ESSURE
Report
- Report Number
- 2951250-2024-00230
- Event Type
- Injury
- Date Received
- April 4, 2024
- Report Date
- April 9, 2024
- 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 27-MAR-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 05-APR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 910516). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2020. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("SEVERE FATIGUE"), DISTURBANCE IN ATTENTION ("LACK OF CONCENTRATION"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCE"), SKIN ODOUR ABNORMAL ("BODY ODOUR"), MIGRAINE ("MIGRAINE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), HEAVY MENSTRUAL BLEEDING ("HEAVY FLOW"), PARAESTHESIA ("FEELING OF NEEDLES IN THE ABDOMEN, KIDNEYS, FEMORAL ARTERY"), DYSPEPSIA ("HEARTBURN"), ARTHRALGIA ("JOINT AND MUSCLE PAIN (BACK, NECK, SHOULDERS, ARM, HAND, HIP)"), HYPERHIDROSIS ("EXCESSIVE SWEATING"), NAUSEA ("NAUSEA"), VERTIGO ("VERTIGO"), FEELING HOT ("HOT BODY"), TRIGEMINAL NEURALGIA ("TRIGEMINAL NEURALGIA"), CHEST PAIN ("SHARP PAIN IN THE CHEST"), PALPITATIONS ("PALPITATION"), DYSPNOEA ("SHORTNESS OF BREATH"), EAR PAIN ("PAIN IN THE LEFT EAR"), TINNITUS ("TINNITUS"), DRY EYE ("DRY EYES"), POLLAKIURIA ("URINATION TOO FREQUENT"), URINARY INCONTINENCE ("URINARY INCONTINENCE"), VISUAL IMPAIRMENT ("VISION DISTURBANCE"), INSOMNIA ("INSOMNIA"), DRY SKIN ("VERY DRY SKIN"), ROSACEA ("ROSACEA"), PERIPHERAL SWELLING ("SWOLLEN LEG"), BURNING FOOT ("BURNING UNDER THE FEET"), PRURITUS ("ITCHING (NECK, FOREHEAD, AXILLAE, EYELASHES)"), EAR PRURITUS ("ITCHING BEHIND AND INSIDE THE EARS"), ALOPECIA ("HAIR LOSS"), BREAST PAIN ("PAIN IN THE BREASTS"), MUSCLE SPASMS ("SPASMS"), TOOTHACHE ("TOOTHACHE"), FLATULENCE ("EXCESSIVE FLATULENCE"), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING"), ABDOMINAL PAIN UPPER ("GASTRIC PAIN"), FEELING DRUNK ("FEELING OF DRUNKENNESS"), NASAL DRYNESS ("DRY NOSE"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), PAIN ("PAIN SIMILAR TO FIBROMYALGIA"), HYPERSENSITIVITY ("ELECTRICAL HYPERSENSITIVITY"), BURNING SENSATION ("BURNING"), EYE PRURITUS ("ITCHY EYES") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("DIFFICULTY HOLDING A PENCIL, THE PHONE, AN OBJECT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL, HYSTERECTOMY ON (B)(6) 2020, ADNEXECTOMY IN (B)(6) 2024). NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FATIGUE, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, SKIN ODOUR ABNORMAL, MIGRAINE, ABDOMINAL PAIN, DYSPAREUNIA, HEAVY MENSTRUAL BLEEDING, PARAESTHESIA, DYSPEPSIA, ARTHRALGIA, HYPERHIDROSIS, NAUSEA, VERTIGO, FEELING HOT, TRIGEMINAL NEURALGIA, CHEST PAIN, PALPITATIONS, DYSPNOEA, EAR PAIN, TINNITUS, DRY EYE, POLLAKIURIA, URINARY INCONTINENCE, VISUAL IMPAIRMENT, INSOMNIA, DRY SKIN, ROSACEA, PERIPHERAL SWELLING, BURNING FOOT, PRURITUS, ALOPECIA, BREAST PAIN, MUSCLE SPASMS, TOOTHACHE, FLATULENCE, ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED, FEELING DRUNK, NASAL DRYNESS, LOSS OF LIBIDO, PAIN, HYPERSENSITIVITY, BURNING SENSATION, EYE PRURITUS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OR EAR PRURITUS. LOT NUMBER: 910516. MANUFACTURE DATE: 2011-10. EXPIRATION DATE: 2014-10. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 05-APR-2024: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(6) ON 27-MAR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("ABDOMINAL PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 910516). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2020. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("SEVERE FATIGUE"), DISTURBANCE IN ATTENTION ("LACK OF CONCENTRATION"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCE"), SKIN ODOUR ABNORMAL ("BODY ODOUR"), MIGRAINE ("MIGRAINE"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), HEAVY MENSTRUAL BLEEDING ("HEAVY FLOW"), PARAESTHESIA ("FEELING OF NEEDLES IN THE ABDOMEN, KIDNEYS, FEMORAL ARTERY"), DYSPEPSIA ("HEARTBURN"), ARTHRALGIA ("JOINT AND MUSCLE PAIN (BACK, NECK, SHOULDERS, ARM, HAND, HIP)"), HYPERHIDROSIS ("EXCESSIVE SWEATING"), NAUSEA ("NAUSEA"), VERTIGO ("VERTIGO"), FEELING HOT ("HOT BODY"), TRIGEMINAL NEURALGIA ("TRIGEMINAL NEURALGIA"), CHEST PAIN ("SHARP PAIN IN THE CHEST"), PALPITATIONS ("PALPITATION"), DYSPNOEA ("SHORTNESS OF BREATH"), EAR PAIN ("PAIN IN THE LEFT EAR"), TINNITUS ("TINNITUS"), DRY EYE ("DRY EYES"), POLLAKIURIA ("URINATION TOO FREQUENT"), URINARY INCONTINENCE ("URINARY INCONTINENCE"), VISUAL IMPAIRMENT ("VISION DISTURBANCE"), INSOMNIA ("INSOMNIA"), DRY SKIN ("VERY DRY SKIN"), ROSACEA ("ROSACEA"), PERIPHERAL SWELLING ("SWOLLEN LEG"), BURNING FOOT ("BURNING UNDER THE FEET"), PRURITUS ("ITCHING (NECK, FOREHEAD, AXILLAE, EYELASHES)"), EAR PRURITUS ("ITCHING BEHIND AND INSIDE THE EARS"), ALOPECIA ("HAIR LOSS"), BREAST PAIN ("PAIN IN THE BREASTS"), MUSCLE SPASMS ("SPASMS"), TOOTHACHE ("TOOTHACHE"), FLATULENCE ("EXCESSIVE FLATULENCE"), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING"), ABDOMINAL PAIN UPPER ("GASTRIC PAIN"), FEELING DRUNK ("FEELING OF DRUNKENNESS"), NASAL DRYNESS ("DRY NOSE"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), PAIN ("PAIN SIMILAR TO FIBROMYALGIA"), HYPERSENSITIVITY ("ELECTRICAL HYPERSENSITIVITY"), BURNING SENSATION ("BURNING"), EYE PRURITUS ("ITCHY EYES") AND LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("DIFFICULTY HOLDING A PENCIL, THE PHONE, AN OBJECT") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE WAS REMOVED ON (B)(6)2020. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL, HYSTERECTOMY ON (B)(6) 2020, ADNEXECTOMY IN (B)(6) 2024). NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FATIGUE, DISTURBANCE IN ATTENTION, MEMORY IMPAIRMENT, SKIN ODOUR ABNORMAL, MIGRAINE, ABDOMINAL PAIN, DYSPAREUNIA, HEAVY MENSTRUAL BLEEDING, PARAESTHESIA, DYSPEPSIA, ARTHRALGIA, HYPERHIDROSIS, NAUSEA, VERTIGO, FEELING HOT, TRIGEMINAL NEURALGIA, CHEST PAIN, PALPITATIONS, DYSPNOEA, EAR PAIN, TINNITUS, DRY EYE, POLLAKIURIA, URINARY INCONTINENCE, VISUAL IMPAIRMENT, INSOMNIA, DRY SKIN, ROSACEA, PERIPHERAL SWELLING, BURNING FOOT, PRURITUS, ALOPECIA, BREAST PAIN, MUSCLE SPASMS, TOOTHACHE, FLATULENCE, ABDOMINAL DISTENSION, ABDOMINAL PAIN UPPER, WEIGHT INCREASED, FEELING DRUNK, NASAL DRYNESS, LOSS OF LIBIDO, PAIN, HYPERSENSITIVITY, BURNING SENSATION, EYE PRURITUS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OR EAR PRURITUS. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2334956 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 910516 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |