAL ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: NEUROPATHY") AND MULTIPLE SCLEROSIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: MULTIPLE SCLEROSIS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NUMBNESS AND HEMORRHAGIC CYST. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), NEUROPATHY PERIPHERAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION,"), HEADACHE ("HEADACHES,"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: JOINT PAIN"), MIGRAINE ("MIGRAINES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY) AND SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, NEUROPATHY PERIPHERAL, MULTIPLE SCLEROSIS, FATIGUE, ALOPECIA, DEPRESSION, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, URINARY TRACT INFECTION, ARTHRALGIA, MIGRAINE, DYSMENORRHOEA, VAGINAL DISCHARGE AND DYSPAREUNIA OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, MULTIPLE SCLEROSIS, NEUROPATHY PERIPHERAL, PERFORATION, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2012: TOTAL BILATERAL OCCLUSION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('PERFORATION OF ORGANS'), FALLOPIAN TUBE PERFORATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: PERFORATED FROM MY FALLOPIAN TUBE'), GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING (GENERAL)'), NEUROPATHY PERIPHERAL ('NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: NEUROPATHY/ NEUROPATHY'), MULTIPLE SCLEROSIS ('AUTOIMMUNE DISORDER TYPE OF DISORDER: MULTIPLE SCLEROSIS') AND TRANSIENT ISCHAEMIC ATTACK ('TIA') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893037) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED NUMBNESS AND HEMORRHAGIC CYST. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES/ MIGRAINES/HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), ARTHRALGIA ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: JOINT PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE),") AND PELVIC DISCOMFORT ("PELVIC PRESSURE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED NEUROPATHY PERIPHERAL (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND FATIGUE ("FATIGUE,"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 1 YEAR 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), TRANSIENT ISCHAEMIC ATTACK (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ALOPECIA ("HAIR LOSS"), DEPRESSION ("DEPRESSION,"), HEADACHE ("HEADACHES,"), URINARY TRACT INFECTION ("INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE: URINARY TRACT"), ABDOMINAL PAIN LOWER ("LOWER ABDOMEN PAIN"), FEELING ABNORMAL ("BRAIN FOG"), DEVICE EXPULSION ("HAVE ONE IN PLACE AND OTHER IS IN UTERUS"), HYPOAESTHESIA ("NUMBNESS OF ANY EXTREMITIES"), PARAESTHESIA ("TINGLING OF ANY EXTREMITIES"), VISION BLURRED ("BLURRED VISION"), BALANCE DISORDER ("BALANCE ISSUES"), BONE PAIN ("DEEP BONE PAIN") AND VERTIGO ("VERTIGO"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, NEUROPATHY PERIPHERAL, MULTIPLE SCLEROSIS, TRANSIENT ISCHAEMIC ATTACK, FATIGUE, ALOPECIA, DEPRESSION, HEADACHE, VAGINAL HAEMORRHAGE, MENORRHAGIA, VAGINAL INFECTION, URINARY TRACT INFECTION, ARTHRALGIA, MIGRAINE, DYSMENORRHOEA, VAGINAL DISCHARGE, DYSPAREUNIA, FEELING ABNORMAL, PELVIC DISCOMFORT, DEVICE EXPULSION, HYPOAESTHESIA, PARAESTHESIA, VISION BLURRED, BALANCE DISORDER, BONE PAIN AND VERTIGO OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ARTHRALGIA, BALANCE DISORDER, BONE PAIN, DEPRESSION, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, FEELING ABNORMAL, GENITAL HAEMORRHAGE, HEADACHE, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, MULTIPLE SCLEROSIS, NEUROPATHY PERIPHERAL, PARAESTHESIA, PELVIC DISCOMFORT, PERFORATION, TRANSIENT ISCHAEMIC ATTACK, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, VERTIGO AND VISION BLURRED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: ONE COIL HAS MIGRATED INTO MY UTERUS. HYSTEROSALPINGOGRAM - IN 2012: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE REPORTED VIA SOCIAL MEDIA: BRAIN FOG, PELVIC PRESSURE, HAVE ONE IN PLACE AND OTHER IS IN UTERUS AND TIA, NUMBNESS OF ANY EXTREMITIES, TINGLING OF ANY EXTREMITIES, BLURRED VISION, BALANCE ISSUES, DEEP BONE PAIN AND VERTIGO. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2019: SOCIAL MEDIA RECEIVED. EVENTS BRAIN FOG, PELVIC PRESSURE, HAVE ONE IN PLACE AND OTHER IS IN UTERUS AND TIA, NUMBNESS OF ANY EXTREMITIES, TINGLING OF ANY EXTREMITIES, BLURRED VISION, BALANCE ISSUES, DEEP BONE PAIN AND VERTIGO WERE ADDED. LABORATORY DATA WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION OF ORGANS"), DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") 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 PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), FATIGUE ("FATIGUE,"), ALOPECIA ("HAIR LOSS") AND DEPRESSION ("DEPRESSION,"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT) AND SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, AUTOIMMUNE DISORDER, FATIGUE, ALOPECIA AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, AUTOIMMUNE DISORDER, DEPRESSION, DEVICE DISLOCATION, FATIGUE AND PERFORATION 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 |
|---|---|---|---|---|---|---|---|
| 835641 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R |