ESSURE
Report
- Report Number
- 2951250-2022-01093
- Event Type
- Injury
- Date Received
- September 19, 2022
- Date of Event
- October 10, 2012
- Report Date
- September 23, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 14-SEP-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-SEP-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIS PAIN") IN A 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 394 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE"), MYALGIA ("MUSCLE PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), TOOTH LOSS ("TOOTH LOSS"), ALOPECIA ("HAIR LOSS"), EAR PRURITUS ("ITCHING IN THE EAR CANAL"), OEDEMA ("OEDEMA"), DRY SKIN ("DRY SKIN"), DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING"), MEMORY IMPAIRMENT ("DIFFICULTY REMEMBERING THINGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING"), MUSCULOSKELETAL STIFFNESS ("STIFFNESS"), MUSCULAR WEAKNESS ("DROPPING OBJECTS"), BURNING SENSATION ("BURNING IN THE BODY, BURN OUT"), DIZZINESS ("DIZZINESS"), VISUAL IMPAIRMENT ("VISION DISORDERS"), SLEEP DISORDER ("SLEEP DISORDERS"), LANGUAGE DISORDER ("LANGUAGE DISORDER, STRUGGLING TO FIND MY WORDS"), ARRHYTHMIA ("HEART RHYTHM DISORDER"), CONSTIPATION ("CONSTIPATION,"), FLATULENCE ("FLATULENCE"), OEDEMA PERIPHERAL ("HAND AND FOOT OEDEMA"), ARTHRALGIA ("HIP PAIN"), SACRAL PAIN ("SACRAL PAIN") AND ABDOMINAL PAIN UPPER ("GASTRIC PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED HYPERTENSION ("HYPERTENSION") AND DIABETES MELLITUS ("DIABETES") AND WAS FOUND TO HAVE BLOOD CHOLESTEROL ("CHOLESTEROL"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY PERFORMED). AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, MYALGIA, FIBROMYALGIA, TOOTH LOSS, ALOPECIA, EAR PRURITUS, OEDEMA, DRY SKIN, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, MUSCULAR WEAKNESS, BURNING SENSATION, DIZZINESS, VISUAL IMPAIRMENT, SLEEP DISORDER, WEIGHT INCREASED, LANGUAGE DISORDER, ARRHYTHMIA, CONSTIPATION, FLATULENCE, OEDEMA PERIPHERAL, ARTHRALGIA, SACRAL PAIN AND ABDOMINAL PAIN UPPER HAD NOT RESOLVED. THE OUTCOMES FOR HYPERTENSION, BLOOD CHOLESTEROL AND DIABETES MELLITUS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALOPECIA, ARRHYTHMIA, ARTHRALGIA, BLOOD CHOLESTEROL, BURNING SENSATION, CONSTIPATION, DIABETES MELLITUS, DISTURBANCE IN ATTENTION, DIZZINESS, DRY SKIN, EAR PRURITUS, FATIGUE, FIBROMYALGIA, FLATULENCE, GAIT DISTURBANCE, HYPERTENSION, LANGUAGE DISORDER, MEMORY IMPAIRMENT, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, MYALGIA, OEDEMA, OEDEMA PERIPHERAL, PELVIC PAIN, SACRAL PAIN, SLEEP DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 91 KG. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 22-SEP-2022: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON (B)(6) 2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIS PAIN") IN A 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 394 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE"), MYALGIA ("MUSCLE PAIN"), FIBROMYALGIA ("FIBROMYALGIA"), TOOTH LOSS ("TOOTH LOSS"), ALOPECIA ("HAIR LOSS"), EAR PRURITUS ("ITCHING IN THE EAR CANAL"), OEDEMA ("OEDEMA"), DRY SKIN ("DRY SKIN"), DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING"), MEMORY IMPAIRMENT ("DIFFICULTY REMEMBERING THINGS"), GAIT DISTURBANCE ("DIFFICULTY WALKING"), MUSCULOSKELETAL STIFFNESS ("STIFFNESS"), MUSCULAR WEAKNESS ("DROPPING OBJECTS"), BURNING SENSATION ("BURNING IN THE BODY, BURN OUT"), DIZZINESS ("DIZZINESS"), VISUAL IMPAIRMENT ("VISION DISORDERS"), SLEEP DISORDER ("SLEEP DISORDERS"), LANGUAGE DISORDER ("LANGUAGE DISORDER, STRUGGLING TO FIND MY WORDS"), ARRHYTHMIA ("HEART RHYTHM DISORDER"), CONSTIPATION ("CONSTIPATION,"), FLATULENCE ("FLATULENCE"), OEDEMA PERIPHERAL ("HAND AND FOOT OEDEMA"), ARTHRALGIA ("HIP PAIN"), SACRAL PAIN ("SACRAL PAIN") AND ABDOMINAL PAIN UPPER ("GASTRIC PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED HYPERTENSION ("HYPERTENSION") AND DIABETES MELLITUS ("DIABETES") AND WAS FOUND TO HAVE BLOOD CHOLESTEROL ("CHOLESTEROL"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY PERFORMED). AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE, MYALGIA, FIBROMYALGIA, TOOTH LOSS, ALOPECIA, EAR PRURITUS, OEDEMA, DRY SKIN, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, MUSCULAR WEAKNESS, BURNING SENSATION, DIZZINESS, VISUAL IMPAIRMENT, SLEEP DISORDER, WEIGHT INCREASED, LANGUAGE DISORDER, ARRHYTHMIA, CONSTIPATION, FLATULENCE, OEDEMA PERIPHERAL, ARTHRALGIA, SACRAL PAIN AND ABDOMINAL PAIN UPPER HAD NOT RESOLVED. THE OUTCOMES FOR HYPERTENSION, BLOOD CHOLESTEROL AND DIABETES MELLITUS WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALOPECIA, ARRHYTHMIA, ARTHRALGIA, BLOOD CHOLESTEROL, BURNING SENSATION, CONSTIPATION, DIABETES MELLITUS, DISTURBANCE IN ATTENTION, DIZZINESS, DRY SKIN, EAR PRURITUS, FATIGUE, FIBROMYALGIA, FLATULENCE, GAIT DISTURBANCE, HYPERTENSION, LANGUAGE DISORDER, MEMORY IMPAIRMENT, MUSCULAR WEAKNESS, MUSCULOSKELETAL STIFFNESS, MYALGIA, OEDEMA, OEDEMA PERIPHERAL, PELVIC PAIN, SACRAL PAIN, SLEEP DISORDER, TOOTH LOSS, VISUAL IMPAIRMENT AND WEIGHT INCREASED TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 91 KG. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250028 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Other| R |