ESSURE
Report
- Report Number
- 2951250-2024-00821
- Event Type
- Injury
- Date Received
- December 12, 2024
- Date of Event
- April 1, 2012
- Report Date
- December 17, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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). 11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS [PELVIC PAIN FEMALE]. I WENT TO THE EMERGENCY DEPARTMENT BECAUSE I HAD HAEMORRHAGES. I WAS GIVEN TREATMENT TO REGULATE THE BLOOD FLOW BUT I HAD HAEMORRHAGES FOR 3 WEEKS [GENITAL BLEEDING]. THE FEMALE PATIENT INITIALLY HAD A CLINICAL PICTURE OF CHRONIC MIGRAINE AND IS NOW FORTUNATELY LEFT WITH EPISODIC MIGRAINE [MIGRAINE]. MUSCULAR TENSION [MUSCLE TENSION]. HEADACHE [HEADACHE]. CONTRACTURES OF THE PARACERVICAL AND TRAPEZIUS MUSCLES TODAY [MUSCLE CONTRACTURE] CHEST PAIN [CHEST PAIN]. MENOMETRORRHAGIA [MENOMETRORRHAGIA]. HETEROGENEOUS NODULE ON THE RIGHT OVARY [UTERINE FIBROIDS]. ADENOMYOSIS [ADENOMYOSIS]. SIGMOIDITIS [SIGMOIDITIS]. METRORRHAGIA [METRORRHAGIA]. MASTODYNIA [MASTODYNIA]. ASTHENIA [ASTHENIA]. MUSCULOSKELETAL PAIN IN THE HIPS [PAIN IN HIP]. BACK PAIN [BACK PAIN]. NECK PAIN EXTENDING TO THE BACK OF THE HEAD [NECK PAIN (WITH RADIATION)]. THERE IS INFREQUENT MENSES WITH CYCLES BETWEEN 5 AND 6 WEEKS RANDOMLY, WHICH ARE CURRENTLY OF NORMAL QUANTITY. [MENSES IRREGULAR]. THERE HAVE BEEN EPISODES OF MENORRHAGIA [MENORRHAGIA]. DYSMENORRHEA [DYSMENORRHEA]. DYSPAREUNIA [DYSPAREUNIA]. ABDOMINAL PAIN/RECURRENT LEFT ILIAC FOSSA PAIN [ILIAC FOSSA PAIN]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 03-DEC-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 16-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS") IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 901336) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF SAPHENOUS VEIN THROMBOSIS AND MYOPIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 27 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("I WENT TO THE EMERGENCY DEPARTMENT BECAUSE I HAD HAEMORRHAGES. I WAS GIVEN TREATMENT TO REGULATE THE BLOOD FLOW BUT I HAD HAEMORRHAGES FOR 3 WEEKS"), MIGRAINE ("THE FEMALE PATIENT INITIALLY HAD A CLINICAL PICTURE OF CHRONIC MIGRAINE AND IS NOW FORTUNATELY LEFT WITH EPISODIC MIGRAINE"), MUSCLE TIGHTNESS ("MUSCULAR TENSION"), HEADACHE ("HEADACHE"), MUSCLE CONTRACTURE ("CONTRACTURES OF THE PARACERVICAL AND TRAPEZIUS MUSCLES TODAY"), CHEST PAIN ("CHEST PAIN"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), ADENOMYOSIS ("ADENOMYOSIS"), COLITIS ("SIGMOIDITIS"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), BREAST PAIN ("MASTODYNIA"), ASTHENIA ("ASTHENIA"), ARTHRALGIA ("MUSCULOSKELETAL PAIN IN THE HIPS"), BACK PAIN ("BACK PAIN"), NECK PAIN ("NECK PAIN EXTENDING TO THE BACK OF THE HEAD"), MENSTRUATION IRREGULAR ("THERE IS INFREQUENT MENSES WITH CYCLES BETWEEN 5 AND 6 WEEKS RANDOMLY, WHICH ARE CURRENTLY OF NORMAL QUANTITY.") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("HETEROGENEOUS NODULE ON THE RIGHT OVARY"). ON (B)(6) 2022, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("THERE HAVE BEEN EPISODES OF MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA"). ESSURE WAS REMOVED ON (B)(6) 2023. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN/RECURRENT LEFT ILIAC FOSSA PAIN"). THE PATIENT WAS TREATED WITH TIGREAT (FROVATRIPTAN SUCCINATE MONOHYDRATE), NSAID N (NEPAFENAC), ISIMIG (FROVATRIPTAN SUCCINATE MONOHYDRATE), SPIFEN (IBUPROFEN), NOCERTONE (OXETORONE FUMARATE), TRIPTAN (ZOLMITRIPTAN) AND LAROXYL (AMITRIPTYLINE HYDROCHLORIDE) AS WELL AS SURGERY (DIAGNOSTIC HYSTEROSCOPY, BILATERAL TOTAL SALPINGECTOMY AND LEFT CORNUECTOMY). AT THE TIME OF THE REPORT, THE MIGRAINE WAS RESOLVING. THE OUTCOMES FOR PELVIC PAIN, GENITAL HAEMORRHAGE, MUSCLE TIGHTNESS, HEADACHE, MUSCLE CONTRACTURE, CHEST PAIN, MENOMETRORRHAGIA, UTERINE LEIOMYOMA, ADENOMYOSIS, COLITIS, INTERMENSTRUAL BLEEDING, BREAST PAIN, ASTHENIA, ARTHRALGIA, BACK PAIN, NECK PAIN, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN LOWER WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADENOMYOSIS, ARTHRALGIA, ASTHENIA, BACK PAIN, BREAST PAIN, CHEST PAIN, COLITIS, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MUSCLE CONTRACTURE, MUSCLE TIGHTNESS, NECK PAIN, PELVIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY IN REMOVAL DATE: ON (B)(6) 2023. 11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS WHO DIDN'T EVEN KNOW THIS DEVICE, I EXPLAINED TO THEM WHAT IT WAS. IT IS THANKS TO THE (B)(6) AND TO THE TESTIMONIES OF WOMEN ON THE INTERNET AS WELL AS THE (B)(6) THAT CARRIED OUT A STUDY ON THE SYMPTOMS AND PAIN, INCLUDING DR WHO REMOVED MY IMPLANTS. BY FOLLOWING THE DEVELOPMENT OF DATA CORROBORATED BY WOMEN, STUDIES, HOSPITALS AND DOCTORS OVER THE YEARS I WAS ABLE TO CONFIRM THAT THIS CONFIGURATION OF PAIN I HAD BEEN EXPERIENCING FOR YEARS WAS PERHAPS LINKED BECAUSE THE PAIN STARTED JUST AFTER HAEMORRHAGES AND THE FOLLOWING YEAR, I BEGAN NEUROLOGICAL MONITORING WHICH STOPPED AFTER THE REMOVAL OF THE MEDICAL DEVICE. NO MORE MEDICINAL PRODUCTS, NO MORE TREATMENTS, NO MORE ABNORMAL PAIN TO THIS DAY THE INTERVENTIONAL PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2023 UNDER GENERAL ANAESTHESIA, CONSISTED OF A BILATERAL TOTAL SALPINGECTOMY WITH LEFT CORNUECTOMY BY LAPAROSCOPIC ROUTE AFTER A DIAGNOSTIC HYSTEROSCOPY. ABSENCE OF PEROPERATIVE COMPLICATIONS. THIS PATIENT UNDERWENT EXCISION OF THE ESSURE IMPLANTS BY RIGHT SALPINGECTOMY AND LEFT CORNUECTOMY ON THE LAST ON (B)(6). THE INTERVENTIONAL PROCEDURE WENT WELL. THE TOTAL REMOVAL OF THE IMPLANTS COULD BE VERIFIED PEROPERATIVELY, WITH VERIFICATION OF THE ABSENCE OF RESIDUAL METAL IN ABDOMINAL X-RAY WITHOUT CONTRAST. SINCE THE INTERVENTIONAL PROCEDURE, THE PATIENT HAS HAD A REDUCTION IN HER GYNAECOLOGICAL SYMPTOMS. IT IS STILL A LITTLE EARLY TO ATTEST TO GENERAL SYMPTOMS. SHE IS COMPLETELY SATISFIED WITH THIS INTERVENTIONAL PROCEDURE AND DOES NOT REGRET THE WAY THINGS HAVE UNFOLDED. I WILL NOT SEE THE PATIENT AGAIN IN A SYSTEMATIC WAY, BUT ADVISE HER TO HAVE A CLASSIC GYNAECOLOGICAL FOLLOW-UP. THIS IS A PATIENT WHO COMPLAINS OF MIGRAINE WITH AURA ACCORDING TO INTERNATIONAL HEADACHE SOCIETY (IHS) CRITERIA. THE PATIENT WAS INFORMED OF THE INCREASED VASCULAR RISK IN WOMEN WITH MIGRAINE. OESTROGEN-PROGESTIN CONTRACEPTION IS CONTRAINDICATED. THE PATIENT IS ALSO BEING MONITORED FOR ADENOMYOSIS. THE ESSURE IMPLANTS HAVE BEEN REMOVED. THE FREQUENCY OF MIGRAINES HAS SIGNIFICANTLY DECREASED SINCE THE REMOVAL OF THE IMPLANTS AND MENOPAUSE. OTHER MEDICINES TRIED FOR RELIEF: OSTEOPATH, HOMEOPATH, HYPNOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 25.53 KG/SQM. [ECHOCARDIOGRAM] (DATE UNKNOWN): THE EXAMINATION REVEALED AN UNDILATED LEFT VENTRICLE WITH AN END-DIASTOLIC DIAMETER OF 50 MM, THE SEGMENTAL AND GLOBAL CONTRACTION WAS NORMAL, WITH AN EJECTION FRACTION OF 70%. THE LEFT ATRIUM HAS AN ANTEROPOSTERIOR DIAMETER OF 32 MM, ABSENCE OF THROMBUS. LARGE, SLIGHTLY THICKENED MITRAL VALVE AT 4.3 MM, COAPTATION IS CAUSING A CENTRAL GRADE 1 LEAK. PHYSIOLOGICAL TYPE MITRAL DOPPLER, NORMAL LEFT VENTRICLE (LV) FILLING PRESSURES. "EARLY DIASTOLIC TRANSMITRAL FLOW VELOCITY (E) TO EARLY DIASTOLIC MITRAL ANNULAR TISSUE VELOCITY (EA) = 6. NARROW AORTIC SIGMOID, VELOCITY 1 M/S AND MAXIMUM GRADIENT 4 MMHG. RIGHT CAVITIES NOT DILATED, RIGHT VENTRICULAR/RIGHT ATRIAL (RV/RA) GRADIENT 16 MMHG AND FINALLY DRY PERICARDIUM. OVERALL: VERY REASSURING ECHOCARDIOGRAM, NO EVIDENCE OF ISCHAEMIC HEART DISEASE. NORMAL EJECTION FRACTION. GRADE 1 MITRAL INSUFFICIENCY NOT REQUIRING ANY SPECIFIC MEASURE OTHER THAN ULTRASOUND MONITORING. CLINICALLY, THERE HAS BEEN NO RECURRENCE OF CHEST PAIN SINCE THE START OF TREATMENT WITH LAROXYL, WHICH IS GOOD NEWS. I SUGGEST CARRYING OUT SIMPLE CLINICAL MONITORING. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): USING A SPECULUM REVEALED THE PRESENCE OF A REGULAR CERVIX AND THE ABSENCE OF ATYPICAL DISCHARGE. DURING THE VAGINAL EXAMINATION THERE WAS NO PAIN UPON MOBILISATION OF THE UTERUS OR THE PELVIC MASSES. [HYSTEROSCOPY] (DATE UNKNOWN): ON PELVIC EXAMINATION, THE UTERUS IS ANTEVERTED AND OF NORMAL SIZE. PLACEMENT OF A SPECULUM AND TRACTION ON THE ANTERIOR LIP OF THE CERVIX USING A POZZI FORCEPS. INTRODUCTION, UNDER VISUAL CONTROL, OF THE HYSTEROSCOPE IN LIQUID PHASE (PHYSIOLOGICAL SERUM) ALLOWING VISUALISATION OF THE UTERINE CAVITY AND THE TWO TUBAL OSTIA. UTERINE CAVITY OF NORMAL SIZE AND MORPHOLOGY. THE IMPLANTS ARE NOT VISIBLE. THIN ATROPHIC ENDOMETRIUM, A SUBENDOMETRIAL CRYPT OF THE UTERINE FUNDUS. REMOVAL OF THE HYSTEROSCOPE UNDER VISUAL CONTROL, NORMAL CERVICO-ISTHMIC OUTLET. FLUID BALANCE IN EQUILIBRIUM. NO COMPLICATIONS. GENTLE CURETTAGE PERFORMED USING A BLUNT CURETTE. THE CURETTAGE PRODUCT IS SENT FOR ANATOMICAL PATHOLOGICAL ANALYSIS. [LAPAROSCOPY] (DATE UNKNOWN): OPEN SUBUMBILICAL LAPAROSCOPY. INSUFFLATION AND CREATION OF A PNEUMOPERITONEUM PLACEMENT OF THE OPTICS BELOW THE UMBILICAL CORD, THEN PLACEMENT UNDER VISUAL CONTROL OF TWO 5 MM TROCARS IN THE LEFT ILIAC FOSSA AND ABOVE THE PUBIS. EXAMINATION OF THE ABDOMINOPELVIC CAVITY, WHICH IS NORMAL, THE ANNEXES ARE NORMAL, WE FIND 2 ESSURES PRESENT IN THE TUBES THAT ARE CLEARLY VISIBLE AND PALPABLE. THERE IS A TYPE 7 FIBROMA OF 25 MM -3 CM IN DIAMETER ON THE RIGHT CORNUAL REGION. SECTION OF THE RIGHT TUBE OPPOSITE THE DEVICE AFTER LIGHT COAGULATION WITH BIPOLAR FORCEPS. EXTRACTION WITHOUT BREAKING THE ENTIRE DEVICE. ON THE LEFT, THE SAME PROCEDURE IS PERFORMED BUT FACED WITH MORE DIFFICULT TRACTION AND A FRACTURE OF THE DEVICE, A LEFT CORNUECTOMY IS PERFORMED. LEFT AND RIGHT SALPINGECTOMY BY COAGULATION/SECTION OF THE MESOSALPINX AND THE TUBO-OVARIAN LIGAMENT. PLACEMENT OF THE SPECIMENS IN A BAG FOR EXTRACTION. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2018: ANTEVERTED UTERUS, MEASURING 95 X 45 X 56 MM. THE ENDOMETRIUM IS THIN, MEASURING 4 MM IN THICKNESS. MILD THICKENING OF THE JUNCTIONAL ZONE (11 MM), > 50% OF THE TOTAL THICKNESS OF THE MYOMETRIUM, ASSOCIATED WITH RARE MICROCYSTIC PARACAVITARY IMAGES, CONFIRMING EARLY SUPERFICIAL ADENOMYOSIS. NO OTHER ABNORMALITY OF THE MYOMETRIUM, NORMAL UTERINE CONTOURS. THE TUBAL IMPLANTS ARE IN PLACE. THE OVARIES ARE PAUCIFOLLICULAR. ON THE RIGHT, TWO FLUID-FILLED IMAGES OF 11 AND 14 MM WITHOUT ABNORMALITY. ON THE LEFT, TWO FLUID-FILLED IMAGES OF 11 AND 9 MM WITHOUT ABNORMALITY. NO HAEMORRHAGIC FORMATION OR INJURY TO OVARIAN TISSUE. PELVIC FLUID-FILLED STRIP. NO ABNORMALITIES IN THE ANTERIOR OR POSTERIOR COMPARTMENTS. NO URINARY TRACT DILATATION. CONCLUSION: THIN ENDOMETRIUM EARLY-STAGE SUPERFICIAL ADENOMYOSIS. PAUCIFOLLICULAR OVARIES WITH NO ATYPICAL LESIONS TODAY. [PATHOLOGY TEST] ON (B)(6) 2023: THE TWO TUBES MEASURE 5 CM AND 5.5 CM IN LENGTH RESPECTIVELY. ABSENCE OF VISIBLE MACROSCOPIC LESION, ASSOCIATED WITH 3 FRAGMENTS OF 9 MM. ABSENCE OF ESSURE FOUND ON MACROSCOPIC EXAMINATION. SAMPLES ARE TAKEN FROM THE FALLOPIAN TUBES. MICROSCOPIC EXAMINATION REVEALED CLEARLY DIFFERENTIATED TUBAL MUCOSA, WITHOUT ABNORMALITY, CONSISTING OF A SINGLE LAYER OF CILIATED AND INTERCALATED CELLS. THE INNER LAYER OF THE CHORION DOES NOT SHOW ANY INFLAMMATORY ELEMENTS. NO ABNORMALITIES DETECTED ON THE REST OF THE WALL. CONCLUSION: ENDOMETRIAL CURETTAGE: SAMPLE WITH FEW MUCOID FRAGMENTS. ABSENCE OF ANALYSABLE MUCOSA. BILATERAL SALPINGECTOMY: TUBES WITH NORMAL HISTOLOGICAL APPEARANCE. ESSURES NOT FOUND IN MACROSCOPY. [ULTRASOUND PELVIS] ON (B)(6) 2021: TRANSCUTANEOUS EXAMINATION FOLLOWED BY ENDOCAVITARY EXAMINATION, PERFORMED WITH THE PATIENT'S CONSENT. ANTEVERTED, ANTEFLEXED, GLOBULAR-SHAPED UTERUS MEASURING 73 X 43 X 60 MM. THE ENDOMETRIUM IS THIN, MEASURING LESS THAN 3 MM IN THICKNESS. MULTIPLE MICROCYSTIC AND PARACAVITARY FLAME-LIKE IMAGES ASSOCIATED WITH SIGNIFICANT MYOMETRIAL HETEROGENEITY CONFIRMING DIFFUSE SUPERFICIAL AND DEEP ADENOMYOSIS. NO ENDOCAVITARY LESION. THE OVARIES ARE PAUCIFOLLICULAR WITH A DOMINANT LEFT OVARIAN FOLLICLE OF 11 MM. NO ADNEXAL MASS. NO INTRAPERITONEAL EFFUSION. CONCLUSION: THIN ENDOMETRIUM, ADENOMYOSIS. NO ADNEXAL MASS. [ULTRASOUND SCAN] (DATE UNKNOWN): ANTEVERTED UTERUS OF 75 MM IN LENGTH, THE ENDOMETRIUM WAS THIN, AT 3 MM, AND UTERINE ADENOMYOSIS WAS OBSERVED. THERE ARE NO ADNEXAL MASSES OR FREE FLUID. 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: 16-DEC-2024: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.
BAYER CASE NUMBER: (B)(4). 11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS [PELVIC PAIN FEMALE]. I WENT TO THE EMERGENCY DEPARTMENT BECAUSE I HAD HAEMORRHAGES. I WAS GIVEN TREATMENT TO REGULATE THE BLOOD FLOW BUT I HAD HAEMORRHAGES FOR 3 WEEKS [GENITAL BLEEDING]. THE FEMALE PATIENT INITIALLY HAD A CLINICAL PICTURE OF CHRONIC MIGRAINE AND IS NOW FORTUNATELY LEFT WITH EPISODIC MIGRAINE [MIGRAINE], MUSCULAR TENSION [MUSCLE TENSION], HEADACHE [HEADACHE], CONTRACTURES OF THE PARACERVICAL AND TRAPEZIUS MUSCLES TODAY [MUSCLE CONTRACTURE], CHEST PAIN [CHEST PAIN], MENOMETRORRHAGIA [MENOMETRORRHAGIA], HETEROGENEOUS NODULE ON THE RIGHT OVARY [UTERINE FIBROIDS], ADENOMYOSIS [ADENOMYOSIS], SIGMOIDITIS [SIGMOIDITIS], METRORRHAGIA [METRORRHAGIA], MASTODYNIA [MASTODYNIA], ASTHENIA [ASTHENIA], MUSCULOSKELETAL PAIN IN THE HIPS [PAIN IN HIP], BACK PAIN [BACK PAIN], NECK PAIN EXTENDING TO THE BACK OF THE HEAD [NECK PAIN (WITH RADIATION)], THERE IS INFREQUENT MENSES WITH CYCLES BETWEEN 5 AND 6 WEEKS RANDOMLY, WHICH ARE CURRENTLY OF NORMAL QUANTITY. [MENSES IRREGULAR], THERE HAVE BEEN EPISODES OF MENORRHAGIA [MENORRHAGIA], DYSMENORRHEA [DYSMENORRHEA], DYSPAREUNIA [DYSPAREUNIA], ABDOMINAL PAIN/RECURRENT LEFT ILIAC FOSSA PAIN [ILIAC FOSSA PAIN]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 03-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS") IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: 901336) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF SAPHENOUS VEIN THROMBOSIS AND MYOPIA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 27 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("I WENT TO THE EMERGENCY DEPARTMENT BECAUSE I HAD HAEMORRHAGES. I WAS GIVEN TREATMENT TO REGULATE THE BLOOD FLOW BUT I HAD HAEMORRHAGES FOR 3 WEEKS"), MIGRAINE ("THE FEMALE PATIENT INITIALLY HAD A CLINICAL PICTURE OF CHRONIC MIGRAINE AND IS NOW FORTUNATELY LEFT WITH EPISODIC MIGRAINE"), MUSCLE TIGHTNESS ("MUSCULAR TENSION"), HEADACHE ("HEADACHE"), MUSCLE CONTRACTURE ("CONTRACTURES OF THE PARACERVICAL AND TRAPEZIUS MUSCLES TODAY"), CHEST PAIN ("CHEST PAIN"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), ADENOMYOSIS ("ADENOMYOSIS"), COLITIS ("SIGMOIDITIS"), INTERMENSTRUAL BLEEDING ("METRORRHAGIA"), BREAST PAIN ("MASTODYNIA"), ASTHENIA ("ASTHENIA"), ARTHRALGIA ("MUSCULOSKELETAL PAIN IN THE HIPS"), BACK PAIN ("BACK PAIN"), NECK PAIN ("NECK PAIN EXTENDING TO THE BACK OF THE HEAD"), MENSTRUATION IRREGULAR ("THERE IS INFREQUENT MENSES WITH CYCLES BETWEEN 5 AND 6 WEEKS RANDOMLY, WHICH ARE CURRENTLY OF NORMAL QUANTITY.") AND DYSPAREUNIA ("DYSPAREUNIA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("HETEROGENEOUS NODULE ON THE RIGHT OVARY"). ON (B)(6) 2022, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING ("THERE HAVE BEEN EPISODES OF MENORRHAGIA") AND DYSMENORRHOEA ("DYSMENORRHEA"). ESSURE WAS REMOVED ON (B)(6) 2023. ON UNKNOWN DATE SHE EXPERIENCED ABDOMINAL PAIN LOWER ("ABDOMINAL PAIN/RECURRENT LEFT ILIAC FOSSA PAIN"). THE PATIENT WAS TREATED WITH TIGREAT (FROVATRIPTAN SUCCINATE MONOHYDRATE), NSAID N (NEPAFENAC), ISIMIG (FROVATRIPTAN SUCCINATE MONOHYDRATE), SPIFEN (IBUPROFEN), NOCERTONE (OXETORONE FUMARATE), TRIPTAN (ZOLMITRIPTAN) AND LAROXYL (AMITRIPTYLINE HYDROCHLORIDE) AS WELL AS SURGERY (DIAGNOSTIC HYSTEROSCOPY, BILATERAL TOTAL SALPINGECTOMY AND LEFT CORNUECTOMY). AT THE TIME OF THE REPORT, THE MIGRAINE WAS RESOLVING. THE OUTCOMES FOR PELVIC PAIN, GENITAL HAEMORRHAGE, MUSCLE TIGHTNESS, HEADACHE, MUSCLE CONTRACTURE, CHEST PAIN, MENOMETRORRHAGIA, UTERINE LEIOMYOMA, ADENOMYOSIS, COLITIS, INTERMENSTRUAL BLEEDING, BREAST PAIN, ASTHENIA, ARTHRALGIA, BACK PAIN, NECK PAIN, MENSTRUATION IRREGULAR, HEAVY MENSTRUAL BLEEDING, DYSMENORRHOEA, DYSPAREUNIA AND ABDOMINAL PAIN LOWER WERE UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ADENOMYOSIS, ARTHRALGIA, ASTHENIA, BACK PAIN, BREAST PAIN, CHEST PAIN, COLITIS, DYSMENORRHOEA, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, HEAVY MENSTRUAL BLEEDING, INTERMENSTRUAL BLEEDING, MENOMETRORRHAGIA, MENSTRUATION IRREGULAR, MIGRAINE, MUSCLE CONTRACTURE, MUSCLE TIGHTNESS, NECK PAIN, PELVIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY IN REMOVAL DATE: ON (B)(6) 2023. 11 YEARS OF PAIN MONITORED BY SPECIALISTS WITHOUT EVER MAKING THE LINK TO THE ESSURE IMPLANTS DUE TO THE LACK OF KNOWLEDGE OF THE DOCTORS WHO DIDN'T EVEN KNOW THIS DEVICE, I EXPLAINED TO THEM WHAT IT WAS. IT IS THANKS TO THE RESIST ASSOCIATION AND TO THE TESTIMONIES OF WOMEN ON THE INTERNET AS WELL AS THE (B)(6) HOSPITAL THAT CARRIED OUT A STUDY ON THE SYMPTOMS AND PAIN, INCLUDING DR WHO REMOVED MY IMPLANTS. BY FOLLOWING THE DEVELOPMENT OF DATA CORROBORATED BY WOMEN, STUDIES, HOSPITALS AND DOCTORS OVER THE YEARS I WAS ABLE TO CONFIRM THAT THIS CONFIGURATION OF PAIN I HAD BEEN EXPERIENCING FOR YEARS WAS PERHAPS LINKED BECAUSE THE PAIN STARTED JUST AFTER HAEMORRHAGES AND THE FOLLOWING YEAR I BEGAN NEUROLOGICAL MONITORING WHICH STOPPED AFTER THE REMOVAL OF THE MEDICAL DEVICE. NO MORE MEDICINAL PRODUCTS, NO MORE TREATMENTS, NO MORE ABNORMAL PAIN TO THIS DAY. THE INTERVENTIONAL PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2023 UNDER GENERAL ANAESTHESIA, CONSISTED OF A BILATERAL TOTAL SALPINGECTOMY WITH LEFT CORNUECTOMY BY LAPAROSCOPIC ROUTE AFTER A DIAGNOSTIC HYSTEROSCOPY. ABSENCE OF PEROPERATIVE COMPLICATIONS. THIS PATIENT UNDERWENT EXCISION OF THE ESSURE IMPLANTS BY RIGHT SALPINGECTOMY AND LEFT CORNUECTOMY ON THE LAST ON (B)(6). THE INTERVENTIONAL PROCEDURE WENT WELL. THE TOTAL REMOVAL OF THE IMPLANTS COULD BE VERIFIED PEROPERATIVELY, WITH VERIFICATION OF THE ABSENCE OF RESIDUAL METAL IN ABDOMINAL X-RAY WITHOUT CONTRAST. SINCE THE INTERVENTIONAL PROCEDURE, THE PATIENT HAS HAD A REDUCTION IN HER GYNAECOLOGICAL SYMPTOMS. IT IS STILL A LITTLE EARLY TO ATTEST TO GENERAL SYMPTOMS. SHE IS COMPLETELY SATISFIED WITH THIS INTERVENTIONAL PROCEDURE AND DOES NOT REGRET THE WAY THINGS HAVE UNFOLDED. I WILL NOT SEE THE PATIENT AGAIN IN A SYSTEMATIC WAY BUT ADVISE HER TO HAVE A CLASSIC GYNAECOLOGICAL FOLLOW-UP. THIS IS A PATIENT WHO COMPLAINS OF MIGRAINE WITH AURA ACCORDING TO INTERNATIONAL HEADACHE SOCIETY (IHS) CRITERIA. THE PATIENT WAS INFORMED OF THE INCREASED VASCULAR RISK IN WOMEN WITH MIGRAINE. OESTROGEN-PROGESTIN CONTRACEPTION IS CONTRAINDICATED. THE PATIENT IS ALSO BEING MONITORED FOR ADENOMYOSIS. THE ESSURE IMPLANTS HAVE BEEN REMOVED. THE FREQUENCY OF MIGRAINES HAS SIGNIFICANTLY DECREASED SINCE THE REMOVAL OF THE IMPLANTS AND MENOPAUSE. OTHER MEDICINES TRIED FOR RELIEF: OSTEOPATH, HOMEOPATH, HYPNOSIS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 25.53 KG/SQM. [ECHOCARDIOGRAM] (DATE UNKNOWN): THE EXAMINATION REVEALED AN UNDILATED LEFT VENTRICLE WITH AN END-DIASTOLIC DIAMETER OF 50 MM, THE SEGMENTAL AND GLOBAL CONTRACTION WAS NORMAL, WITH AN EJECTION FRACTION OF 70%. THE LEFT ATRIUM HAS AN ANTEROPOSTERIOR DIAMETER OF 32 MM, ABSENCE OF THROMBUS. LARGE, SLIGHTLY THICKENED MITRAL VALVE AT 4.3 MM, COAPTATION IS CAUSING A CENTRAL GRADE 1 LEAK. PHYSIOLOGICAL TYPE MITRAL DOPPLER, NORMAL LEFT VENTRICLE (LV) FILLING PRESSURES. "EARLY DIASTOLIC TRANSMITRAL FLOW VELOCITY (E) TO EARLY DIASTOLIC MITRAL ANNULAR TISSUE VELOCITY (EA) = 6. NARROW AORTIC SIGMOID, VELOCITY 1 M/S AND MAXIMUM GRADIENT 4 MMHG. RIGHT CAVITIES NOT DILATED, RIGHT VENTRICULAR/RIGHT ATRIAL (RV/RA) GRADIENT 16 MMHG AND FINALLY DRY PERICARDIUM. OVERALL: VERY REASSURING ECHOCARDIOGRAM, NO EVIDENCE OF ISCHAEMIC HEART DISEASE. NORMAL EJECTION FRACTION. GRADE 1 MITRAL INSUFFICIENCY NOT REQUIRING ANY SPECIFIC MEASURE OTHER THAN ULTRASOUND MONITORING. CLINICALLY, THERE HAS BEEN NO RECURRENCE OF CHEST PAIN SINCE THE START OF TREATMENT WITH LAROXYL, WHICH IS GOOD NEWS. I SUGGEST CARRYING OUT SIMPLE CLINICAL MONITORING. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): USING A SPECULUM REVEALED THE PRESENCE OF A REGULAR CERVIX AND THE ABSENCE OF ATYPICAL DISCHARGE. DURING THE VAGINAL EXAMINATION THERE WAS NO PAIN UPON MOBILISATION OF THE UTERUS OR THE PELVIC MASSES. [HYSTEROSCOPY] (DATE UNKNOWN): ON PELVIC EXAMINATION, THE UTERUS IS ANTEVERTED AND OF NORMAL SIZE. PLACEMENT OF A SPECULUM AND TRACTION ON THE ANTERIOR LIP OF THE CERVIX USING A POZZI FORCEPS. INTRODUCTION, UNDER VISUAL CONTROL, OF THE HYSTEROSCOPE IN LIQUID PHASE (PHYSIOLOGICAL SERUM) ALLOWING VISUALISATION OF THE UTERINE CAVITY AND THE TWO TUBAL OSTIA. UTERINE CAVITY OF NORMAL SIZE AND MORPHOLOGY. THE IMPLANTS ARE NOT VISIBLE. THIN ATROPHIC ENDOMETRIUM, A SUBENDOMETRIAL CRYPT OF THE UTERINE FUNDUS. REMOVAL OF THE HYSTEROSCOPE UNDER VISUAL CONTROL, NORMAL CERVICO-ISTHMIC OUTLET. FLUID BALANCE IN EQUILIBRIUM. NO COMPLICATIONS. GENTLE CURETTAGE PERFORMED USING A BLUNT CURETTE. THE CURETTAGE PRODUCT IS SENT FOR ANATOMICAL PATHOLOGICAL ANALYSIS. [LAPAROSCOPY] (DATE UNKNOWN): OPEN SUBUMBILICAL LAPAROSCOPY. INSUFFLATION AND CREATION OF A PNEUMOPERITONEUM PLACEMENT OF THE OPTICS BELOW THE UMBILICAL CORD, THEN PLACEMENT UNDER VISUAL CONTROL OF TWO 5 MM TROCARS IN THE LEFT ILIAC FOSSA AND ABOVE THE PUBIS. EXAMINATION OF THE ABDOMINOPELVIC CAVITY, WHICH IS NORMAL, THE ANNEXES ARE NORMAL, WE FIND 2 ESSURES PRESENT IN THE TUBES THAT ARE CLEARLY VISIBLE AND PALPABLE. THERE IS A TYPE 7 FIBROMA OF 25 MM -3 CM IN DIAMETER ON THE RIGHT CORNUAL REGION. SECTION OF THE RIGHT TUBE OPPOSITE THE DEVICE AFTER LIGHT COAGULATION WITH BIPOLAR FORCEPS. EXTRACTION WITHOUT BREAKING THE ENTIRE DEVICE. ON THE LEFT, THE SAME PROCEDURE IS PERFORMED BUT FACED WITH MORE DIFFICULT TRACTION AND A FRACTURE OF THE DEVICE, A LEFT CORNUECTOMY IS PERFORMED. LEFT AND RIGHT SALPINGECTOMY BY COAGULATION/SECTION OF THE MESOSALPINX AND THE TUBO-OVARIAN LIGAMENT. PLACEMENT OF THE SPECIMENS IN A BAG FOR EXTRACTION. [MAGNETIC RESONANCE IMAGING] ON (B)(6) 2018: ANTEVERTED UTERUS, MEASURING 95 X 45 X 56 MM. THE ENDOMETRIUM IS THIN, MEASURING 4 MM IN THICKNESS. MILD THICKENING OF THE JUNCTIONAL ZONE (11 MM), > 50% OF THE TOTAL THICKNESS OF THE MYOMETRIUM, ASSOCIATED WITH RARE MICROCYSTIC PARACAVITARY IMAGES, CONFIRMING EARLY SUPERFICIAL ADENOMYOSIS. NO OTHER ABNORMALITY OF THE MYOMETRIUM, NORMAL UTERINE CONTOURS. THE TUBAL IMPLANTS ARE IN PLACE. THE OVARIES ARE PAUCIFOLLICULAR. ON THE RIGHT, TWO FLUID-FILLED IMAGES OF 11 AND 14 MM WITHOUT ABNORMALITY. ON THE LEFT, TWO FLUID-FILLED IMAGES OF 11 AND 9 MM WITHOUT ABNORMALITY. NO HAEMORRHAGIC FORMATION OR INJURY TO OVARIAN TISSUE. PELVIC FLUID-FILLED STRIP. NO ABNORMALITIES IN THE ANTERIOR OR POSTERIOR COMPARTMENTS. NO URINARY TRACT DILATATION CONCLUSION: THIN ENDOMETRIUM EARLY-STAGE SUPERFICIAL ADENOMYOSIS. PAUCIFOLLICULAR OVARIES WITH NO ATYPICAL LESIONS TODAY. [PATHOLOGY TEST] ON (B)(6) 2023: THE TWO TUBES MEASURE 5 CM AND 5.5 CM IN LENGTH RESPECTIVELY. ABSENCE OF VISIBLE MACROSCOPIC LESION, ASSOCIATED WITH 3 FRAGMENTS OF 9 MM. ABSENCE OF ESSURE FOUND ON MACROSCOPIC EXAMINATION. SAMPLES ARE TAKEN FROM THE FALLOPIAN TUBES. MICROSCOPIC EXAMINATION REVEALED CLEARLY DIFFERENTIATED TUBAL MUCOSA, WITHOUT ABNORMALITY, CONSISTING OF A SINGLE LAYER OF CILIATED AND INTERCALATED CELLS. THE INNER LAYER OF THE CHORION DOES NOT SHOW ANY INFLAMMATORY ELEMENTS. NO ABNORMALITIES DETECTED ON THE REST OF THE WALL. CONCLUSION: ENDOMETRIAL CURETTAGE: SAMPLE WITH FEW MUCOID FRAGMENTS. ABSENCE OF ANALYSABLE MUCOSA. BILATERAL SALPINGECTOMY: TUBES WITH NORMAL HISTOLOGICAL APPEARANCE. ESSURES NOT FOUND IN MACROSCOPY. [ULTRASOUND PELVIS] ON (B)(6) 2021: TRANSCUTANEOUS EXAMINATION FOLLOWED BY ENDOCAVITARY EXAMINATION, PERFORMED WITH THE PATIENT'S CONSENT. ANTEVERTED, ANTEFLEXED, GLOBULAR-SHAPED UTERUS MEASURING 73 X 43 X 60 MM. THE ENDOMETRIUM IS THIN, MEASURING LESS THAN 3 MM IN THICKNESS. MULTIPLE MICROCYSTIC AND PARACAVITARY FLAME-LIKE IMAGES ASSOCIATED WITH SIGNIFICANT MYOMETRIAL HETEROGENEITY CONFIRMING DIFFUSE SUPERFICIAL AND DEEP ADENOMYOSIS. NO ENDOCAVITARY LESION. THE OVARIES ARE PAUCIFOLLICULAR WITH A DOMINANT LEFT OVARIAN FOLLICLE OF 11 MM. NO ADNEXAL MASS. NO INTRAPERITONEAL EFFUSION. CONCLUSION: THIN ENDOMETRIUM, ADENOMYOSIS. NO ADNEXAL MASS. [ULTRASOUND SCAN] (DATE UNKNOWN): ANTEVERTED UTERUS OF 75 MM IN LENGTH, THE ENDOMETRIUM WAS THIN, AT 3 MM, AND UTERINE ADENOMYOSIS WAS OBSERVED. THERE ARE NO ADNEXAL MASSES OR FREE FLUID. CASE COMMENTS: 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 |
|---|---|---|---|---|---|---|---|
| 2164382 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Required Intervention |