ESSURE
Report
- Report Number
- 2951250-2025-00558
- Event Type
- Injury
- Date Received
- September 10, 2025
- Date of Event
- April 1, 2014
- Report Date
- September 17, 2025
- 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
BAYER CASE NUMBER: (B)(4) HAEMORRHAGIC PERIODS [HEAVY PERIODS], ABDOMINAL SWELLING [SWELLING ABDOMEN] , ABDOMINAL HEAVINESS [ABDOMINAL DISCOMFORT] , EXCESSIVE FLATULENCE [EXCESSIVE FLATULENCE] , ALTERNATING CONSTIPATION AND DIARRHOEA [ALTERNATION BETWEEN CONSTIPATION AND DIARRHOEA], FATIGUE [FATIGUE] , SHINGLES [SHINGLES] , MIGRAINES [MIGRAINE] , INSOMNIA [INSOMNIA] , TENDENCY TO DEPRESSION [DEPRESSION] , DIFFICULTY CONCENTRATING [CONCENTRATION IMPAIRMENT] , BLURRED VISION [BLURRED VISION] , STIFFNESS IN THE NECK [NECK STIFFNESS] , STIFFNESS IN TENDON [TENDON DISORDER] , INCONTINENCE [INCONTINENCE] , FREQUENT URINATION [FREQUENCY URINARY] , LOOSE TEETH [LOOSE TOOTH] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 05-SEP-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 13-SEP-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") IN A 44-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50758783) 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) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 53 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING"), ABDOMINAL DISCOMFORT ("ABDOMINAL HEAVINESS"), FLATULENCE ("EXCESSIVE FLATULENCE"), GASTROINTESTINAL MOTILITY DISORDER ("ALTERNATING CONSTIPATION AND DIARRHOEA"), FATIGUE ("FATIGUE"), HERPES ZOSTER ("SHINGLES"), MIGRAINE ("MIGRAINES"), INSOMNIA ("INSOMNIA"), DEPRESSION (" TENDENCY TO DEPRESSION"), DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING"), VISION BLURRED (" BLURRED VISION"), MUSCULOSKELETAL STIFFNESS ("STIFFNESS IN THE NECK "), TENDON DISORDER ("STIFFNESS IN TENDON"), INCONTINENCE ("INCONTINENCE"), POLLAKIURIA ("FREQUENT URINATION ") AND LOOSE TOOTH ("LOOSE TEETH"). AT THE TIME OF THE REPORT, THE FATIGUE AND INSOMNIA HAD NOT RESOLVED. THE OUTCOMES FOR HEAVY MENSTRUAL BLEEDING, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, FLATULENCE, GASTROINTESTINAL MOTILITY DISORDER, HERPES ZOSTER, MIGRAINE, DEPRESSION, DISTURBANCE IN ATTENTION, VISION BLURRED, MUSCULOSKELETAL STIFFNESS, TENDON DISORDER, INCONTINENCE, POLLAKIURIA AND LOOSE TOOTH WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, FLATULENCE, GASTROINTESTINAL MOTILITY DISORDER, FATIGUE, HERPES ZOSTER, MIGRAINE, INSOMNIA, DEPRESSION, DISTURBANCE IN ATTENTION, VISION BLURRED, MUSCULOSKELETAL STIFFNESS, TENDON DISORDER, INCONTINENCE, POLLAKIURIA OR LOOSE TOOTH. THE REPORTER COMMENTED: CURRENT CONDITION OF THE FEMALE PATIENT: ALTHOUGH I AM IN GOOD PHYSICAL CONDITION, I FEEL VERY TIRED DUE TO INSOMNIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 46 KG. BATCH NUMBER 50758783, MANUFACTURE DATE 2013-09-30, EXPIRATION DATE 2016-09-30. 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: 13-SEP-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4). HAEMORRHAGIC PERIODS [HEAVY PERIODS]. ABDOMINAL SWELLING [SWELLING ABDOMEN]. ABDOMINAL HEAVINESS [ABDOMINAL DISCOMFORT]. EXCESSIVE FLATULENCE [EXCESSIVE FLATULENCE]. ALTERNATING CONSTIPATION AND DIARRHOEA [ALTERNATION BETWEEN CONSTIPATION AND DIARRHOEA]. FATIGUE [FATIGUE]. SHINGLES [SHINGLES]. MIGRAINES [MIGRAINE]. INSOMNIA [INSOMNIA]. TENDENCY TO DEPRESSION [DEPRESSION]. DIFFICULTY CONCENTRATING [CONCENTRATION IMPAIRMENT]. BLURRED VISION [BLURRED VISION]. STIFFNESS IN THE NECK [NECK STIFFNESS]. STIFFNESS IN TENDON [TENDON DISORDER]. INCONTINENCE [INCONTINENCE]. FREQUENT URINATION [FREQUENCY URINARY]. LOOSE TEETH [LOOSE TOOTH]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON (B)(6) 2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") IN A 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 50758783) 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) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 53 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ABDOMINAL DISTENSION ("ABDOMINAL SWELLING"), ABDOMINAL DISCOMFORT ("ABDOMINAL HEAVINESS"), FLATULENCE ("EXCESSIVE FLATULENCE"), GASTROINTESTINAL MOTILITY DISORDER ("ALTERNATING CONSTIPATION AND DIARRHOEA"), FATIGUE ("FATIGUE"), HERPES ZOSTER ("SHINGLES"), MIGRAINE ("MIGRAINES"), INSOMNIA ("INSOMNIA"), DEPRESSION (" TENDENCY TO DEPRESSION"), DISTURBANCE IN ATTENTION ("DIFFICULTY CONCENTRATING"), VISION BLURRED (" BLURRED VISION"), MUSCULOSKELETAL STIFFNESS ("STIFFNESS IN THE NECK "), TENDON DISORDER ("STIFFNESS IN TENDON"), INCONTINENCE ("INCONTINENCE"), POLLAKIURIA ("FREQUENT URINATION ") AND LOOSE TOOTH ("LOOSE TEETH"). AT THE TIME OF THE REPORT, THE FATIGUE AND INSOMNIA HAD NOT RESOLVED. THE OUTCOMES FOR HEAVY MENSTRUAL BLEEDING, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, FLATULENCE, GASTROINTESTINAL MOTILITY DISORDER, HERPES ZOSTER, MIGRAINE, DEPRESSION, DISTURBANCE IN ATTENTION, VISION BLURRED, MUSCULOSKELETAL STIFFNESS, TENDON DISORDER, INCONTINENCE, POLLAKIURIA AND LOOSE TOOTH WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, FLATULENCE, GASTROINTESTINAL MOTILITY DISORDER, FATIGUE, HERPES ZOSTER, MIGRAINE, INSOMNIA, DEPRESSION, DISTURBANCE IN ATTENTION, VISION BLURRED, MUSCULOSKELETAL STIFFNESS, TENDON DISORDER, INCONTINENCE, POLLAKIURIA OR LOOSE TOOTH. THE REPORTER COMMENTED: CURRENT CONDITION OF THE FEMALE PATIENT: ALTHOUGH I AM IN GOOD PHYSICAL CONDITION, I FEEL VERY TIRED DUE TO INSOMNIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 46 KG. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2506764 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 50758783 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Other |