ESSURE
Report
- Report Number
- 2951250-2023-02760
- Event Type
- Injury
- Date Received
- August 4, 2023
- Date of Event
- June 1, 2011
- Report Date
- August 11, 2023
- 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 01-AUG-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 10-AUG-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("IMPLANT MISSING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 356 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FOOD ALLERGY ("FOOD ALLERGIES (DEVELOPED NEW EXCESSIVE SENSITIVITY TO MANY FOODS)"), FATIGUE ("EXCESSIVE FATIGUE (STOPPED EXERCISING)"), VISUAL ACUITY REDUCED ("VISION PROBLEMS (DECREASED ACUITY AND SIGNIFICANT SENSITIVITY TO LIGHT)"), PHOTOPHOBIA ("VISION PROBLEMS (DECREASED ACUITY AND SIGNIFICANT SENSITIVITY TO LIGHT)"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), NAUSEA ("DAILY NAUSEA"), VOMITING ("VOMITING"), HEADACHE ("HEADACHES") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAI"), SERUM FERRITIN INCREASED ("FERRITIN LEVEL HIGH"), TRANSAMINASES INCREASED ("TRANSAMINASES LEVEL HIGH") AND GAMMA-GLUTAMYLTRANSFERASE INCREASED ("GAMMA-GLUTAMYL TRANSFER"). AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY TO REMOVE ESSURE ON (B)(6) 2022 (BILATERAL SALPINGECTOMY EXCISION OF AN ESSURE DEVICE THE ABDOMINAL WALL + TENSION-FREE VAGINAL TAPE AND HYSTERECTOMY WITH OVARIAN CONSERVATION IN 2013). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FOOD ALLERGY, FATIGUE, WEIGHT INCREASED, VISUAL ACUITY REDUCED, PHOTOPHOBIA, ARTHRALGIA, TENDON PAIN, SERUM FERRITIN INCREASED, TRANSAMINASES INCREASED, GAMMA-GLUTAMYLTRANSFERASE INCREASED, NAUSEA, VOMITING, HEADACHE, ALOPECIA, ABDOMINAL PAIN OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 90 KG. [GAMMA-GLUTAMYLTRANSFERASE] (DATE UNKNOWN): INCREASED. [SERUM FERRITIN] (DATE UNKNOWN): INCREASED. [TRANSAMINASES] (DATE UNKNOWN): TRANSAMINASES. 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: 10-AUG-2023: 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 01-AUG-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("IMPLANT MISSING") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 356 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ABDOMINAL PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FOOD ALLERGY ("FOOD ALLERGIES (DEVELOPED NEW EXCESSIVE SENSITIVITY TO MANY FOODS)"), FATIGUE ("EXCESSIVE FATIGUE (STOPPED EXERCISING)"), VISUAL ACUITY REDUCED ("VISION PROBLEMS (DECREASED ACUITY AND SIGNIFICANT SENSITIVITY TO LIGHT)"), PHOTOPHOBIA ("VISION PROBLEMS (DECREASED ACUITY AND SIGNIFICANT SENSITIVITY TO LIGHT)"), ARTHRALGIA ("JOINT PAIN"), TENDON PAIN ("TENDON PAIN"), NAUSEA ("DAILY NAUSEA"), VOMITING ("VOMITING"), HEADACHE ("HEADACHES") AND ALOPECIA ("HAIR LOSS") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAI"), SERUM FERRITIN INCREASED ("FERRITIN LEVEL HIGH"), TRANSAMINASES INCREASED ("TRANSAMINASES LEVEL HIGH") AND GAMMA-GLUTAMYLTRANSFERASE INCREASED ("GAMMA-GLUTAMYL TRANSFER"). ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY EXCISION OF AN ESSURE DEVICE THE ABDOMINAL WALL + TENSION-FREE VAGINAL TAPE AND HYSTERECTOMY WITH OVARIAN CONSERVATION IN 2013). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO FOOD ALLERGY, FATIGUE, WEIGHT INCREASED, VISUAL ACUITY REDUCED, PHOTOPHOBIA, ARTHRALGIA, TENDON PAIN, SERUM FERRITIN INCREASED, TRANSAMINASES INCREASED, GAMMA-GLUTAMYLTRANSFERASE INCREASED, NAUSEA, VOMITING, HEADACHE, ALOPECIA, ABDOMINAL PAIN OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 90 KG. [GAMMA-GLUTAMYLTRANSFERASE] (DATE UNKNOWN): INCREASED. [SERUM FERRITIN] (DATE UNKNOWN): INCREASED. [TRANSAMINASES] (DATE UNKNOWN): TRANSAMINASES. 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 |
|---|---|---|---|---|---|---|---|
| 960424 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention |