ESSURE
Report
- Report Number
- 2951250-2025-00476
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- January 15, 2016
- Report Date
- February 23, 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
BAYER CASE NUMBER: (B)(4) BACK PAIN//LUMBAR PAIN [BACK PAIN] , THE PATIENT STILL HAD PELVIC PAIN [PELVIC PAIN FEMALE], GENERAL HEALTH DETERIORATION [GENERAL PHYSICAL HEALTH DETERIORATION] , DIZZINESS [DIZZINESS] , JOINT PAIN [JOINT PAIN] , TINNITUS [TINNITUS] , WALKING RANGE VERY GREATLY REDUCED [DIFFICULTY IN WALKING], COGNITIVE DISORDERS [COGNITIVE DISORDERS] , HEADACHES [HEADACHE] , EYE PAIN [EYE PAIN] , VARIOUS INFLAMMATORY REACTIONS [INFLAMMATORY REACTION] , MIGRAINES [MIGRAINE], ASTHENIA [ASTHENIA] , DIFFUSE MUSCULOSKELETAL PAIN [MUSCULOSKELETAL PAIN] , URINARY DISORDERS LIKE BURNING DURING URINATION [BURNING MICTURITION] , POLLAKIURIA [POLLAKIURIA] , DIFFUSE PAIN [DIFFUSE PAIN] , CHEST PAIN [CHEST PAIN] , PAIN IN JAW [PAIN IN JAW] , HIGH BLOOD PRESSURE [BLOOD PRESSURE HIGH] , VOMITING [VOMITING] , TENDINOPATHY [TENDINOPATHY] , KIDNEY FAILURE [KIDNEY FAILURE] , UTERINE LEIOMYOFIBROMAS [UTERINE FIBROMYOMA] , HYPOTROPHIC ENDOMETRIUM [ENDOMETRIAL ATROPHY] , SUBACUTE ATROPHIC CERVICITIS [UTERINE CERVIX ATROPHY] , TUBAL WALLS SLIGHTLY CONGESTIVE [FALLOPIAN TUBE CONGESTION] , FEVER [FEVER] , PAIN IN THE LEFT ILIAC FOSSA [ILIAC FOSSA PAIN] , GERD [GERD] , COUGH [COUGH] , NECK PAIN [NECK PAIN] , ESSURE IN PLACE PATIENT HAD PAIN [PROCEDURAL PAIN]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 16-JUL-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 17-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN//LUMBAR PAIN") AND PELVIC PAIN ("THE PATIENT STILL HAD PELVIC PAIN") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF BLOOD PRESSURE HIGH, SKIN RASH, DYSLIPIDEMIA, GERD, HIATAL HERNIA, TOBACCO USER, HEPATITIS A, GILBERT'S SYNDROME, DE QUERVAIN THYROIDITIS, ENDOBRACHYOESOPHAGUS, APPENDECTOMY, PERITONITIS AND PARITY 1. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: NOVA T. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER AND THYROID CANCER. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 3 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("GENERAL HEALTH DETERIORATION"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("JOINT PAIN"), TINNITUS ("TINNITUS"), GAIT DISTURBANCE ("WALKING RANGE VERY GREATLY REDUCED"), COGNITIVE DISORDER ("COGNITIVE DISORDERS"), HEADACHE ("HEADACHES"), EYE PAIN ("EYE PAIN") AND INFLAMMATION ("VARIOUS INFLAMMATORY REACTIONS"). ESSURE WAS REMOVED ON (B)(6) 2025. ON UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), ASTHENIA ("ASTHENIA"), MUSCULOSKELETAL PAIN ("DIFFUSE MUSCULOSKELETAL PAIN"), DYSURIA ("URINARY DISORDERS LIKE BURNING DURING URINATION"), POLLAKIURIA ("POLLAKIURIA"), PAIN ("DIFFUSE PAIN"), CHEST PAIN ("CHEST PAIN "), PAIN IN JAW ("PAIN IN JAW"), HYPERTENSION ("HIGH BLOOD PRESSURE"), VOMITING ("VOMITING"), TENDON DISORDER ("TENDINOPATHY"), RENAL FAILURE ("KIDNEY FAILURE"), ENDOMETRIAL ATROPHY ("HYPOTROPHIC ENDOMETRIUM"), UTERINE CERVIX ATROPHY ("SUBACUTE ATROPHIC CERVICITIS"), FALLOPIAN TUBE CONGESTION ("TUBAL WALLS SLIGHTLY CONGESTIVE"), PYREXIA ("FEVER"), ABDOMINAL PAIN LOWER ("PAIN IN THE LEFT ILIAC FOSSA"), GASTROOESOPHAGEAL REFLUX DISEASE ("GERD"), COUGH ("COUGH"), NECK PAIN ("NECK PAIN") AND PROCEDURAL PAIN ("ESSURE IN PLACE PATIENT HAD PAIN") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("UTERINE LEIOMYOFIBROMAS"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE BACK PAIN, PELVIC PAIN, GENERAL PHYSICAL HEALTH DETERIORATION, DIZZINESS, ARTHRALGIA, TINNITUS, GAIT DISTURBANCE, COGNITIVE DISORDER, HEADACHE, EYE PAIN AND INFLAMMATION HAD NOT RESOLVED. THE OUTCOMES FOR MIGRAINE, ASTHENIA, MUSCULOSKELETAL PAIN, DYSURIA, POLLAKIURIA, PAIN, CHEST PAIN, PAIN IN JAW, HYPERTENSION, VOMITING, TENDON DISORDER, RENAL FAILURE, UTERINE LEIOMYOMA, ENDOMETRIAL ATROPHY, UTERINE CERVIX ATROPHY, FALLOPIAN TUBE CONGESTION, PYREXIA, ABDOMINAL PAIN LOWER, GASTROOESOPHAGEAL REFLUX DISEASE, COUGH, NECK PAIN AND PROCEDURAL PAIN WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ARTHRALGIA, ASTHENIA, BACK PAIN, CHEST PAIN, COGNITIVE DISORDER, COUGH, DIZZINESS, DYSURIA, ENDOMETRIAL ATROPHY, EYE PAIN, FALLOPIAN TUBE CONGESTION, GAIT DISTURBANCE, GASTROOESOPHAGEAL REFLUX DISEASE, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, HYPERTENSION, INFLAMMATION, MIGRAINE, MUSCULOSKELETAL PAIN, NECK PAIN, PAIN, PAIN IN JAW, PELVIC PAIN, POLLAKIURIA, PROCEDURAL PAIN, PYREXIA, RENAL FAILURE, TENDON DISORDER, TINNITUS, UTERINE CERVIX ATROPHY, UTERINE LEIOMYOMA AND VOMITING TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THICKENED UTERINE MUCOSA 6 COILS ON THE LEFT SIDE 8 COILS ON THE RIGHT SIDE ESSURE IN PLACE ON (B)(6) 2016 (PATIENT HAD PAIN). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 84 KG. [ANGIOCARDIOGRAM] (DATE UNKNOWN): DID NOT SHOW ANY ANOMALY [COMPUTERISED TOMOGRAM] ON (B)(6) 2022: DUE TO DETERIORATION OF GENERAL HEALTH STATUS AND DIFFUSE PAIN. [COMPUTERISED TOMOGRAM HEAD] ON (B)(6) 2023: NORMAL [ULTRASOUND SCAN] ON (B)(6) 2022: NO FINDING; ON (B)(6) 2025: ESSURE VISIBLE ON THE RIGHT SIDE [X-RAY] ON (B)(6) 2022: DID NOT FIND ANOMALY LINKED TO NECK PAIN; (DATE UNKNOWN): NO ABNORMAL DISCOVERY. 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: 17-FEB-2026: UPON RECEIPT OF NEW FOLLOW UP IT WAS NOTED THAT ARGUS CASES (B)(4) ARE DUPLICATE OF EACH OTHER THEREFORE ARGUS CASE (B)(4) NULLIFY FROM ARGUS DATABASE. ALL SOURCE DOCUMENTS, REFERENCES. EVENTS, REPORTERS, LAB DATA & RELEVANT INFORMATION HAS BEEN TRANSFERRED TO RETENTION CASE. (LEGACY DEVICE NUMBER 2951250-2026-00035). CASE COMMENTS: 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. 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) BACK PAIN//LUMBAR PAIN [BACK PAIN]. GENERAL HEALTH DETERIORATION [GENERAL PHYSICAL HEALTH DETERIORATION]. DIZZINESS [DIZZINESS]. JOINT PAIN [JOINT PAIN]. TINNITUS [TINNITUS]. WALKING RANGE VERY GREATLY REDUCED [DIFFICULTY IN WALKING]. COGNITIVE DISORDERS [COGNITIVE DISORDERS]. HEADACHES [HEADACHE]. EYE PAIN [EYE PAIN]. VARIOUS INFLAMMATORY REACTIONS [INFLAMMATORY REACTION]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 16-JUL-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-JUL-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN//LUMBAR PAIN") IN A 41-YEAR-OLD 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) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 3 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("GENERAL HEALTH DETERIORATION"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("JOINT PAIN"), TINNITUS ("TINNITUS"), GAIT DISTURBANCE ("WALKING RANGE VERY GREATLY REDUCED"), COGNITIVE DISORDER ("COGNITIVE DISORDERS"), HEADACHE ("HEADACHES"), EYE PAIN ("EYE PAIN") AND INFLAMMATION ("VARIOUS INFLAMMATORY REACTIONS"). ESSURE WAS REMOVED ON 08-JUL-2025. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA, BACK PAIN, COGNITIVE DISORDER, DIZZINESS, EYE PAIN, GAIT DISTURBANCE, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, INFLAMMATION AND TINNITUS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 84 KG. [X-RAY] (DATE UNKNOWN): NO ABNORMAL DISCOVERY. 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-JUL-2025: QUALITY SAFETY EVALUATION OF PTC. CASE COMMENTS: 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. 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) BACK PAIN//LUMBAR PAIN [BACK PAIN] , GENERAL HEALTH DETERIORATION [GENERAL PHYSICAL HEALTH DETERIORATION] , DIZZINESS [DIZZINESS] , JOINT PAIN [JOINT PAIN] , TINNITUS [TINNITUS] , WALKING RANGE VERY GREATLY REDUCED [DIFFICULTY IN WALKING], COGNITIVE DISORDERS [COGNITIVE DISORDERS] , HEADACHES [HEADACHE] , EYE PAIN [EYE PAIN] , VARIOUS INFLAMMATORY REACTIONS [INFLAMMATORY REACTION] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 16-JUL-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN//LUMBAR PAIN") IN A 41-YEAR-OLD 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) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 3 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENERAL PHYSICAL HEALTH DETERIORATION ("GENERAL HEALTH DETERIORATION"), DIZZINESS ("DIZZINESS"), ARTHRALGIA ("JOINT PAIN"), TINNITUS ("TINNITUS"), GAIT DISTURBANCE ("WALKING RANGE VERY GREATLY REDUCED"), COGNITIVE DISORDER ("COGNITIVE DISORDERS"), HEADACHE ("HEADACHES"), EYE PAIN ("EYE PAIN") AND INFLAMMATION ("VARIOUS INFLAMMATORY REACTIONS"). ESSURE WAS REMOVED ON (B)(6) 2025. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA, BACK PAIN, COGNITIVE DISORDER, DIZZINESS, EYE PAIN, GAIT DISTURBANCE, GENERAL PHYSICAL HEALTH DETERIORATION, HEADACHE, INFLAMMATION AND TINNITUS TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 84 KG. [X-RAY] (DATE UNKNOWN): NO ABNORMAL DISCOVERY. CASE COMMENTS: 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. 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 |
|---|---|---|---|---|---|---|---|
| 2037320 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention |