ESSURE
Report
- Report Number
- 2951250-2017-03309
- Event Type
- Injury
- Date Received
- September 1, 2017
- Date of Event
- January 1, 2016
- Report Date
- August 13, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ABDOMEN/ COIL IN ABDOMEN/THE LOCATION OF THE PERFORATION: ABDOMINAL WALL,") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D08054) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MICRONOR) SINCE (B)(6) 2016 AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING") AND IRRITABLE BOWEL SYNDROME ("IBS") WITH GASTROINTESTINAL PAIN AND ABDOMINAL DISTENSION. ON (B)(6) 2016, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). ON (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), VISION BLURRED ("BLURRED VISION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / SPOTTING IN BETWEEN PERIOD"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ARTHRALGIA ("JOINT PAIN/HIP PAIN"). IN 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANXIETY ("ANXIETY"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), LIBIDO DECREASED ("LIBIDO DECREASED"), ALOPECIA ("HAIR LOSS"), MENTAL IMPAIRMENT ("MENTAL FOGGINESS"), MOOD ALTERED ("MOODINESS"), HOT FLUSH ("HOT FLASHES"), NIGHT SWEATS ("NIGHT SWEATS"), VARICOSE VEINS VAGINAL ("VULVOVAGINAL VARICOSITIES") AND PELVIC CONGESTION ("PELVIC CONGESTION SYNDROME"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FLUSHING ("INTERMITTENT FLUSHING"), MUSCULOSKELETAL DISCOMFORT ("RIGHT POSTERIOR HIP AND LOW BACK DISCOMFORT"), PAIN ("PAINS THROUGHOUT BODY") AND BACK PAIN ("LOW BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (B)(6) 2016 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FEELING ABNORMAL, MOOD SWINGS, FATIGUE, VISION BLURRED, FEMALE SEXUAL DYSFUNCTION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, ABDOMINAL PAIN LOWER, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, FLUSHING, MUSCULOSKELETAL DISCOMFORT, PAIN, MENTAL IMPAIRMENT, MOOD ALTERED, HOT FLUSH, NIGHT SWEATS, VARICOSE VEINS VAGINAL, PELVIC CONGESTION AND BACK PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED AND ALOPECIA HAD RESOLVED AND THE ARTHRALGIA AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FLUSHING, HEADACHE, HOT FLUSH, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, MENORRHAGIA, MENTAL IMPAIRMENT, MIGRAINE, MOOD ALTERED, MOOD SWINGS, MUSCULOSKELETAL DISCOMFORT, NAUSEA, NIGHT SWEATS, PAIN, PELVIC CONGESTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VARICOSE VEINS VAGINAL, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 131 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IT WAS SUCCESSFUL AND MY TUBES WERE CLOSED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-2018: PFS RECEIVED. EVENTS: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: COIL FOUND IN RIGHT UPPER ABDOMEN WERE UPDATED TO PERFORATION OF ORGAN, MOODINESS, HOT FLASHES AND NIGHT SWEATS,VULVOVAGINAL VARICOSITIES AND PELVIC CONGESTION SYNDROME WERE ADDED. CONCOMITANT DISEASE 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ABDOMEN/ COIL IN ABDOMEN/THE LOCATION OF THE PERFORATION: ABDOMINAL WALL,") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D08054) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MICRONOR) SINCE (B)(6) 2016 AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING") AND IRRITABLE BOWEL SYNDROME ("IBS") WITH GASTROINTESTINAL PAIN AND ABDOMINAL DISTENSION. ON (B)(6) 2016, 28 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED HEADACHE ("HEADACHES"). ON (B)(6) 2016, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), VISION BLURRED ("BLURRED VISION"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / SPOTTING IN BETWEEN PERIOD"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND ARTHRALGIA ("JOINT PAIN/HIP PAIN"). IN 2016, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANXIETY ("ANXIETY"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), LIBIDO DECREASED ("LIBIDO DECREASED"), ALOPECIA ("HAIR LOSS"), MENTAL IMPAIRMENT ("MENTAL FOGGINESS"), MOOD ALTERED ("MOODINESS"), HOT FLUSH ("HOT FLASHES"), NIGHT SWEATS ("NIGHT SWEATS"), VARICOSE VEINS VAGINAL ("VULVOVAGINAL VARICOSITIES") AND PELVIC CONGESTION ("PELVIC CONGESTION SYNDROME"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FLUSHING ("INTERMITTENT FLUSHING"), MUSCULOSKELETAL DISCOMFORT ("RIGHT POSTERIOR HIP AND LOW BACK DISCOMFORT"), PAIN ("PAINS THROUGHOUT BODY") AND BACK PAIN ("LOW BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (B)(6) 2016 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FEELING ABNORMAL, MOOD SWINGS, FATIGUE, VISION BLURRED, FEMALE SEXUAL DYSFUNCTION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, ABDOMINAL PAIN LOWER, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, FLUSHING, MUSCULOSKELETAL DISCOMFORT, PAIN, MENTAL IMPAIRMENT, MOOD ALTERED, HOT FLUSH, NIGHT SWEATS, VARICOSE VEINS VAGINAL, PELVIC CONGESTION AND BACK PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE, MENORRHAGIA, WEIGHT INCREASED AND ALOPECIA HAD RESOLVED AND THE ARTHRALGIA AND HEADACHE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FLUSHING, HEADACHE, HOT FLUSH, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, MENORRHAGIA, MENTAL IMPAIRMENT, MIGRAINE, MOOD ALTERED, MOOD SWINGS, MUSCULOSKELETAL DISCOMFORT, NAUSEA, NIGHT SWEATS, PAIN, PELVIC CONGESTION, UTERINE PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VARICOSE VEINS VAGINAL, VISION BLURRED AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CURRENT WEIGHT 131 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IT WAS SUCCESSFUL AND MY TUBES WERE CLOSED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-AUG-2018: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAIN). 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 ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ABDOMEN/ COIL IN ABDOMEN") AND PERFORATION ("PERFORATION") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D08054) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL. CONCOMITANT PRODUCTS INCLUDED NORETHISTERONE (MICRONOR) SINCE (B)(6) 2016 AND NORETHISTERONE (MINI-PILL). ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("CRAMPING") AND IRRITABLE BOWEL SYNDROME ("IBS") WITH GASTROINTESTINAL PAIN AND ABDOMINAL DISTENSION. IN 2016, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), FATIGUE ("FATIGUE"), VISION BLURRED ("BLURRED VISION"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)"), ANXIETY ("ANXIETY"), MIGRAINE ("MIGRAINES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), WEIGHT INCREASED ("WEIGHT GAIN"), ALOPECIA ("HAIR LOSS") AND ARTHRALGIA ("JOINT PAIN/ HIP PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL) / SPOTTING IN BETWEEN PERIOD"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"), LIBIDO DECREASED ("LIBIDO DECREASED"), FLUSHING ("INTERMITTENT FLUSHING"), THE FIRST EPISODE OF MENTAL IMPAIRMENT ("MENTAL FOGGINESS"), MUSCULOSKELETAL DISCOMFORT ("RIGHT POSTERIOR HIP AND LOW BACK DISCOMFORT"), PAIN ("PAINS THROUGHOUT BODY") AND THE SECOND EPISODE OF MENTAL IMPAIRMENT ("MENTAL FOGGINESS"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2016 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY ((B)(6) 2016 HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PERFORATION, FEELING ABNORMAL, MOOD SWINGS, FATIGUE, VISION BLURRED, VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION, ANXIETY, MIGRAINE, NAUSEA, DYSMENORRHOEA, VAGINAL DISCHARGE, WEIGHT INCREASED, ABDOMINAL PAIN LOWER, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, FLUSHING, MUSCULOSKELETAL DISCOMFORT, ALOPECIA, PAIN AND THE LAST EPISODE OF MENTAL IMPAIRMENT OUTCOME WAS UNKNOWN AND THE ARTHRALGIA WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, ARTHRALGIA, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEELING ABNORMAL, FEMALE SEXUAL DYSFUNCTION, FLUSHING, IRRITABLE BOWEL SYNDROME, LIBIDO DECREASED, MENORRHAGIA, MIGRAINE, MOOD SWINGS, MUSCULOSKELETAL DISCOMFORT, NAUSEA, PAIN, PERFORATION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, VISION BLURRED, WEIGHT INCREASED, THE FIRST EPISODE OF MENTAL IMPAIRMENT AND THE SECOND EPISODE OF MENTAL IMPAIRMENT TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.2 KG/SQM. ULTRASOUND SCAN VAGINA - ON (B)(6) 2016: IT WAS SUCCESSFUL AND MY TUBES WERE CLOSED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 02-APR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED AND CASE UPDATED TO MEDICALLY CONFIRM. PATIENT¿S DEMOGRAPHICS, CONCOMITANT DISEASE AND CONCOMITANT MEDICATIONS ADDED. ESSURE LOT NUMBER AND INDICATION ADDED. NEW EVENTS MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT UPPER ABDOMEN/ COIL IN ABDOMEN WITH PAIN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA, (INABILITY TO HAVE SEXUAL INTERCOURSE) ANXIETY, MIGRAINES / HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, BLURRED VISION, FATIGUE, WEIGHT GAIN, CRAMPING, IBS WITH BLOATING IN ABDOMEN AND LOWER BOWEL PAIN, JOINT PAIN, PAINS THROUGHOUT BODY; DECREASED LIBIDO; CRAMPING; INTERMITTENT FLUSHING; MENTAL FOGGINESS; RIGHT POSTERIOR HIP AND LOW BACK DISCOMFORT, HAIR LOSS 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. IN 2016, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FEELING ABNORMAL ("BRAIN FOG"), MOOD SWINGS ("MOOD SWINGS"), FATIGUE ("FATIGUE") AND VISION BLURRED ("BLURRED VISION"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FEELING ABNORMAL, MOOD SWINGS, FATIGUE AND VISION BLURRED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FATIGUE, FEELING ABNORMAL, MOOD SWINGS, PELVIC PAIN AND VISION BLURRED 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 |
|---|---|---|---|---|---|---|---|
| 617652 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D08054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | MICRONOR.| MICRONOR.| MICRONOR.| MINI-PILL.| MINI-PILL.| MINI-PILL. |