ESSURE
Report
- Report Number
- 2951250-2024-00296
- Event Type
- Injury
- Date Received
- April 23, 2024
- Report Date
- March 2, 2026
- 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 17-APR-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-APR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D40624) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 56 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DIZZINESS ("PROBLEMS WITH DIZZINESS") AND TINNITUS ("RINGING IN THE EARS"). ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), EYE PAIN ("INTENSE PAIN IN THE EYES STILL PERSISTING AT PRESENT"), ABDOMINAL PAIN (" ABDOMEN PAIN") AND FATIGUE ("CHRONIC FATIGUE"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, TINNITUS, EYE PAIN, ABDOMINAL PAIN, PELVIC PAIN OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58 KG. BATCH NO D40624 PRODUCTION DATE~2014-12-11 EXPIRATION DATE 2017-12-28. 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: 27-APR-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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)(4) ON 17-APR-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 07-JUN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D40624) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 56 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DIZZINESS ("PROBLEMS WITH DIZZINESS") AND TINNITUS ("RINGING IN THE EARS"). ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), EYE PAIN ("INTENSE PAIN IN THE EYES STILL PERSISTING AT PRESENT"), ABDOMINAL PAIN (" ABDOMEN PAIN"), FATIGUE ("CHRONIC FATIGUE"), MIGRAINE ("MIGRAINES"), EAR PAIN ("EAR PAIN"), DEAFNESS ("HEARING LOSS"), ABDOMINAL PAIN LOWER (" LOWER ABDOMINAL PAIN") AND DEPRESSION ("I AM DEPRESSED"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, TINNITUS, EYE PAIN, ABDOMINAL PAIN, PELVIC PAIN, FATIGUE, MIGRAINE, EAR PAIN, DEAFNESS, ABDOMINAL PAIN LOWER OR DEPRESSION. THE REPORTER COMMENTED: I AM CONSIDERING HAVING MY TUBE REMOVED. I CAN'T TAKE ANY MORE OF THIS PAIN, IT'S UNRELENTING. I WAKE UP WITH PAIN IN MY EYES AND I SLEEP WITH THIS PAIN. IT'S UNBEARABLE. I AM DEPRESSED. I NO LONGER HAVE A LIFE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58 KG. BATCH NO D40624 PRODUCTION DATE~2014-12-11 EXPIRATION DATE 2017-12-28. 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: 07-JUN-2024: NEW EVENTS MIGRAINES, HEARING LOSS, EAR PAIN, LOWER ABDOMINAL PAIN & DEPRESSION WERE ADDED. 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.
BAYER CASE NUMBER: (B)(4). PELVIC PAIN FEMALE, ABDOMEN PAIN, PROBLEMS WITH DIZZINESS, RINGING IN THE EARS, INTENSE PAIN IN THE EYES STILL PERSISTING AT PRESENT, CHRONIC FATIGUE, MIGRAINES, EAR PAIN, HEARING LOSS, LOWER ABDOMINAL PAIN, I AM DEPRESSED, FOLLOWING THIS PROCEDURE, HER HEALTH BEGAN TO DETERIORATE [GENERAL PHYSICAL HEALTH DETERIORATION], PALPITATIONS, IRREGULAR CYCLES, DYSPAREUNIA, OPHTHALMIC MIGRAINES, CONJUNCTIVITIS, DECLINE IN HEARING, THE ALLERGIST MENTIONED METAL HYPERSENSITIVITY [ALLERGY TO METALS], CANDIDAL OESOPHAGITIS, INCIPIENT HIATAL HERNIA, RECURRENT MIGRAINE ATTACKS [MIGRAINE], FAINTING, HEADACHES, NAUSEA, BLURRED VISION, URINARY INCONTINENCE, RETROOCULAR PAIN [RETRO-ORBITAL PAIN], ADENOMYOSIS, DYSMENORRHOEA, OPHTHALMIC DISORDERS [EYE DISORDER], DECREASE IN LIBIDO [LIBIDO DECREASED], CONJUNCTIVAL PRURITUS [EYE PRURITUS], CHRONIC ASTHENIA, PERSISTENT INFLAMMATION, HORMONAL IMBALANCE, RIGHT ADNEXAL CYST [ADNEXA UTERI CYST], IMPLANT WAS INSERTED ON THE LEFT SIDE, AS THE RIGHT FALLOPIAN TUBE WAS ALREADY BLOCKED [DEVICE INSERTION FAILED]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 17-APR-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 24-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE"), ABDOMINAL PAIN ("ABDOMEN PAIN") AND SYNCOPE ("FAINTING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D40624) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION FAILED ("IMPLANT WAS INSERTED ON THE LEFT SIDE, AS THE RIGHT FALLOPIAN TUBE WAS ALREADY BLOCKED"). THE PATIENT HAD A MEDICAL HISTORY OF SPONTANEOUS ABORTION (2003 AND 2007 AND ABORTION IN 2009), PARITY 5 (FIVE CHILDREN BORN IN 1998, TWO IN 2001, 2004 AND 2008) AND FALLOPIAN TUBE OBSTRUCTION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 56 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DIZZINESS ("PROBLEMS WITH DIZZINESS") AND TINNITUS ("RINGING IN THE EARS"). ON (B)(6) 2016 SHE EXPERIENCED PALPITATIONS ("PALPITATIONS"). ON (B)(6) 2016 SHE EXPERIENCED A FIRST EPISODE OF MIGRAINE ("MIGRAINES"), OPHTHALMIC MIGRAINE ("OPHTHALMIC MIGRAINES") AND CONJUNCTIVITIS ("CONJUNCTIVITIS"). ON (B)(6) 2016 SHE EXPERIENCED HYPOACUSIS ("DECLINE IN HEARING"). ON (B)(6) 2017 SHE EXPERIENCED ALLERGY TO METALS ("THE ALLERGIST MENTIONED METAL HYPERSENSITIVITY"). ON (B)(6) 2018 SHE EXPERIENCED OESOPHAGEAL CANDIDIASIS ("CANDIDAL OESOPHAGITIS") AND HIATUS HERNIA ("INCIPIENT HIATAL HERNIA."). ON (B)(6) 2020 SHE EXPERIENCED A SECOND EPISODE OF MIGRAINE ("RECURRENT MIGRAINE ATTACKS"). ESSURE WAS REMOVED ON (B)(6) 2025. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERION HOSPITALISATION), EYE PAIN ("INTENSE PAIN IN THE EYES STILL PERSISTING AT PRESENT"), FATIGUE ("CHRONIC FATIGUE"), EAR PAIN ("EAR PAIN"), DEAFNESS ("HEARING LOSS"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), DEPRESSION ("I AM DEPRESSED"), GENERAL PHYSICAL HEALTH DETERIORATION ("FOLLOWING THIS PROCEDURE, HER HEALTH BEGAN TO DETERIORATE"), MENSTRUATION IRREGULAR ("IRREGULAR CYCLES"), DYSPAREUNIA ("DYSPAREUNIA"), SYNCOPE (SERIOUSNESS CRITERION HOSPITALISATION), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), VISION BLURRED ("BLURRED VISION"), URINARY INCONTINENCE ("URINARY INCONTINENCE"), RETRO-ORBITAL PAIN ("RETROOCULAR PAIN"), ADENOMYOSIS ("ADENOMYOSIS"), DYSMENORRHOEA ("DYSMENORRHOEA"), EYE DISORDER ("OPHTHALMIC DISORDERS"), LIBIDO DECREASED ("DECREASE IN LIBIDO"), EYE PRURITUS ("CONJUNCTIVAL PRURITUS"), ASTHENIA ("CHRONIC ASTHENIA"), INFLAMMATION ("PERSISTENT INFLAMMATION") AND ADNEXA UTERI CYST ("RIGHT ADNEXAL CYST") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE"). THE PATIENT WAS TREATED WITH BOTULINUM TOXIN (BOTULINUM TOXIN TYPE A) AS WELL AS SURGERY (BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS OR THEIR LATEST EPISODE WERE UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, ADNEXA UTERI CYST, ALLERGY TO METALS, ASTHENIA, CONJUNCTIVITIS, DYSMENORRHOEA, DYSPAREUNIA, EYE DISORDER, RETRO-ORBITAL PAIN, EYE PRURITUS, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, HIATUS HERNIA, HORMONE LEVEL ABNORMAL, HYPOACUSIS, INFLAMMATION, LIBIDO DECREASED, MENSTRUATION IRREGULAR, THE SECOND EPISODE OF MIGRAINE, NAUSEA, OESOPHAGEAL CANDIDIASIS, OPHTHALMIC MIGRAINE, PALPITATIONS, SYNCOPE, URINARY INCONTINENCE AND VISION BLURRED TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, TINNITUS, EYE PAIN, ABDOMINAL PAIN, PELVIC PAIN, FATIGUE, THE FIRST EPISODE OF MIGRAINE, EAR PAIN, DEAFNESS, ABDOMINAL PAIN LOWER OR DEPRESSION. THE REPORTER COMMENTED: I AM CONSIDERING HAVING MY TUBE REMOVED. I CAN'T TAKE ANY MORE OF THIS PAIN, IT'S UNRELENTING. I WAKE UP WITH PAIN IN MY EYES AND I SLEEP WITH THIS PAIN. IT'S UNBEARABLE. I AM DEPRESSED. I NO LONGER HAVE A LIFE. ON (B)(6) 2025, THE PROCEDURE WAS PERFORMED. A SINGLE ESSURE IMPLANT WAS INSERTED ON THE LEFT SIDE, AS THE RIGHT FALLOPIAN TUBE WAS ALREADY BLOCKED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58 KG. [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): NO ABNORMALITIES. [PATHOLOGY TEST] ON (B)(6) 2025: THE SURGICAL REPORT MENTIONED PRESENCE OF AN IMPLANT, ONE OF WHICH WAS IN THE LEFT MESOSALPINX. [SCAN] (DATE UNKNOWN): NO ACUTE LESIONS OR SIGNS OF TRAUMA. [ULTRASOUND ABDOMEN] ON (B)(6) 2014: THE LEFT PELVIC PROJECTION, A 27 MM RIGHT ADNEXAL CYST, AND RENAL ABNORMALITIES SUGGESTIVE OF NEPHROCALCINOSIS TO BE CORRELATED WITH A CT SCAN. BATCH NO D40624 PRODUCTION DATE~2014-12-11 EXPIRATION DATE 2017-12-28. 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: 24-FEB-2026: MEDICAL RECORD RECEIVED. NEW EVENTS HEALTH BEGAN TO DETERIORATE, PALPITATIONS, IRREGULAR CYCLES, DYSPAREUNIA, OPHTHALMIC MIGRAINES, CONJUNCTIVITIS, DECLINE IN HEARING, THE ALLERGIST MENTIONED METAL HYPERSENSITIVITY, CANDIDAL OESOPHAGITIS, INCIPIENT HIATAL HERNIA., RECURRENT MIGRAINE ATTACKS, FAINTING, HEADACHES, NAUSEA, BLURRED VISION, URINARY INCONTINENCE, RETROOCULAR PAIN, ADENOMYOSIS, DYSMENORRHOEA, OPHTHALMIC DISORDERS, DECREASE IN LIBIDO, CONJUNCTIVAL PRURITUS, CHRONIC ASTHENIA, PERSISTENT INFLAMMATION, HORMONAL IMBALANCE, RIGHT ADNEXAL CYST, IMPLANT WAS INSERTED ON THE LEFT SIDE, AS THE RIGHT FALLOPIAN TUBE WAS ALREADY BLOCKED WERE ADDED. LAB DATA, ADDITIONAL REPORTER, ESSURE REMOVAL DATE & DETAILS, CONCOMITANT DRUG, WERE ADDED. CASE COMMENTS: 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)(4) ON 17-APR-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D40624) 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) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 56 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DIZZINESS ("PROBLEMS WITH DIZZINESS") AND TINNITUS ("RINGING IN THE EARS"). ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), EYE PAIN ("INTENSE PAIN IN THE EYES STILL PERSISTING AT PRESENT"), ABDOMINAL PAIN (" ABDOMEN PAIN") AND FATIGUE ("CHRONIC FATIGUE"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DIZZINESS, TINNITUS, EYE PAIN, ABDOMINAL PAIN, PELVIC PAIN OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 58 KG. 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 |
|---|---|---|---|---|---|---|---|
| 350409 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D40624 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H| O |