ESSURE
Report
- Report Number
- 2951250-2024-00377
- Event Type
- Injury
- Date Received
- May 30, 2024
- Date of Event
- July 11, 2017
- Report Date
- June 3, 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 23-MAY-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-JUN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") IN A 39 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) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 1831 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ON (B)(6) 2023 SHE EXPERIENCED PELVIC PAIN ("RECURRENT PELVIC PAIN IN THE LEFT ILIAC FOSSA"). ON UNKNOWN DATE SHE EXPERIENCED ADNEXA UTERI PAIN ("MILD TENDERNESS IN BOTH FALLOPIAN TUBES"), ADENOMYOSIS ("DIFFUSE UTERINE ADENOMYOSIS"), PELVIC DISCOMFORT ("INITIAL DISCOMFORT"), IRON DEFICIENCY ANAEMIA ("HAEMORRHAGIC PERIODS (AROUND 5 YEARS) CAUSING IRON DEFICIENCY"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN LOWER ("VERY PAINFUL ABDOMINAL CRAMPS"), ARTHRITIS ("JOINT INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), ALOPECIA ("HAIR LOSS"), ONYCHOCLASIS ("BRITTLE NAILS"), HIRSUTISM ("HIRSUTISM ON THE LOWER FACE AND NECK"), WEIGHT LOSS POOR ("DIFFICULTY LOSING THE WEIGHT"), AMNESIA ("MEMORY LOSS"), SPEECH DISORDER ("SPEECH PROBLEMS"), CARPAL TUNNEL SYNDROME ("CARPAL TUNNEL SYNDROME"), SYNOVITIS ("SYNOVITIS") AND BREAST MASS ("FIBROADENOMATOUS-LOOKING NODULE IN THE LOWER QUADRANTS OF THE RIGHT BREAST") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL CURETTAGE ON (B)(6) 2017). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ADNEXA UTERI PAIN, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, ADENOMYOSIS, PELVIC DISCOMFORT, IRON DEFICIENCY ANAEMIA, FATIGUE, ABDOMINAL PAIN LOWER, ARTHRITIS, ARTHRALGIA, ALOPECIA, ONYCHOCLASIS, HIRSUTISM, WEIGHT INCREASED, WEIGHT LOSS POOR, AMNESIA, SPEECH DISORDER, CARPAL TUNNEL SYNDROME, SYNOVITIS OR BREAST MASS. THE REPORTER COMMENTED: 07-JUN-2012) WHEN THE INSERTS WERE PLACED, THE UTERINE MUCOSA WAS NOTED TO BE HEALTHY AND THE INSERT PLACEMENT CAUSED MILD TENDERNESS IN BOTH FALLOPIAN TUBES. ((B)(6) 2012) THE FOLLOW-UP ABDOMINAL X-RAY OF ESSURE INSERT PLACEMENT INDICATED THAT THE INSERTS WERE PROPERLY IN PLACE. ((B)(6) 2017) THE FIRST SYMPTOMS WERE HAEMORRHAGIC PERIODS. AS THE SITUATION DID NOT IMPROVE, A MEDICAL APPOINTMENT CONCLUDED THAT THE ENDOMETRIUM NEEDED TO BE VAPOURISED USING THE NOVASSURE METHOD. ((B)(6) 2017) ENDOMETRIAL CURETTAGE PERFORMED. MENORRHAGIA; QUIESCENT MUCOSA WITH FIBROEPITHELIAL POLYP, NO SIGN OF MALIGNANCY. ANALYSIS REVEALED A BENIGN POLYP REPORT FROM ENDOMETRIAL CURETTAGE SAMPLING FROM 11-JUL-2017 CLINICAL INFORMATION: MENORRHAGIA. MUCOUS AND HAEMATIC FRAGMENTS INCLUDED ENTIRELY IN ONE CASSETTE. NEXT TO MILDLY TROPHIC MUCOSA FLAPS COMPOSED OF TUBULAR GLANDS THAT ARE SLIGHTLY MITOTIC, WE FIND FRAGMENTS THAT MAY COME FROM AN ENDOMETRIAL POLYP COMPOSED OF GLANDS OF VARIABLE SIZE, SOMETIMES WITH A CUBIC COATING, SOMETIMES FLATTENED, UNISTRATIFIED, WITH NO NUCLEAR ATYPIA. THE CHORION IS DENSE, FIBROUS, WITH VESSELS, WITH THICKENED WALLS AND SOMETIMES GROUPED IN BOUQUETS. CONCLUSION: QUIESCENT MUCOSA WITH FIBROEPITHELIAL POLYP. NO SIGNS OF MALIGNANCY. EN TO TREAT THE PATIENT IN THE HEALTHCARE FACILITY: COMMENTS THE CONSEQUENCES ARE NUMEROUS, BOTH REGARDING PERFORMING MY PROFESSIONAL ACTIVITIES (FATIGUE) AND ON A DAILY BASIS. IT IS ALSO VERY TIME-CONSUMING TO UNDERSTAND HOW THESE INSERTS WORK IN ORDER TO TRY TO FIND SPECIALISTS AND SOLUTIONS. THIS TAKES A LOT OF RESEARCH, ESPECIALLY SINCE ACCESS TO INFORMATION IS DIFFICULT. I AM NOT SUFFICIENTLY INFORMED ABOUT ESSURE NEWS THROUGH OFFICIAL PRESS RELEASES. I THEREFORE APPROACHED AN ASSOCIATION TO FEEL SUPPORTED IN THESE DIFFICULT PROCESSES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 74 KG. [HYSTEROSCOPY] ON (B)(6) 2012: HYSTEROSCOPE INSERTION AND UTERINE VISUALISATION EASY WITH THE HELP OF NORMAL SALINE: - TUBAL OSTIA SEEN - HEALTHY UTERINE MUCOSA SURGICAL PROCEDURES: PLACEMENT OF INSERTS ON THE RIGHT AND LEFT. MILDLY TENDER WHEN PASSING THE 2 FALLOPIAN TUBES. NUMBER OF COIL TURNS: 4 ON THE RIGHT AND 5 ON THE LEFT. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2024: THE MRI CONFIRMED DIFFUSE UTERINE ADENOMYOSIS.; (DATE UNKNOWN): UTERINE THICKENING AND HYPER SIGNALS IN THE MYOMETRIUM, REFLECTING DIFFUSE UTERINE ADENOMYOSIS. BILATERAL ESSURE INSERTS. PELVIC MRI NORMAL OTHERWISE. [ULTRASOUND PELVIS] ON (B)(6) 2023: THE RESULT OF WHICH IS SUSPICION OF UTERINE ADENOMYOSIS [X-RAY] ON (B)(6) 2012: ESSURE INSERT PLACEMENT INDICATED THAT THE INSERTS WERE PROPERLY IN PLACE. [X-RAY LIMB] (DATES UNKNOWN): IRREGULARITY REVEALED WITH OSTEOCONDENSATION OF THE MARGIN OF THE GREATER TUBEROSITY WHICH MAY REFLECT TENDINOPATHY, ESPECIALLY SINCE THERE ARE CALCIFICATIONS IN THE PROJECTIONS OF THE CUFF TENDONS. DEGENERATIVE ACROMIOCLAVICULAR ARTHROPATHY. NO ALTERATION OF THE GLENOHUMERAL SPACE. SATISFACTORY BONE MINERALISATION, BONE INTEGRITY. MILD NARROWING OF THE INTERPHALANGEAL SPACES. SATISFACTORY BONE MINERALISATION. NO SOFT TISSUE ABNORMALITIES AND NARROWING OF THE INTERNAL FEMOROTIBIAL COMPARTMENT. MOREOVER, NO ALTERATION OF JOINT SPACES. PATELLA WELL CENTRED. NO SIGNIFICANT INTRA-ARTICULAR EFFUSION. BATCH: 925779 IS NOT VALID. 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: 03-JUN-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 23-MAY-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HAEMORRHAGIC PERIODS") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 925779) 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) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 1831 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON 08-NOV-2023 SHE EXPERIENCED PELVIC PAIN (" RECURRENT PELVIC PAIN IN THE LEFT ILIAC FOSSA"). ON UNKNOWN DATE SHE EXPERIENCED ADNEXA UTERI PAIN ("MILD TENDERNESS IN BOTH FALLOPIAN TUBES"), ADENOMYOSIS ("DIFFUSE UTERINE ADENOMYOSIS"), PELVIC DISCOMFORT ("INITIAL DISCOMFORT"), IRON DEFICIENCY ANAEMIA ("HAEMORRHAGIC PERIODS (AROUND 5 YEARS) CAUSING IRON DEFICIENCY"), FATIGUE ("FATIGUE"), ABDOMINAL PAIN LOWER ("VERY PAINFUL ABDOMINAL CRAMPS"), ARTHRITIS ("JOINT INFLAMMATION"), ARTHRALGIA ("JOINT PAIN"), ALOPECIA ("HAIR LOSS"), ONYCHOCLASIS ("BRITTLE NAILS"), HIRSUTISM ("HIRSUTISM ON THE LOWER FACE AND NECK"), WEIGHT LOSS POOR ("DIFFICULTY LOSING THE WEIGHT"), AMNESIA ("MEMORY LOSS"), SPEECH DISORDER ("SPEECH PROBLEMS"), CARPAL TUNNEL SYNDROME ("CARPAL TUNNEL SYNDROME"), SYNOVITIS ("SYNOVITIS") AND BREAST MASS ("FIBROADENOMATOUS-LOOKING NODULE IN THE LOWER QUADRANTS OF THE RIGHT BREAST") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ENDOMETRIAL CURETTAGE ON 17-JUL-17). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ADNEXA UTERI PAIN, HEAVY MENSTRUAL BLEEDING, PELVIC PAIN, ADENOMYOSIS, PELVIC DISCOMFORT, IRON DEFICIENCY ANAEMIA, FATIGUE, ABDOMINAL PAIN LOWER, ARTHRITIS, ARTHRALGIA, ALOPECIA, ONYCHOCLASIS, HIRSUTISM, WEIGHT INCREASED, WEIGHT LOSS POOR, AMNESIA, SPEECH DISORDER, CARPAL TUNNEL SYNDROME, SYNOVITIS OR BREAST MASS. THE REPORTER COMMENTED: 07-JUN-2012) WHEN THE INSERTS WERE PLACED, THE UTERINE MUCOSA WAS NOTED TO BE HEALTHY AND THE INSERT PLACEMENT CAUSED MILD TENDERNESS IN BOTH FALLOPIAN TUBES. (05-SEP-2012) THE FOLLOW-UP ABDOMINAL X-RAY OF ESSURE INSERT PLACEMENT INDICATED THAT THE INSERTS WERE PROPERLY IN PLACE. (11-JUL-2017) THE FIRST SYMPTOMS WERE HAEMORRHAGIC PERIODS. AS THE SITUATION DID NOT IMPROVE, A MEDICAL APPOINTMENT CONCLUDED THAT THE ENDOMETRIUM NEEDED TO BE VAPOURISED USING THE NOVASSURE METHOD. (17-JUL-2017) ENDOMETRIAL CURETTAGE PERFORMED. MENORRHAGIA; QUIESCENT MUCOSA WITH FIBROEPITHELIAL POLYP, NO SIGN OF MALIGNANCY. ANALYSIS REVEALED A BENIGN POLYP REPORT FROM ENDOMETRIAL CURETTAGE SAMPLING FROM 11-JUL-2017 CLINICAL INFORMATION: MENORRHAGIA MUCOUS AND HAEMATIC FRAGMENTS INCLUDED ENTIRELY IN ONE CASSETTE. NEXT TO MILDLY TROPHIC MUCOSA FLAPS COMPOSED OF TUBULAR GLANDS THAT ARE SLIGHTLY MITOTIC, WE FIND FRAGMENTS THAT MAY COME FROM AN ENDOMETRIAL POLYP COMPOSED OF GLANDS OF VARIABLE SIZE, SOMETIMES WITH A CUBIC COATING, SOMETIMES FLATTENED, UNISTRATIFIED, WITH NO NUCLEAR ATYPIA. THE CHORION IS DENSE, FIBROUS, WITH VESSELS, WITH THICKENED WALLS AND SOMETIMES GROUPED IN BOUQUETS. CONCLUSION: QUIESCENT MUCOSA WITH FIBROEPITHELIAL POLYP. NO SIGNS OF MALIGNANCY. EN TO TREAT THE PATIENT IN THE HEALTHCARE FACILITY: COMMENTS THE CONSEQUENCES ARE NUMEROUS, BOTH REGARDING PERFORMING MY PROFESSIONAL ACTIVITIES (FATIGUE) AND ON A DAILY BASIS. IT IS ALSO VERY TIME-CONSUMING TO UNDERSTAND HOW THESE INSERTS WORK IN ORDER TO TRY TO FIND SPECIALISTS AND SOLUTIONS. THIS TAKES A LOT OF RESEARCH, ESPECIALLY SINCE ACCESS TO INFORMATION IS DIFFICULT. I AM NOT SUFFICIENTLY INFORMED ABOUT ESSURE NEWS THROUGH OFFICIAL PRESS RELEASES. I THEREFORE APPROACHED AN ASSOCIATION TO FEEL SUPPORTED IN THESE DIFFICULT PROCESSES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 74 KG. [HYSTEROSCOPY] ON 07-JUN-2012: HYSTEROSCOPE INSERTION AND UTERINE VISUALISATION EASY WITH THE HELP OF NORMAL SALINE: - TUBAL OSTIA SEEN - HEALTHY UTERINE MUCOSA SURGICAL PROCEDURES: PLACEMENT OF INSERTS ON THE RIGHT AND LEFT. MILDLY TENDER WHEN PASSING THE 2 FALLOPIAN TUBES. NUMBER OF COIL TURNS: 4 ON THE RIGHT AND 5 ON THE LEFT. [MAGNETIC RESONANCE IMAGING] ON 13-MAR-2024: THE MRI CONFIRMED DIFFUSE UTERINE ADENOMYOSIS.; (DATE UNKNOWN): UTERINE THICKENING AND HYPER SIGNALS IN THE MYOMETRIUM, REFLECTING DIFFUSE UTERINE ADENOMYOSIS. BILATERAL ESSURE INSERTS. PELVIC MRI NORMAL OTHERWISE. [ULTRASOUND PELVIS] ON 08-NOV-2023: THE RESULT OF WHICH IS SUSPICION OF UTERINE ADENOMYOSIS [X-RAY] ON (B)(6) 2012: ESSURE INSERT PLACEMENT INDICATED THAT THE INSERTS WERE PROPERLY IN PLACE. [X-RAY LIMB] (DATES UNKNOWN): IRREGULARITY REVEALED WITH OSTEOCONDENSATION OF THE MARGIN OF THE GREATER TUBEROSITY WHICH MAY REFLECT TENDINOPATHY, ESPECIALLY SINCE THERE ARE CALCIFICATIONS IN THE PROJECTIONS OF THE CUFF TENDONS. DEGENERATIVE ACROMIOCLAVICULAR ARTHROPATHY. NO ALTERATION OF THE GLENOHUMERAL SPACE. SATISFACTORY BONE MINERALISATION, BONE INTEGRITY. MILD NARROWING OF THE INTERPHALANGEAL SPACES. SATISFACTORY BONE MINERALISATION. NO SOFT TISSUE ABNORMALITIES AND NARROWING OF THE INTERNAL FEMOROTIBIAL COMPARTMENT. MOREOVER, NO ALTERATION OF JOINT SPACES. PATELLA WELL CENTRED. NO SIGNIFICANT INTRA-ARTICULAR EFFUSION. 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 |
|---|---|---|---|---|---|---|---|
| 1286364 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 925779 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Other |